Sotatercept
As of the edition of 20 October 2026, Sotatercept is a protein: marketed, first approved in 2024 (US); acts on INHBA; US protection ends in 2036.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Protein
- Brand name
- Winrevair
- First approved
- 26 March 2024 (US)
- Approvals on record
- 10 in 5 regions
- Holder of the most recent approval
- Merck & Co.
- Registered trials
- 37, 7 stopped early
- Disease areas
- Lungs and airways; Blood and lymph; Heart and blood vessels; Cancer; Inherited and neonatal; Immune system
US protection
US protection ends in 2036.
US protection ends in 2036, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Merck & Co.. The date is computed, not published.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product2 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 2 listings behind itRequest access. Nothing is shown until you do.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Sotatercept.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| INHBA | Inhibin beta A chain | P08476 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 0 | 0 |
| Phase 1 | 4 | 3 | 1 | 0 |
| Phase 2 | 21 | 9 | 6 | 6 |
| Phase 3 | 6 | 3 | 2 | 1 |
| Phase 4 | 5 | 1 | 4 | 0 |
| All trials | 37 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck & Co. | Originator and Lead sponsor of trials | 2008 to now |