A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of VT-1161 Oral Capsules Versus Fluconazole and Placebo in the Treatment of Acute Vulvovaginal Candidiasis Episodes in Subjects With Recurrent Vulvovaginal Candidiasis
Latest Information Update: 26 Aug 2022
At a glance
- Drugs Oteseconazole (Primary) ; Fluconazole
- Indications Vulvovaginal candidiasis
- Focus Registrational; Therapeutic Use
- Acronyms ultraVIOLET
- Sponsors Mycovia Pharmaceuticals
Most Recent Events
- 25 Aug 2022 Results presented in the Mycovia Pharmaceuticals Media Release.
- 18 Jul 2022 Results published in the American Journal of Obstetrics and Gynecology
- 28 Apr 2022 According to a Mycovia Pharmaceuticals media release, U.S. Food and Drug Administration (FDA) approved VIVJOA (oteseconazole capsules), an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential. VIVJOA's FDA approval is based upon the positive results from two global, pivotal VIOLET studies and one U.S.-focused ultraVIOLET study.