Search API

ACI-35.030 Alzheimer's Disease Vaccine

ACI-35.030 Alzheimer's Disease vaccine candidate is designed to elicit antibodies against phosphorylated pathological Tau protein. It is designed to reduce and facilitate the clearance of related Tau aggregates, slowing the progression of Tau-pathology and/or treating the underlying Tauopathy. The ACI-35.030 anti-pTau vaccine candidate is being developed in collaboration with Janssen Pharmaceuticals, Inc. (Janssen), part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

ACI-35.030 is a first-in-class vaccine candidate designed to generate a specific antibody response against pTau proteins in the brain. pTau is a key component of Alzheimer's disease. It can be measured in plasma to identify who is at risk of developing Alzheimer's disease up to 20 years before the onset of clinical symptoms. Anti-pTau antibodies generated by ACI-35.030 can potentially reduce the spread and seeding of Tau pathology, a major hallmark of AD.

On February 11, 2021, Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "These remarkable data show that ACI-35.030 can generate unprecedented antibody responses against pTau in an elderly population, with very high antigen-specific titers. Importantly, it generated a much stronger antibody response than a direct injection of exogenous antibodies." On November 30, 2022, AC Immune SA announced that based on the Phase 1b/2a interim data, ACI-35.030, a potential first-in-class anti-phosphorylated-Tau (pTau) vaccine candidate, has been selected for further development.

LAUSANNE, Switzerland-based AC Immune SA is a Nasdaq-listed clinical-stage biopharmaceutical company that aims to become a global leader in precision medicine for neurodegenerative diseases.

ACI-35.030 Indication

ACI-35.030 Alzheimer's Disease (AD) vaccine candidate is indicated to reduce the spread and seeding of Tau pathology, a major hallmark of AD. Immunization with anti-Tau vaccines has become an essential strategy for treating AD and other neurodegenerative diseases characterized by Tau pathology. ACI-35.030 is the first AD vaccine candidate designed to generate a specific antibody response against pathologic phospho-Tau (pTau) proteins in the brain. Anti-pTau antibodies generated by ACI-35.030 can potentially reduce the spread and seeding of Tau pathology throughout the brain, says the Company.

ACI-35.030 News 2020 - 2022

November 30, 2022 - The Company announced data presented at CTAD 2022 confirm the excellent clinical performance of the ACI-35.030 vaccine candidate. This new clinical data shows that ACI-35.030 has been selected for further development, representing significant progress for the anti-pTau vaccine candidate.

February 15, 2022 - AC Immune SA announced new interim 10-week data from the high-dose cohort of a placebo-controlled Phase 1b/2a trial evaluating ACI-35.030, a first-in-class phosphorylated-Tau (pTau) vaccine candidate in participants with early AD. Results indicate that the induced immune response selectively targets pTau, as shown by an increase in the anti-pTau/anti-Tau IgG ratio up to week 10. In this interim data set to week 10, median levels of antibodies reactive with pathological Tau (ePHF) were boosted with both the first and second vaccine injections. Safety data support ACI-35.030's favorable safety and tolerability profile, as no clinically relevant safety concerns have been observed.

August 31, 2021 - "The top-line results of the Lauriet Phase II clinical trial of semorinemab are remarkable in that it is the first time we have seen a therapeutic effect by a monoclonal anti-Tau antibody therapy," said Andrea Pfeifer, chief executive officer of AC Immune. "We also are excited that this is the first time a monoclonal antibody has had a therapeutic impact on cognition in the mild-to-moderate AD patient population."

February 11, 2021 - AC Immune's Alzheimer's Vaccine Generates Potent Anti-pTau Antibody Response in a Phase 1b/2a Study "These remarkable data show that ACI-35.030 is capable of generating unprecedented antibody responses against pTau in an elderly population, with very high antigen-specific titers. Importantly, it generated a much stronger antibody response than a direct injection of exogenous antibodies. As pathological pTau is present as a precursor many years before Tau accumulation in the brain is detectable via brain imaging, such results highlight the significant promise of ACI-35.030 as an early intervention for AD, especially when combined with cutting-edge pTau diagnostics that would enable the identification of people at risk of developing Tau-driven disease.

We look forward to continuing to advance ACI-35.030 in our collaboration with Janssen Pharmaceuticals, Inc., as we aim to bring this potentially breakthrough vaccine to patients," said Prof. Andrea Pfeifer, CEO of AC Immune SA.

January 25, 2021 - Barron's article: The Covid-19 Vaccine Offers a Road Map for Tackling Dementia. Here's How.

July 16, 2020 - AC Immune SA announced initiating the second-highest dosing group in the Company's Phase 1b/2a clinical trial evaluating ACI-35.030 to treat Alzheimer's disease (AD). The decision to advance to the higher dosing group follows encouraging interim safety, tolerability, and immunogenicity results from the initial dosing group.

May 4, 2020 - Dear Investor, 2020 continues to be an important and eventful year for AC Immune and the entire field of neurodegenerative diseases, even in the context of the challenges posed by the COVID-19 pandemic. With the publication of our Q1 2020 results, we have again confirmed our strong cash position of CHF 277.9 million. This provides the Company with a solid foundation and a cash runway extending through at least Q1 2024 without including any potential future milestone payments from partnerships. Moving forward, we remain on track to meet multiple value-creating milestones this year, with five clinical readouts expected. Of these readouts, we are particularly excited about the anticipated announcement of the first Phase 2 proof-of-concept data for semorinemab, an anti-Tau antibody, achieved through our partnership with Genentech, a member of the Roche group.

ACI-35.030 Alzheimer's Disease Vaccine Clinical Trials

ACI-35.030 clinical studies.

Clinical Trial NCT04445831: A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Tau Targeted Vaccines in 56 Participants With Early Alzheimer's Disease - Last update posted on June 4, 2021. On November 12, 2021, AC Immune presented interim results for this Phase 1b/2a trial. ACI-35.030 treatment led to the strong induction of antibodies specific for pathological forms of Tau, such as pTau and its aggregated form, enriched paired helical filaments (ePHF).

FluBlok® Vaccine Clinical Trials, Dosage, Indication, Side Effects

Sanofi Flublok® is a recombinant influenza vaccine produced without using eggs. It, therefore, is not subject to the mutations that are sometimes introduced into the vaccine during the process of egg adaptation that can cause the traditional vaccines to be ineffective. Flublok was initially licensed (STN: 125285) for use in the USA by the Food and Drug Administration (FDA) in 2013 and the European Medicines Agency (EMA, EMEA/H/C/005159). It has been used since 2016 and distributed to over 9 million people. The FDA considers the vaccine safe and acceptable for use. Unlike other flu vaccines, Flublok is highly purified and does not contain influenza virus, antibiotics, formaldehyde, preservatives, egg protein, latex, gluten, or gelatin. Flublok Quadrivalent is given to people 18 years of age and older.

On December 14, 2023, an Original Article published by the NEJM reported that the high-dose recombinant vaccine FluBlok conferred more protection against PCR-confirmed influenza than an egg-based standard-dose vaccine among adults between the ages of 50 and 64.

FluBlok quadrivalent is marketed in the E.U. as Supemtek. The European Commission authorized it on November 18, 2020. Visit SanofiFluShots.com to learn about potential flu complications, including heart attack, stroke, and pneumonia, and more about Sanofi's Flublok Quadrivalent (Influenza Vaccine). 

Sanofi is located at 14 Espace Henry Vallée, 69007 Lyon, France.

FluBlok Vaccine Price

Sanofi provides a guide for coding and reimbursement for vaccines. According to CMS.gov, the payment allowance for FluBlok in 2022-2023 is $69.94.

FluBlok Vaccine Indication

Flublok vaccine is given to people 18 years and older. Flublok should not be given to anyone with a severe allergic reaction (anaphylaxis) to any vaccine component (including eggs or egg products for Fluzone High-Dose Quadrivalent).

On October 16, 2024, the U.S. FDA updated the label for FLUBLOK to include data from a new safety study involving pregnant women 18 years and older. In this study, FLUBLOK demonstrated no increased risk of pregnancy, birth, or neonatal/infant outcomes compared to a standard-dose flu vaccine and estimated pregnancy outcomes for the general population. Recombinant or inactivated flu vaccines are recommended by the U.S. CDC, Advisory Committee on Immunization Practices, and American College of Obstetricians and Gynecologists for individuals who are or will become pregnant during flu season.

FluBlok and COVID-19 Vaccines

The US Centers for Disease Control and Prevention (CDC) issued interim clinical considerations stating that 'COVID-19 vaccines and other vaccines, including influenza vaccines, can be administered without regard to timing.

FluBlok Vaccine Dosage

Administer Flublok Quadrivalent as a single 0.5 mL dose intramuscular injection only.

FluBlok Vaccine News

October 16, 2024 - Thomas Grenier, Head of Vaccines, North America, Sanofi, stated, "Today, we're proud to announce an important update to our label for FLUBLOK, from one of Sanofi's largest flu vaccine safety studies ever done in pregnant women, an important at-risk population group for influenza."

September 13, 2023 - "The flu can be a serious public health threat, leading to complications such as heart attack, stroke, and pneumonia. These can be especially dangerous for older adults, ethnic and racial minority groups who are at an increased risk for being hospitalized from the flu, and those living with chronic conditions, like asthma, diabetes, and heart disease," commented Michael Greenberg, MD, MPH, North America Medical Head of Vaccines at Sanofi.

August 26, 2022 - Sanofi's Flublok® Quadrivalent Vaccine was among the flu vaccines preferentially recommended by the U.S. CDC's ACIP for adults 65+.

October 22, 2020 - Flublok has been given authorization for temporary supply by the U.K. Department of Health and Social Care and the Medicines and Healthcare products Regulatory Agency (MHRA) for immunization against flu in this year's seasonal flu program to meet public health needs. Their assessment was partly based on evidence from another closely related Sanofi flu vaccine, Supemtek. This was recommended for approval by the European Medicines Agency in September 2020. The MHRA assessment showed that the two products are fundamentally similar based on a review of the manufacturing, control, quality, non-clinical, and clinical evaluations.

FluBlok Vaccine Clinical Trials

As of October 2024, the Flublok vaccine has been studied in various clinical trials.

The results from the study of more than 48,000 pregnant individuals across multiple flu seasons were recently published in the American Journal of Obstetricians and Gynecologists (AJOG) Global Reports. They demonstrate that FLUBLOK safety is consistent with a standard-dose flu vaccine and pregnancy-related outcomes in the general population.

A phase 3 efficacy trial demonstrated improved protection against influenza compared to a standard-dose influenza vaccine and reduced the risk of flu by an additional 30% in adults aged 50 years and older.

