Drugs / Oteseconazole
Oteseconazole
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed vulvovaginal candidiasis 1 milestone | |||||
| Filed | US (FDA) | — | vulvovaginal candidiasis | 2021-06-01 | “today announced it has submitted its New Drug Application (NDA) for oteseconazole, an oral antifungal product for the treatment of recurrent vulvovaginal candidiasis (RVVC).” mycovia.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | VIVJOA | — | 2022-04-26 | fda.gov ↗ |
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 25 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT07804368 | Dec 2026 → Dec 2028 expected | blastomycosis, coccidioidomycosis, histoplasmosis | University of Minnesota | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT02267356 | Feb 2015 → Oct 2016 | tinea unguium | Viamet | Completed | No outcome recorded |
| Phase 2 | NCT02267382 | Feb 2015 → Nov 2016 | vulvovaginal candidiasis | Viamet | Completed | Met primary |
| Phase 2 | NCT01891331 | Aug 2013 → Dec 2014 | vulvovaginal candidiasis | Viamet | Completed | Missed primary |
| Phase 2 | NCT01891305 | Aug 2013 → Dec 2014 | tinea pedis | Viamet | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT06666322 | May 2025 → Apr 2032 expected | Cryptococcal meningitis, HIV infectious disease | University of Minnesota | Recruiting | No outcome recorded |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT03840616 | Mar 2019 → Dec 2020 | vulvovaginal candidiasis | Mycovia Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03561701 | Aug 2018 → Oct 2020 | vulvovaginal candidiasis | Mycovia Pharmaceuticals Inc. | Completed | Met primary |
| Phase 3 | NCT03562156 | Aug 2018 → Oct 2020 | vulvovaginal candidiasis | Mycovia Pharmaceuticals Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2025-11-18 | Mycovia Pharmaceuticals Inc. | Results Mycovia Pharmaceuticals, Inc. Announces Publication of 2-Year VIVJOA® Efficacy Results from an Extension of the VIOLET Phase 3 Studies in Women with Recurrent Vulvovaginal Candidiasis (RVVC) in the Journal of Women’s Health mycovia.com ↗
Mycovia Pharmaceuticals, Inc. (“Mycovia”) has announced the publication of long-term efficacy results from an extension study of the VIOLET Phase 3 clinical program which evaluated VIVJOA (oteseconazole) capsules in women with RVVC in the Journal of Women’s Health. |
| 2025-04-02 | Mycovia Pharmaceuticals Inc. | Regulatory Mycovia Pharmaceuticals, Inc. Announces Partner Jiangsu Hengrui Pharmaceuticals Co., Ltd.’s Recognition for the Inclusion of VIVJOA® (Oteseconazole) Capsules in the Chinese National Reimbursement Drug List mycovia.com ↗
VIVJOA is now included in the National Reimbursement Drug List for treating severe VVC in China |
| 2024-01-31 | Mycovia Pharmaceuticals Inc. | Results Mycovia Pharmaceuticals, Inc. Announces Publication of Partner Jiangsu Hengrui Pharmaceuticals’ Phase 3 Clinical Study Evaluating the Efficacy and Safety of VIVJOA® (Oteseconazole) Versus Fluconazole in Women with Vulvovaginal Candidiasis (VVC) in the Journal Antimicrobial Agents and Chemotherapy mycovia.com ↗ |
| 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). |
| 2022-08-25 | Mycovia Pharmaceuticals Inc. | Results Mycovia Pharmaceuticals’ Phase 3 ultraVIOLET Study Evaluating the Efficacy and Safety of VIVJOA™ (oteseconazole) in Women with Recurrent Vulvovaginal Candidiasis (RVVC) Published in the American Journal of Obstetrics and Gynecology mycovia.com ↗
The authors concluded that VIVJOA was statistically superior to placebo in preventing recurrence of VVC through 50 weeks in women with a history of RVVC. |
| 2022-07-26 | Mycovia Pharmaceuticals Inc. | Results Mycovia Pharmaceuticals Announces Publication of Positive Phase 3 Data Evaluating VIVJOA™ (oteseconazole) Capsules in Patients with Recurrent Vulvovaginal Candidiasis (RVVC) in NEJM Evidence mycovia.com ↗
Two global VIOLET Phase 3 studies met primary and key secondary endpoints, with authors concluding VIVJOA is highly efficacious in preventing recurrence of VVC through 48 weeks in participants with a history of RVVC |
