sotatercept
Trade name: WINREVAIR
Recombinant proteinapprovedOrphan Drug FDABreakthrough Therapy FDA
Approved
Mar 26, 2024
Clinical trial activity
34 trials · 15 clinical orgs · 1 marketing orgs
Phase 1
6
Phase 2
24
Phase 3
7
Phase 4
3
Earliest trial started Jan 1, 2008 (NCT00709540)
Timeline
Indications
Approved for
Studied for
- Anemia · Phase 2/Phase 3
- Anemia, Diamond-Blackfan · Phase 1/Phase 2
- beta-Thalassemia · Phase 2
- Carcinoma, Non-Small-Cell Lung · Phase 2/Phase 3
- Drug-Related Side Effects and Adverse Reactions · Phase 2
- Head and Neck Neoplasms · Phase 2/Phase 3
- Healthy Volunteers · Phase 1
- Hypertension · Phase 4
- Hypertension, Pulmonary · Phase 4
- Kidney Failure, Chronic · Phase 2
- Leukemia, Myelomonocytic, Chronic · Phase 2
- Multiple Myeloma · Phase 2
- Myelodysplastic Syndromes · Phase 2
- Myeloproliferative Disorders · Phase 2
- Neoplasms · Phase 2
- Osteoporosis · Phase 1
- Primary Myelofibrosis · Phase 2
- Pulmonary Arterial Hypertension · Phase 4
- Small Cell Lung Carcinoma · Phase 2/Phase 3
- Urinary Bladder Neoplasms · Phase 2/Phase 3
- Uterine Cervical Neoplasms · Phase 2/Phase 3
Mechanism of action
- Inhibin beta A chainINHIBITOR
INHBA inhibitor
By binding activin, Sotatercept prevents activin from binding endogenous receptors and thus acts as a decoy.
- Activin receptor type-2AINHIBITOR
ACVR2A inhibitor
Approval history
- approvedPriority reviewBreakthroughMar 26, 2024
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
First in class
Sources
- ChEMBLCHEMBL1743073 ↗
Also known as
- ace-001
- ace-011
- ace-011
- ace-011
- ace-011
- sotatercept
- sotatercept
- sotatercept
- sotatercept
- sotatercept
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07266519 | Phase 2 | Jul 1, 2026 | Merck, Philipps University of Marburg |
| NCT07218029 | Phase 3 | Nov 14, 2025 | Merck |
| NCT07140484 | Phase 4 | Oct 6, 2025 | Merck, University of Alberta, University of Calgary |
| NCT06930664 | Phase 1 | May 16, 2025 | Merck |
| NCT06925750 | Phase 2 | May 12, 2025 | Merck |
| NCT06814145 | Phase 2 | Apr 11, 2025 | Merck |
| NCT06658522 | Phase 4 | Jan 1, 2025 | Free University of Amsterdam, Merck |
| NCT06664801 | Phase 2 | Dec 6, 2024 | Merck |
| NCT06409026 | Phase 4 | Jul 5, 2024 | Mayo Clinic |
| NCT06843460 | Phase 1 | Nov 22, 2023 | Merck |
| NCT05818137 | Phase 3 | May 10, 2023 | Merck |
| NCT05587712 | Phase 2 | Jan 4, 2023 | Merck |
| NCT04945460 | Phase 2 | Oct 31, 2021 | Acceleron Pharma, Inc. |
| NCT04896008 | Phase 3 | Oct 13, 2021 | Acceleron Pharma, Inc. |
| NCT04811092 | Phase 3 | Jul 28, 2021 | Acceleron Pharma, Inc. |
| NCT04796337 | Phase 3 | May 12, 2021 | Acceleron Pharma, Inc. |
| NCT04576988 | Phase 3 | Dec 31, 2020 | Acceleron Pharma, Inc. |
| NCT03738150 | Phase 2 | May 1, 2019 | Acceleron Pharma, Inc. |
| NCT03496207 | Phase 2 | Jun 27, 2018 | Acceleron Pharma, Inc. |
| NCT06193031 | Phase 1 | Nov 17, 2015 | Insmed, Inc. |
Showing 20 of 34 trials
Page 1 / 2
Organizations
Research & Development (15)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Celgene | For profit | 11 | 9 | 3 | 2008 |
| Merck | For profit | 11 | 8 | 4 | 2023 |
| Acceleron Pharma, Inc. | For profit | 9 | 8 | 3 | 2008 |
| Free University of Amsterdam | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Harvard University | Academic/Hospital | 1 | 1 | 1 | 2012 |
| Indiana University | Academic/Hospital | 1 | 1 | 1 | 2014 |
| Insmed, Inc. | For profit | 1 | 1 | 1 | 2015 |
| Mayo Clinic | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Multiple Myeloma Research Consortium | Academic/Hospital | 1 | 0 | 1 | 2012 |
| Northwell Health | Academic/Hospital | 1 | 1 | 1 | 2012 |
| Philipps University of Marburg | Academic/Hospital | 1 | 1 | 1 | 2026 |
| University of Alberta | Academic/Hospital | 1 | 1 | 1 | 2025 |
| University of Calgary | Academic/Hospital | 1 | 0 | 1 | 2025 |
| University of Texas at Houston | Academic/Hospital | 1 | 1 | 1 | 2013 |
| WCCT Global | For profit | 1 | 0 | 1 | 2008 |
15 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Merck | For profit | NDA | Mar 26, 2024 |