16 completed, 7 recruiting, 6 terminated, 5 active not recruiting. 21 Phase 2, 6 Phase 3, 6 Phase 4, 5 Phase 1.
Follow ACE-011: new trials by email Literature Review of ACE-011 trials Research Report on ACE-011
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Clinical Study of Sotatercept (MK-7962) in People With Combined Postcapillary and Precapillary Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (MK-7962-041) Sotatercept, Placebo - Pulmonary Hypertension | Phase 3 | Not yet recruiting | Merck Sharp & Dohme LLC | 352 | 2026-11-26 | 2026-10-06 |
| A Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (PAH) in India (MK-7962-037) Sotatercept, Background PAH Therapy - Pulmonary Arterial Hypertension | Phase 4 | Recruiting | Merck Sharp & Dohme LLC | 30 | 2026-10-08 | 2026-10-22 |
| A Study of Sotatercept (MK-7962) in Japanese Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-032) Sotatercept - Pulmonary Arterial Hypertension | Phase 2 | Recruiting | Merck Sharp & Dohme LLC | 6 | 2026-09-17 | 2026-10-06 |
| Sota-ES - Sotatercept in Patients With Congenital Heart Disease and Eisenmenger´s Syndrome Sotatercept - Congenital Heart Disease (CHD), Eisenmenger Syndrome | Phase 2 | Not yet recruiting | Philipps University Marburg | 40 | 2026-09-01 | 2026-03-27 |
| SIRIUS - Initial Combination Therapy With an Endothelin Receptor Antagonist, a Phosphodiesterase-5 Inhibitor and Sotatercept in Patients With Newly Diagnosed Pulmonary Arterial Hypertension Sotatercept 0.3 mg/kg escalating to 0.7 mg/kg, Sotatercept - Pulmonary Arterial Hypertension (PAH) | Phase 2 | Not yet recruiting | Philipps University Marburg | 25 | 2026-07-01 | 2025-12-05 |
| A Study of Sotatercept for Patients With Eisenmenger Syndrome or Unrepaired Shunt-Associated Pulmonary Arterial Hypertension Resistant to Vasodilator Therapy Sotatercept, vasodilator-based PAH therapy - Eisenmenger Syndrome, Pulmonary Arterial Hypertension of Congenital Heart Disease | Phase 4 | Recruiting | Kazuya Hosokawa | 36 | 2025-10-07 | 2026-01-21 |
| Sotatercept in Pulmonary Arterial Hypertension Sotatercept - Pulmonary Artery Hypertension | Phase 4 | Recruiting | University of Alberta | 27 | 2025-10-06 | 2026-07-09 |
| A Study of Sotatercept (MK-7962) in Healthy Females Administered as a Liquid Formulation in an Autoinjector Versus the Lyophilized Formulation (MK-7962-027) Sotatercept, Sotatercept Autoinjector - Healthy | Phase 1 | Completed | Merck Sharp & Dohme LLC | 146 | 2025-05-16 | 2025-12-15 |
| 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) Sotatercept - Pulmonary Arterial Hypertension PAH, Pulmonary Arterial Hypertension WHO Group I | Phase 4 | Recruiting | Amsterdam UMC, location VUmc | 20 | 2025-05-14 | 2025-09-22 |
| A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-031/LIGHTRAY EXTENSION) Sotatercept, Background PAH Therapy - Pulmonary Arterial Hypertension | Phase 2 | Active not recruiting | Merck Sharp & Dohme LLC | 130 | 2025-05-12 | 2025-12-05 |
| Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023) Sotatercept - Hypertension, Pulmonary | Phase 2 | Active not recruiting | Merck Sharp & Dohme LLC | 440 | 2025-04-16 | 2026-07-22 |
| A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (PAH) (MK-7962-024) Sotatercept, Background PAH Therapy - Pulmonary Arterial Hypertension | Phase 2 | Completed | Merck Sharp & Dohme LLC | 164 | 2024-11-14 | 2025-12-05 |
