Urinary Tract Infection (UTI) Vaccine and Treatment

Urinary Tract Infection (UTI) Vaccine and Treatments June 2025

Urinary tract infections (UTIs) are among the most common bacterial infections, affecting hundreds of millions of people worldwide each year. Most UTIs are caused by uropathogenic E. coli (E. coli). Less common pathogens, such as Enterococcus faecalis and other enterococci, cause infections by infecting an abnormal or catheterized urinary tract. As of June 1, 2025,   Uncomplicated and Recurrent UTI patients in the United States require prophylactic antibiotic regimens, as vaccines are not yet available. UTIs place an economic burden on the U.S. healthcare system, with direct and indirect costs estimated at around $3.5 billion annually.

As of 2025, the U.S. Centers for Disease Control and Prevention (CDC) says most UTIs can be treated with antibiotics prescribed by a healthcare professional. European guidelines recommend an immunoreactive (vaccine) strategy for preventing Urinary tract infections (UTIs). The Infectious Diseases Society of America announced in February 2025 that it accepts comments on the updated 2025 Guideline on the Management and Treatment of Complicated Urinary Tract Infections (cUTI). This update provides clinical practice guidelines for patients with cUTI, with and without sepsis.

On November 4, 2024, the JAMA Network published a Consensus Statement for the development of UTI clinical guidelines. However, most topics relating to the prevention, diagnosis, and treatment of UTIs lack high-quality prospective data. A mini-review published in January 2025 summarizes the current state of UTI diagnostics and covers both existing and emerging technologies, including rapid molecular-based pathogen identification, next-generation sequencing, and advanced antimicrobial susceptibility testing. However, these methods represent unique challenges, and as they are implemented, they will require the field to adapt to new concepts to avoid misdiagnosis and overtreatment.

As of June 2025, international travelers seeking a UTI vaccine appointment can submit a request at this Vax-Before-Travel link.

Urinary Tract Infection (UTI) Vaccines

Immunotek S.L. Uromune™ (MV140), an oral spray for recurrent urinary tract infections, has been approved for adults in countries such as Mexico and the United Kingdom.

Uro-Vaxom® (OM-89) is an immunostimulant vaccine consisting of an oral tablet with 18 heat-killed strains of E coli bacteria. Uro-Vaxom activates the immunocompetent cells of the intestinal lining (Peyer’s plaques). In humans, Uro-Vaxom stimulates white blood cells and promotes the production of antibodies, thereby preventing urinary tract infections (UTIs). A review found that the risk ratio for developing at least one UTI in the female population was significantly lower in the OM-89 group (risk ratio, 0.61; 95% confidence interval, 0.48–0.78), and the mean number of UTIs was approximately half that of the placebo group. It has been used in Europe with minimal documented adverse events and is recommended by the European Association of Urology.

StroVac® (Solco-Urovac, Strovac) is a vaccine against UTIs containing 10 strains of bacteria known to cause them. It acts not only through the adaptive immune system but also by stimulating the innate immune system. It is available in Germany.

Urinary Tract Infection (UTI) Vaccine Candidates

A Research Article published in March 2021 - Local induction of bladder Th1 responses to combat urinary tract infections - concluded that intravesical vaccination with one or more UPEC antigens to induce bladder Th1 responses represents a superior strategy to combat UTIs, especially in UTI-prone subjects.

Urinary Tract Infection (UTI) Treatment

There are approximately 40 million uUTI prescriptions generated annually in the U.S., and approximately 1% of those UTI infections are caused by pathogens that are resistant to common oral antibiotics. The four leading oral antibiotic treatments for uUTI (slide #6) account for approximately 75% of the prescription market, but have resistance rates of 20% or higher.

Spero Therapeutics, Inc. and GSK plc announced on May 28, 2025, that the pivotal, multi-country, Phase 3 PIVOT-PO trial evaluating tebipenem HBr ((TBP-PI-HBr) an investigational oral treatment for complicated urinary tract infections (cUTIs), including pyelonephritis, met its primary endpoint and will stop early for efficacy (NCT06059846). The decision follows a recommendation from the Independent Data Monitoring Committee, which completed a pre-specified interim analysis of data from 1,690 patients enrolled in the trial.

GSK plc announced on March 25, 2025, that the U.S. FDA approved Blujepa (gepotidacin), a topoisomerase inhibitor antibiotic for treating uncomplicated urinary tract infections (uUTIs). Blujepa is the first in a new class of oral antibiotics for uUTIs in nearly 30 years.

Pivya™ (Pivmecillinam) is an extended-spectrum penicillin antibiotic and a U.S. FDA-approved oral prodrug of mecillinam. Pivya has a unique mechanism of action, targeting penicillin-binding protein-2 (PBP-2) in the cell wall of Gram-negative bacteria. The Pivya tablet has been used throughout Europe for years and is expected to be available in the U.S. in 2025.

ORLYNVAH™ (sulopenem etzadroxil and probenecid) is a U.S. FDA-approved novel oral penem antibiotic for the treatment of uncomplicated urinary tract infections (uUTIs) caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women. Orlynvah is taken as one oral tablet twice daily for 5 days. 

RECCE® 327 (R327) is an investigational synthetic anti-infective developed for treating severe, potentially life-threatening infections caused by Gram-positive and Gram-negative bacteria, including the full suite of ESKAPE pathogens, even in their superbug forms. 

In various clinical trials, Locus Biosciences is developing LBP-EC01, a CRISPR-enhanced bacteriophage therapy for treating Urinary tract infections (UTIs) and other infections caused by the pathogen E. coli. It is a bacteriophage cocktail engineered with a CRISPR-Cas3 construct targeting the E. coli gene. It is not a broad-spectrum antibacterial that kills various bacterial species. The precision medicine product works through a unique dual mechanism of action, utilizing both the natural lytic activity of the bacteriophage and the DNA-targeting activity of CRISPR-Cas3.

UTI Tests

A Viewpoint published by The JAMA Network on May 5, 2025, stated urinary nitrites provide diagnostic redundancy in confirming the presence of bacteriuria at best and promote the unnecessary use of antibiotics in asymptomatic patients at worst. Future research should examine the effects of suppressing the nitrite result from the urinary dipstick to determine the downstream impact on antimicrobial prescribing. Additionally, future research should focus on refining diagnostic techniques to distinguish between true urinary tract infections (UTIs) and symptomatic bacteriuria. We believe urinary nitrites should no longer be used to diagnose UTI in pediatric or adult patients.