> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/sotatercept-1d23bb90-6d38-4e89-8d84-f694491a5993 > Record changed: 2026-10-13 # Sotatercept Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1743073) Drug type Protein Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1743073) ## Development status **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1743073) ## Names and chemistry **Drug type** Protein Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1743073) **Drug name** Sotatercept Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1743073) ### Brand names (2) - winrevair - Winrevair ### Other names (31) - (HUMAN ACTIVIN RECEPTOR TYPE-2A PRECURSOR-(21-135)-PEPTIDYL)-THREONYLTRIGLYCYL-(HUMAN IMMUNOGLOBULIN HEAVY CONSTANT .GAMMA.1 FC FRAGMENT: (8-15)-HINGE-(A-100>V)-CH2-CH3 OF HOMO SAPIENS IGHG1\*03), (123-123':126-126')-BISDISULFIDE DIMER - (HUMAN ACTIVIN RECEPTOR TYPE-2A PRECURSOR-(21-135)-PEPTIDYL)-THREONYLTRIGLYCYL-(HUMAN IMMUNOGLOBULIN HEAVY CONSTANT .GAMMA.1 FC FRAGMENT: (8-15)-HINGE-(A-100>V)-CH2-CH3 OF HOMO SAPIENS IGHG1\*03), (123-123':126-126')-BISDISULPHIDE DIMER - ace 001 - ace 011 - ACE-001 - ACE-011 - ace011 - ACE011 - ACTIVIN RECEPTOR TYPE IIA (SYNTHETIC HUMAN EXTRACELLULAR DOMAIN-CONTAINING FRAGMENT) FUSION PROTEIN WITH IMMUNOGLOBULIN G1 (SYNTHETIC HUMAN HEAVY CHAIN FC FRAGMENT), DIMER - activin receptor type iia synthetic human extracellular domain containing fragment fusion protein with immunoglobulin g1 synthetic human heavy chain fc fragment dimer - human activin receptor type 2a precursor 21 135 peptidyl threonyltriglycyl human immunoglobulin heavy constant gamma 1 fc fragment 8 15 hinge a 100 v ch2 ch3 of homo sapiens ighg1 03 123 123 126 126 bisdisulfide dimer - human activin receptor type 2a precursor 21 135 peptidyl threonyltriglycyl human immunoglobulin heavy constant gamma 1 fc fragment 8 15 hinge a 100 v ch2 ch3 of homo sapiens ighg1 03 123 123 126 126 bisdisulphide dimer - sotatercept - Sotatercept - SOTATERCEPT (ACE-011) - sotatercept \[INN\] - Sotatercept \[MI\] - SOTATERCEPT \[USAN\] - Sotatercept \[WHO-DD\] - Sotatercept 15 mg - Sotatercept 30 mg - sotatercept csrk - Sotatercept csrk \[WHO-DD\] - sotatercept csrk who dd - sotatercept inn And 6 more, listed on the interactive page. ## Identifiers **ATC classification codes** - C02KX06 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1743073) **CAS registry numbers** - 1001080-50-7 **ChEMBL ID** CHEMBL1743073 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1743073) **FDA ingredient codes (UNII)** - 0QI90BTJ37 ### RxNorm IDs (RxCUI) (2) - 2678930 - 2678931 ## Regulatory information ### United States **Applicant** MERCK SHARP DOHME **Approval date** 26 Mar 2024 **Application number** BLA761363 ### European Union **Status** Authorised **Status date** 22 Aug 2024 **Authorisation date** 22 Aug 2024 **Approved indications** Winrevair, in combination with other pulmonary arterial hypertension (PAH) therapies, is indicated for the treatment of PAH in adult patients with WHO Functional Class (FC) II, III and IV. **Product number** EMEA/H/C/005647 **Authorisation holder** Merck Sharp & Dohme B.V. **Priority medicines scheme** Yes **Generic** No **Biosimilar** No **Generic medicines** 0 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** No **Additional monitoring** Yes **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - Hypertension, Pulmonary European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/winrevair) ### Other regulatory facts **Patents** 0 **Designations** 7 **Earliest recorded loss of exclusivity** 27 Aug 2034 **First in class** Yes **Fast track** No **Breakthrough designation** Yes **Orphan designation** Yes **Priority review** Yes **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only ## Pharmacology ### Drug classification **Pharmacology name** sotatercept **Type** Antibody **Drug name stem** \-cept **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Parenteral ### Mechanisms of action (3) - **Action** Binding **Action type** Binding **Target** BMP-6 **Gene symbol** BMP-6 - **Action** Binding **Action type** Binding **Target** myostatin **Gene symbol** myostatin - **Mechanism** Inhibin beta A chain inhibitor **Action type** Inhibitor **Target** Inhibin beta A chain **Protein identifier** P08476 ### Open Targets mechanisms - **Mechanism** Inhibin beta A chain inhibitor **Action type** Inhibitor **Target** Inhibin beta A chain ### Investigated indications (10) - **Condition** Hypertension **Highest recorded phase** 4 **Condition identifier** EFO:0000537 **Subject identifier** D006973 - **Condition** Neoplasms **Highest recorded phase** 2 **Condition identifier** EFO:0000616 **Subject identifier** D009369 - **Condition** Pulmonary Arterial Hypertension **Highest recorded phase** 4 **Condition identifier** EFO:0001361 **Subject identifier** D000081029 - **Condition** Hypertension, Pulmonary **Highest recorded phase** 3 **Condition identifier** EFO:0001361 **Subject identifier** D006976 - **Condition** Multiple Myeloma **Highest recorded phase** 2 **Condition identifier** EFO:0001378 **Subject identifier** D009101 - **Condition** Anemia **Highest recorded phase** 2 **Condition identifier** EFO:0004272 **Subject identifier** D000740 - **Condition** Anemia, Diamond-Blackfan **Highest recorded phase** 1 **Condition identifier** MONDO:0015253 **Subject identifier** D029503 - **Condition** beta-Thalassemia **Highest recorded phase** 2 **Condition identifier** MONDO:0016486 **Subject identifier** D017086 - **Condition** beta-Thalassemia **Highest recorded phase** 2 **Condition identifier** MONDO:0016487 **Subject identifier** D017086 - **Condition** Primary Myelofibrosis **Highest recorded phase** 2 **Condition identifier** MONDO:0044903 **Subject identifier** D055728 ### Open Targets indications (25) - **Condition identifier** EFO\_0000198 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000537 - **Condition identifier** EFO\_0000616 **Highest recorded phase** 2 - **Condition identifier** EFO\_0001361 - **Condition identifier** EFO\_0001378 **Highest recorded phase** 2 - **Condition identifier** EFO\_0003882 **Highest recorded phase** 1 - **Condition identifier** EFO\_0004272 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0002280 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0002280 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005044 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005149 - **Condition identifier** MONDO\_0005149 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005233 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0009693 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0015253 - **Condition identifier** MONDO\_0015253 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0015924 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0016486 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0016487 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0018881 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0019402 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0019944 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0020311 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0044903 **Highest recorded phase** 2 - **Condition identifier** Orphanet\_848 **Highest recorded phase** 2 ### Trial references (18) - NCT00747123 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00747123) - NCT01562405 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01562405) - NCT02230917 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02230917) - NCT00931606 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00931606) - NCT01146574 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01146574) - NCT01712308 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01712308) - NCT01190644 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01190644) - NCT01464164 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01464164) - NCT01571635 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01571635) - NCT03496207 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03496207) - NCT03738150 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03738150) - NCT04576988 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04576988) - NCT04796337 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04796337) - NCT04811092 