FDA Approves Gepotidacin (Blujepa) for Uncomplicated Urinary Tract Infections

GSK announced today that its antibiotic, gepotidacin (Blujepa), was approved by the FDA. It is is indicated for uncomplicated urinary tract infections in female patients aged at least 12 years and weighing at least 40 kg.

“I think with this recent approval, it gives another option. I think to infectious disease hospitalists and family medicine this really helps identify and treat uncomplicated UTI. We know this is something that is evident across the board, whether it's in family practice or in the hospitals. And so there still is a high unmet need,” said Ryan Haumschild, PharmD, MS, MBA, CPEL, vice president of pharmacy at Emory Healthcare and Winship Cancer Institute. It's a new mechanism of action and I think that's what's exciting about this treatment.”

Study Data

The approval is based on positive results from the pivotal phase 3 EAGLE-2 and EAGLE-3 trials which demonstrated non-inferiority to nitrofurantoin, one of the leading current standard of care options for uUTI, in female adults (≥40 kg) and paediatric patients (≥12 years, ≥40 kg) with a confirmed uUTI. In EAGLE-2, gepotidacin demonstrated non-inferiority in therapeutic success which occurred in 50.6% (162/320) of participants compared to 47.0% (135/287) for nitrofurantoin (covariate-adjusted treatment difference 4.3%, 95% CI (-3.6, 12.1)).

In EAGLE-3, gepotidacin demonstrated statistically significant superiority versus nitrofurantoin (one-sided p-value 0.0003). Therapeutic success occurred in 58.5% (162/277) of participants compared to 43.6% (115/264) for nitrofurantoin (covariate-adjusted treatment difference 14.6%, 95% CI (6.4, 22.8)).

The safety and tolerability profile of gepotidacin in the EAGLE-2 and EAGLE-3 phase III trials was consistent with previous trials. The most commonly reported adverse events (AEs) in gepotidacin participants were gastrointestinal (GI). Diarrhea was the most common (16% of participants), followed by nausea (9%). Of the participants who reported GI AEs in the gepotidacin group, the most common maximum severity was mild (69% Grade 1) and moderate (28% Grade 2). Participants with Grade 3 GI events accounted for 3% of all patients with GI events and occurred in <1% of all participants. There was one drug-related serious adverse event in each treatment arm (Blujepa and nitrofurantoin) across the 2 trials.

"I think the exciting thing here is we still have nitrofurantoin, we still have fluoroquinolones, but how can we use this new option that might have a different side effect profile and leverage that for specific patient populations, then we can decrease resistance," Haumschild said. "We can add another option, if patients do progress on therapy or somehow are unresponsive."

GSK is planning a US commercial launch in the second half of 2025.

Reference
Blujepa (gepotidacin) approved by US FDA for treatment of uncomplicated urinary tract infections (uUTIs) in female adults and paediatric patients 12 years of age and olderGSK. March 25, 2025. Accessed March 25, 2025.
https://www.gsk.com/en-gb/media/press-releases/blujepa-gepotidacin-approved-by-us-fda-for-treatment-of-uncomplicated-urinary-tract-infections/