Oral gepotidacin achieved over 92% cure rates for uncomplicated urogenital gonorrhea, matching the efficacy of a current leading injectable therapy.
The U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental New Drug Application for gepotidacin as an oral treatment for uncomplicated urogenital gonorrhea in patients aged at least 12 years old and weighing at least 45 kg, with a Prescription Drug User Fee Act action date of December 11, 2025.
If approved, gepotidacin would provide the first oral treatment option for gonorrhea in the U.S., where the current standard of care relies on injectable therapy. Gonorrhea, caused by Neisseria gonorrhoeae, is the second most reported sexually transmitted infection in the U.S., with more than 600,000 cases reported in 2023. The pathogen is classified as a priority pathogen by the World Health Organization and an urgent public health threat by the Centers for Disease Control and Prevention.
The submission is supported by data from the phase 3 EAGLE-1 trial, published in The Lancet, which demonstrated noninferiority of gepotidacin (oral, 2 doses of 3,000 mg) to intramuscular ceftriaxone (500 mg) plus oral azithromycin (1,000 mg) for uncomplicated urogenital gonorrhea. The primary endpoint was achieved in 92.6% of patients receiving gepotidacin and 91.2% of patients receiving comparator therapy. No failures due to persistent N. gonorrhoeae were reported in either arm. The safety profile was consistent with previous studies, with no serious drug-related adverse events observed. The most common treatment-related adverse events were gastrointestinal, predominantly mild (45%) to moderate (29%) in severity.
Gepotidacin, marketed as Blujepa for uncomplicated urinary tract infection since its FDA approval in March 2025, is a first-in-class triazaacenaphthylene antibiotic that inhibits bacterial DNA replication via a novel binding site, providing balanced inhibition of two type II topoisomerase enzymes. This mechanism confers activity against N. gonorrhoeae and most target uropathogens, including resistant strains. Development has been partially funded by the Biomedical Advanced Research and Development Authority and the U.S. Department of Defense’s Threat Reduction Agency.
Regulatory reviews for the uncomplicated urinary tract infection indication are ongoing in the United Kingdom and Australia. GSK notes that gepotidacin’s development aligns with its longstanding strategy to advance treatments for infectious diseases and address antimicrobial resistance.
Source: GSK
