Sotatercept 60mg powder and solvent for solution for injection vials
Requires a prescription from a doctor or prescriber
Sotatercept is an activin signalling inhibitor.
Official documents, adverse reaction reporting, and safety monitoring
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Drug safety updates
MHRA alerts for Sotatercept
Safety monitoring data
Yellow Card reports
The MHRA Yellow Card scheme collects reports of suspected side effects from healthcare professionals and patients. View the Drug Analysis Profile (iDAP) for real-world adverse reaction data.
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Submit a Yellow Card report to the MHRA
Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
EudraVigilance
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Suspected adverse reactions reported for Sotatercept
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EudraVigilance data is published by the European Medicines Agency (EMA). A suspected adverse reaction is not necessarily caused by the medicine.
1 branded products available
MHRA licensed products
View all licensed products for Sotatercept on the MHRA register
Winrevair 60mg powder and solvent for solution for injection vials
Therapeutically similar medicines
Similarity is based on WHO Anatomical Therapeutic Chemical (ATC) classification and on a factual NHS dm+d therapeutic-grouping code prefix. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
NHS prescribing volume and spending trends
Guidelines from the National Institute for Health and Care Excellence
NICE clinical guidance(1)
Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
Check stock at pharmacies and supply information
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Supply & safety information
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Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. Shortage and safety information sourced from MHRA drug safety updates (gov.uk, Crown Copyright under OGL v3.0).
Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
Browse tools
SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Academic studies and reviews for this medicine's active substance
Showing the 50 most relevant studies.
Reviews & meta-analyses: 33 · Randomised trials: 6 · 2021–2026
Showing the 50 most relevant studies, sorted by most relevant.
T. Pitre, Kairavi Desai, J. Mah, et al.
Annals of the American Thoracic Society, 2024
M. Hoeper, D. Badesch, H. Ghofrani, et al.
The New England journal of medicine, 2023
Giorgi Chilingarashvili, Ruben Joseph Mylvaganam, Roberto J. Bernardo, et al.
Pulmonary Circulation, 2026
Mohamed R. Murad, Ameer Awashra, Mohamed S. Elgendy, et al.
Therapeutic Advances in Respiratory Disease, 2026
- Recombinant Fusion Proteins
- Antihypertensive Agents
- Hemodynamics
Jovanda A. Harjanto, Vivia Desmi Saputri, Aldo Antares Anom, et al.
Journal of Hypertension, 2025
Dutta S, Shah R, Singhal S, et al.
2026
Farva Zaib Khan, Ahmed Sajid, Amina Khan, et al.
CHEST, 2024
Hamza Naeem, R. Tarar, M. Ganiyani, et al.
CHEST, 2024
Vikash Jaiswal, Song Peng Ang, Vibhor Agrawal, et al.
European Heart Journal Open, 2023
M Lúcio, M Pereira, C Barata
American Journal of Respiratory and Critical Care Medicine, 2026
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
6 found
Half-life
24 days
Mechanism
There are several members of the transforming growth factor β (TGF-β) superfamil…
Food interactions
None known
Human targets
4 targets
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
66%
Half-life
24 days
[L50351]
Volume of distribution
5.3 L
Metabolism
[L50351]
Clearance
0.18 L
[L50351]
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
On March 26, 2024, sotatercept was approved by the FDA for the treatment of pulmonary arterial hypertension (PAH).[L50361] Sotatercept works to resolve the imbalance in activin–growth differentiation factor and BMP pathway signalling observed in PAH.[A263481] Sotatercept was approved by the European Commission on August 26, 2024.[L51549]
[L50351][L54526]
Known interactions with other medicines. Always consult a healthcare professional.
Showing 50 of 1006 interactions
Sotatercept is not dialyzable and there is no known antidote for this drug.
[L50351]
Sotatercept is a recombinant activin receptor type IIA-Fc (ActRIIA-Fc) fusion protein.[L50351] It acts as a ligand trap for multiple activin-class ligands by directing binding to and sequestering them,[A263496] thereby improving the balance between the growth-promoting activin growth differentiation factor pathway and the growth-inhibiting BMP pathway.[A263491][L50351]
Increased hemoglobin levels and thrombocytopenia were observed with sotatercept use.[L50351]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[L50351]
Following subcutaneous administration of 0.7 mg/kg sotatercept every three weeks to PAH patients, the steady state geometric mean (%CV) area under the time concentration curve (AUC) is 172 mcg × d/mL (34.2%), and peak concentration (Cmax) is 9.7 mcg/mL (30%). The AUC and Cmax increased proportionally with dose.
