Lancet

Recently approved oral antibiotic shows promise against drug-resistant gonorrhea

April 25, 2025

Study details: The phase 3 randomized, open-label EAGLE-1 trial evaluated the efficacy and safety of oral gepotidacin (two doses of 3,000 mg) compared with the standard treatment regimen of IM ceftriaxone (500 mg) plus PO azithromycin (1,000 mg) in 628 patients ≥12 years of age with uncomplicated urogenital gonorrhea. The primary endpoint was the microbiological response at the test-of-cure visit (3-7 days post-treatment).

Results: Gepotidacin demonstrated non-inferiority to the combination therapy, achieving a 92.6% microbiological success rate, vs. 91.2% for ceftriaxone plus azithromycin. The safety profile of gepotidacin was consistent with previous trials, with GI adverse events being the most common.

Clinical impact: Gepotidacin may offer a promising new oral treatment option for uncomplicated urogenital gonorrhea, particularly in the context of rising antimicrobial resistance. Its efficacy and safety profile support its potential role in addressing the urgent need for new antibiotics in the face of growing resistance to existing treatments.

Source:

Ross JDC, et al. (2025, April 15). Lancet. Oral gepotidacin for the treatment of uncomplicated urogenital gonorrhoea (EAGLE-1): a phase 3 randomised, open-label, non-inferiority, multicentre study. https://pubmed.ncbi.nlm.nih.gov/40245902/