The FDA has approved gepotidacin, marketed as Blujepa, as a first-in-class oral antibiotic for the treatment of uncomplicated urinary tract infections in female adults and pediatric patients aged 12 years or older.

Gepotidacin is a triazaacenaphthylene bacterial type II topoisomerase inhibitor, representing a novel chemical class, and is the first oral antibiotic with a new mechanism of action approved for uncomplicated urinary tract infections in nearly 30 years. The approval was based on data from two phase III trials showing gepotidacin's therapeutic success and its in vitro activity against common uropathogens, making it a promising addition to the treatment options for uncomplicated urinary tract infections. The safety profile of gepotidacin was consistent with prior studies, with gastrointestinal events being the most common adverse events.

A U.S. commercial launch is anticipated in the second half of 2025.