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A Multi-center, Randomized, Open-label, Non Inferiority Trial to Evaluate the Efficacy and Safety of a Single, Oral Dose of Zoliflodacin Compared to a Combination of a Single Intramuscular Dose of Ceftriaxone and a Single Oral Dose of Azithromycin in the Treatment of Patients With Uncomplicated Gonorrhoea

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Trial Profile

A Multi-center, Randomized, Open-label, Non Inferiority Trial to Evaluate the Efficacy and Safety of a Single, Oral Dose of Zoliflodacin Compared to a Combination of a Single Intramuscular Dose of Ceftriaxone and a Single Oral Dose of Azithromycin in the Treatment of Patients With Uncomplicated Gonorrhoea

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Dec 2025

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At a glance

  • Drugs Zoliflodacin (Primary) ; Azithromycin; Ceftriaxone
  • Indications Gonococcal urethritis; Gonorrhoea
  • Focus Registrational; Therapeutic Use

Most Recent Events

  • 19 Dec 2025 According to an Innoviva media release, the U.S. Food and Drug Administration (FDA) approved Nuzolvence (zoliflodacin for oral suspension) for the treatment of uncomplicated urogenital gonorrhea in adults and children aged 12 years and older weighing at least 35 kg.
  • 12 Dec 2025 Results presented in an Innoviva media release.
  • 11 Dec 2025 According to an Innoviva media release, The Phase 3 trial was supported with funding from the governments of Germany (BMFTR), UK (GAMRIF, part of DHSC, and DFID), Japan (MHLW), the Netherlands (Ministries of VWS and BZ), Switzerland (FOPH), The Grand Duchy of Luxembourg, the Canton of Geneva, the South African Medical Research Council (SAMRC), and the Leo Model Foundation.

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