| Sotatercept on Central Cardiopulmonary Performance and Peripheral Oxygen Transport During Exercise in Pulmonary Arterial Hypertension Sotatercept - Pulmonary Arterial Hypertension | Phase 4 | Completed | Mayo Clinic | 30 | 2024-07-05 | 2026-04-16 |
| A Clinical Study of MK-7962 in Healthy Chinese Participants (MK-7962-021) Sotatercept, Placebo - Healthy | Phase 1 | Completed | Merck Sharp & Dohme LLC | 24 | 2023-11-22 | 2025-02-25 |
| Pulmonary Hypertension: Intensification and Personalisation of Combination Rx Selexipag, Riociguat, CardioMEMS pulmonary artery pressure monitor - Pulmonary Arterial Hypertension | Phase 4 | Active not recruiting | Sheffield Teaching Hospitals NHS Foundation Trust | 70 | 2023-06-14 | 2026-08-07 |
| A Study of Sotatercept in Japanese Pulmonary Arterial Hypertension (PAH) Participants (MK-7962-020) Sotatercept - Pulmonary Arterial Hypertension | Phase 3 | Completed | Merck Sharp & Dohme LLC | 46 | 2023-05-10 | 2026-06-10 |
| Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008) Sotatercept - Pulmonary Arterial Hypertension | Phase 2 | Recruiting | Merck Sharp & Dohme LLC | 42 | 2023-01-19 | 2026-04-20 |
| Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13) Sotatercept, Placebo - Pulmonary Arterial Hypertension | Phase 3 | Terminated | Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA | 321 | 2022-03-18 | 2026-06-08 |
| A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16) Sotatercept 0.3 mg/kg, Placebo, Sotatercept 0.3 mg/kg escalating to 0.7 mg/kg - Hypertension, Pulmonary | Phase 2 | Completed | Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA | 165 | 2021-12-29 | 2026-09-23 |
| A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/ZENITH) Sotatercept, Placebo - Pulmonary Arterial Hypertension | Phase 3 | Completed | Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA | 173 | 2021-12-01 | 2026-05-29 |
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Pulmonary Arterial Hypertension (17) · Anemia (6) · Hypertension, Pulmonary (4) · Hypertension (3) · Multiple Myeloma (3) · Eisenmenger Complex (2) · Kidney Failure, Chronic (2) · Myelodysplastic Syndromes (2) · Aase Smith syndrome 2 (1) · Anemia, Diamond-Blackfan (1) · Anemia, Hypoplastic, Congenital (1) · Bone Marrow Failure Disorders (1) · Carcinoma, Non-Small-Cell Lung (1) · Critical Illness (1) · Familial Primary Pulmonary Hypertension (1)
Merck Sharp & Dohme LLC (15) · Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA (7) · Celgene (5) · Philipps University Marburg (2) · Amsterdam UMC, location VUmc (1) · Duke University (1) · Kazuya Hosokawa (1) · M.D. Anderson Cancer Center (1) · Massachusetts General Hospital (1) · Mayo Clinic (1) · Northwell Health (1) · Rebecca Silbermann (1) · Sheffield Teaching Hospitals NHS Foundation Trust (1) · University of Alberta (1)
United States (24) · United Kingdom (13) · France (12) · Spain (11) · Germany (10) · Israel (10) · Canada (9) · Italy (9) · Australia (8) · Netherlands (8) · Belgium (7) · Poland (7) · Argentina (5) · Colombia (5) · Czechia (5)
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PMID 42246435, PMID 23417027, PMID 26370220, PMID 29331635, PMID 33789009, PMID 36041750, PMID 36877098, PMID 37485397, PMID 37696565, PMID 37851297, PMID 38572639, PMID 39978862, PMID 40035659, PMID 40167274, PMID 40526255, PMID 41025556, PMID 41618947, PMID 41819579, PMID 41885673, PMID 41904795, PMID 42770225
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