| 2022-06-22 | Mycovia Pharmaceuticals Inc. | Results Mycovia Pharmaceuticals Announces Positive New Clinical Findings Evaluating VIVJOA™ (oteseconazole) Capsules in Patients with Recurrent Vulvovaginal Candidiasis (RVVC) mycovia.com ↗
Mycovia Pharmaceuticals, Inc. (“Mycovia”), an emerging biopharmaceutical company dedicated to recognizing and empowering those living with unmet medical needs by developing novel therapies, today shared topline results from evaluating VIVJOA™ (oteseconazole) capsules in patients suffering from recurrent vulvovaginal candidiasis (RVVC). |
| 2022-04-28 | Mycovia Pharmaceuticals Inc. | Regulatory FDA Approves Mycovia Pharmaceuticals’ VIVJOA™ (oteseconazole), the First and Only FDA-Approved Medication for Recurrent Vulvovaginal Candidiasis (Chronic Yeast Infection) mycovia.com ↗ |
| 2021-07-29 | Mycovia Pharmaceuticals Inc. | Results Mycovia Pharmaceuticals, Inc. Announces Presentation of Oteseconazole (VT-1161) Phase 3 Data Demonstrating Safety and Efficacy for Treatment of Recurrent Vulvovaginal Candidiasis (RVVC) at the 2021 IDSOG Annual Meeting mycovia.com ↗
The studies successfully met both their primary and key secondary endpoints. |
| 2021-07-28 | Mycovia Pharmaceuticals Inc. | Regulatory Mycovia Pharmaceuticals, Inc. Announces U.S. FDA Acceptance and Priority Review of New Drug Application for Oteseconazole for the Treatment of Recurrent Vulvovaginal Candidiasis mycovia.com ↗ |
| 2021-06-01 | Mycovia Pharmaceuticals Inc. | Regulatory Mycovia Pharmaceuticals, Inc. Submits New Drug Application to the U.S. FDA for Oteseconazole for the Treatment of Recurrent Vulvovaginal Candidiasis mycovia.com ↗
Mycovia Pharmaceuticals, Inc. (“Mycovia”), an emerging biopharmaceutical company dedicated to recognizing and empowering those living with unmet medical needs by developing novel therapies, today announced it has submitted its New Drug Application (NDA) for oteseconazole, an oral antifungal product for the treatment of recurrent vulvovaginal candidiasis (RVVC). |
| 2021-01-06 | Mycovia Pharmaceuticals Inc. | Results Mycovia Pharmaceuticals, Inc. Announces Positive Topline Results from its Third Phase 3 Clinical Trial (ultraVIOLET) of Oteseconazole for the Treatment of Recurrent Vulvovaginal Candidiasis mycovia.com ↗
Mycovia Pharmaceuticals Announces Positive Topline Results from its Third Phase 3 Clinical Trial (ultraVIOLET) of Oteseconazole for the Treatment of Recurrent Vulvovaginal Candidiasis |
| 2020-12-09 | Mycovia Pharmaceuticals Inc. | Results Mycovia Pharmaceuticals, Inc. Announces Positive Topline Results from Phase 3 VIOLET Studies of Oteseconazole in Patients with Recurrent Vulvovaginal Candidiasis mycovia.com ↗
Oteseconazole met studies’ primary efficacy endpoint in treatment of RVVC through Week 48 |
| 2020-08-26 | Mycovia Pharmaceuticals Inc. | Results Mycovia Pharmaceuticals Announces Peer-Reviewed Publication of Positive Study Results of Oteseconazole for the Treatment of Acute Vulvovaginal Candidiasis mycovia.com ↗
Mycovia Pharmaceuticals Announces Peer-Reviewed Publication of Positive Study Results of Oteseconazole for the Treatment of Acute Vulvovaginal Candidiasis |
All press releases naming this drug 29 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | oteseconazole | “VT-1161 (oteseconazole) is an oral agent with increased selectivity for fungal CYP51.” PMID 32818963 ↗ Oct 2021 |
| Known as | Oteseconazol | ChEMBL registry synonym — accepted as the source's own label CHEMBL3311228 ↗ |
| Known as | Vivjoa | ChEMBL registry synonym — accepted as the source's own label CHEMBL3311228 ↗ |
| Known as | VIVOJA | “Oteseconazole (VIVOJA) for prevention of recurrent vulvovaginal candidiasis.” PMID 36396498 ↗ Nov 2022 |
| Known as | VT-1161 | “A Study of Oral Oteseconazole (VT-1161) for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)” NCT03561701 ↗6“Oteseconazole (VT-1161) 150mg capsule” NCT03562156 ↗ “Oteseconazole (VT-1161) 150mg capsule” NCT03840616 ↗ |
| Action | Inhibit | “VT-1161 has been designed to inhibit CYP51” NCT01891305 ↗ |
| Modality | Small molecule | — CHEMBL3311228 ↗ |
| Route | Oral | “novel oral agent VT-1161” NCT01891305 ↗ |