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Sotatercept - Merck & Co

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Drug Profile

Sotatercept - Merck & Co

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

Latest Information Update: 08 Jul 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

Highest Development Phases

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

Most Recent Events

  • 02 Jul 2025 Preregistration for Chemotherapy-induced anaemia (Adjunctive treatment) in USA (SC)
  • 02 Jul 2025 FDA accepts sBLA for Sotatercept for Pulmonary arterial hypertension (Adjunctive treatment) for review
  • 02 Jul 2025 FDA assigns PDUFA action date of 25/10/2025 for Sotatercept for Pulmonary arterial hypertension (Adjunctive treatment)

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