Zyesami (Aviptadil) Therapeutic Description 2022

Zyesami® (Aviptadil, RLF-100) is a formulation of synthetic human Vasoactive Intestinal Peptide (VIP), which was first discovered in 1970. VIP is known to target the VPAC1 receptor of the alveolar type II (ATII) cell and protect that cell against all manner of injuries, including smoke inhalation, exposure to stomach acid, and exposure to infectious agents. In addition, VIP prevents apoptosis, blocks cytokines, lowers TNFα levels, reverses CD4/CD8 ratio, and reduces cough and dyspnea in nonclinical and clinical studies.

Although first identified in the intestinal tract, VIP is produced throughout the body, primarily concentrated in the lungs. In addition, VIP has been shown in more than hundreds of peer-reviewed studies to have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation says the Company.

Because of its lack of toxicity and low cost of manufacture compared to proprietary biologics, VIP may be uniquely attractive to those focused on global countermeasures against COVID-19, says the Company.

NRx Pharmaceuticals was the first to formulate aviptadil for human intravenous and inhaled use under the "Good Manufacturing Practices" standards in 2020. Zyesami (Aviptadil) (RLF-100) COVID-19 therapeutic has received orphan drug designation from the U.S. Food and Drug Administration (FDA) in acute respiratory distress syndrome, chronic lung diseases, and the treatment of sarcoidosis. In June 2020, the FDA awarded Fast Track Designation to NRx for the use of aviptadil for the treatment of Acute Lung Injury/Acute Respiratory Distress Syndrome associated with COVID-19. 

Additionally, the U.S. FDA has approved an expanded access protocol for RLF-100 in patients with Critical COVID-19 and Respiratory Failure. Those respiratory conditions include Acute Respiratory Distress Syndrome, Chronic Obstructive Pulmonary Disease, acute smoke inhalation, sarcoidosis, and checkpoint inhibitor pneumonitis. On Jan. 18, 2022, the Company expanded its Right to Try programs. On Jan. 18, 2022, NRx expanded programs enabling patients with respiratory failure from COVID-19, who have tried all approved medicines, including remdesivir, and who cannot participate in a clinical study, to receive ZYESAMI upon a physician's prescription. NRx Pharmaceuticals announced on Jan. 26, 2022, a first safety report from the hospital indicated that of the first 19 patients treated by Dec. 31, 2021, three had died and 16 (84%) were reported to be alive by Jan. 22, 2021. This data regarding patients treated under the U.S. FDA's Right to Try law does not involve a control group and are not part of a research study designed to test efficacy. 

The Company confirmed on Dec. 29, 2021; it filed a Breakthrough Therapy Designation request after the FDA requested clinical data on ZYESAMI® vs. Remdesivir in high-risk patients. Patients treated with ZYESAMI vs. placebo demonstrated a statistically significant (P=.03) 2.8-fold increased odds of being alive and free of respiratory failure at day 28 and day 60; A highly significant (P=.006) four-fold increased odds of survival is seen in these patients; Patients at the highest risk - those on ventilators at time of randomization - demonstrated a 10-fold increased odds of survival (P=.03).

Aviptadil [USAN:INN:BAN]; RN: 40077-57-4; UNII: A67JUW790C; InChIKey: VBUWHHLIZKOSMS-RIWXPGAOSA-N; ChemSpider ID: 17288959; ChEMBL Id: 2106041

Switzerland-based RELIEF THERAPEUTICS Holding AG, a biopharmaceutical company, developed the compound RLF-100™ (aviptadil). On March 22, 2022, it received the certificate of registration (Reg. No. 6,674,978) for a trademark for RLF-100(R), from the United States Patent and Trademark Office.

Radnor, PA-based NeuroRx, Inc. (Nasdaq: NRXP) is developing innovative therapies for high-mortality unmet needs. NeuroRx has signed an agreement to complete a business combination with Big Rock Partners Acquisition Corporation.

Zyesami Indication

Zyesami (Aviptadil) COVID-19 Therapeutic is used to treat infections known to cause Respiratory Failure, which is the hallmark of Acute COVID-19, as defined by the new NIH/FDA classification. Approximately 50% of those who develop Critical COVID-19 die, despite intensive care and mechanical ventilation.

Patients with Critical COVID-19 and respiratory failure, currently treated with high flow nasal oxygen, noninvasive ventilation, or mechanical ventilation, will be treated with RLF-100 (Aviptadil). The ability to deliver VIP directly to the lung via inhalation could have important therapeutic implications and potentially broaden the application to patients less severely affected with COVID-19, says the Company.

Separately, the National Institutes of Health conducts a confirmatory trial that randomizes patients with COVID-19 respiratory failure to ZYESAMI vs. Veklury® (remdesivir) and placebo in a factorial design trial (NCT04843761). In addition, a second nationwide trial to determine if similar benefits may be achieved in critically ill patients with inhaled ZYESAMI™ is being conducted on the I-SPY platform, maintained by the Quantum Leap Healthcare Collaborative.

Zyesami Dosage

Phase 2b/3 study Intervention: 3 successive 12-hour intravenous infusions of Aviptadil at 50/100/150 pmol/kg/hr.

Zyesami Side Effects

No unexpected side effects were identified as of February 9, 2021. The most common side effects of ZYESAMI in the clinical trial were mild to moderate diarrhea (seen in 30% of ZYESAMI-treated vs. 1.5% of placebo-treated patients) and systemic hypotension (low blood pressure) seen in 31 ZYESAMI-treated patients vs. 25 placebo patients. In addition, after a Review of 232 Enrolled Patients in ACTIV-3b Critical Care Study, No New Safety Concerns Raised by Independent Data Safety Monitoring Board as of September 29, 2021.

On October 14, 2021, a peer-reviewed study found no unexpected drug-related Serious Adverse Events (SAEs) were recorded. Hypotension was seen in two patients that were successfully managed, and treatment with aviptadil was continued. Diarrhea was observed in 4 aviptadil-treated patients compared to three control patients (19% vs. 10%; p=0.2). These adverse events are congruent with those seen in the Phase 2b/3 randomized clinical trial of aviptadil in Critical COVID-19 patients.

VAERS is a passive reporting system, meaning it relies on individuals to send in reports of their experiences. Anyone can submit a report to VAERS, including parents and patients. Furthermore, healthcare providers are required by law to report to VAERS.

Zyesami Production

NRx confirmed on August 16, 2021, the development of the first shelf-stable formulation of ZYESAMI, which was announced in early Q3'21, along with engagement in scaling up aviptadil drug substance from 100,000 doses per manufacturing batch to a projected three million doses per batch, combined with a 90% reduction in cost per gram of aviptadil drug substance.

On November 11, 2021, the Company confirmed the FDA responded to NRx's October 8, 2021, submission of updated manufacturing information for ZYESAMI® (aviptadil). The completion of this review, without the imposition of any clinical hold by the FDA, enables NRx to distribute ZYESAMI, produced at a commercial scale, under Good Manufacturing Practices for clinical trials and other future purposes approved in future regulatory actions. NRx looks forward to working with the FDA to complete the chemistry, manufacturing, and controls review that will ultimately be required for any potential drug approval.

Zyesami Availability

NRx confirmed on January 18, 2022, that it will continue to provide ZYESAMI to hospitals enrolled in NRx's Expanded Access Protocol under U.S. FDA guidelines. And NRx is also making ZYESAMI available as an investigational medicine under the Federal Right to Try Act. NRx finalized and announced its logistics and drug distribution contract with Cardinal Health, Inc., and a drug launch and commercialization support agreement with IQVIA, Inc. Cardinal Health Specialty Pharmaceutical Distribution will serve as the exclusive distributor for ZYESAMI. Cardinal Health services more than 90% of hospitals in the USA.

Nasal Spray Sentinox

The Company reported positive interim results from its clinical trial of nasal spray Sentinox in SARS-CoV-2 infected patients, confirming its safety and tolerability. Relief also reported that data from the study suggest that Sentinox could effectively reduce the SARS-CoV-2 viral load at the level of the nasal mucosa.

NRx Pharmaceuticals Financial News (Nasdaq: NRXP)

April 5, 2022 - RELIEF THERAPEUTICS Holding SA reported that it has entered into a stipulation to stay the proceedings in its pending litigation with NeuroRx, Inc. and Jonathan Javitt to allow the parties to attempt to seek to mediate their dispute. 

March 31, 2022 - Net loss for the year ended December 31, 2021, was $93.1 million, or $1.98 per share, compared with a net loss of $51.8 million, or $1.51 per share for the year ended December 31, 2020.

March 8, 2022 - The Company announced that Jonathan Javitt, MD, MPH, has retired as CEO immediately. The Board of Directors appointed Robert Besthof as Interim CEO.

February 2, 2022 - NRx announced that it closed its previously announced private placement. - NRx Pharmaceuticals announced that it has entered into definitive agreements with investors to purchase 7,824,727 shares of common stock in a private placement priced at a premium to market under Nasdaq rules. The purchase price for one share of common stock and one investment option to purchase one share of common stock is $3.195. The investment options have an exercise price of $3.07 per share.

December 15, 2021 - NRx Pharmaceuticals announced that Nasdaq added the Company to the Nasdaq Biotechnology Index effective December 20, 2021.

November 16, 2021 - NRx Pharmaceuticals provided financial results for the quarter ended September 30, 2021. NRx completed a $30 million private placement in August by selling 2,727,273 shares of common stock and Preferred Investment Options. Net loss for the three months ended September 30, 2021, was $20.8 million, or $0.40 per share, compared with a net loss of $5.2 million, or $0.15 per share, for the three months ended September 30, 2020.

Zyesami (Aviptadil) Therapeutic News For 2021 - 2022

July 1, 2022 - NRx Pharmaceuticals announced the U.S. FDA declined to issue emergency use authorization for Zyesami for a sub-group of patients with critical Covid-19.

June 10, 2022 - NRx Pharmaceuticals, Inc. announced that the U.S. FDA denied the Breakthrough Therapy designation request for ZYESAMI®.

April 22, 2022 - RELIEF THERAPEUTICS Holding SA reported that NRx Pharmaceuticals, Inc. announced that it filed a new Breakthrough Therapy Designation request with the U.S. FDA. The request was based on a post-hoc analysis focused on a subgroup of patients with Critical COVID-19 that, in addition to aviptadil or placebo, were also treated with remdesivir and whose respiratory failure due to Critical COVID-19 continued to progress. NRx also reported that the request includes cumulative safety data on approximately 750 patients treated with intravenous aviptadil for Critical COVID-19.

April 1, 2022 - RELIEF THERAPEUTICS Holding SA reported today that the Swiss Patent Office IPI had issued a patent WO2020/225246 entitled, "Vasoactive Intestinal Peptide (VIP) for the Use in the Treatment of Drug-induced Pneumonitis," to Relief's subsidiary, AdVita Lifescience GmbH. The patent will provide intellectual property protection for RLF-100(R) (aviptadil) 's inhaled formulation into 2039.

March 31, 2022 - The Company confirmed it is now geographically focused primarily in the U.S. on Phase III clinical trial for which it has Fast Track and Breakthrough Therapy designation, respectively: intravenous ZYESAMI® for Critical COVID-19.

