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Antibiotic Noninferior to Ceftriaxone + Azithromycin for Gonorrhea

Medically reviewed by Carmen Pope, BPharm. Last updated on April 21, 2025.

By Elana Gotkine HealthDay Reporter

MONDAY, April 21, 2025 -- For uncomplicated urogenital gonorrhea, gepotidacin, which inhibits bacterial DNA replication, is noninferior to ceftriaxone plus azithromycin, according to a study published online April 14 in The Lancet.

Jonathan D.C. Ross, M.D., from the Birmingham University Hospitals NHS Foundation Trust in the United Kingdom, and colleagues conducted a phase 3 noninferiority study comparing oral gepotidacin (two 3,000-mg doses administered 10 to 12 hours apart) to 500 mg intramuscular ceftriaxone plus 1 g oral azithromycin for gonorrhea treatment. Eligible participants aged 12 years or older with suspected uncomplicated urogenital gonorrhea, a positive laboratory test for Neisseria gonorrhoeae, or both were randomly assigned to the treatment groups (314 to each group).

The microbiological intention-to-treat population included 406 participants (202 and 204 in the gepotidacin and ceftriaxone plus azithromycin groups, respectively). The researchers found that the results of the primary analysis of microbiological response at test-of-cure (days 4 to 8) demonstrated microbiological success rates of 92.6 and 91.2 percent in the gepotidacin and ceftriaxone plus azithromycin groups, respectively, demonstrating the noninferiority of gepotidacin. At test-of-cure, neither group had bacterial persistence of urogenital N. gonorrhoeae. Higher rates of adverse events and drug-related adverse events were seen in the gepotidacin group, which was mainly due to gastrointestinal adverse events and almost all of which were mild or moderate. Neither group reported treatment-related severe or serious adverse events.

"Gepotidacin is a novel oral antibacterial treatment with the potential to become an alternative option for the treatment of gonococcal infections, supported by an acceptable safety and tolerability profile," the authors write.

Several authors disclosed ties to pharmaceutical companies, including GSK, which manufactures gepotidacin and partially funded the study.

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Posted April 2025

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