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A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) Compared to Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)

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Trial Profile

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) Compared to Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Jun 2023

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At a glance

  • Drugs Ibrexafungerp (Primary) ; Fluconazole
  • Indications Vulvovaginal candidiasis
  • Focus Registrational; Therapeutic Use
  • Acronyms CANDLE; CANDLE 304s
  • Sponsors SCYNEXIS

Most Recent Events

  • 01 Dec 2022 According to a SCYNEXIS media release, the U.S. Food and Drug Administration (FDA) has approved a second indication for BREXAFEMME (ibrexafungerp tablets) for the reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC), on November 30, 2022.
  • 04 Aug 2022 Results published in the SCYNEXIS Media Release.
  • 04 Aug 2022 According to a SCYNEXIS media release, results from the study were presented during the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) Annual Meeting.

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