Complicated Urinary Tract Infection Oral Antibiotic Approaches Approval

There are various types of Urinary Tract Infections (UTIs) impacting millions of women and men each year. Most uncomplicated urinary tract infections (UTIs) resolve on their own or with antibiotic treatment.

However, complicated UTIs (cUTIs) have a higher risk of treatment failures. An estimated 2.9 million cases of cUTIs are treated annually in the U.S. alone.

This situation arises as antibiotic resistance is a growing health risk. 

Approximately 40 million UTI prescriptions are generated annually in the U.S., and around 1% of those UTI infections are caused by pathogens that are resistant to common oral antibiotics. 

To address these health needs, Spero Therapeutics, Inc. and GSK plc recently announced that the pivotal Phase 3 PIVOT-PO trial evaluating the investigational oral treatment tebipenem HBr for cUTIs, including pyelonephritis, met its primary endpoint.

These companies stated on May 28, 2025, that the study would be stopped early due to efficacy.

This decision follows a recommendation from an Independent Data Monitoring Committee (IDMC), which completed a pre-specified interim analysis of data from 1,690 patients enrolled in the trial.

The clinical trial met the primary endpoint of non-inferiority of tebipenem HBr compared to intravenous imipenem-cilastatin in hospitalized adult patients with cUTI, including pyelonephritis, in terms of overall response (a composite of clinical cure and microbiological eradication) at the test-of-cure visit.

The IDMC review did not identify any new safety concerns beyond those reported in other studies with tebipenem, with diarrhea and headache being the two most frequently reported adverse events.

GSK stated in a press release that it plans to work with U.S. regulatory authorities to include the data as part of a filing in the second half of 2025. Full results will be submitted for presentation at an upcoming scientific congress and for publication in a peer-reviewed journal.

Tony Wood, Chief Scientific Officer, GSK, commented, "These positive results add to our growing anti-infectives portfolio and reinforce the potential of tebipenem HBr as an effective oral alternative taken at home."

In September 2022, Spero entered into an exclusive license agreement with GSK for the development and commercialization of tebipenem HBr in all markets, except certain Asian territories. As of late May 2025, Spero Therapeutics, Inc. (SPRO) stock price substantially increased. 

The development of tebipenem HBr is supported in part with federal funds from the U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response, and the Biomedical Advanced Research and Development Authority.

The current standard of care for cUTIs includes carbapenem, a crucial subclass of antibiotics, especially in cases of sepsis, allergies, or resistance to other antibiotics. 

However, they are only available for IV administration. This results in a significant number of emergency department visits and hospitalizations, leading to substantial healthcare costs.

As of May 31, 2025, other types of UTIs have innovative treatment options on the horizon. An oral spray recurring UTI vaccine, Uromune™ (MV140), is available in various countries abroad.