GEPOTIDACIN provided rapid symptom improvement for patients with uncomplicated urinary tract infections (uUTIs), with 54.4% experiencing improvement within 24 hours of treatment initiation, according to a Phase 3b clinical trial.
The open-label, single-arm, multicentre study evaluated females aged 12 years and older with clinically diagnosed uUTIs at 21 US sites. Participants received oral gepotidacin 1,500 mg twice daily for five days, with researchers assessing symptom improvement from 24 hours through to 96 hours and again on day 10.
Of the 97 participants who enrolled, 90 were included in the clinically evaluable population for the primary outcome. Clinical symptom improvement was defined as a reduction of at least one point in the total clinical symptom score without additional systemic antimicrobials.
At 24 hours, 49 of 90 participants experienced symptom improvement: 54.4% (95% CI: 43.6%–65.0%). Improvement increased to 79.8% at 48 hours and 90.0% at 72 hours. At 96 hours, 86.5% of participants had experienced symptom improvement.
These data indicate that gepotidacin was associated with symptom improvement as early as the first day of treatment.
Complete clinical symptom resolution increased over the course of follow-up. At 24 hours, three of 90 participants had achieved complete resolution: 3.3%. By day 10, this had increased to 81 of 90 participants: 90.0%.
The study authors highlighted the importance of early symptom improvement for patients and healthcare professionals, noting that relatively few studies have evaluated the clinical effects of uUTI treatment during the initial stages of therapy.
Safety findings were also assessed during the study. Overall, 58 adverse events were reported among 27 participants in the safety population. Most adverse events were mild or moderate, and no serious adverse events were reported.
The researchers concluded that patients with uUTIs experienced a rapid clinical response to gepotidacin, with symptom improvement observed from 24 hours after treatment initiation. The data may support informed decision-making regarding gepotidacin treatment for uUTIs.
Ramírez M et al. Gepotidacin and early symptom improvement in uncomplicated urinary tract infection: a nonrandomized clinical trial. JAMA Netw Open. 2026;9;(9):e2634116.
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