FDA Grants Priority Review for Gepotidacin for Gonorrhea

FDA grants priority review to gepotidacin for uncomplicated urogenital gonorrhea

The target action date for the application is December 11, 2025.

FDA Grants Priority Review for Gepotidacin for Gonorrhea

If this GSK antibiotic is approved, it will provide a new oral option to patients in the US who are currently relying on injectable treatments.

FDA accepts gepotidacin for priority review for gonorrhea oral treatment

FDA accepts priority review of gepotidacin, a first-in-class oral antibiotic, for treating uncomplicated urogenital gonorrhea in patients ≥12 years.

FDA accepts priority review for gepotidacin as oral treatment for gonorrhea

FDA accepts priority review of gepotidacin, a first-in-class oral antibiotic, for treating uncomplicated urogenital gonorrhea in patients ≥12 years.