A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects with Acute Vulvovaginal Candidiasis
Phase of Trial: Phase III
Latest Information Update: 06 Dec 2019
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At a glance
- Drugs Ibrexafungerp (Primary)
- Indications Vulvovaginal candidiasis
- Focus Registrational; Therapeutic Use
- Sponsors SCYNEXIS
- 06 Dec 2019 Planned number of patients changed from 435 to 470.
- 03 Jan 2019 According to a SCYNEXIS media release, the company remains on track to report top-line data in 1H 2020.
- 03 Jan 2019 According to a SCYNEXIS media release, the VANISH phase 3 registration program comprises two phase 3 trials (CTP profiles 294107,301066).Pending successful completion of these two trials, SCYNEXIS plans to file an initial NDA for oral ibrexafungerp for the treatment of Vulvovaginal Candidiasis (VVC) in 2H 2020.