Drug Profile

Sotatercept - Merck & Co

Alternative Names: ACE-011; ACTRIIA-Fc - Merck & Co; Airwin; MK-7962; Sotatercept-csrk - Merck & Co; WINREVAIR

Latest Information Update: 18 Dec 2025

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At a glance

Originator Acceleron Pharma
Developer Acceleron Pharma; Celgene Corporation; Indiana University; Merck & Co; University of Texas M. D. Anderson Cancer Center
Class Antianaemics; Antihypertensives; Antineoplastics; Immunoglobulin Fc fragments; Osteoporosis therapies; Recombinant fusion proteins
Mechanism of Action Activin inhibitors; Transforming growth factor beta inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Pulmonary arterial hypertension
New Molecular Entity Yes

Marketed Pulmonary arterial hypertension
Phase II Pulmonary hypertension
Discontinued Anaemia; Beta-thalassaemia; Bone metastases; Chemotherapy-induced anaemia; Diamond-Blackfan syndrome; Myelodysplastic syndromes; Myelofibrosis; Postmenopausal osteoporosis; Renal osteodystrophy; Sickle cell anaemia; Vascular calcification

12 Dec 2025 The Committee for Medicinal Products for Human Use (CHMP) recommends approval of Sotatercept for expanded indication of Pulmonary arterial hypertension
20 Nov 2025 Merck & Co completes a phase II trial in Pulmonary arterial hypertension in the US, the Netherlands, France, Italy, Spain, Hungary, Poland, Germany, Taiwan, Singapore, the United Kingdom, China, South Korea, the US, Thailand, Turkey, Argentina, Japan, Australia, Colombia, Israel and Canada (SC) (NCT06664801) (CTIS2024-512278-92-00)
18 Nov 2025 Efficacy and adverse event data from a phase II CADENCE trial for Pulmonary arterial hypertension released by Merck

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