March 31, 2022 - Quantum Leap Healthcare Collaborative announced in collaboration with NRx Pharmaceuticals, Inc., that the nebulized form of ZYESAMI in the I-SPY COVID Trial of Critical COVID-19 patients had been stopped. 

February 15, 2022 - The Company announced the results of a review conducted by the Therapeutics and Prevention Data Safety and Monitoring Board reviewed data on 448 ICU patients with Critical COVID-19 Respiratory Failure who were enrolled in the ACTIV-3b (TESICO) trial. The TESICO protocol was cleared by the U.S. FDA as a Phase 3 trial that, if positive, may be used in the submission of a New Drug Application for ZYESAMI.

January 26, 2022 - NRx Pharmaceuticals announced it received a first safety report where physicians administered ZYESAMI® (Aviptadil) to patients with COVID-19 respiratory failure. The safety update report received from the hospital indicated that of the first 19 patients treated by Dec. 31, 2021, three had died and 16 (84%) were reported to be alive by Jan. 22, 2021. At the time of the report, 14 of these 16 patients had been discharged to a rehabilitation center or home and two remained in the hospital. 

January 18, 2022 - NRx Pharmaceuticals announced enhancements to its Expanded Access and Right to Try programs which enable patients with respiratory failure from COVID-19, who have tried all approved medicines, including remdesivir, and who are not able to participate in a clinical study, to receive ZYESAMI® (aviptadil) upon a physician's prescription. The U.S. NIH is currently studying ZYESAMI as part of its ACTIV-3b (TESICO) trial, which has enrolled approximately two-thirds of patients and has not identified unexpected safety concerns.

January 3, 2022 - NRx announced filing a provisional composition of matter patent application with the US Patent and Trademark Office entitled "Stable, Buffer-free Compositions of Vasoactive Intestinal Peptide (VIP)." The current invention relies on specific approaches to controlling the chemical environment of VIP, an extremely delicate peptide, in order to maintain its stability without the use of such additives. 

December 29, 2021 - NRx Pharmaceuticals announced that it has filed a new Breakthrough Therapy Designation request with the U.S. FDA focused on patients with Critical COVID-19 and respiratory failure who are at immediate risk of death despite treatment with remdesivir and other approved therapies.

December 14, 2021 - NRx Pharmaceuticals provided a new safety update on ZYESAMI's third scheduled analysis. The study's Independent Data Safety Monitoring Board found no new safety concerns after reviewing a total of 348 patients and recommended continued enrollment in the study the ACTIV-3b Critical Care. This Phase 3 study is sponsored by the US National Institutes of Health and anticipates rerolling participants in Brazil during 2022.

December 9, 2021 - The Company announced Hungarian health officials have agreed on a regulatory path for Emergency Use of ZYESAMI® in the Central European region, which will start with a compassionate care program expected to begin by the end of 2021. Confirmatory demonstration of clinical effect under this program will be submitted with safety and efficacy data in support of Emergency Use Authorization in Hungary.

November 29, 2021 - NRx Pharmaceuticals announced that it has completed an analysis to identify clinical evidence from a phase 2/3 study that indicates a substantial improvement after treatment with ZYESAMI® (aviptadil) in patients with Critical COVID-19 and Respiratory Failure over existing therapies such as remdesivir. NRx to submit new analysis and safety data to the FDA in support of Emergency Use Authorization and Breakthrough Therapy Designation Requests.

November 22, 2021 - The US Food and Drug Administration denied NRx Pharmaceuticals' request for Breakthrough Therapy Designation (BTD) for ZYESAMI® (aviptadil). BTD is not required for drug approval or emergency use authorization. The FDA already granted the first two benefits (priority and rolling review) as part of the Fast Track Designation awarded in July 2020. This denial, therefore, does not impede NRx's ability to seek drug approval. In denying BTD, the FDA noted that NRx did not distinguish the effects of ZYESAMI from the reported effects of remdesivir in critically-ill patients. In order to award BTD, the sponsor must present evidence that the candidate Breakthrough Therapy meets an unmet medical need for a serious medical condition.

November 16, 2021 - The Company confirmed during the 3rd quarter of 2021, NRx developed and validated a patentable formulation, manufacturing method, and container closure system that enables NRx to produce ZYESAMI (aviptadil) at a commercial scale in lot sizes of up to 100,000 doses with shelf stability of 150 days or more. And NRx is preparing a New Drug Application for ZYESAMI to be submitted under the Accelerated Approval pathway with the U.S. FDA. And the NIH has introduced ZYESAMI to E.U. and U.K. regulators via the ACTIV-3b trial.

November 11, 2021 - NRx Pharmaceuticals announced receipt of the U.S. FDA Food review that enables high volume production of ZYESAMI® (aviptadil) and shelf life extension from 62 Days to 150 Days. ZYESAMI was previously manufactured for clinical trials purposes in handmade, 300 dose batches, with a limited shelf life of 62 days. 

November 8, 2021 - The Company's CEO published an update: ZYESAMI® (aviptadil) Next Steps: 'I recently received the letter below from a shareholder. The correspondence from them (taken exactly from their email) and my response regarding our next steps for ZYESAMI ® (aviptadil) can be found here.'

November 4, 2021 - NRx Pharmaceuticals announced that the U.S. FDA had declined to issue a EUA for ZYESAMI® (aviptadil). The FDA stated that it was unable to issue the EUA at this time due to insufficient data regarding the known and potential benefits of the medicine and the known and potential risks of ZYESAMI in patients suffering from Critical COVID-19 with respiratory failure. Last week, the study's Data Safety and Monitoring Board reviewed the ongoing NIH ACTIV-3b trial and found no new safety issues.

November 2, 2021 - NRx Pharmaceuticals provided a new safety update on ZYESAMI® (aviptadil). In its third scheduled analysis, the study's Independent Data Safety Monitoring Board found no new safety concerns after reviewing a total of more than 300 patients and recommended continued enrollment.

October 14, 2021 - NRx Pharmaceuticals announced the publication in the Journal of Infectious Diseases and Treatment peer-reviewed study results from a prospective, open-label, administratively controlled trial of aviptadil for the treatment of respiratory failure in patients with Critical COVID-19. The study reported 60-day survival in 81% of those treated with aviptadil, compared to 21% survival among those who received standard of care treatment at the Houston Methodist Hospital. A similar 9-fold advantage was seen in the cumulative probability of recovery from respiratory failure. Meaning - Intravenous Aviptadil demonstrated a dramatic level of efficacy that is consistent with FDA guidance for administratively controlled clinical trials and may be warranted for use in highly comorbid patients with Critical COVID-19 and respiratory failure.

October 12, 2021 - NRx Pharmaceuticals announced that a revised Investigational New Drug module on the manufacturing of ZYESAMI™ (aviptadil) was submitted to the U.S. Food and Drug Administration, containing documentation that confirmed Nephron Pharmaceuticals, Inc. is prepared to supply ZYESAMI on a commercial scale. This module will now be used as part of the FDA's rolling review process supporting the New Drug Application for ZYESAMI. NRx has also received notification that a European QP (Qualified Person) Auditor has completed an inspection at a separate manufacturing facility with no adverse findings. NRx awaits a Q.P. Declaration that is required by the E.U. regulatory authorities for the release of ZYESAMI. 

September 30, 2021 - RELIEF THERAPEUTICS Holding S.A. (SIX: RLF)(OTCQB: RLFTF) reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc., issued a press release providing a safety update on ZYESAMI (RLF-100 / aviptadil).

September 29, 2021 - NRx Pharmaceuticals announced a safety update on ZYESAMI™ (aviptadil) which is being tested in the ACTIV-3b Critical Care Phase 3 study sponsored by the National Institutes of Health. In its second scheduled analysis, the study's Independent Data Safety Monitoring Board found no new safety concerns, after reviewing a total of 231 patients, and recommended continued enrollment. "With this second independent safety analysis in the ACTIV-3b trial, the safety database on ZYESAMI has grown to more than 500 patients across our various clinical trials and expanded access programs. So far, there have been no reports of unexpected, drug-related serious adverse events," said Prof. Jonathan Javitt, MD, MPH, Chairman and CEO of NRx

September 27, 2021 - NRx Pharmaceuticals announced top-line data demonstrating improved outcomes at one year in highly comorbid patients with COVID-19 who were treated with ZYESAMI™. Between June and September 2020, a trial was conducted at a leading tertiary care hospital involving patients with Critical COVID-19 whose level of comorbidity excluded them from the randomized phase 2b/3 clinical trial of ZYESAMI. A statistically significant difference in both survival and recovery from respiratory failure was reported at 28 days.

September 10, 2021 - NRX Pharmaceuticals, Inc. Form S-1 (Form 8-K) relevant excerpts.

August 30, 2021 - NRx Pharmaceuticals (Nasdaq: NRXP) announced an additional finding in its phase 2b/3 clinical trial investigating ZYESAMI™ (aviptadil) for the treatment of patients with Acute Respiratory Failure due to Critical COVID-19. NRx's new analysis shows that patients treated with ZYESAMI demonstrated improved blood oxygen, indicating improved lung function, within a day of treatment. The average difference in Respiratory Distress Ratio between those treated with aviptadil and placebo was clinically meaningful and statistically significant. This latest analysis also supports NRx's application for Breakthrough Therapy Designation to the U.S. FDA for ZYESAMI.

August 24, 2021 - NRx Pharmaceuticals (Nasdaq: NRXP) announced the gross proceeds from the private placement were $30 million before deducting placement agent fees and other offering expenses.

August 19, 2021 - NRx Pharmaceuticals announced that it has entered into definitive agreements with investors to purchase common and preferred stock shares in a private placement. The gross proceeds from the private placement are expected to be approximately $30 million before deducting placement agent fees and other offering expenses. The private placement is expected to close on or about August 23, 2021, subject to the satisfaction of customary closing conditions. "The proceeds of this investment will be targeted towards accelerating the forward path of our CNS/psychiatry franchise and COVID vaccine franchises, together with supporting the transition of ZYESAMI from clinical to the commercial stage as regulatory approval is obtained from national regulators," said Jonathan C. Javitt, M.D., MPH, CEO, and Chairman of NRx Pharmaceuticals.

August 18, 2021 - NRx Pharmaceuticals provided a safety update on ZYESAMI™ (aviptadil) being tested in the ACTIV-3 Critical Care Phase 3 study sponsored by the National Institutes of Health. The study's Data Safety Monitoring Board found no new safety concerns in the trial and recommended continued enrollment. ACTIV-3 is a randomized, blinded, placebo-controlled clinical trial testing ZYESAMI™ and the antiviral remdesivir (Veklury) in hospitalized patients with acute respiratory failure due to COVID-19 who require high-flow supplemental oxygen, delivered by nasal cannula, mechanical ventilation, or extracorporeal membrane oxygenation. 

