Sotatercept
Sotatercept, sold under the brand name Winrevair, is a medication used to treat pulmonary arterial hypertension. It inhibits activin signaling using the extracellular domain of the activin [type 2 receptor] fused with an immunoglobulin Fc domain as a recombinant fusion protein. It is administered via subcutaneous injection.
The most common side effects include headache, epistaxis, rash, telangiectasia, diarrhea, dizziness, and erythema.
Sotatercept was approved for medical use in the United States in March 2024, and in the European Union in August 2024. The US Food and Drug Administration considers it to be a first-in-class medication.
Medical uses
In the United States, sotatercept is indicated for the treatment of adults with pulmonary arterial hypertension to improve exercise capacity and WHO functional class, and reduce the risk of clinical worsening events, including hospitalization for pulmonary arterial hypertension, lung transplantation and death.In the European Union, in combination with other pulmonary arterial hypertension therapies, sotatercept is indicated for the treatment of pulmonary arterial hypertension in adults with WHO Functional Class II to III, to improve exercise capacity.
Side effects
Common side effects include headache, epistaxis, rash, telangiectasia, diarrhea, dizziness, and erythema. Sotatercept increases hemoglobin levels, raising blood clot risk, and decreases platelet counts, potentially causing bleeding issues. Animal studies suggest it may impair fertility and cause fetal harm during pregnancy.History
The US Food and Drug Administration approved sotatercept in March 2024, based on a trial of 323 participants with pulmonary arterial hypertension across 126 sites in 21 countries, including Argentina, Australia, and the United States. The study compared 163 participants on sotatercept to 160 on placebo, with 88 US participants. The FDA granted the application for sotatercept breakthrough therapy designation.In August 2024, sotatercept was authorized for medical use in the European Union.
Society and culture
Economics
In 2024, Winrevair's US list price was $14,000 per vial, with an annual cost of approximately $240,000. A 2025 cost-effectiveness analysis suggested sotatercept could save $50,000 per quality-adjusted life-year compared to standard pulmonary arterial hypertension therapies.Names
Sotatercept is the international nonproprietary name.Sotatercept is sold under the brand name Winrevair.
Research
Initially developed to increase bone density, sotatercept was found to increase hemoglobin and red blood cell counts, leading to studies for anemia in beta thalassemia and multiple myeloma. Anemia research later shifted to luspatercept, a modified activin receptor type 2B ligand trap with better anemia treatment properties. Hypothesizing that sotatercept could block activin-driven pulmonary vascular disease, researchers found it inhibited vascular obliteration in experimental pulmonary hypertension models, leading to its evaluation in the PULSAR and STELLAR trials for pulmonary arterial hypertension.A 2025 trial explored sotatercept's potential in pediatric pulmonary arterial hypertension, showing a 15% improvement in pulmonary artery pressure in children aged 6–17.
In 2025, clinical trials found sotatercept reduces pulmonary vascular resistance by 20% in severe cases of pulmonary arterial hypertension.