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Sotatercept - Merck & Co

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Drug Profile

Sotatercept - Merck & Co

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

Latest Information Update: 25 Feb 2026

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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

Highest Development Phases

  • 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

Most Recent Events

  • 04 Feb 2026 US FDA accepts sBLA for sotatercept for label indication
  • 03 Feb 2026 FDA assigns PDUFA action date of September 21, 2026 for sotatercept for Pulmonary arterial hypertension
  • 31 Jan 2026 European Commission approves sotatercept for indication expansion treatment of Pulmonary arterial hypertension

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