WINREVAIR (sotatercept-csrk) · Merck
WINREVAIR (sotatercept-csrk) is an activin signaling inhibitor indicated for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1). The therapy is used to improve exercise capacity and World Health Organization (WHO) functional class in this patient population. Additionally, it is intended to reduce the risk of clinical worsening events, including hospitalization for PAH, lung transplantation, and death.
How WINREVAIR Works
Sotatercept-csrk is a recombinant fusion protein that binds to activin A and other TGF-β superfamily ligands to inhibit activin signaling. This process improves the balance between pro-proliferative and anti-proliferative signaling pathways to modulate vascular proliferation. By regulating these pathways, the drug inhibits the proliferation of endothelial and smooth muscle cells in diseased vasculature. These cellular changes are associated with thinner vessel walls, improved hemodynamics, and the partial reversal of right ventricular remodeling.
Details
- Status
- Prescription
- First Approved
- 2024-03-26
- PDUFA Date
- 2026-09-21 (72d)
- Patent Cliff
- 2036
- Revenue
- $467M (Q4-2025)
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
WINREVAIR Approval History
What WINREVAIR Treats
1 indicationsWINREVAIR is approved for 1 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
WINREVAIR Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in WINREVAIR's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications WINREVAIR treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to WINREVAIR
3 of 18FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Merck's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
WINREVAIR FDA Label Details
Indications & Usage
FDA Label (PDF)WINREVAIR™ is indicated for the treatment of adults with pulmonary arterial hypertension (PAH, Group 1 pulmonary hypertension) to improve exercise capacity and World Health Organization (WHO) functional class (FC), and reduce the risk of clinical worsening events including hospitalization for PAH, lung transplantation and death [see Clinical Studies ] . WINREVAIR is an activin signaling inhibitor indicated for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1 pulmonary hypertension) to improve exercise capacity and WHO functional class (FC), and reduce the risk of ...
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Deep insights for WINREVAIR
Revenue Insights
- • Q4-2025: $467M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • Generic/biosimilar risk
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 18 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.