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GSK’s Gepotidacin Granted Priority Review by U.S. FDA

If approved, gepotidacin would offer a new oral option to U.S. patients currently relying on injectable treatments for uncomplicated urogenital gonorrhea.

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By: Charlie Sternberg

Associate Editor

GSK plc’s experimental antibiotic, gepotidacin, has been granted priority review by the U.S. Food and Drug Administration (FDA) for a new use, positioning it as a potential oral treatment for uncomplicated urogenital gonorrhea in patients aged 12 and older. The FDA’s decision sets a Prescription Drug User Fee Act (PDUFA) action date of December 11, 2025, for the supplemental New Drug Application. This marks the second major regulatory milestone for gepotidacin in the U.S. this yea...

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