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

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 year. In March, the FDA approved Blujepa for the treatment of uncomplicated urinary tract infections (uUTI) in a similar patient population.

Clinical Trial Data Supports Efficacy

The FDA’s review is based on data from the EAGLE-1 phase III trial, which was published in The Lancet. The study demonstrated that gepotidacin was non-inferior to the leading combination treatment regimen for gonorrhea—intramuscular ceftriaxone plus oral azithromycin.

According to the trial results, gepotidacin, administered as two oral 3,000mg doses, showed a 92.6% success rate at the urogenital site. This compared favorably to the 91.2% success rate observed in the comparator arm. The study also noted there were no failures due to bacterial persistence in either treatment group.

“The safety and tolerability profile of gepotidacin in the EAGLE-1 trial was consistent with results seen in previous clinical trials, with no serious drug related adverse events observed in either the gepotidacin or the comparator arm,” the company said. “The most common reported adverse reactions were mild to moderate gastrointestinal events.”

The development of gepotidacin has received partial funding from federal sources, including the U.S. Department of Health and Human Services and the U.S. Department of Defense’s Threat Reduction Agency.