August 16, 2021 - NRx Pharmaceuticals (Nasdaq: NRXP) provided a business update and financial results for the quarter ended June 30, 2021. Primary clinical activities during the quarter centered around the analysis and regulatory filing of data from the phase 2b/3 trial of intravenous ZYESAMI™ for COVID-19 Respiratory Failure, support of the NIH-sponsored ACTIV3b Critical Care study of ZYESAMI compared to Veklury (remdesivir) alone and in combination, support of the BARDA-sponsored I-SPY trial of inhaled ZYESAMI, and the NRx-sponsored trial of inhaled ZYESAMI.

August 4, 2021 - NRx Pharmaceuticals announced it had signed an agreement with MannKind Corporation to develop a dry powder formulation of ZYESAMI™ (aviptadil), a synthetic form of human Vasoactive Intestinal Peptide (VIP), produced by the body to help protect cells against inflammatory conditions. The development will be based on MannKind's proven Technosphere® platform, which is the basis of the U.S. Food and Drug Administration-Approved Afrezza® inhaled insulin product. MannKind Corporation (Nasdaq: MNKD) focuses on developing and commercializing inhaled therapeutic products for patients with endocrine and orphan lung diseases. 

July 27, 2021 - NRx Pharmaceuticals announced that the Nation of Georgia's Prime Minister and Minister of Health had issued an Emergency Use Authorization for intravenous ZYESAMI™ (aviptadil) to treat Critical COVID-19.

July 22, 2021 - NRx Pharmaceuticals Inc. said it had validated the first commercial formulation of Zyesami aviptadil for intravenous use, allowing for high volume manufacture, with an anticipated one year or greater stability, under appropriate storage conditions. The Company said it had achieved a 30-to-50-fold increase in its manufactured lot size of aviptadil, with a concurrent 90% reduction in the cost of its peptide supply.

July 19, 2021 - NRx Pharmaceuticals presented data at the Disease Control and Prevention Summit on July 21, 2021, via the following link. The presentation identifies a statistically significant effect of ZYESAMI™ (aviptadil) in preventing the sharp rise in cytokines, commonly associated with mortality in patients with COVID-19. In the recently completed phase 2b/3 trial, patients treated with placebo experienced a statistically significant elevation in interleukin 6 (IL-6) cytokine levels, whereas those treated with ZYESAMI™ had a minimal increase in IL-6. Change in cytokine level was a prespecified endpoint of the study.

June 2, 2021 – RELIEF THERAPEUTICS Holding AG, a biopharmaceutical company with its lead compound RLF-100™ (aviptadil), reported today that its collaboration partner, NRx Pharmaceuticals, Inc. has announced that it has submitted an application to the U.S. Food and Drug Administration seeking Emergency Use Authorization (EUA) for the use of aviptadil in the treatment of critical COVID-19 in patients with respiratory failure.

June 1, 2021 - NRx Pharmaceuticals announced it had filed an application with U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for ZYESAMI™ (Aviptadil-acetate) to treat Critically Ill COVID-19 patients suffering from respiratory failure. Consistent with previously announced top-line data, the study identified a statistically significant increase in the likelihood that patients treated with ZYESAMI™ would be alive and free of respiratory failure at 60 days, compared to those treated with placebo, and identified a significantly shorter median hospital stay. The clinical study report filed with FDA further documents statistically significant advantages for ZYESAMI™ on all major secondary endpoints.

April 26, 2021 - Dosing of the first patient in phase 3 clinical trial of ZYESAMI (aviptadil acetate) was announced by the National Institutes of Health (NIH). Dr. Anthony Fauci elaborated on the need for new COVID-19 therapeutics and discussed this trial in a White House press briefing on April 23, 2021. 

April 6, 2021 - NeuroRx, Inc. reported that aviptadil, supplied by NeuroRx, was identified by the National Institutes of Health for inclusion in phase III clinical trial in the USA and multiple foreign countries.

March 29, 2021 - NeuroRx, Inc. reported 60-day results of the Phase 2b/3 trial of intravenously administered ZYESAMI™ (aviptadil acetate) to treat respiratory failure in critically ill patients with COVID-19, which is being developed in collaboration with Relief Therapeutics Holding AG (RLFTF). Across all patients and sites, ZYESAMI™ met the primary endpoint for a successful recovery from respiratory failure at days 28 (P = .014) and 60 (P = .013) and also demonstrated a meaningful benefit in survival (P = < .001) after controlling for ventilation status and treatment site.

March 9, 2021 - NeuroRx, Inc. and TFF Pharmaceuticals, Inc. announced that the companies have entered into a feasibility and material transfer agreement (Feasibility Agreement). Under the Feasibility Agreement, NeuroRx is delivering ZYESAMI™ (aviptadil, synthetic VIP) materials to TFF to perform feasibility formulation work and testing. This feasibility work aims to formulate and identify an optimal, long-term stable formulation of ZYESAMI™ into a dry powder form with superior aerosol properties for delivery directly to the lungs. "The work being done by the NeuroRx team with ZYESAMI on behalf of critically ill patients with COVID-19 respiratory failure is both remarkable and gratifying," said Glenn Mattes, President & CEO of TFF Pharmaceuticals. "The potential opportunity to bring this important new therapy for patients earlier in the treatment cycle is exciting."

February 23, 2021 - NeuroRx, Inc. announced that the Phase 2b/3 trial* of ZYESAMI™ (aviptadil, previously RLF-100™) for the treatment of Respiratory Failure in critically ill patients with Covid-19 had demonstrated multidimensional benefit around its prespecified primary endpoint of Recovery from Respiratory Failure with discharge from hospital and ICU (without relapse) by day 28 in patients with critical Covid-19 who were treated with High Flow Nasal Oxygen. Although not envisioned at the start of the clinical trial, high-flow nasal oxygen has become the predominant form of treatment in Covid-19 respiratory failure. Mechanical ventilation is reserved for those whose blood oxygen levels cannot be maintained on this less invasive modality. The trial was conducted at 10 U.S. hospitals under the direction of NeuroRx in collaboration with RELIEF THERAPEUTICS Holding AG.

February 23, 2021 - Big Rock Partners Acquisition Corp. filed Form 8-K.

February 9, 2021 - NeuroRx, Inc. reported preliminary results from their Phase 2b/3 trial of ZYESAMI™ (aviptadil, previously RLF-100) in collaboration with Relief Therapeutics Holdings, AG in patients with respiratory failure due to Critical COVID-19. The study showed that patients treated with the maximal standard of care plus ZYESAMI were discharged sooner from the hospital than those treated with placebo plus maximal standard of care. Thus, if authorized for use, ZYESAMI would be the first drug indicated specifically for COVID-19 patients critically ill with respiratory failure.

January 18, 2021 - The Government of India's Subject Expert Committee (SEC) meeting examined COVID-19 related proposals under accelerated approval process made in its 140th meeting held on 18.01.2021 & 19.01.2021 at CDSCO, H.Q. New Delhi.

December 10, 2020 - Last update: Patients with Critical COVID-19 and respiratory failure who are ineligible for enrollment in NCT04311697, who live more than 50 miles from an existing collaborating research center, or who are already hospitalized and cannot safely be transferred to a collaborating research facility may be considered for expanded access by the sponsor. Treating physicians must complete FDA Form 3396 and receive a letter of authorization from NeuroRx, along with local IRB authorization.

January 11, 2021- NeuroRx, Relief, and Quantum Leap announce the inclusion of ZYESAMI™ (RLF-100™: aviptadil) in the I-SPY COVID-19 Trial. "We at NeuroRx, together with our partners at Relief, are honored to have been selected by Quantum Leap for inclusion in the I-SPY trials platform. This will enable us to gather data on the use of inhaled aviptadil to treat Critical COVID-19 as a complement to data on intravenous aviptadil in the phase 2b/3 trial we are just concluding. We also hope to demonstrate in a second phase 2b/3 trial that aviptadil can be given in a more convenient mode of administration and show benefit in patients who can self-administer inhaled medications," said Jonathan C. Javitt, MD, MPH, CEO and Chairman of NeuroRx.

December 30, 2020 - FDA rejects COVID-19 emergency approval. "The FDA did not agree to grant (emergency use authorization), as applied for in September," said Jonathan Javitt, the chief executive officer of U.S.-based NeuroRx, Inc., which has partnered with Relief on aviptadil, an older drug that the companies are seeking to repurpose during the pandemic. The Company is now calling the drug Zyesami in its formulation against COVID-19.

November 24, 2020 - NeuroRx and Relief announce initial successful results from expanded access use of RLF-100™ (aviptadil) in patients with Critical COVID-19 and Severe Comorbidity: 72% survival seen in ICU patients. All patients had severe comorbidities (such as organ transplant, recent heart attack, and cancer) that rendered them ineligible for the ongoing randomized, controlled phase 2b/3 trial to ascertain the safety and efficacy of RLF-100™, and all patients were deteriorating despite treatment with approved therapies for COVID-19. Of the 90 patients who have reached 28 days of follow-up, 72% survived today 28.   

August 3, 2020 - According to the companies, the first report of rapid clinical recovery under emergency use was from Houston Methodist Hospital doctors.

August 2, 2020 - Critically ill COVID-19 patients recovered rapidly from respiratory failure after three days of treatment with RLF-100, a therapy granted fast-track designation in the United States, two drug companies said Sunday.

June 9, 2020 -  Relief Therapeutics and NeuroRx have expanded the Phase II/III clinical trial of RLF-100 (Aviptadil) to include Covid-19 patients on ventilators, high flow oxygen, and noninvasive ventilation (CPAP).

Zyesami (Aviptadil) COVID-19 Clinical Trials

Zyesami (Aviptadil) COVID-19 Therapeutic continues to be tested in clinical trials.

September 29, 2021 - After Review of 232 Enrolled Patients in ACTIV-3b Critical Care Study, No New Safety Concerns Raised by Independent Data Safety Monitoring Board; ACTIV-3b Critical Care Study is Evaluating ZYESAMI™ and Remdesivir, in Critical COVID-19 Patients, as Monotherapy and in Combination Against Placebo; Study Cleared to Continue Enrollment to Target More than 600 Patients. ACTIV-3b represents one of three ongoing studies of ZYESAMI™ in Severe or Critical COVID-19.

Participants in this trial have now been followed for one year from initial enrollment. Top-line results show a statistically significant (P<.0001) 3-fold advantage in the likelihood of being alive at one year, post-treatment (60% vs. 20%) among those treated with ZYESAMI, in addition to standard of care, compared to those who received the standard of care alone. Assignment to ZYESAMI in the trial was based on the specific medical team which admitted the patient to the intensive care unit (ICU). Once in the ICU, all patients were cared for by the same medical team, and according to the same treatment protocols.

Inhaled ZYESAMI™ (Aviptadil Acetate) for the Treatment of Severe COVID-19.

Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure (COVID-AIV).

Avigan (Favipiravir) Antiviral Description For 2022

Avigan (Favipiravir) (T-705) (Reeqonus) Tablet is a pyrazinecarboxamide derivative with activity against RNA viruses. Host enzymes convert Favipiravir to the ribofuranosyltriphosphate derivative and selectively inhibit the influenza viral RNA-dependent RNA polymerase.

