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Winrevair (SOTATERCEPT)
Winrevair works by binding to and inhibiting the activity of activin receptors, which play a role in the development of pulmonary arterial hypertension.
Winrevair (sotatercept) is a biologic modality developed by Merck Sharp Dohme, currently owned by the same company. It is approved for the treatment of pulmonary arterial hypertension (PAH) in both Group 1 and WHO Group 1 pulmonary hypertension. The drug has a half-life of 24 days. Winrevair is a relatively new treatment option, having received FDA approval in 2025. Key safety considerations include the typical risks associated with biologic therapies.
At a glance
| Generic name | SOTATERCEPT |
|---|---|
| Sponsor | Merck Sharp Dohme |
| Modality | Recombinant protein |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
| First approval | 2025 |
| Annual revenue | 1443 |
Mechanism of action
Sotatercept-csrk, a recombinant activin receptor type IIA-Fc (ActRIIA-Fc) fusion protein, is an activin signaling inhibitor that binds to activin A and other TGF- β superfamily ligands. As a result, sotatercept-csrk improves the balance between the pro-proliferative (ActRIIA/Smad2/3-mediated) and anti-proliferative (BMPRII/Smad1/5/8-mediated) signaling to modulate vascular proliferation. In rat models of PAH, a sotatercept-csrk analog reduced inflammation and inhibited proliferation of endothelial and smooth muscle cells in diseased vasculature. These cellular changes were associated with thinner vessel walls, partial reversal of right ventricular remodeling, and improved hemodynamics.
Approved indications
- pulmonary arterial hypertension (PAH, Group 1 pulmonary hypertension)
- pulmonary arterial hypertension (PAH, WHO Group 1 pulmonary hypertension)
Common side effects
- Infections
- Epistaxis
- Diarrhea
- Telangiectasia
- Increased hemoglobin
- Rash
- Erythema
- Gingival bleeding
- Headache
- Dizziness
- Thrombocytopenia
- Intrapulmonary Right-to-Left Shunting
Key clinical trials
- Sota-ES - Sotatercept in Patients With Congenital Heart Disease and Eisenmenger´s Syndrome (PHASE2)
- Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023) (PHASE2)
- A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038) (PHASE3)
- Reverse Remodeling of the Pulmonary Vasculature: a Longitudinal, Investigational Study of the Effects of Sotatercept.
- Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008) (PHASE2)
- Sotatercept in Pulmonary Arterial Hypertension (PHASE4)
- A Study of Sotatercept in Japanese Pulmonary Arterial Hypertension (PAH) Participants (MK-7962-020) (PHASE3)
- A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/ZENITH) (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
| Biologic Exclusivity |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Winrevair CI brief — competitive landscape report
- Winrevair updates RSS · CI watch RSS
- Merck Sharp Dohme portfolio CI