FDA grants priority review to gepotidacin for uncomplicated urogenital gonorrhea

The FDA has granted priority review to a supplemental new drug application (sNDA) seeking approval of gepotidacin as an oral treatment for uncomplicated urogenital gonorrhea in patients 12 years of age and older (weighing ≥45 kg), GSK announced in a news release.¹

The Prescription Drug User Fee Act target action date for the application is December 11, 2025.

According to GSK, “There is currently no vaccine licensed in the US for the prevention of gonorrhea infection, and the standard of care is injectable treatment, which may not be suitable or available for all patients.” If approved, gepotidacin would offer patients with gonorrhea an oral treatment option.

Data on Gepotidacin

The sNDA is supported by data from the phase 3 EAGLE-1 trial (NCT04010539), which showed that gepotidacin was non-inferior to combined treatment with intramuscular ceftriaxone plus oral azithromycin in regard to the treatment success rates (microbiological response) at the urogenital site.² Specifically, treatment with gepotidacin led to a 92.6% (95% CI, 88.0 to 95.8) success rate at the urogenital site compared with a rate of 91.2% (95% CI, 86.4 to 94.7) in the intramuscular ceftriaxone plus oral azithromycin arm (treatment difference, -0.1; 95% CI, -5.6 to 5.5; P = .5072).

There were no reported cases of failure at the urogenital site due to bacterial persistence of N. gonorrhoeae in either treatment arm.

In total, the open-label EAGLE-1 trial enrolled 628 patients with uncomplicated urogenital gonorrhea. Patients enrolled in the study were randomly assigned 1:1 to receive gepotidacin (2 doses of 3000 mg administered orally) or to intramuscular ceftriaxone (500mg) plus oral azithromycin (1000mg).

The primary end point for the trial was microbiological success, defined as culture-confirmed bacterial eradication of N. gonorrhoeae from the urogenital body site at the test-of-cure visit (days 4–8), assessed in the microbiological intention-to-treat population (n = 406; 202 in the gepotidacin arm and 204 in the combination arm).

Data from the trial also showed that gepotidacin was well-tolerated. There were no new safety concerns associated with gepotidacin, with data consistent with the known safety profile of the agent. No serious treatment-related adverse events (AEs) occurred in either arm. Reported AEs in the gepotidacin arm were generally mild to moderate gastrointestinal events. A post-hoc analysis of the data showed that most gastrointestinal AEs of special interest occurred on day 1, with few incidents occurring after day 2.

The most frequent AEs in the gepotidacin arm were diarrhea (49%) and nausea (24%).

Gepotidacin (Blujepa) was previously approved in March 2025 for female adult and pediatric patients 12 years of age and older (weighing ≥40 kg) with uncomplicated urinary tract infection (uUTI). Regulatory authorities in the UK and Australia are also reviewing applications for gepotidacin in the uUTI indication.

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 12, 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. Ross JDC, Wilson K, Workowski KA, et al. Oral gepotidacin for the treatment of uncomplicated urogenital gonorrhoea (EAGLE-1): a phase 3 randomised, open-label, non-inferiority, multicentre study. Lancet. 2025;405(10489):1608-1620. doi:10.1016/S0140-6736(25)00628-2