The U.S. FDA has approved gepotidacin, a first-in-class oral antibiotic with a novel mechanism of action, for treating uncomplicated urinary tract infections (uUTIs) in female adults and pediatric patients aged 12 years and older, weighing at least 40 kg. Gepotidacin is a triazaacenaphthylene bacterial type II topoisomerase inhibitor indicated specifically for uUTIs caused by Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis.
Clinical evidence In two clinical trials involving 3,136 female patients, gepotidacin was found to be non-inferior to nitrofurantoin. Notably, gepotidacin achieved clinical cure rates of 66.7% and 68.2% compared to 65.8% and 63.6% with nitrofurantoin, respectively. Dosage and administration Available as tablets 1,500 mg (two 750 mg tablets) taken orally, twice daily (approximately 12 hours…
