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A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate the Safety and Efficacy of Ibrexafungerp Compared to Placebo in Patients with Vulvovaginal Candidiasis (VVC)

Trial Profile

A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate the Safety and Efficacy of Ibrexafungerp Compared to Placebo in Patients with Vulvovaginal Candidiasis (VVC)

Planning
Phase of Trial: Phase III

Latest Information Update: 30 Oct 2018

At a glance

  • Drugs Ibrexafungerp (Primary)
  • Indications Vulvovaginal candidiasis
  • Focus Registrational; Therapeutic Use
  • Most Recent Events

    • 30 Oct 2018 New trial record
    • 23 Oct 2018 According to a SCYNEXIS media release, the company is well-positioned to successfully execute the proposed phase 3 program.Pending successful completion of these trials (CT profiles 294107,301066 and 301067) , the company anticipates filing an initial NDA for oral ibrexafungerp for the treatment of VVC in 2020 and a supplemental NDA for the prevention of recurrent VVC in 2021.
    • 23 Oct 2018 According to a SCYNEXIS media release, SCYNEXIS expects to initiate the proposed phase III program in the fourth quarter of 2018.This VVC registration program will be comprised of three global studies which includes two phase III trials for treatment of vulvovaginal candidiasis (CT profile 294107 and 301066) and one phase III trial for prevention of recurrent vulvovaginal candidiasis (CT profile 301067) .
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