fezolinetant
Trade name: Veozah
Small moleculeapproved
Approved
May 12, 2023
Fezolinetant, sold under the brand name Veozah, among others, is a medication used for the treatment of hot flashes (vasomotor symptoms) due to menopause. It is a small-molecule, selective neurokinin-3 (NK3) receptor antagonist taken by mouth. It was developed by Astellas Pharma, which acquired it from Ogeda (formerly Euroscreen) in April 2017. — Wikipedia
Clinical trial activity
25 trials · 7 clinical orgs · 2 marketing orgs
Phase 1
6
Phase 2
18
Phase 3
10
Phase 4
0
Earliest trial started Sep 21, 2015 (NCT05419908)
Timeline
2010s
2020s
- May 12, 2023
Leo Pharma — Earliest FDA Approval
- May 12, 2023
Astellas — Marketing Organization
- May 12, 2023
Leo Pharma — NDA Secondary Org
- May 12, 2023
Leo Pharma — NDA Organization
Indications
Approved for
Studied for
Mechanism of action
- Neurokinin 3 receptorANTAGONIST
TACR3 antagonist
Approval history
- approvedPriority reviewMay 12, 2023
Chemistry & pharmacology
Loading structure…
SMILES
Cc1nsc(-c2nnc3n2CCN(C(=O)c2ccc(F)cc2)[C@@H]3C)n1- Mol. weight
- 358.4 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Black box warningFirst in class
Sources
- WikipediaFezolinetant ↗
- ChEMBLCHEMBL3608680 ↗
Also known as
- fezolinetant
- fezolinetant
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07077395 | Phase 2 | Jan 31, 2026 | Harvard University |
| NCT06957691 | Phase 2 | Dec 20, 2025 | Astellas, Harvard University |
| NCT06917313 | Phase 2 | Nov 30, 2025 | Astellas, Yale University |
| NCT06975111 | Phase 2/Phase 3 (Phase 3) | Oct 1, 2025 | University of Colorado, Denver |
| NCT06972875 | Phase 2 | Aug 31, 2025 | University of Vermont |
| NCT06812754 | Phase 2 | Feb 25, 2025 | Astellas |
| NCT06617455 | Phase 2 | Dec 1, 2024 | University of Michigan |
| NCT06440967 | Phase 3 | Jul 31, 2024 | Astellas |
| NCT06206421 | Phase 3 | Feb 22, 2024 | Astellas |
| NCT06206408 | Phase 3 | Feb 16, 2024 | Astellas |
| NCT05033886 | Phase 3 | Oct 25, 2021 | Astellas |
| NCT05034042 | Phase 2 | Oct 22, 2021 | Astellas |
| NCT04793204 | Phase 1 | Mar 24, 2021 | Astellas |
| NCT04641260 | Phase 1 | Nov 18, 2020 | Astellas |
| NCT04482270 | Phase 1 | Sep 2, 2020 | Astellas |
| NCT04476849 | Phase 1 | Aug 10, 2020 | Astellas |
| NCT04451226 | Phase 3 | Jul 30, 2020 | Astellas |
| NCT04277624 | Phase 1 | Feb 29, 2020 | Astellas |
| NCT04234204 | Phase 3 | Dec 20, 2019 | Astellas |
| NCT04003155 | Phase 3 | Jul 31, 2019 | Astellas |
Showing 20 of 25 trials
Page 1 / 2
Organizations
Research & Development (7)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Astellas | For profit | 19 | 17 | 3 | 2018 |
| Harvard University | Academic/Hospital | 2 | 2 | 1 | 2025 |
| Ogeda S.A. | For profit | 2 | 2 | 1 | 2015 |
| University of Colorado, Denver | Academic/Hospital | 1 | 1 | 1 | 2025 |
| University of Michigan | Academic/Hospital | 1 | 1 | 1 | 2024 |
| University of Vermont | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Yale University | Academic/Hospital | 1 | 1 | 1 | 2025 |
7 organizations
Page 1 / 1
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Astellas | For profit | MKTG | May 12, 2023 |
| Leo Pharma | For profit | NDA2 | May 12, 2023 |
| Leo Pharma | For profit | NDA | May 12, 2023 |