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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: 19 Jun 2025

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At a glance

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

Most Recent Events

  • 12 Jun 2025 According to an Innoviva media release, the U.S.FDA has granted Priority Review for the New Drug Application for zoliflodacin, for the treatment of uncomplicated gonorrhea in adults and pediatric patients 12 years and older. The FDA assigned a target action date of December 15, 2025 under the Prescription Drug User-Fee Act. It is expected the FDA will notify company FDA's decision to conduct an Advisory Committee Meeting in the Day 74 letter.
  • 10 Jun 2025 According to an Innoviva media release, the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for zoliflodacin,for the treatment of uncomplicated gonorrhea in adults and pediatric patients 12 years and older. If approved, zoliflodacin would be the first new antibiotic for treating gonorrhea in decades.
  • 07 May 2025 According to an Innoviva media release, Zoliflodacin NDA is on track for filing with the U.S. FDA in 1H 2025.

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