Avigan (Favipiravir) was approved for manufacture and sale in Japan in 2014 as an influenza antiviral. However, Avigan is considered for use only when there is an outbreak of novel or re-emerging influenza virus infections.

Favipiravir-based drugs are sold worldwide, such as Avigan, FabiFlu, Avifavir, Favijaj, Ciplenza, FluGuard, Avifavir, Coronavir, and Reeqonus in Canada.

Avigan undergoes an intracellular phosphoribosylation to be an active form, favipiravir-RTP (favipiravir ribofuranosyl-5′-triphosphate) is recognized as a substrate RdRp and inhibits the RNA polymerase activity, and is a pyrazinecarboxamide derivative. Favipiravir-RTP is a nucleoside analogue. It mimics both guanosine and adenosine for the viral RdRP.

Since the catalytic domain of RdRp is conserved among various types of RNA viruses, this mechanism of action underpins a broader spectrum of antiviral activities of favipiravir.

The active favipiravir-RTP selectively inhibits RNA polymerase and prevents replication of the viral genome. In addition, studies have shown that favipiravir-RTP is incorporated into a nascent RNA strand prevents RNA strand elongation and viral proliferation. Studies have also found that the presence of purine analogs can reduce favipiravir's antiviral activity, suggesting competition between favipiravir-RTP and purine nucleosides for RdRp binding.

Toyama Chemical Co., Ltd. discovered Avigan (favipiravir), which selectively inhibits RNA polymerase necessary for influenza virus replication. Due to this mechanism of action, it is expected that Avigan may potentially have an antiviral effect on the new coronavirus, SARS-CoV-2, because, like influenza viruses, coronaviruses are single-stranded RNA viruses that also depend on viral RNA polymerase.

Glenmark Pharmaceuticals confirmed on September 15, 2021, a prospective, open-label, multicentre, single-arm phase 4 study of Favipiravir showed that fever resolution was four days, while the time for a clinical cure was seven days. And, no new safety signals or concerns with the use of Favipiravir, and already-known side effects were found to be mild.

Appili Therapeutics Inc. announced that the Phase 3 PRESECO clinical trial evaluating oral antiviral Avigan (Reeqonus) (favipiravir) for the treatment of mild-to-moderate COVID-19 did not achieve statistical significance on the primary endpoint of time to sustained clinical recovery.

Favipiravir Accession Number: DB12466; Chemical Formula: C5H4FN3O2; ATC code: J05AX27 

Avigan (Favipiravir) Antiviral History

On September 23, 2020, Fujifilm Toyama Chemical Co. announced a small phase III trial in Japan, which began in March 2020, was now complete. It intends to apply the medication to be approved for treating coronavirus patients after trials showed it could shorten recovery time. In this study, the median value of primary endpoints, using 156 individuals as analysis targets, was 11.9 days for the Avigan group and 14.7 days for the placebo group. FUJIFILM Toyama Chemical confirmed, with a statistically significant difference (p-value = 0.0136), that the administration of Avigan to COVID-19 patients with non-serious pneumonia demonstrates a shorter time to resolution. The adjusted hazard ratio*2 showed 1.593 (95% confidence interval of 1.024 – 2.479). No new safety concerns were noted in this trial.

Previously, Fujifilm signed a patent license agreement on its anti-influenza medication Avigan (favipiravir) Tablet with China's significant pharmaceutical Company Zhejiang Hisun Pharmaceutical in June 2016.

On June 1, 2020, Avifavir (Favipiravir) received a temporary registration certificate from the Ministry of Health of the Russian Federation, which has included Avifavir in its latest 7th edition of the prevention guidelines diagnosis, and treatment of new coronavirus infection COVID-19. Starting June 10, 2020, Avifavir was delivered to more than 50 Russian regions and Belarus and Kazakhstan.

Favipiravir-based drugs, such as Coronavir, have demonstrated efficacy in clinical trials held in the leading medical centers across Russia, involving patients with confirmed cases of COVID-19. The drugs disrupt the coronavirus's reproduction mechanisms, relieve symptoms, and halve the treatment period compared to standard therapy.

On July 13, 2020, Glenmark Pharmaceuticals announced that it would lower the price of its generic version of favipiravir, FabiFlu, to 75 rupees ($0.9983) per tablet. This indicates a treatment course with FabiFlu would require a patient to take 122 tablets over 14 days and will now cost 8,475 rupees ($112.80) per patient at the new price.

Glenmark reported results from a phase 3 trial on July 22, 2020, that showed numerical improvements for the primary efficacy endpoint with 28.6% faster viral clearance in the overall population as measured by the median time until cessation of oral shedding virus in the Favipiravir treatment arm. In addition, Glenmark's Favipiravir was well tolerated with no serious adverse events or fatalities in the Favipiravir-treated arm.

Avigan is not approved for distribution in the USA by the U.S. FDA.

FUJIFILM Toyama Chemical Co., Ltd. is located at 14-1, Kobayashi 2-Chome, Chuo-Ku, Tokyo 104-0031 Japan. The Drugbank Accession Number is DB12466.

Avigan (Favipiravir) Antiviral Indication

Avigan (favipiravir) (REEQONUS) is effective against a wide range of types and subtypes of influenza viruses, including strains resistant to existing anti-influenza drugs, says a study published by the U.S. NIH.

Of note is that favipiravir shows antiviral activities against other RNA viruses such as arenaviruses, bunyaviruses, and filoviruses, all known to cause fatal hemorrhagic fever. These unique antiviral profiles will make Avigan a potentially promising drug for specifically untreatable RNA viral infections. The main advantages of favipiravir are that it is administered orally. Thus, it can be given in patients who are symptomatic but not ill enough to be hospitalized, stated a study published in September 2020. Favipiravir has been investigated to treat life-threatening pathogens such as the Ebola virus and Lassa virus.

Avigan (Favipiravir) Antiviral Indication For COVID-19

Appili Therapeutics Inc. announced on November 12, 2021, that the Phase 3 PRESECO (PREventing SEvere COVID-19) clinical trial evaluating oral antiviral  Avigan / Reeqonus(favipiravir) for the treatment of mild-to-moderate COVID-19 did not achieve statistical significance on the primary endpoint of time to sustained clinical recovery.

eBioMedicine published a study on September 23, 2021, The combined treatment of Molnupiravir and Favipiravir results in a potentiation of antiviral efficacy in a SARS-CoV-2 hamster infection model. When animals were treated with a combination of suboptimal doses of Molnupiravir and Favipiravir at the time of infection, a marked combined potency at the endpoint is observed. 

On September 15, 2021: Glenmark Pharmaceuticals announced the successful completion of its Post Marketing Surveillance study on Favipiravir (FabiFlu®) in India. The time for fever resolution was 4 days, while the time for a clinical cure was 7 days.

On June 19, 2020, Glenmark Pharmaceutical became the first Company in India to receive restricted emergency use approval from India's drug regulator for FabiFlu®, making it the first oral Favipiravir-approved medication in India for the treatment of mild to moderate COVID-19. The mortality rate in the Favipiravir study group was approximately 30% less than the control group when used early in the treatment of a SARS-CoV-2 virus infection, reported the journal Nature on May 26, 2021.

Avigan (Favipiravir) Antiviral Availability For 2022

Cellvera holds directly, or through its affiliates worldwide (excluding Japan), exclusive rights to Avigan® and all strengths and formulations of Favipiravir, as of January 24, 2022. Regulators authorized Avigan® in several markets to treat COVID-19 and/or influenza, including Japan, Malaysia, Thailand, United Arab Emirates, Indonesia, Mexico, and India. Several other countries purchase it on a compassionate patient basis, including the United Kingdom, Greece, Hungary, and Saudi Arabia. The governments of those countries have ordered a total of 80m tablets in the past 12 months.

On July 12, 2021, FDC Limited announced the launch of India's first oral suspension of Favipiravir – Favenza Oral Suspension, used to treat mild to moderate cases of COVID-19. This prescription-only solution is currently available at all retail, medical outlets, and hospital pharmacies across the country.

Avigan (Favipiravir) Antiviral Dosage

As an influenza antiviral drug approved for manufacture and sale in Japan, Avigan (Favipiravir) selectively inhibits RNA polymerase necessary for influenza virus replication. The dosage of Avigan to treat COVID-19 disease patients is currently being evaluated in various clinical studies. For example, in a phase 2 study in Boston, Massachusetts, Aviagn tablets are being evaluated: on the first day, once for 1600 mg, twice a day; From the 2nd day to the 10th day, once for 600 mg, twice a day; maximum of ten days for oral administration of the drug.

However, reports indicate Avigan cannot be administered to expecting mothers or those who may become pregnant. On September 2, 2020, a study from India found that the drug's side-effect profile also seems acceptable, with asymptomatic hyperuricemia and mild, reversible elevation in transaminases being the most frequently reported adverse effects. In the Indian trial, no special safety signal was elicited. However, it is teratogenic and must never be used in pregnant women.

The main disadvantage is a high pill burden, which works out to a loading dose of 18-tablets on the first day and then 8-tablets a day for the rest of the course.

Avigan (Favipiravir) Antiviral Side Effects

A CLINICAL COMMENTARY was published on January 21, 2022: Angioedema after favipiravir treatment: Two cases. Clinicians should be careful about the side effects and possible skin manifestations, especially including angioedema, related to the use of favipiravir.

Dove Press published a study on July 30, 2021, that included, 'Favipiravir is a prodrug converted to favipiravir-RTP, an active form of ribofuranosyl-5-triphosphate that competes for polymerase active binding sites. Favipiravir is capable of inhibiting the RdRp enzyme of RNA viruses like influenza.'

Avigan (Favipiravir) Antiviral News For 2015 - 2022

March 11, 2022 - Fujifilm Holdings Corp announced it was halting enrolment in the phase 3 clinical trial of Avigan. With the recent spread of the Omicron variant that has lower symptom severity rates than conventional strains, and the assumption that a vast majority of patients who had recently been enrolled in the trial having infected by the Omicron strain, Fujifilm decided that, even if trials were continued under the current clinical trial protocol, it would be difficult to verify Avigan’s efficacy to suppress the symptoms from becoming severe, and that continuation of the placebo control trial would not lead to the subjects’ benefits. 

January 24, 2022 - Cellvera announced a supply of millions of its COVID-19 oral antiviral Avigan to Malaysia in the coming weeks. Favipiravir works by inhibiting a viral enzyme called RNA polymerase, preventing viral replication within human cells. This viral enzyme is common to several viruses, including SARS-CoV-2, which causes COVID-19.

November 12, 2021 - “While we are disappointed by the topline results of the PRESECO trial, we remain steadfast in our belief that safe and effective oral antivirals are urgently needed for patients who are still struggling to overcome COVID-19,” said Dr. Armand Balboni, CEO, Appili Therapeutics.

