FDA Approves Gepotidacin for Treatment of Uncomplicated UTIs: Daily Dose

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On March 25, 2025, we reported on the US FDA approval of gepotidacin (Blujepa; GSK) for the treatment of uncomplicated urinary tract infections (uUTIs) in female patients aged 12 and older.

The approval

The approval marks the first new class of oral antibiotics for uUTIs in nearly 30 years. The approval is based on results from the pivotal phase 3 EAGLE-2 and EAGLE-3 clinical trials. In EAGLE-2, gepotidacin demonstrated non-inferiority to nitrofurantoin, with a therapeutic success rate of 50.6% compared to 47.0% for nitrofurantoin (covariate-adjusted treatment difference 4.3%, 95% CI [-3.6, 12.1]). In EAGLE-3, gepotidacin showed statistically significant superiority over nitrofurantoin, with therapeutic success in 58.5% of participants compared to 43.6% for nitrofurantoin (covariate-adjusted treatment difference 14.6%, 95% CI [6.4, 22.8], P = 0.0003).

The safety profile of gepotidacin in phase 3 trials was consistent with previous studies. The most commonly reported adverse events were gastrointestinal-related, with diarrhea occurring in 16% of participants and nausea in 9%. The majority of these adverse events were mild (69% Grade 1) or moderate (28% Grade 2), with Grade 3 events occurring in <1% of participants. One drug-related serious adverse event was reported in each treatment arm (gepotidacin and nitrofurantoin).

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