oteseconazole
Trade name: Vivjoa
Small moleculeapprovedFast Track FDA
Approved
Apr 26, 2022
Clinical trial activity
9 trials · 3 clinical orgs · 1 marketing orgs
Phase 1
0
Phase 2
9
Phase 3
5
Phase 4
0
Earliest trial started Aug 1, 2013 (NCT01891331)
Timeline
2010s
- Jan 1, 2013
Earliest Phase 2 Sponsor(trial)
- Jan 1, 2018
Mycovia Pharmaceuticals Inc. — Earliest Phase 3 Sponsor(trial)
2020s
- Apr 26, 2022
Mycovia Pharmaceuticals Inc. — Earliest FDA Approval
- Apr 26, 2022
Mycovia Pharmaceuticals Inc. — Marketing Organization
- Apr 26, 2022
Mycovia Pharmaceuticals Inc. — NDA Secondary Org
- Apr 26, 2022
Mycovia Pharmaceuticals Inc. — NDA Organization
Indications
Approved for
Mechanism of action
- 14-alpha sterol demethylaseANTAGONIST
cyp51B antagonist
- Lanosterol 14-alpha demethylaseINHIBITOR
Lanosterol 14-alpha demethylase inhibitor
Approval history
- approvedPriority reviewFast trackApr 26, 2022
Chemistry & pharmacology
Loading structure…
SMILES
O[C@@](Cn1cnnn1)(c1ccc(F)cc1F)C(F)(F)c1ccc(-c2ccc(OCC(F)(F)F)cc2)cn1- Mol. weight
- 527.4 g/mol
- Lipinski Ro5
- 1 violation(s)
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL3311228 ↗
Also known as
- oteseconazole
- vt-1161
- vt-1161
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05074602 | Phase 3 | Sep 14, 2021 | Hengrui Therapeutics, Inc. |
| NCT04956419 | Phase 3 | Apr 24, 2021 | Hengrui Therapeutics, Inc. |
| NCT03840616 | Phase 3 | Mar 13, 2019 | Mycovia Pharmaceuticals Inc. |
| NCT03561701 | Phase 3 | Aug 23, 2018 | Mycovia Pharmaceuticals Inc. |
| NCT03562156 | Phase 3 | Aug 16, 2018 | Mycovia Pharmaceuticals Inc. |
| NCT02267382 | Phase 2 | Feb 1, 2015 | Viamet |
| NCT02267356 | Phase 2 | Dec 1, 2014 | Viamet |
| NCT01891305 | Phase 2 | Aug 1, 2013 | Viamet |
| NCT01891331 | Phase 2 | Aug 1, 2013 | Viamet |
Showing 9 of 9 trials
Page 1 / 1
Organizations
Research & Development (3)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Viamet | For profit | 4 | 4 | 1 | 2013 |
| Mycovia Pharmaceuticals Inc. | For profit | 3 | 3 | 1 | 2018 |
| Hengrui Therapeutics, Inc. | For profit | 2 | 2 | 1 | 2021 |
3 organizations
Page 1 / 1
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Mycovia Pharmaceuticals Inc. | For profit | MKTG | Apr 26, 2022 |
| Mycovia Pharmaceuticals Inc. | For profit | NDA2 | Apr 26, 2022 |
| Mycovia Pharmaceuticals Inc. | For profit | NDA | Apr 26, 2022 |