November 5, 2021 - National Geographic published an article: How the rise of antivirals may change the course of the pandemic.

November 3, 2021 - The journal Nature published an article - In a bid to stave off looming disaster, scientists are trying to repurpose drugs used for malaria and other diseases, but infrastructure and recruitment challenges stymie progress.

October 28, 2021 - AiPharma owned Global Response Aid and Pharmax announced they have partnered to supply Avigan (Favipiravir) in the UAE. Favipiravir was added to the list of approved therapeutics in the Dubai Health Authority's National Guidelines for Clinical Management and Treatment of COVID-19 in June 2020.

October 14, 2021 - Appili Therapeutics (TSX: APLI) announced the closing of a Public Offering of $7,000,220. Dr. Armand Balboni, CEO, Appili Therapeutics, commented, "With the COVID-19 pandemic continuing to evolve, the need for at-home oral antivirals remains urgent. As Appili rapidly approaches the top-line readout from our Phase 3 PRESECO trial, which is evaluating the oral antiviral Avigan®/Reeqonus™ (favipiravir) for the treatment of mild-to-moderate COVID-19, this funding will support us as we move aggressively to deliver this critically needed medicine and hopefully change the trajectory of this pandemic."

September 29, 2021 - Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) and AiPharma Global Holdings LLC announced a strategic alliance to advance the global development of Avigan® / Reeqonus™ (favipiravir).

September 20, 2021 - Appili Therapeutics Inc. announced it entered into an agreement with FUJIFILM Toyama Chemical Co., Ltd., that will provide funding support for its Phase 3 PRESECO (PREventing SEvere COVID-19) clinical trial. The new funding of $1,000,000 USD was secured from FFTC, one of the Company's partners in a global consortium focused on the worldwide development, commercialization, and distribution of Avigan®/Reeqonus™ (favipiravir) tablets for the potential treatment and prevention of COVID-19.

September 17, 2021 - Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) announced it has completed patient enrollment in the viral shedding sub-study portion of its Phase 3 PRESECO (PREventing SEvere COVID-19) trial evaluating Avigan®/Reeqonus™ (favipiravir) as a potential oral antiviral COVID-19 treatment in the USA. The viral shedding sub-study is designed to identify COVID-19 variants in study patients and evaluate the direct antiviral effect of favipiravir against the SARS-CoV-2 virus, including recent and emerging variants. 

September 15, 2021 - Glenmark Pharmaceuticals announced the successful completion of its Post Marketing Surveillance phase 4 study on Favipiravir (FabiFlu®) in India. The study commenced in July 2020 to evaluate the safety and efficacy of Favipiravir in mild to moderate COVID-19 patients. A total of 1,083 patients were enrolled in the prospective, open-label, multicentre, single-arm study. Results showed no new safety signals or concerns with the use of Favipiravir.

August 8, 2021 - Thailand's Department of Medical Services Public Health Ministry decided to administer Favipiravir to more groups of Covid-19 patients and is planning to stockpile 420 million tablets of the drug, reported local media.

July 7, 2021 - The Indonesian Food and Drug Supervisory Agency granted an emergency permit to use Avigan to treat COVID-19 patients.

June 24, 2021 - Appili Therapeutics Inc. announced in a press statement: "We are encouraged that an independent Data and Safety Monitoring Board has recommended continuation without modification of Appili's ongoing Phase 3 PRESECO trial evaluating Avigan® / Reeqonus™ (favipiravir). We look forward to the completion of the PRESECO trial and are hopeful that Avigan/Reeqonus will emerge as one of the first prescription oral medicine for newly diagnosed patients with COVID-19," commented Dr. Balboni. 

June 17, 2021 - Appili Therapeutics Inc. has added several clinical research sites in Mexico and Brazil to its Phase 3 clinical trial evaluating Avigan® / Reeqonus™ (favipiravir) as a potential oral therapy for patients with mild-to-moderate COVID-19. The expansion into Mexico and Brazil will ensure timely completion of this pivotal trial and reaffirm favipiravir as one of the most advanced oral COVID-19 antiviral candidates in development, with top-line data expected in Q3 2021.

June 14, 2021 - Ireland-based AiPharma announced a production and distribution deal for China and the Russian Federation with FUJIFILM for its influenza antiviral drug Avigan® for COVID-19.

June 8, 2021 - Glenmark Pharmaceuticals announced interim data of 503 patients from its Post Marketing Surveillance study on Favipiravir (FabiFlu) in India. The time to fever resolution was seen on day 3, while two-third of the patients achieved clinical cure on day 7. The study commenced in July 2020 aimed to evaluate the safety and efficacy of Favipiravir in mild to moderate Covid-19 patients. A total of 1,083 patients have been enrolled in the prospective, open-label, multicenter, single-arm study. A total of 13 sites – both Government and private institutions – across Mumbai, Bangalore, Hyderabad, Nashik, Nagpur, and Trivandrum took part. Glenmark's interim data to the regulator reveals no new safety signals or concerns using Favipiravir and already-known side effects such as weakness, gastritis, diarrhea, vomiting, etc., which were found to be mild in nature. The time to fever resolution was seen on day 3, while two-third of the patients achieved clinical cure on day 7.

June 7, 2021 - India's Union health and family welfare ministry revised the Covid-19 treatment guidelines and removed the use of the antiviral drug favipiravir from its list of advised treatment.

May 27, 2021 - BMC published: Favipiravir for treating patients with COVID-19: a systematic review and meta-analysis. Conclusions - Favipiravir induces viral clearance by 7 days and contributes to clinical improvement within 14 days. The results indicated that favipiravir is strongly capable of treating COVID-19, especially in patients with the mild-to-moderate illness. However, additional well-designed studies, including examinations of the dose and duration of treatment, are crucial for reaching definitive conclusions.

May 26, 2021 - The journal Nature published a study: The efficacy and safety of Favipiravir in treatment of COVID-19: a systematic review and meta-analysis of clinical trials. Finding: The mortality rate in the Favipiravir group was approximately 30% less than the control group, but this finding was not statistically significant. Favipiravir possibly exerted no significant beneficial effect in the term of mortality in the general group of patients with mild to moderate COVID-19. We should consider that perhaps the use of antiviral once the patient has symptoms is too late, which would explain their low efficacy in the clinical setting.

May 22, 2021 - India-based Bharat Parenterals confirmed it received approval from the Drugs Controller General of India for favipiravir l00mg/ml oral suspension for treating COVID-19.

May 17, 2021 - Appili Therapeutics Inc. announced that an independent Data and Safety Monitoring Board had recommended continuation without modifying the ongoing Phase 3 PRESECO trial evaluating Avigan® / Reeqonus™ (favipiravir) as a potential oral therapy for patients with mild-to-moderate COVID-19.

May 10, 2021 - Vivimed Labs received India's approval to manufacture and market Favipiravir Tablet 200 mg and 400 mg for the Indian market.

May 4, 2021 -  PTI reported India-based Bajaj Healthcare announced the launch of its antiviral Favipiravir tablets under the brand name 'Favijaj' to treat mild to moderate COVID-19 infections in India said in a BSE filing. The Company successfully developed the active pharmaceutical ingredient and formulated favipiravir through its own in-house R&D team.

April 21, 2021 - FUJIFILM Toyama Chemical Co., Ltd. announced a new phase III clinical trial in Japan concerning its anti-influenza drug Avigan® Tablet (Avigan; favipiravir), targeting patients infected with COVID-19. The trial is a double-blind, placebo-controlled clinical trial investigating the drug's efficacy and safety in patients with early-onset COVID-19 with risk factors for progression to severe symptoms.

April 19, 2021 - Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) announced that Dr. Armand Balboni would present at the fully virtual Bloom Burton & Co. Healthcare Investor Conference taking place on April 20 and 21, 2021.

April 12, 2021 - Philippines-based My Med Rx Plus Corporation announced it had placed orders for 1 million Favipiravir (Avigan) and 3 million tablets of Umifenovir (Arbidol) tablets to secure supplies for hospitals and patients.

March 31, 2021 - The journal Nature published a study: Safety and efficacy of favipiravir versus hydroxychloroquine in management of COVID-19: A randomized controlled trial. Finding: Favipiravir is a safe, effective alternative for hydroxychloroquine in mild or moderate COVID-19 infected patients.

March 24, 2021 - The Russian Direct Investment Fund and the ChemRar group of companies announce that they have received a registration certificate from the Indonesian Medicines and Foods Control Agency for the Avifavir antiviral (favipiravir). Registration of Avifavir in Indonesia was carried out according to an accelerated procedure based on data from an extended phase II-III clinical trial, which took place from April to September 2020, at 30 specialized centers throughout Russia with the participation of 460 patients.

March 17, 2021 – Appili Therapeutics Inc. announced that it would present at the fully virtual Inaugural Emerging Growth Virtual Conference, presented by M Vest LLC and Maxim Group LLC taking place on March 17th through 19th. In addition, Appili CEO Dr. Armand Balboni, M.D., Ph.D., will participate in a Fireside Chat on Friday, March 19th at 4:30 PM ET. Appili is developing a version of Avigan (Favipiravir) for use in Canada and the USA. "While we are encouraged by the early signals that favipiravir may be active against COVID-19, we realize that there is a duty to provide robust clinical data evaluating favipiravir as an early treatment option and prophylactic agent. Appili is honored to be a part of this world-class clinical program as we race to find options for the greatest public health threat of our lifetime."

March 9, 2021 - According to IQVIA data, Favipiravir posted total sales of Rs 424 crore from June to December 2020 in India.

February 21, 2021 - Kyodo News reported that Fujifilm Holdings Corp is considering restoring a clinical trial for its drug Avigan in treating COVID-19 patients. Details, including when the trial would start in Japan, have yet to be determined.

February 12, 2021 - Appili Therapeutics Inc. announced recent operational highlights including: Signing a collaboration, development, and supply agreement to create a global consortium with Dr. Reddy's Laboratories Ltd. and Global Response Aid for oral COVID-19 antiviral candidate favipiravir (REEQONUS); Working with partner DRL to support the filing of an application under Health Canada's interim order for favipiravir oral tablets (REEQONUS in Canada) on behalf of the global consortium; Dosing the first participant and activating over 50% of the planned sites in the U.S. for its Phase 3 PRESECO study evaluating favipiravir for the early treatment of mild-to-moderate COVID-19 infections; Receiving a 'No Objection Letter' from Health Canada to initiate the Phase 3 PEPCO study evaluating favipiravir for the prevention of COVID-19 in exposed individuals in the community setting.

January 28, 2021 - Appili Therapeutics Inc. announced that its Phase 3 PRESECO (PReventing SEvere COvid-19) clinical trial actively recruited participants in 12 out of 20 sites in the USA. Based on current forecasts, Appili believes it will reach the enrollment threshold required to provide an interim data readout by late March 2021. PRESECO evaluates favipiravir, an oral antiviral, in the early treatment of COVID-19 in the outpatient setting. The Company is also pursuing regulatory approvals to expand PRESECO into Mexico, Brazil, and Colombia.

