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A Phase 3, Multicenter, Randomized, Double-blind Study of the Efficacy and Safety of Rezafungin for Injection vs. Intravenous Caspofungin Followed by Oral Fluconazole Step Down in the Treatment of Subjects With Candidemia and/or Invasive Candidiasis

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A Phase 3, Multicenter, Randomized, Double-blind Study of the Efficacy and Safety of Rezafungin for Injection vs. Intravenous Caspofungin Followed by Oral Fluconazole Step Down in the Treatment of Subjects With Candidemia and/or Invasive Candidiasis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Aug 2024

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At a glance

  • Drugs Rezafungin (Primary) ; Caspofungin; Fluconazole
  • Indications Candidaemia; Invasive candidiasis
  • Focus Registrational; Therapeutic Use
  • Acronyms ReSTORE
  • Sponsors Cidara Therapeutics

    • Most Recent Events

    • 23 May 2024 According to Melinta Therapeutics Media Release, data from the study were presented in the American Society for Microbiology Antimicrobial Agents and Chemotherapy
    • 23 May 2024 Results presented in the Melinta Therapeutics Media Release.
    • 02 Feb 2024 According to a Napp Pharmaceuticals media release, company announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised rezafungin for the treatment of invasive candidiasis in adults in Great Britain. The authorisation was based on positive results from the pivotal ReSTORE Phase III clinical trial. The findings are supported by the STRIVE Phase II clinical trial and an extensive nonclinical development program.

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