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A Phase 3, Multicenter, Prospective, Randomized, Double-blind Study of Two Treatment Regimens for Candidemia and/or Invasive Candidiasis: Intravenous Echinocandin Followed by Oral Ibrexafungerp Versus Intravenous Echinocandin Followed by Oral Fluconazole (MARIO)

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Trial Profile

A Phase 3, Multicenter, Prospective, Randomized, Double-blind Study of Two Treatment Regimens for Candidemia and/or Invasive Candidiasis: Intravenous Echinocandin Followed by Oral Ibrexafungerp Versus Intravenous Echinocandin Followed by Oral Fluconazole (MARIO)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 22 Jun 2025

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At a glance

  • Drugs Ibrexafungerp (Primary) ; Anidulafungin; Caspofungin; Fluconazole; Micafungin; Voriconazole
  • Indications Candidaemia; Invasive candidiasis
  • Focus Registrational; Therapeutic Use
  • Acronyms MARIO
  • Sponsors SCYNEXIS

Most Recent Events

  • 31 May 2025 Planned End Date changed from 1 Aug 2024 to 28 Feb 2027.
  • 31 May 2025 Planned primary completion date changed from 1 Jun 2024 to 31 Dec 2026.
  • 28 May 2025 According to Scynexis media release, first new patient dosed in Phase 3 MARIO study following the lifting of the FDA clinical hold. Resumption of dosing in this study triggers a $10M milestone payment from GSK plus an additional $20M milestone due in six months; as previously disclosed GSK disputes these milestone payments, and SCYNEXIS vigorously disagrees with their position.

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