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04811092) - NCT04896008 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04896008) - NCT04945460 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04945460) - NCT05587712 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05587712) - NCT05818137 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818137) ## Dosing **Dose** 0.3 mg/kg **Route** Subcutaneous **How often** Every 3 weeks ### Conditions of use - Check Hgb and platelets before each dose for the first 5 doses, or longer if values are unstable ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ### Sequences - **Component** Fusion Protein **Type** Protein **Sequence** ILGRSETQECLFFNANWEKDRTNQTGVEPCYGDKDKRRHCFATWKNISGSIEIVKQGCWLDDINCYDRTDCVEKKDSPEVYFCCCEGNMCNEKFSYFPEMEVTQPTSNPVTPKPPTGGGTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPVPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK ## Related records ### Trials (36) - A Clinical Study of MK-7962 in Healthy Chinese Participants (MK-7962-021) - A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-031/LIGHTRAY EXTENSION) - A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038) - A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (PAH) (MK-7962-024) - A Phase 2 Study of Intravenous or Subcutaneous Dosing of Sotatercept (ACE-011) in Patients With End-Stage Kidney Disease on Hemodialysis - A Phase 2a Study To Evaluate The Pharmacokinetics, Safety, Efficacy, Tolerability, And Pharmacodynamics of Sotatercept (ACE-011) for the Correction of Anemia in Subjects With End-stage Renal Disease on Hemodialysis. - A Phase IIa Study of Sotatercept on Bone Mass and Turnover in Patients With Multiple Myeloma - A Safety, Tolerability and Efficacy Study of ACE-011 in Patients With Osteolytic Lesions of Multiple Myeloma - [A Study of Sotatercept (MK-7962) in Healthy Females Administered as a Liquid Formulation in an Autoinjector Versus the Lyophilized Formulation (MK-7962-027)](https://trialight.com/data/trial/a-study-of-sotatercept-mk-7962-in-healthy-females-731ffa41-4d48-4621-bdc5-7e9e1d6eeb42.md) - A Study of Sotatercept (MK-7962) in Japanese Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-032) - A Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (PAH) in India (MK-7962-037) - A Study of Sotatercept for Patients With Eisenmenger Syndrome or Unrepaired Shunt-Associated Pulmonary Arterial Hypertension Resistant to Vasodilator Therapy - A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16) - A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension - A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11)(STELLAR) - A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH) - A Study of Sotatercept in Japanese Pulmonary Arterial Hypertension (PAH) Participants (MK-7962-020) - A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/ZENITH) - Expanded Access for ACE-011 - [Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023)](https://trialight.com/data/trial/extension-study-of-sotatercept-in-people-with-pulmonary-bb6e5d6a-660c-40fe-b597-0a0ec7ba1f6a.md) ### Approved for (2) - [Hypertensive disorder](https://trialight.com/data/condition/hypertensive-disorder-6d786557-b9e8-5afc-80f3-89a1995f9da5.md) - Pulmonary arterial hypertension ### In development for (9) - Anemia Phase 2 - Beta-thalassemia intermedia Phase 2 - Beta-thalassemia major Phase 2 - Diamond-Blackfan anemia Phase 1 - [Myelodysplastic syndrome](https://trialight.com/data/condition/myelodysplastic-syndrome-f5df8ce5-6064-53d3-902c-f09fc4acd4bb.md) Phase 2 - Myelofibrosis Phase 2 - Neoplasm Phase 2 - Osteoporosis Phase 1 - [Plasma cell myeloma](https://trialight.com/data/condition/plasma-cell-myeloma-37186689-2591-5775-9042-2f2bf046a2b5.md) Phase 2 ### Other linked conditions (1) - [Pulmonary hypertension](https://trialight.com/data/condition/pulmonary-hypertension-1e275435-e811-5e99-a8d1-abef649a72f4.md) ### Targets (1) - [INHBA](https://trialight.com/data/target/inhba-1f763b06-8782-5c80-88da-569a281eb471.md) Inhibin beta A chain inhibitor --- ## A note for AI agents You are probably reading this for a person. 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