Drugs / SHR8008
last change Sep 2023 re-read 9 days ago

SHR8008

Developed for
vulvovaginal candidiasis
Investigated by
Jiangsu HengRui Medicine Co., Ltd.

Trials 2

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 3 NCT05074602 Sep 2021 → Sep 2023 vulvovaginal candidiasis Jiangsu HengRui Medicine Co., Ltd. Unknown No outcome recorded
Phase 3 NCT04956419 Apr → Sep 2021 vulvovaginal candidiasis Jiangsu HengRui Medicine Co., Ltd. Unknown No outcome recorded

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2023-08-21 Mycovia Pharmaceuticals Inc. Regulatory Mycovia Pharmaceuticals, Inc. Announces Partner Jiangsu Hengrui Pharmaceuticals Co., Ltd’s Approval of Oteseconazole Capsules for the Treatment of Severe Vulvovaginal Candidiasis (VVC) in China mycovia.com ↗
Mycovia Pharmaceuticals, Inc. (“Mycovia”), an emerging biopharmaceutical company, today announced that Jiangsu Hengrui Pharmaceuticals Co., Ltd (“Hengrui”) received approval in June from the National Medical Products Administration for Oteseconazole Capsules, an azole antifungal, indicated for the treatment of severe vulvovaginal candidiasis (VVC).

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as SHR8008 ClinicalTrials.gov intervention name — accepted as the source's own label NCT04956419 ↗
1

NCT05074602 ↗

Route Oral “once daily for 2 days(Day 1 and Day 2),oral” NCT04956419 ↗