FDA approves gepotidacin for uncomplicated urogenital gonorrhea

On December 11, 2025, the FDA granted an expanded approval to gepotidacin (Blujepa) as an oral treatment for uncomplicated urogenital gonorrhea caused by susceptible strains of Neisseria gonorrhoeae in patients 12 years of age and older weighing at least 45 kg who have limited or no alternative options, GSK announced.¹

Gepotidacin was previously approved in March 2025 for female adult and pediatric patients 12 years of age and older (weighing at least 40 kg) with uncomplicated urinary tract infection (uUTI). The agent received priority review for the expanded indication for gonorrhea in August 2025.

"We're proud to have delivered the first new class of antibiotics for gonorrhoea in over 3 decades and a new oral option for US patients," said Tony Wood, Chief Scientific Officer of GSK, in a release by the comapny.¹ "The ability of N. gonorrhoeae to develop resistance to currently available options, including standard of care, makes it important to expand the range of effective oral treatments"

Data on gepotidacin

The approval 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 (adjusted 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 (500 mg) plus oral azithromycin (1000 mg).

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%).

REFERENCES

1. Blujepa (gepotidacin) approved by US FDA as oral option for treatment of uncomplicated urogenital gonorrhoea (uGC). GSK. December 11, 2025. Accessed December 11, 2025. https://www.gsk.com/en-gb/media/press-releases/blujepa-gepotidacin-approved-by-us-fda-as-oral-option-for-treatment-of-uncomplicated-urogenital-gonorrhoea-ugc/

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