WINREVAIR
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
- 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.
- Pulmonary Arterial Hypertension
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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
ProIndications & 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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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.