Sotatercept
Highest phase reached
Approved
Drug type
Protein
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Protein
- Drug name
- Sotatercept
- winrevair
- Winrevair
- (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.
- ATC classification codes
- C02KX06
Sources for recorded values
- CAS registry numbers
- 1001080-50-7
- ChEMBL ID
- CHEMBL1743073
- FDA ingredient codes (UNII)
- 0QI90BTJ37
- 2678930
- 2678931
- Applicant
- MERCK SHARP DOHME
- Approval date
- 26 Mar 2024
- Application number
- BLA761363
- 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
- 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 name
- sotatercept
- Type
- Antibody
- Drug name stem
- -cept
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- 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
- 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
- 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
- NCT00747123
- NCT01562405
- NCT02230917
- NCT00931606
- NCT01146574
- NCT01712308
- NCT01190644
- NCT01464164
- NCT01571635
- NCT03496207
- NCT03738150
- NCT04576988
- NCT04796337
- NCT04811092
- NCT04896008
- NCT04945460
- NCT05587712
- NCT05818137
- 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
- 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)
- 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)
Approved for (2)
- Hypertensive disorder
- 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 Phase 2
- Myelofibrosis Phase 2
- Neoplasm Phase 2
- Osteoporosis Phase 1
- Plasma cell myeloma Phase 2
Other linked conditions (1)
Targets (1)
- INHBA Inhibin beta A chain inhibitor