GSK announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for gepotidacin, an oral antibiotic, for the treatment of uncomplicated urogenital gonorrhea in patients aged 12 and older. The application has been granted priority review, with a decision expected by December 11, 2025.
If approved, gepotidacin would be the first new oral treatment for gonorrhea in decades, offering an alternative to current injectable therapies. The drug, marketed under the name Blujepa, is already approved in the U.S. for treating uncomplicated urinary tract infections (uUTIs) in certain female patients.
Gonorrhea, caused by Neisseria gonorrhoeae, is the second most commonly reported sexually transmitted infection in the U.S., with over 600,000 cases recorded in 2023. The infection can lead to serious reproductive health complications if left untreated. With no licensed vaccine and growing concerns about antibiotic resistance, the need for new treatment options is pressing.
The FDA’s decision to grant priority review follows promising results from the Phase III EAGLE-1 trial. The study, published in The Lancet, demonstrated that gepotidacin (given as two oral doses of 3,000mg) was non-inferior to the current standard of care—an injectable combination of ceftriaxone and oral azithromycin. Gepotidacin achieved a 92.6% cure rate at the urogenital site, compared to 91.2% with the comparator treatment. No bacterial persistence of N. gonorrhoeae was observed in either group.
Safety data from the trial showed that gepotidacin was well-tolerated, with no serious drug-related adverse events. The most common side effects were mild to moderate gastrointestinal symptoms.
This marks the second major indication GSK has filed for gepotidacin in the U.S., with regulatory reviews for its uUTI use ongoing in the UK and Australia.
Development of gepotidacin has been supported by the U.S. Biomedical Advanced Research and Development Authority (BARDA) and the Department of Defense’s Threat Reduction Agency.