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: 12 Nov 2019
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At a glance
- Drugs Ibrexafungerp (Primary)
- Indications Vulvovaginal candidiasis
- Focus Registrational; Therapeutic Use
- Acronyms VANISH 303
- Sponsors SCYNEXIS
- 12 Nov 2019 According to a SCYNEXIS media release, the company anticipates submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ibrexafungerp for the treatment of VVC in the second half of 2020.
- 07 Nov 2019 According to a SCYNEXIS media release, the comprehensive analysis of the totality of the data from this study is still ongoing.
- 07 Nov 2019 According to a SCYNEXIS media release, the top-line results come earlier than originally anticipated due to faster-than-expected enrollment in this study.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History