Steady-state is achieved after approximately 15 weeks following initiation of multiple dosing. The accumulation ratio of sotatercept AUC is approximately 2.2.
[L50351]
[L50351]
[L50351]
[L50351]
[L50351]
Proteins and enzymes this drug interacts with in the body
PMID:17911401 PMID:10652306
Mediates induction of adipogenesis by GDF6 (By similarity)
Within the receptor complex, type-2 receptors (ACVR2A and/or ACVR2B) act as a primary activin receptors whereas the type-1 receptors like ACVR1B act as downstream transducers of activin signals. Activin binds to type-2 receptor at the plasma membrane and activates its serine-threonine kinase. The activated receptor type-2 then phosphorylates and activates the type-1 receptor such as ACVR1B.
Once activated, the type-1 receptor binds and phosphorylates the SMAD proteins SMAD2 and SMAD3, on serine residues of the C-terminal tail. Soon after their association with the activin receptor and subsequent phosphorylation, SMAD2 and SMAD3 are released into the cytoplasm where they interact with the common partner SMAD4. This SMAD complex translocates into the nucleus where it mediates activin-induced transcription.
Inhibitory SMAD7, which is recruited to ACVR1B through FKBP1A, can prevent the association of SMAD2 and SMAD3 with the activin receptor complex, thereby blocking the activin signal. Activin signal transduction is also antagonized by the binding to the receptor of inhibin-B via the IGSF1 inhibin coreceptor. ACVR1B also phosphorylates TDP2
PMID:31215115
Signals through activin receptors type-2, ACVR2A and ACVR2B, and activin receptors type-1, ACVR1B, ACVR1C and TGFBR1 leading to the phosphorylation of SMAD2 and SMAD3 PMID:28257634
ATC C02KX06
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Sotatercept
Additional database identifiers
Drugs Product Database (DPD)
24003
HUGO Gene Nomenclature Committee (HGNC)
HGNC:173
GenAtlas
ACVR2A
GeneCards
ACVR2A
GenBank Gene Database
BC069707
Guide to Pharmacology
1791
UniProt Accession
AVR2A_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:172
GenAtlas
ACVR1B
GeneCards
ACVR1B
GenBank Gene Database
Z22536
GenBank Protein Database
402189
Guide to Pharmacology
1787
UniProt Accession
ACV1B_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:4223
GenAtlas
MSTN
GeneCards
MSTN
GenBank Gene Database
AF019627
UniProt Accession
GDF8_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:4216
GeneCards
GDF11
UniProt Accession
GDF11_HUMAN
DrugBank citations
If you use DrugBank data in your research, please cite:
- DrugBank 6.02024Recommended citationKnox C., Wilson M., Klinger C.M., et alDrugBank 6.0: the DrugBank Knowledgebase for 2024Nucleic Acids Res. 2024 Jan 552(D1):D1265-D1275
- DrugBank 5.02018Wishart D.S., Feunang Y.D., Guo A.C., et alDrugBank 5.0: a major update to the DrugBank database for 2018Nucleic Acids Res. 2017 Nov 846(D1):D1074-D1082
- DrugBank 4.02014Law V., Knox C., Djoumbou Y., et alDrugBank 4.0: shedding new light on drug metabolismNucleic Acids Res. 2014 Jan 142(1):D1091-7
- DrugBank 3.02011Knox C., Law V., Jewison T., et alDrugBank 3.0: a comprehensive resource for 'omics' research on drugsNucleic Acids Res. 2011 Jan39(Database issue):D1035-41
- DrugBank 2.02008Wishart D.S., Knox C., Guo A.C., et alDrugBank: a knowledgebase for drugs, drug actions and drug targets.Nucleic Acids Research2008 Jan36(Database issue):D901-6
- DrugBank 1.02006Wishart D.S., Knox C., Guo A.C., et alDrugBank: a comprehensive resource for in silico drug discovery and exploration.Nucleic Acids Research2006 Jan 134(Database issue):D668-72