Observational studyDrug design, development and therapy2026
Efficacy and Safety of Oteseconazole in Severe Vulvovaginal Candidiasis Categorized by
Observational study in Drug design, development and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04956419 (A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Fluconazole Controlled, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole in Subjects With Acute Vulvovaginal Candidiasis), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Fluconazole Controlled, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole in Subjects With Acute Vulvovaginal Candidiasis (VVC)
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Purpose: Oteseconazole, a novel selective fungal CYP51 inhibitor, demonstrated superior efficacy over fluconazole for severe vulvovaginal candidiasis (SVVC) in a phase 3 trial. However, whether the efficacy and safety of oteseconazole on SVVC varies by Patients and Methods: In this exploratory post hoc analysis of a phase 3 trial (NCT04956419), data were analyzed from patients with SVVC receiving oteseconazole (600 mg on day 1 and 450 mg on day 2) or fluconazole (150 mg on days 1 and 4). The primary outcome was therapeutic cure rate at day 28, assessed in subgroups categorized by Results: Of 319 patients categorized by Conclusion: Oteseconazole may offer benefits and is generally well tolerated in patients with SVVC, irrespective of
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