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A Global, Multi-center, Randomized, Double-blind, Placebo-Controlled, Phase III Trial to Evaluate the Safety and Efficacy of Ibrexafungerp Compared to Placebo for Prevention of Recurrent Vulvovaginal Candidiasis (VVC) in Patients with Vulvovaginal Candidiasis (VVC)

Trial Profile

A Global, Multi-center, Randomized, Double-blind, Placebo-Controlled, Phase III Trial to Evaluate the Safety and Efficacy of Ibrexafungerp Compared to Placebo for Prevention of Recurrent Vulvovaginal Candidiasis (VVC) in Patients with Vulvovaginal Candidiasis (VVC)

Planning
Phase of Trial: Phase III

Latest Information Update: 03 Jan 2019

At a glance

  • Drugs Ibrexafungerp (Primary)
  • Indications Vulvovaginal candidiasis
  • Focus Therapeutic Use
  • Sponsors SCYNEXIS
  • Most Recent Events

    • 03 Jan 2019 According to a SCYNEXIS media release, the company plans to initiate this trial in 1H 2019.
    • 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.
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