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)
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
- 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.