January 27, 2021 - India-based Dr. Reddy's Laboratories Ltd. and Global Response Aid FZCO announced the termination of the Avigan Trial Study conducted in Kuwait focused on moderate to severe COVID-19 patients in a hospital setting.

January 6, 2021 - The Lancet published a commentary: Understanding the pharmacokinetics of Favipiravir: Implications for treating influenza and COVID-19. Results from this study, as well as others, demonstrate a highly complex pharmacokinetic profile.

January 1, 2021 - Study: Role of favipiravir in the treatment of COVID-19. Conclusion: Considering the approved status, evidence on the safety, and key indicators of efficacy of favipiravir in COVID-19 from trials/registries in Russia, Japan, China, and Thailand, it appears to be useful management of COVID-19, particularly mild to moderate disease.

December 22, 2020 - Dr. Reddy's Laboratories Ltd., Appili Therapeutic, and Global Response Aid FZCO announced that Dr. Reddy's Canada had filed an application on behalf of the consortium for REEQONUS™ (favipiravir) Tablets for the acute treatment of mild to moderate COVID-19 adult patients under Health Canada's Interim Order Respecting the Importation, Sale, and Advertising of Drugs for Use concerning COVID-19. REEQONUS is also known as Avigan® (favipiravir) Tablets, developed by FUJIFILM Toyama Chemical Co., Ltd.

December 19, 2020 - According to the National Institute of Pharmacy and Food Health (OGYÉI), a new coronavirus drug-containing favipiravir, manufactured by the Hungarian pharmaceutical company Egis, has been approved, so it is expected to be used in the treatment of coronavirus patients from mid-January. The preparation is managed by the state health reserve and delivered to health care providers, writes MTI.

December 17, 2020 - Japanese authorities have found it difficult to conclude the effectiveness of antiviral drug Avigan in treating COVID-19 patients based on clinical testing results by its developer, FUJIFILM Toyama Chemical Co., Ltd. However, according to local media, the Pharmaceuticals and Medical Devices Agency's latest assessment will likely decide whether to approve the use of Avigan to treat COVID-19 in Japan.

December 14, 2020 - The Philippines Department of Health announced it had to tweak the Avigan clinical trial protocol against COVID-19 to get more participants. The anti-flu drug Avigan is among the off-label drugs being studied as a possible treatment for the new coronavirus disease. As of December 7, the study had a total of 16 participants.

December 11, 2020 - Professor Fehmi Tabak of Istanbul University's Cerrahpaşa Faculty of Medicine says favipiravir is one of the strongest currently available medicines against COVID-19. Still, people stopping intake based on rumors see their situation worsen. "The drug might have minor side effects on people with liver problems, but it does not have any side effect for COVID-19 patients without any underlying disease," he said.

December 10, 2020 - Nepal Health Research Council has decided to test antiviral medicine favipiravir on Covid-19 patients admitted to Kathmandu and Pokhara hospitals. The drug, administered under a phase-III trial, will be given to 600 patients with mild or moderate contagious disease symptoms. Favipiravir is being manufactured by Deurali-Janta Pharmaceuticals Pvt. Ltd in Nepal.

December 2, 2020 - Appili Therapeutics Inc. announced that investigators had dosed the first participant in its Phase 3 trial (referred to as the "PRESECO" clinical trial) evaluating oral Avigan® tablets (favipiravir) for the treatment of COVID-19. Appili expects to report early data from the PRESECO study in the first half of 2021. Appili is initially focusing the trial in the United States but may expand it to other areas of the world affected by COVID-19.

November 30, 2020 - The sovereign wealth fund of the Russian Federation and the ChemRar group of companies announce an increase in production of the first Russian drug against the new coronavirus infection, Avifavir. The production level is now 200,000 packs per month. Avifavir (favipiravir) is the first drug globally with the active ingredient favipiravir, registered to treat new coronavirus infections.

November 24, 2020 - Appili Therapeutics Inc. announced the initiation of its Phase 3 Post Exposure Prophylaxis for COVID-19 (PEPCO) study to evaluate Avigan® tablets (favipiravir) in the prevention of COVID-19. And Health Canada has provided a 'No Objection Letter (NOL)' for Appili's proposed study; the U.S. FDA accepted a submission of a protocol amendment to conduct the trial in the USA. This is the second Phase 3 study that Appili has announced to evaluate Avigan tablets' utility against COVID-19 in the community setting. The other study, also known as the PRESECO study, evaluates Avigan for treating adults with mild-to-moderate symptoms of COVID-19.

November 20, 2020 - The Ministry of Healthcare of the Russian Federation confirmed the 'permanent registration of Avifavir, which enables the drug to be used both in outpatient and inpatient settings. 

November 16, 2020 - Phase III study published in the International Journal of Infectious Diseases showed that early treatment with favipiravir might be associated with more rapid viral clearance of COVID-19.

November 6, 2020 - The Russian Direct Investment Fund and the ChemRar group of companies announced a permit for the outpatient use of the first Russian anti-coronavirus drug, Avifavir (Favipiravir), provided to COVID-19 patients free of charge. The drug is already provided free of charge under the compulsory medical insurance program to patients undergoing treatment for coronavirus in medical institutions.

October 30, 2020 - Appili Therapeutics Inc. announced that it had signed a collaboration, development, and supply agreement with Dr. Reddy's Laboratories Ltd. Global Response Aid. The agreements work together to coordinate and accelerate the worldwide development, commercialization, and distribution of Avigan® tablets (favipiravir) for the potential treatment and prevention of COVID-19.

October 30, 2020 - FDC Limited announced the launch of new strength variants of its Favipiravir brands– PiFLU and Favenza- to treat mild to moderate cases of COVID-19 in India. These prescription-only drugs will be available at all retail, medical outlets, and hospital pharmacies across the country from the 1st of November, 2020. The 800mg version of the drugs will help reduce the number of tablets taken by any patient by 75%. Patients must take 18 pills on the first day, followed by 8 tablets every day for the next 13 days.

October 29, 2020 - A review provides insights into the evidence-based evolving role of favipiravir in the management of COVID-19 infection with emphasis on the benefits of initiating an early antiviral therapy with a special focus on favipiravir, its pharmacodynamic, pharmacokinetic, in vitro, clinical data, and inclusion in the treatment protocols of COVID-19.

October 22, 2020 - Fujifilm Holdings Corp. announced it has partnered with Shanghai-based Carelink Pharmaceutical Co. to seek approval in China for Avigan to treat COVID-19 and influenza.

October 20, 2020 - Appili Therapeutics Inc. announced that investigators enrolled and dosed the first cluster of participants in Appili's CONTROL COVID-19 clinical trial. 

October 16, 2020 - FUJIFILM Toyama Chemical Co., Ltd. announced that the Company filed an Application for Partial Changes to manufacturing and marketing approval matters of its anti-influenza drug Avigan® Tablet the Ministry of Health, Labour and Welfare in Japan. The filing seeks to add an indication and other items relating to novel coronavirus infections (COVID-19).

October 9, 2020 - Pre-clinical study: The potent antiviral efficacy of high favipiravir doses is in line with a recent study in which thrice-daily dosing of ∼1,400 mg⋅kg−1⋅d−1 of favipiravir resulted in significant reductions in virus infection in hamsters. Favipiravir plasma exposures were consistent in both studies, although the doses used were not completely the same.

October 3, 2020 - Moscow's Mayor Sobyanin said 'COVID-19 outpatients in Moscow will receive the antiviral drugs "Areplivir" and "Coronavir," which are versions of Avigan, for free.'

September 24, 2020 - The Russian Direct Investment Fund (RDIF), Russia's sovereign wealth fund, and ChemRar Group have agreed to supply Avifavir, the world's first registered favipiravir-based drug against coronavirus and Russia's first drug approved for the treatment of COVID-19, to 17 countries. The drug has already been delivered to Belarus, Bolivia, Kazakhstan, Kyrgyzstan, Turkmenistan, and Uzbekistan.

September 23, 2020 - FUJIFILM Toyama Chemical Co., Ltd. announced that the primary endpoint had been met in phase III clinical trial of "Avigan Tablet" (generic name: favipiravir, "Avigan") conducted in Japan for patients with novel coronavirus infections. As an influenza antiviral drug approved for manufacture and sale in Japan, Avigan selectively inhibits RNA polymerase necessary for influenza virus replication.

September 18, 2020 - Russia-based R-Pharm announced the approval of Coronavir for outpatient treatment of mild to moderate COVID-19 coronavirus infection. Coronavir is manufactured at R-Pharm's facility in Yaroslavl, will be available in Russian pharmacies.

September 17, 2020 - Article: Rapid incorporation of Favipiravir by the fast and permissive viral RNA polymerase complex results in SARS-CoV-2 lethal mutagenesis. 

September 11, 2020 - Appili Therapeutics Inc. announced that it had submitted a new protocol to its open investigational new drug application with the U.S. FDA to conduct a Phase 3 clinical study evaluating favipiravir, the early treatment outpatient setting for adult COVID-19 infections. Favipiravir is a broad-spectrum antiviral administered in oral tablet form.

September 3, 2020 - The start of clinical trials for the Japanese flu drug, Avigan, in the Philippines has been delayed anew because the ethics board of the Department of Health has not given its approval for the participation of three of four local hospitals in the trials, Health Undersecretary Maria Rosario Vergeire said. Japan turned over the Avigan (favipiravir) tablets to the Philippines, used by 100 patients with coronavirus disease (COVID-19).

September 2, 2020 - India review article 'Favipiravir: A new and emerging antiviral option in COVID-19. The main advantages of favipiravir are that it is administered orally and that it can be given to patients who are symptomatic but not ill enough to be hospitalized. '

August 19, 2020 - Dr. Reddy's Laboratories Ltd. announced the launch of AVIGAN® (Favipiravir) 200 mg Tablets in India. The launch is part of the global licensing agreement with FUJIFILM Toyama Chemical Co. Ltd. It grants Dr. Reddy's exclusive rights to manufacture, sell, and distribute AVIGAN (Favipiravir) 200 mg Tablets in India.

August 17, 2020 - The Philippines started 9-month clinical trials for Avigan to study the anti-flu drug's efficacy against the COVID-19 disease. Health Undersecretary Maria Rosario Vergeire said the clinical trials would include just four hospitals in Metro Manila.

August 14, 2020 - Fujifilm Holdings Corp. announced it expects to complete clinical tests in Japan of the antiviral drug Avigan, a potential candidate treatment for COVID-19, after a delay caused by difficulty in September securing enough patient data.

August 10, 2020 - Appili Therapeutics announced the U.S. FDA had granted the Company clearance to proceed after Appili filed an investigational new drug application for broad-spectrum antiviral favipiravir known as Avigan. Appili's Phase 2 clinical trial is leveraging the versatility of favipiravir as an oral tablet suitable for administration across a wide variety of care settings, including long-term care. Appili intends to enroll up to 760 participants in this Phase 2 clinical trial across the U.S. and Canada. In addition, health Canada provided regulatory clearance on May 21, 2020, for Appili's Phase 2 study evaluating FUJIFILM Toyama Chemical's (FFTC) favipiravir as a preventative measure against COVID-19 outbreaks.

