Sotatercept
drugOn this page
Also known as ACE-001ACE-011ACE011Sotatercept-csrkWinrevair
Summary
Sotatercept (CHEMBL1743073) is an approved protein (ATC C02KX06); indicated across 9 conditions including pulmonary arterial hypertension and hypertensive disorder.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Protein
- ATC class: C02KX06
- Indications: 9 conditions
- Clinical trials: 34
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL1743073 |
| Name | Sotatercept |
| Type | Protein |
| Max phase | 4 |
| ATC | C02KX06 |
Also known as: ACE-001, ACE-011, ACE011, Sotatercept, Sotatercept-csrk, Winrevair, SOTATERCEPT
Targets
Targets
No target linkage available.
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
No target-pathway data for this drug (no mapped target genes).
Indications & clinical
Indications
9 indications (2 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| pulmonary arterial hypertension | 4 | MONDO:0015924 | EFO:0001361 |
| hypertensive disorder | 4 | MONDO:0005044 | EFO:0000537 |
| plasma cell myeloma | 2 | MONDO:0009693 | EFO:0001378 |
| anemia | 2 | MONDO:0002280 | EFO:0004272 |
| primary myelofibrosis | 2 | MONDO:0009692 | MONDO:0044903 |
| beta thalassemia | 2 | MONDO:0019402 | MONDO:0016486 |
| neoplasm | 2 | MONDO:0005070 | EFO:0000616 |
| Diamond-Blackfan anemia | 1 | MONDO:0015253 | MONDO:0015253 |
1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.
Clinical trials
Total trials: 34.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE2 | 19 |
| PHASE4 | 5 |
| PHASE3 | 5 |
| PHASE1 | 3 |
| PHASE1/PHASE2 | 1 |
| Not specified | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT06658522 | PHASE4 | RECRUITING | Right Ventricular Compensation With Sotatercept: A Prospective Single Arm Open Label Phase 4 Study to Evaluate the Effects of Sotatercept on Right Ventricular Function in Pulmonary Arterial Hypertension (RECOMPENSE) |
| NCT07140484 | PHASE4 | RECRUITING | Sotatercept in Pulmonary Arterial Hypertension |
| NCT07356778 | PHASE4 | RECRUITING | A Study of Sotatercept for Patients With Eisenmenger Syndrome or Unrepaired Shunt-Associated Pulmonary Arterial Hypertension Resistant to Vasodilator Therapy |
| NCT07600723 | PHASE4 | NOT_YET_RECRUITING | A Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (PAH) in India (MK-7962-037) |
| NCT06409026 | PHASE4 | COMPLETED | Sotatercept on Central Cardiopulmonary Performance and Peripheral Oxygen Transport During Exercise in Pulmonary Arterial Hypertension |
| NCT07218029 | PHASE3 | RECRUITING | A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038) |
| NCT04576988 | PHASE3 | COMPLETED | A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11)(STELLAR) |
| NCT04811092 | PHASE3 | TERMINATED | Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13) |
| NCT04896008 | PHASE3 | COMPLETED | A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/ZENITH) |
| NCT05818137 | PHASE3 | COMPLETED | A Study of Sotatercept in Japanese Pulmonary Arterial Hypertension (PAH) Participants (MK-7962-020) |
| NCT05587712 | PHASE2 | RECRUITING | Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008) |
| NCT06814145 | PHASE2 | RECRUITING | Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023) |
| NCT06925750 | PHASE2 | ACTIVE_NOT_RECRUITING | A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-031/LIGHTRAY EXTENSION) |
| NCT07266519 | PHASE2 | NOT_YET_RECRUITING | SIRIUS - Initial Combination Therapy With an Endothelin Receptor Antagonist, a Phosphodiesterase-5 Inhibitor and Sotatercept in Patients With Newly Diagnosed Pulmonary Arterial Hypertension |
| NCT07498803 | PHASE2 | NOT_YET_RECRUITING | Sota-ES - Sotatercept in Patients With Congenital Heart Disease and Eisenmenger´s Syndrome |
| NCT00747123 | PHASE2 | COMPLETED | A Safety, Tolerability and Efficacy Study of ACE-011 in Patients With Osteolytic Lesions of Multiple Myeloma |
| NCT00931606 | PHASE2 | TERMINATED | Study of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer (MK-7962-012) |
| NCT01146574 | PHASE2 | COMPLETED | 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. |
| NCT01190644 | PHASE2 | TERMINATED | Study to Evaluate Effect of a Single Dose of Sotatercept (ACE-011) on Red Blood Cell Mass and Plasma Volume in Participants With Solid Tumors |
| NCT01284348 | PHASE2 | TERMINATED | To Determine Safe and Effective Dose of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Participants With Advanced Non-small Cell Lung Cancer |
| NCT01464164 | PHASE1/PHASE2 | TERMINATED | Safety and Efficacy Study of Sotatercept in Adults With Transfusion Dependent Diamond Blackfan Anemia |
| NCT01571635 | PHASE2 | TERMINATED | Study to Determine the Safety and Tolerability of Sotatercept (ACE-011) in Adults With Beta( β)- Thalassemia. |
| NCT01712308 | PHASE2 | COMPLETED | Sotatercept in Treating Patients With Myeloproliferative Neoplasm-Associated Myelofibrosis or Anemia |
| NCT01736683 | PHASE2 | COMPLETED | Study of Sotatercept for the Treatment of Anemia in low-or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) or Non-proliferative Chronic Myelomonocytic Leukemia (CMML) |
| NCT01999582 | PHASE2 | COMPLETED | A Phase 2 Study of Intravenous or Subcutaneous Dosing of Sotatercept (ACE-011) in Patients With End-Stage Kidney Disease on Hemodialysis |
| NCT02230917 | PHASE2 | WITHDRAWN | A Phase IIa Study of Sotatercept on Bone Mass and Turnover in Patients With Multiple Myeloma |
| NCT03496207 | PHASE2 | COMPLETED | A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH) |
| NCT03738150 | PHASE2 | COMPLETED | A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension |
| NCT04945460 | PHASE2 | COMPLETED | A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16) |
| NCT06664801 | PHASE2 | COMPLETED | A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (PAH) (MK-7962-024) |
| NCT01562405 | PHASE1 | ACTIVE_NOT_RECRUITING | Sotatercept (ACE-011) With Lenalidomide or Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma |
| NCT06843460 | PHASE1 | COMPLETED | A Clinical Study of MK-7962 in Healthy Chinese Participants (MK-7962-021) |
| NCT06930664 | PHASE1 | COMPLETED | A Study of Sotatercept (MK-7962) in Healthy Females Administered as a Liquid Formulation in an Autoinjector Versus the Lyophilized Formulation (MK-7962-027) |
| NCT03724227 | Not specified | NO_LONGER_AVAILABLE | Expanded Access for ACE-011 |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).