FDA Approves Gepotidacin as Oral Treatment of Uncomplicated Urogential Gonorrhea

The US Food and Drug Administration (FDA) has approved gepotidacin (Blujepa) as an oral treatment for patients with uncomplicated urogenital gonorrhea.1

This December 11 announcement by biopharmaceutical company GSK plc follows the FDA’s acceptance of the gepotidacin supplemental New Drug Application (sNDA) for priority review.2 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.

"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.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".

Gonorrhea is a widespread sexually transmitted infection caused by Neisseria gonorrhoeae, and the condition has been labeled a priority pathogen by the World Health Organization (WHO). Gonorrhea infection appears in individuals of all genders and, when untreated or inadequately treated, can result in infertility as well as other serious sexual and reproductive health concerns.

The US Centers for Disease Control and Prevention (CDC) recorded more than 600,000 cases across the US in 2023, making this infection the country’s second most commonly reported sexually transmitted disease. There is no vaccine currently licensed in the US to prevent gonorrhea, and existing care relies on injectable treatments. Such options may not be accessible or appropriate for every individual.

Gepotidacin was designed to address patients' needs as a bactericidal, first-in-class triazaacenaphthylene antibiotic inhibiting the replication of bacterial DNA. It was evaluated in the phase 3 EAGLE-1 analysis, reported in The Lancet. Oral gepotidacin was provided in EAGLE-1 to participants in two 3,000-mg doses. Those given the treatment saw a 92.6% success rate at the urogenital site (95% CI 88.0–95.8).

In the company's release, they noted this outcome met the study's criterion for non-inferiority when compared with the 91.2% success rate identified with the standard regimen of intramuscular ceftriaxone (500 mg) combined with oral azithromycin (1,000 mg) (95% CI 86.4–94.7). Additionally, the EAGLE-1 investigators had observed a lack of treatment group-reported urogenital failures attributable to persistent N. gonorrhoeae.

The safety profile of gepotidacin also showed alignment with earlier research, as no serious drug-related adverse events were seen among those in either cohort. EAGLE-1 investigators found the most frequently reported side effects to this treatment were gastrointestinal symptoms, primarily mild (45% Grade 1) or moderate (29% Grade 2).

This approval is the second major US indication for gepotidacin. Regulatory review for the treatment's implementation for individuals with uncomplicated urinary tract infection is underway in both the United Kingdom and Australia.

References

1. Blujepa (gepotidacin) approved by US FDA as oral option for treatment of uncomplicated urogenital gonorrhoea (uGC). Investis Digital (IDX). https://otp.tools.investis.com/clients/us/gsk/SEC/sec-show.aspx?Type=html&FilingId=18990029&CIK=0001131399&Index=10000.

2. Gepotidacin accepted for priority review by the US FDA for the oral treatment of uncomplicated urogenital gonorrhea. GSK plc. August 11, 2025. Accessed December 9, 2025. https://us.gsk.com/en-us/media/press-releases/gepotidacin-accepted-for-priority-review-by-the-us-fda-for-the-oral-treatment-of-uncomplicated-urogenital-gonorrhea/.