dm+d

Unassigned

New Medicines

Recurrent vulvovaginal candidiasis

Information

New molecular entity
Gedeon Richter
Mycovia Pharmaceuticals

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Pre-registration (Filed)
Jun 21Filed in US [8]
Nov 20Mycovia plan to file NDA with US FDA H1 2021, with fast track status. Gideon Richter has an exclusive license to commercialise oteseconazole in Europe [5].

Category

14α-demethylase (CYP51) inhibiitor
About 8% of women suffer recurrent vulvovaginal candidiasis (RVVC) [1].
Recurrent vulvovaginal candidiasis
Oral

Trial or other data

Jan 21Mycovia announce PIII ultraVIOLET study (n=220) met all primary and secondary endpoints. In women treated with oteseconazole recurrence rate of VVC was 5.1% vs. 42.2% with fluconazole to placebo (p
Dec 20Mycovia announce PIII VIOLET studies achieved primary endpoint of proportion of subjects with one or more culture-verified acute vulvovaginal candidiasis (VVC) episodes during the maintenance phase (post-randomization through Week 48) in the intent-to-treat population [6].
Feb 19PIII ultraVIOLET study (NCT03840616) in patients with RVVC starts in US. During part 1 of the study, participants will either take 150mg VT-1161 orally once daily for 2 days or fluconazole 150mg for 3 sequential doses at 72 hour intervals. During part two they will take VT-1161 or placebo once weekly for 11 weeks starting on day 14 [4].
Jun 18Two PIII VIOLET trials (NCT03561701, NCT03562156) to evaluate efficacy and safety of VT-1161 150mg oral capsule in patients aged ≥12 years with RVVC start in US [2,3].