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Synonyms: ACE-011 | ACE011 | ActRIIA-IgG1 | MK-7962 | MK7962 | sotatercept-csrk | Winrevair®
sotatercept is an approved drug (EMA & FDA (2024))
Compound class:
Antibody
Comment: Sotatercept (MK-7962) is a soluble activin receptor 2A (ACVR2A; ActR2) ligand trap type inhibitor. Structurally it is a fusion protein of the extracellular domain of the ActR2 and a human IgG Fc domain. In pulmonary blood vessels sotatercept sequesters ActR2 endogenous ligands (e.g. activins A and B, and growth differentiation factors 8 and 11, BMP6 and BMP7), and prevents their interaction with ActR2s to restore normal cell proliferation [3,7].
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Summary of Clinical Use  |
| Sotatercept (MK-7962, formerly ACE-011) was advanced to clinical development for the treatment of pulmonary arterial hypertension (PAH) [4,8], in which excessive activin pathway signaling is associated with the aberrant pulmonary vascular remodeling and cellular proliferation that characterises PAH. It was granted orphan drug designation bt both the FDA (May 2019) and EMA. Sotatercept is also being evaluated for the treatment of anaemia, bone loss (in cancer) and myelodysplastic syndromes. The FDA granted full approval to treat PAH, in March 2024 [5], with EMA authorisation for this indication following in August 2024 [1,10]. |
| Clinical Trials | |||||
| Clinical Trial ID | Title | Type | Source | Comment | References |
| NCT03496207 | A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH) | Phase 2 Interventional | Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA | 2 | |
| NCT04576988 | A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11)(STELLAR) | Phase 3 Interventional | Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA | 6,9 | |
