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Gepotidacin, a new oral antibiotic that was approved by the Food and Drug Administration in March 2025 for the treatment of female adults and pediatric patients (≥12 years, ≥40 kg) with uncomplicated urinary tract infections (UTIs) was found to provide rapid symptom improvement—as early as 24 hours after the first dose—according to results of a clinical trial published in JAMA Network Open. The nonrandomized study enrolled 97 patients at 21 U.S. sites who received gepotidacin 1,500 mg twice daily for 5 days. Among patients adherent to the study’s treatment requirement, 54.4% (95% confidence interval [CI], 43.6%-65.0%) had clinical symptom improvement at 24 hours, increasing to 79.8% (95% CI, 69.9%-87.6%) at 48 hours and 90% (95% CI, 81.9%-95.3%) at 72 hours. By day 10, 95.6% (95% CI, 89.0%-98.8%) had improved, and no patients required additional antibiotics before day 10. Adverse events occurred in 28% of participants, most commonly diarrhea (16%). The mean clinical symptom score for each symptom (dysuria, frequency, urgency, and lower abdominal or suprapubic pain) decreased by 24 hours after gepotidacin initiation and continued to decrease over time through day 10, according to the study.
Treatment option: The authors conclude that gepotidacin offers symptom relief and represents another oral treatment option for uncomplicated UTIs, although the small, uncontrolled study did not directly compare its effectiveness with other antibiotics. Full prescribing information for providers is available on the GSK website.