August 4, 2020 - Sun Pharmaceutical Industries Ltd., the world's 4th largest generic pharmaceutical company, announced on Twitter that it would launch favipiravir (Avigan) under the brand 'FluGuard' ₹35 per pill, making it the cheapest brand of the antiviral drug in India. Favipiravir is used to treat mild to moderate Covid-19 disease through an emergency use authorization from India's Drug Controller General. 'FluGuard' is the sixth generic of favipiravir to be launched in India, with Glenmark Pharmaceuticals Ltd being the first to launch it in June after conducting a 150-patient clinical trial.

August 4, 2020 - The Philippine government announced that it had begun clinical trials for Japanese anti-flu drug Avigan to see whether it would effectively treat COVID-19, the disease caused by the new coronavirus.

August 3, 2020 – Chromis, a joint venture established by the Russian Direct Investment Fund and ChemRar Group, announced the signing of a distribution agreement with South Africa's 3Sixty Biopharmaceuticals, a subsidiary of 3Sixty Global Solutions Group, to deliver Avifavir, the first Russian anti-COVID drug, to South Africa.

July 30, 2020 - The Philippine government said Thursday it would stockpile Japanese anti-flu drug Avigan to treat severe cases of the new coronavirus, as planned clinical trials for the drug draw closer.

July 28, 2020 - Fujifilm has not yet submitted the drug for approval to Japanese authorities as a treatment for COVID-19 and has said it will take that step as soon as possible. Health ministry official Yasuyuki Sahara said the government stands ready to review Avigan once Fujifilm submits it for approval. And Stanford University is soon to start a phase II trial of 120 patients with mild symptoms and could move to a phase III around September, said Stanford professor Yvonne Maldonado.

July 24, 2020 - Hyderabad: Optimus Pharma Pvt. Ltd Director P. Prashanth Reddy announced that their Company had received approval from the Drugs Controller General of India (DCGI) to manufacture the active pharmaceutical ingredient, Favipiravir, through its subsidiary, Optrix Laboratories, and manufacture and market its antiviral drug, Favipiravir tablets. The drug was jointly developed by Cipla and the Council of Scientific and Industrial Research's Indian Institute of Chemical Technology.

July 22, 2020 - Glenmark Pharmaceuticals Ltd. announced top-line results from a Phase 3 clinical trial in mild to moderate COVID-19 patients conducted across seven clinical sites in India.

July 18, 2020 - Fujifilm Holdings Corp. announced it would start a clinical study of the antiviral drug Avigan in Kuwait in collaboration with India's Dr. Reddy's Laboratories Ltd, up to 1,000 people to assess the flu drug's effectiveness as a COVID-19 preventive therapy.

July 17, 2020 - The Kingdom of Saudi Arabia is set to play a key role in developing a Russian COVID-19 vaccine that produced promising results in the first phase of human trials. Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said the Kingdom could be part of Phase III, involving thousands of people, expected to begin in August 2020.

July 13, 2020 - Glenmark Pharmaceuticals Ltd said it would lower its generic version of favipiravir, FabiFlu, to 75 rupees ($0.9983) per tablet for restricted emergency use for patients with mild-to-moderate COVID-19 symptoms in India. Due to better yield and scale, Glenmark benefits patients by reducing the price of oral antiviral FabiFlu® by 27 % in India. 

July 1, 2020 - FUJIFILM Corporation announced a partnership with Dr. Reddy's Laboratories Ltd. and Global Response Aid concerning the development, manufacture, and sales of Avigan® Tablets (favipiravir), a potential drug for the treatment of COVID-19 disease. Because it has a mechanism of action that selectively inhibits viral RNA polymerase, thereby preventing viral proliferation, Avigan may have an antiviral effect on the novel SARS-CoV-2 coronavirus, classified into the same type of RNA virus as influenza viruses. 

June 30, 2020 - Stanford Medicine researchers are launching a clinical trial to test whether an oral drug can reduce symptoms and viral shedding in people with COVID-19. The researchers aim to enroll 120 participants, beginning July 6, who was recently diagnosed with the disease but were not hospitalized.

June 15, 2020 - Istanbul Medipol University Faculty Member Assoc. Prof. Dr. Mustafa Guzel and his team managed to create the local synthesis of Favipiravir, used to treat COVID-19.

June 11, 2020 - Russian Direct Investment Fund and ChemRar Group have delivered the 1st batch of Avifavir drugs against the coronavirus to Russian hospitals. As many as 60,000 courses of Avifavir will be delivered to Russian hospitals in June. If necessary, production of Avifavir could be increased to 2m courses per year. Clinics and pharmaceutical organizations in Moscow, Leningrad, Novgorod, Kirov, and Nizhny Novgorod regions and the Republic of Tatarstan and Ekaterinburg have already received the first deliveries drug.

June 8, 2020 - Fujifilm Holdings said it would continue clinical tests of its anti-influenza drug Avigan, a potential treatment for people infected with SARS-CoV-2 coronavirus, beyond the initially scheduled end in June 2020 due to a lack of sufficient data.

June 2, 2020 - Dr. Monika Tandon, VP & Head, Clinical Development Global Specialty/Branded Portfolio, Glenmark Pharmaceuticals, told Telangana Today, "Combining antiviral agents that have a good safety profile and act on different stages of viral life-cycle is an effective treatment approach to rapidly suppress initial high viral load and lead to an overall improvement in clinical parameters." Simultaneously Glenmark is also conducting phase 3 clinical trials of Favipiravir as a COVID-19 monotherapy option with 150 patients enrolled from 9 leading government and private hospitals across India.

June 1, 2020 - The Russian Direct Investment Fund, Russia's sovereign wealth fund, and the ChemRar Group announced that Avifavir, a Favipiravir-based drug, has received a temporary registration certificate from the Ministry of Health of the Russian Federation. Avifavir is Russia's first COVID-19 drug and has shown high efficacy in treating patients with coronavirus during clinical trials.

May 22, 2020 - Fujifilm Holdings Corp. said it is on course to supply the anti-influenza drug Avigan for 2 million COVID-19 patients by next March 2021, meeting a target set by the Japanese government to ramp up production of the potential treatment for the new coronavirus.

May 20, 2020 - Avigan, a candidate drug for treating COVID-19, has not shown apparent efficacy in treating respiratory disease in clinical trials so far, raising doubts about its approval by the end of this month as sought by the government sources familiar with the matter. "There is currently no data showing that Avigan has high efficacy," said Daisuke Tamura, an associate professor at Jichi Medical University specializing in pediatric infectious disease.

May 15, 2020 - Favipiravir Observational Study Group (principal investigator: Dr. Yohei Doi, Fujita Health University) released a preliminary report of the Favipiravir Observational Study in Japan on the Japanese Association for Infectious Diseases website. Given that over 80% of COVID-19 patients have a mild disease that often improves by supportive therapy, caution is required to interpret the efficacy of favipiravir based on the data presented here.

May 13, 2020: The ChemRar Group and Russia's sovereign wealth fund announced interim results of the multi-center, randomized, open comparative clinical trial of the drug Favipiravir (Avigan) tablets hospitalized with COVID-19 disease.

May 13, 2020: Japan's health ministry decided to allow pharmaceutical companies to bypass standard clinical trial procedures to facilitate the fast-track approval of the anti-flu medicine Avigan as an early-stage treatment for COVID-19 disease.

May 12, 2020: Glenmark Pharmaceuticals has initiated Phase 3 clinical trials in India on the antiviral tablet Favipiravir, for which it received approval from India's drug regulator DCGI in late April. Clinical trials have commenced, and over 10 leading government & private hospitals in India are enrolled for the study. Glenmark estimates study completion by July/August 2020.

May 4, 2020:  Japanese Prime Minister Shinzo Abe said Monday he wants Avigan (favipiravir) approved for COVID-19 treatment in May, as Japan moves to fast-track approval remdesivir as well.

May 1, 2020: Japan will provide anti-flu drug Avigan free of charge to 43 countries for clinical studies on its efficacy as a coronavirus treatment, Foreign Minister Toshimitsu Motegi said to local media.

April 30, 2020:  FUJIFILM Diosynth Biotechnologies teams with COVID-19 Therapeutics Accelerator to reserve manufacturing capacity and provide technical expertise to deliver future COVID-19 therapies.

April 30, 2020: Glenmark Pharmaceuticals announced that it had received approval from the Drug Controller General of India to conduct clinical trials on Favipiravir Antiviral tablets on COVID-19 disease patients. The product is a generic version of Avigan® of Fujifilm Toyama Chemical Co. Ltd., Japan, a Fujifilm Corporation subsidiary.

April 15, 2020: Fujifilm accelerates the production of its influenza antiviral drug "Avigan® Tablet" for COVID-19.

April 9, 2020:  Fujifilm announces phase II clinical study of its influenza antiviral drug "Avigan® Tablet" (favipiravir) for patients with COVID-19 collaboration Brigham and Women's Hospital, Massachusetts General Hospital, and UMass Medical School.

March 17, 2020: China's health leadership announced they found the Japanese-developed anti-influenza drug Avigan to treat COVID-19 disease patients effectively.

February 17, 2020:  The Taizhou government of Zhejiang province China announced Avigan (favipiravir) was approved for marketing.

June 22, 2016: Fujifilm signs a patent license agreement on its anti-influenza drug Avigan Tablet* with China's major pharmaceutical Company Zhejiang Hisun Pharmaceutical.

November 11, 2015:  Phase 3 Efficacy and Safety Study of Favipiravir for Treatment of Uncomplicated Influenza in Adults.

Avigan (Favipiravir) Clinical Trials

FujiFilm announces a new Phase III Clinical Trial of Anti-influenza Drug Avigan Tablet in Japan, Targeting COVID-19 Patients. Avigan (Favipiravir) continues to be tested in clinical trials.

ClinicalTrials.gov Identifier: NCT04600895 - The Phase 3 PRESECO (PREventing SEvere COVID-19 Disease) study is a double-blind, placebo-controlled, randomized, multi-center superiority trial investigating the safety and efficacy of Avigan/Reeqonus in the early treatment for adults infected with COVID-19 and showing mild-to-moderate symptoms. Investigators are enrolling participants at multiple clinical trial sites in the United States, Brazil, and Mexico. Participants are outpatients with mild-to-moderate symptoms who have had a recent positive COVID-19 test (within 72 hours of enrollment). Participants self-administer the drug regimen in their homes, with clinical investigators monitoring patients remotely. Last updated on August 13, 2021.

Stanford University is conducting a phase II trial of 120 patients with mild coronavirus symptoms in the USA. This study was last updated on July 27, 2020. And a separate phase II study in Massachusetts was last updated on September 9, 2020.