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Find Clinical Drug Pipeline Developments & Deals for Oteseconazole
Vivjoa (oteseconazole) is a selective and orally bioavailable CYP51 inhibitor antifungal, which is approved in China for the treatment of severe vulvovaginal candidiasis.
VIVJOA® (oteseconazole) is an azole antifungal and designed to selectively inhibit fungal CYP51, which is indicated for the treatment of severe vulvovaginal candidiasis (VVC).
VIVJOA (oteseconazole) was statistically superior to placebo in preventing recurrence of infection in women with RVVC and noninferior to fluconazole in treating acute VVC in women with RVVC.
Of the 71 VIVJOA (oteseconazole) treated participants in the observational extension study, 85% completed 96 weeks without a recurrent VVC episode, where they had experienced at least three episodes in the year prior to study entry.
Two global VIOLET Phase 3 studies met primary and key secondary endpoints, with authors concluding VIVJOA (oteseconazole) is highly efficacious in preventing recurrence of VVC through 48 weeks in participants with a history of RVVC.
VIVJOA™ (oteseconazole) capsules are 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.
85% of patients who took a 12-week course of Vivjoa (oteseconazole) completed 96 weeks without a recurrent VVC episode, with an average time of 92 weeks without recurrence.
Approval of VIVJOA™ marks a significant therapeutic advancement for reducing the incidence of RVVC, a condition with substantial unmet need, in permanently infertile and postmenopausal women.
Oteseconazole (VT-1161) is a novel, oral therapy for RVVC that is designed with the goal of having greater selectivity, fewer side effects and improved efficacy for treatment of recurrent vulvovaginal candidiasis (RVVC).
Oteseconazole’s clinical development plan was comprised of three trials – two global VIOLET studies and one U.S.-focused ultraVIOLET study, including more than 870 patients at 232 sites across 11 countries.
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