Women with uncomplicated urinary tract infections (uUTIs) saw symptom relief as early as 24 hours after taking gepotidacin, according to the results of a single-arm, nonrandomized clinical trial.
Approved by the US Food and Drug Administration for treating uUTIs in March 2025, gepotidacin is a novel antibiotic that uses a distinct mechanism of action to inhibit bacterial replication. It was developed to provide an additional treatment option amid rising drug resistance in the bacteria that commonly cause uUTIs.
“Treatment with an inappropriate or ineffective antibiotic can lead to suboptimal outcomes, such as lack of symptom relief, increased antimicrobial resistance rates, treatment failure, and recurrence,” researchers with British drugmaker GSK, which developed the antibiotic in collaboration with the US government’s Biomedical Advanced Research and Development Authority, wrote yesterday in JAMA Network Open.
For the study, the researchers wanted to assess how quickly patients experienced symptom improvement. They enrolled 97 female patients aged 12 and older who had at least two UTI symptoms to receive oral gepotidacin twice daily for five days. The primary outcome was clinical symptom improvement within 24 hours of treatment initiation. The secondary outcomes were clinical symptom improvement and resolution at 48, 72, and 96 hours after treatment initiation (two, three, and four days later).
54% see symptom improvement at 24 hours
Among the 90 women in the clinically evaluable population for the primary outcome, 49 (54%) had symptom improvement at 24 hours. The proportion of women with symptom improvement at 48, 72, and 96 hours was 80%, 90%, and 87%, respectively. Clinical symptom resolution increased from 3% of participants at 24 hours to 90% at day 10.
No serious adverse events were observed.
“Few previous antibiotic studies have reported symptom improvement in uUTIs at similar early time points,” the authors wrote. “Together these findings support gepotidacin as an option to address the unmet need for new oral antibacterials in uUTI treatment and provide a basis for more informed discussions between patients and clinicians regarding treatment expectations.”