FDA Expands Use of GSK's Gepotidacin as Oral Treatment for Uncomplicated Urogenital Gonorrhea

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The US Food and Drug Administration (FDA) has approved gepotidacin (Blujepa, GSK) for the treatment of uncomplicated urogenital gonorrhea. This oral antibiotic is indicated for people aged 12 years and older who have limited or no alternative treatment options.1

The approval, announced on December 11, makes gepotidacin the first in a new class of antibiotics approved for gonorrhea in over 3 decades.1

“We’re proud to have delivered the first new class of antibiotics for gonorrhoea in over three decades and a new oral option for US patients,” Tony Wood, Chief Scientific Officer of GSK, said in a statement. “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."1

Th approval follows the FDA’s acceptance of the gepotidacin supplemental New Drug Application (sNDA) for priority review in August 2025. The application for this oral treatment of uncomplicated urogenital gonorrhea was submitted as an option for patients 12 years of age and older who weigh ≥45 kg.2

Gonorrhea is a common sexually transmitted infection (STI) caused by the bacterium Neisseria gonorrhoeae. It affects both men and women and, if left untreated or inadequately treated, can lead to serious sexual and reproductive health complications, including infertility.

In 2023, the US Centers for Disease Control and Prevention (CDC) reported more than 600 000 cases of gonorrhea across the US. This figure makes it the country’s second most commonly reported STI, behind chlamydia. Current standard care for gonorrhea relies on an injectable antibiotic treatment.3

The approval was based on data from the phase 3 EAGLE-1 trial. The analysis found that oral gepotidacin, administered as two 3000-mg doses, met the study’s criterion for non-inferiority when compared with the standard regimen of intramuscular ceftriaxone (500 mg) combined with oral azithromycin (1000 mg).4

Specifically, gepotidacin demonstrated a 92.6% microbiological success rate at the urogenital site (95% CI 88.0–95.8), compared to 91.2% for the standard combination regimen (95% CI 86.4–94.7). Investigators also observed no urogenital failures in the gepotidacin group attributable to persistent N. gonorrhoeae.4

The safety profile of gepotidacin in the trial was consistent with earlier research. No serious drug-related adverse events were observed. The most frequently reported side effects were gastrointestinal symptoms, which were primarily mild (45% Grade 1) or moderate (29% Grade 2).4

This is the second major US indication for gepotidacin, which is already approved for women aged 12 years and older to treat uncomplicated urinary tract infections.5

References:

1. US FDA expands use of GSK's Blujepa as treatment for gonorrhea. Reuters. News release. December 11, 2025. Accessed December 11, 2025. https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-gsks-oral-treatment-gonorrhea-2025-12-11/
2. Gepotidacin accepted for priority review by the US FDA for the oral treatment of uncomplicated urogenital gonorrhoea. News release. GSK. August 11, 2025. Accessed December 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/
3. Centers for Disease Control and Prevention. Sexually Transmitted Infections Surveillance, 2023. https://www.cdc.gov/sti-statistics/annual/index.html. Published November 12, 2024. Accessed December 11, 2025.
4. Ross JDC, Wilson J, 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. Published online April 14, 2025. doi:10.1016/S0140-6736(25)00628-2
5. Blujepa (gepotidacin) approved by US FDA for treatment of uncomplicated urinary tract infections (uUTIs) in female adults and paediatric patients 12 years of age and older. News release. GSK. March 25, 2025. Accessed December 11, 2025. https://www.gsk.com/en-gb/media/press-releases/blujepa-gepotidacin-approved-by-us-fda-for-treatment-of-uncomplicated-urinary-tract-infections/