- Gepotidacin, marketed as Blujepa, is a first-in-class oral antibiotic.
- It is FDA-approved for the treatment of uncomplicated urinary tract infections in female adults and pediatric patients aged 12 years or older.
- Gepotidacin demonstrated activity against common uropathogens and is the first oral antibiotic with a new mechanism of action approved for uncomplicated urinary tract infections in nearly 30 years.
- Data from two phase III trials, EAGLE-2 and EAGLE-3, supported its approval.
- The safety profile of gepotidacin was consistent with prior studies, with gastrointestinal adverse events being the most common.
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