Sotatercept
Winrevair (sotatercept) is a protein pharmaceutical. Sotatercept was first approved as Winrevair on 2024-03-26. It is used to treat pulmonary arterial hypertension in the USA. It is known to target inhibin beta A chain.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Winrevair
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Sotatercept
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Winrevair | sotatercept-csrk | Merck & Co | N-761363 RX | 2024-03-26 | 2 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| winrevair | Biologic Licensing Application | 2025-10-24 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| pulmonary arterial hypertension | — | D000081029 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
36 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pulmonary arterial hypertension | D000081029 | — | — | — | 4 | 2 | 2 | — | 8 |
| Familial primary pulmonary hypertension | D065627 | — | I27.0 | — | — | 1 | 1 | — | 2 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anemia | D000740 | EFO_0004272 | D64.9 | — | 3 | — | — | — | 3 |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | — | 2 | — | — | — | 2 |
| Neoplasms | D009369 | — | C80 | — | 1 | — | — | — | 1 |
| Leukemia | D007938 | — | C95 | — | 1 | — | — | — | 1 |
| Myelodysplastic syndromes | D009190 | — | D46 | — | 1 | — | — | — | 1 |
| Myelomonocytic leukemia chronic | D015477 | — | C93.1 | — | 1 | — | — | — | 1 |
| Myelomonocytic leukemia acute | D015479 | — | C92.5 | — | 1 | — | — | — | 1 |
| Myelomonocytic leukemia juvenile | D054429 | — | C93.3 | — | 1 | — | — | — | 1 |
| Preleukemia | D011289 | — | — | — | 1 | — | — | — | 1 |
| Syndrome | D013577 | — | — | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Sotatercept |
| INN | sotatercept |
| Description | Sotatercept (immunoadhesin) |
| Classification | Protein |
| Drug class | receptor molecules or membrane ligands, natural, modified or modified: transforming growth factor receptors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 1001080-50-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1743073 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB12118 |
| UNII ID | 0QI90BTJ37 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
INHBA
INHBA
Organism
Homo sapiens
Gene name
INHBA
Gene synonyms
NCBI Gene ID
Protein name
inhibin beta A chain
Protein synonyms
Activin beta-A chain, EDF, erythroid differentiation factor, Erythroid differentiation protein, follicle-stimulating hormone-releasing protein, FSH-releasing protein, inhibin beta A subunit, inhibin, beta A (activin A, activin AB alpha polypeptide), Inhibin, beta-1
Uniprot ID
Mouse ortholog
Inhba (16323)
inhibin beta A chain (Q04998)
Variants
No data
Financial
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Winrevair – Merck & Co
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Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 811 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,190 adverse events reported
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