FDA Accepts Gepotidacin for Priority Review for the Treatment of Uncomplicated Urogenital Gonorrhea

The US Food and Drug Administration (FDA) has accepted for priority review a supplemental New Drug Application for gepotidacin for the treatment of uncomplicated urogenital gonorrhea in persons aged 12 years and older weighing at least 45 kg. The Prescription Drug User Fee Act (PDUFA) goal date for a regulatory decision is December 11, 2025.¹

If approved, gepotidacin would be the first new oral treatment option for gonorrhea in the US in decades. Current standard therapy involves injectable ceftriaxone, which may not be suitable or accessible for all patients. Gonorrhea, caused by Neisseria gonorrhoeae, is recognized by the World Health Organization as a priority pathogen and by the US Centers for Disease Control and Prevention (CDC) as an urgent public health threat. In 2023, the CDC reported more than 600 000 cases of gonorrhea in the US, making it the second most commonly reported sexually transmitted infection in the country.^1,2

The FDA submission is supported by data from the phase 3 EAGLE-1 trial, which randomized approximately 600 patients with uncomplicated urogenital gonorrhea to receive either gepotidacin (oral, 2 doses of 3000 mg) or the current leading regimen of intramuscular ceftriaxone (500 mg) plus oral azithromycin (1000 mg). Gepotidacin achieved a 92.6% microbiological success rate at the urogenital site, compared with 91.2% for the comparator regimen, meeting the non-inferiority endpoint. No cases of bacterial persistence were reported in either group. The safety profile was consistent with previous studies, with no serious drug-related adverse events; the most common adverse effects were mild to moderate gastrointestinal events.¹

Gepotidacin, discovered by GSK, is a first-in-class triaza-acenaphthylene antibiotic with a novel mechanism of action that inhibits bacterial DNA replication via dual type II topoisomerase enzyme inhibition. It is active against N. gonorrhoeae and other uropathogens, including strains resistant to existing antibiotics.¹

This is the second US indication under review for gepotidacin; it was approved in March 2025 under the brand name Blujepa for the treatment of uncomplicated urinary tract infections in adult and pediatric females.³

References:

1. Gepotidacin accepted for priority review by the US FDA for the oral treatment of uncomplicated urogenital gonorrhoea. News release. GSK. August 11, 2025. Accessed August 11, 2025. https://www.gsk.com/en-gb/media/press-releases/gepotidacin-accepted-for-priority-review-by-the-us-fda-for-the-oral-treatment-of-uncomplicated-urogenital-gonorrhoea/
2. Jennings S. STI epidemic in US shows signs of slowing, according to new CDC report. Patient Care Online. November 13, 2024. https://www.patientcareonline.com/view/sti-epidemic-in-us-shows-signs-of-slowing-according-to-new-cdc-report
3. Jennings S. FDA approves gepotidacin (Blujepa) for treatment of uncomplicated UTIs. Patient Care Online. March 25, 2025. https://www.patientcareonline.com/view/fda-approves-gepotidacin-blujepa-for-treatment-of-uncomplicated-utis