A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea
Summary
This is a phase III, randomized, multicenter, open-label study which will be performed to evaluate efficacy and safety of oral Gepotidacin compared to intramuscular (IM) ceftriaxone plus oral azithromycin for the treatment of uncomplicated urogenital infection caused by Neisseria gonorrhoeae (N. gonorrhoeae) in adolescent and adult participants. In this study, participants will be randomly assigned to receive either oral gepotidacin or IM ceftriaxone plus oral azithromycin.
Timeline
- Start
- 2019-10-21
- Primary completion
- 2023-10-10
- Completion
- 2023-10-10
Outcome
Met primary endpoint
paper Gepotidacin was non-inferior to ceftriaxone plus azithromycin. PMID 40245902 ↗
release “EAGLE-1 trial met its primary efficacy endpoint of non-inferiority comparing gepotidacin with intramuscular ceftriaxone plus oral azithromycin combination therapy” gsk.com ↗
release “EAGLE-1 phase III trial which demonstrated that gepotidacin was non-inferior to standard of care combination treatment for gonorrhoea” gsk.com ↗
Publications
- Ross JDC, Wilson J, Workowski KA, Taylor SN, Lewis DA, Gatsi S, Flight W, Scangarella-Oman NE, Jakielaszek C, Lythgoe D, Powell M, Janmohamed S, Absalon J, Perry C. Oral gepotidacin for the treatment of uncomplicated urogenital gonorrhoea (EAGLE-1): a phase 3 randomised, open-label, non-inferiority, multicentre study. Lancet. 2025 May 3;405(10489):1608-1620. doi: 10.1016/S0140-6736(25)00628-2. Epub 2025 Apr 14.
- Perry CR, Scangarella-Oman NE, Millns H, Flight W, Gatsi S, Jakielaszek C, Janmohamed S, Lewis DA. Efficacy and Safety of Gepotidacin as Treatment of Uncomplicated Urogenital Gonorrhea (EAGLE-1): Design of a Randomized, Comparator-Controlled, Phase 3 Study. Infect Dis Ther. 2023 Sep;12(9):2307-2320. doi: 10.1007/s40121-023-00862-6. Epub 2023 Sep 26.
- Fishman C, Caverly Rae JM, Posobiec LM, Laffan SB, Lerman SA, Pearson N, Janmohamed S, Dumont E, Nunn-Floyd D, Stanislaus DJ. Novel Bacterial Topoisomerase Inhibitor Gepotidacin Demonstrates Absence of Fluoroquinolone-Like Arthropathy in Juvenile Rats. Antimicrob Agents Chemother. 2022 Nov 15;66(11):e0048322. doi: 10.1128/aac.00483-22. Epub 2022 Oct 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Azithromycin | Small molecule | 1000 mg | Oral |
| Comparator | Ceftriaxone | Other / unclassified | 500 mg | Intramuscular |
| Subject | Gepotidacin | Small molecule | 3000 mg | Oral |