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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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
Winrevairsotatercept-csrkMerck & CoN-761363 RX2024-03-26
2 products
Labels
FDA
EMA
Brand Name
Status
Last Update
winrevairBiologic Licensing Application2024-03-26
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
30 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I10—41——5
Pulmonary arterial hypertensionD000081029———31——4
Familial primary pulmonary hypertensionD065627—I27.0—31——4
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AnemiaD000740EFO_0004272D64.9—3———3
Pulmonary hypertensionD006976EFO_0001361I27.20—2———2
NeoplasmsD009369—C80—1———1
LeukemiaD007938—C95—1———1
Myelodysplastic syndromesD009190—D46—1———1
Myelomonocytic leukemia chronicD015477—C93.1—1———1
Myelomonocytic leukemia acuteD015479—C92.5—1———1
Myelomonocytic leukemia juvenileD054429—C93.3—1———1
PreleukemiaD011289———1———1
SyndromeD013577———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———1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSotatercept
INNsotatercept
Description
Sotatercept (immunoadhesin)
Classification
Protein
Drug classreceptor molecules or membrane ligands, natural, modified or modified: transforming growth factor receptors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID1001080-50-7
RxCUI—
ChEMBL IDCHEMBL1743073
ChEBI ID—
PubChem CID—
DrugBankDB12118
UNII ID0QI90BTJ37 (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
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Uniprot ID
Mouse ortholog
Inhba (16323)
inhibin beta A chain (Q04998)
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 626 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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874 adverse events reported
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