Oral Gepotidacin Rivals Standard Gonorrhea Regimen in Trial: Daily Dose

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On April 15, 2025, we reported on a study published in The Lancet that examined the efficacy and safety of gepotidacin for the treatment of uncomplicated urogenital gonorrhea.

The study

The EAGLE-1 study was a phase 3, randomized, open-label, sponsor-blinded, multicenter trial conducted across multiple countries between 2019 and 2023. Investigators enrolled 628 participants and compared 2 oral doses of gepotidacin (3000 mg, 10–12 hours apart) with a single standard dose of ceftriaxone (500 mg IM) plus azithromycin (1 g PO).

The findings

In the primary analysis population, culture-confirmed eradication of Neisseria gonorrhoeae from the urogenital site at 4–8 days post-treatment was achieved in 92.6% of participants receiving gepotidacin, compared with 91.2% in the comparator group. The adjusted difference (–0.1%, 95% CI –5.6 to 5.5) met the predefined noninferiority margin of –10%.

Eradication rates at rectal sites were 100% with gepotidacin in the evaluable population and 80% in the ceftriaxone-azithromycin group. Pharyngeal site clearance was lower with gepotidacin (78%) than with ceftriaxone-azithromycin (94%).

Of note, 12% of isolates carried the ParC Asp86Asn mutation, a known marker of resistance to quinolones and potential contributor to gepotidacin resistance. No isolates had the GyrA Ala92Thr mutation. All urethral isolates remained susceptible to ceftriaxone.

Authors' comments

"Gepotidacin demonstrated non-inferiority to ceftriaxone plus azithromycin for urogenital N gonorrhoeae, with no new safety concerns, offering a novel oral treatment option for uncomplicated urogenital [gonorrhea]."

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