Drugs / Sotatercept

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Winrevair 2024-08-22 europa.eu

Trials 34 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT06843460 Nov 2023 → May 2024 Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1 NCT01562405 May 2012 → Dec 2026 expected plasma cell myeloma Massachusetts General Hospital Active not recruiting No outcome recorded
Phase 1 NCT00709540 Jan → Nov 2008 osteoporosis Acceleron Pharma, Inc. Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT01464164 Jan 2012 → Apr 2021 Diamond-Blackfan anemia Northwell Health Terminated No outcome recorded
Phase 220 trials
Phase 2 NCT07498803 Sep 2026 → Mar 2028 expected Eisenmenger syndrome, congenital heart disease Philipps University Marburg Not yet recruiting No outcome recorded
Phase 2 NCT07646860 Aug 2026 → May 2029 expected pulmonary arterial hypertension Merck Sharp & Dohme LLC Not yet recruiting No outcome recorded
Phase 2 NCT07266519 Jul 2026 → Oct 2028 expected pulmonary arterial hypertension Philipps University Marburg Not yet recruiting No outcome recorded
Phase 2 NCT06925750 May 2025 → Jun 2028 expected pulmonary arterial hypertension Merck Sharp & Dohme LLC Active not recruiting No outcome recorded
Phase 2 NCT06814145 Apr 2025 → Aug 2035 expected pulmonary hypertension Merck Sharp & Dohme LLC Active not recruiting No outcome recorded
Phase 2 NCT06664801 Nov 2024 → Nov 2025 pulmonary arterial hypertension Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 2 NCT05587712 Jan 2023 → Sep 2028 expected pulmonary arterial hypertension Merck Sharp & Dohme LLC Recruiting No outcome recorded
Phase 2 NCT04945460 Dec 2021 → Sep 2025 pulmonary hypertension Acceleron Pharma, Inc. Completed No outcome recorded
Phase 2 NCT03738150 Apr 2019 → Dec 2021 pulmonary arterial hypertension Acceleron Pharma, Inc. Completed No outcome recorded
Phase 2 NCT03496207 Jun 2018 → Mar 2022 pulmonary arterial hypertension Acceleron Pharma, Inc. Completed No outcome recorded
Phase 35 trials
Phase 3 NCT05818137 May 2023 → Mar 2024 pulmonary arterial hypertension Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 3 NCT04811092 Mar 2022 → Apr 2025 pulmonary arterial hypertension Acceleron Pharma, Inc. Terminated No outcome recorded
Phase 3 NCT04896008 Dec 2021 → Jul 2024 pulmonary arterial hypertension Acceleron Pharma, Inc. Completed No outcome recorded
Phase 3 NCT07218029 May 2021 → Dec 2028 expected pulmonary arterial hypertension Merck Sharp & Dohme LLC Recruiting No outcome recorded
Phase 3 NCT04576988 Jan 2021 → Aug 2022 pulmonary arterial hypertension Acceleron Pharma, Inc. Completed No outcome recorded
Phase 45 trials
Phase 4 NCT07600723 Jul 2026 → Apr 2028 expected pulmonary arterial hypertension Merck Sharp & Dohme LLC Not yet recruiting No outcome recorded
Phase 4 NCT07356778 Oct 2025 → Aug 2027 expected Eisenmenger syndrome Kazuya Hosokawa Recruiting No outcome recorded
Phase 4 NCT07140484 Oct 2025 → Jan 2029 expected pulmonary arterial hypertension University of Alberta Recruiting No outcome recorded
Phase 4 NCT06658522 May 2025 → May 2026 overdue pulmonary arterial hypertension Amsterdam UMC, location VUmc Recruiting No outcome recorded
Phase 4 NCT06409026 Jul 2024 → Jan 2026 pulmonary arterial hypertension Mayo Clinic Completed No outcome recorded
Also used as a comparator or background therapy in 2 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT06930664 Comparator May → Nov 2025 Merck Sharp & Dohme LLC Completed No outcome recorded
Phase not stated1 trial
NCT03724227 Background myelodysplastic syndrome Celgene Corporation No longer available No outcome recorded

Evidence & citations 11 cited values

Every value below carries the sentence it was read from. 38 sources stand behind the page.

FieldValueCited text
Known as Sotatercept ClinicalTrials.gov intervention name — accepted as the source's own label NCT04896008
31

NCT04945460

NCT06658522

NCT07646860

NCT05587712

NCT07498803

NCT04811092

NCT00931606

NCT02230917

NCT06930664

NCT01464164

NCT01146574

NCT07266519

NCT07140484

NCT01284348

NCT01571635

NCT07600723

NCT04576988

NCT07356778

NCT01712308

NCT01190644

NCT03496207

NCT06814145

NCT06409026

NCT07218029

NCT01736683

NCT01999582

NCT06925750

NCT05818137

NCT06843460

NCT06664801

NCT03738150

Known as ACE-001 ChEMBL registry synonym — accepted as the source's own label CHEMBL1743073
Known as ACE-011 “Sotatercept (ACE-011) in Adults With Red Blood Cell Transfusion- Dependent Diamond Blackfan Anemia” NCT01464164
4

NCT03724227

NCT00709540

NCT01562405

NCT00747123

Known as hActRIIA-IgG1 “ACE-011 (hActRIIA-IgG1)” NCT00747123
Known as Sotatercept-csrk ChEMBL registry synonym — accepted as the source's own label CHEMBL1743073
Known as Winrevair ChEMBL registry synonym — accepted as the source's own label CHEMBL1743073
Action Inhibit “acts as a ligand trap to neutralise negative regulators of late-stage erythropoiesis” PMID 29331635 Jan 2018
1

“Inhibin beta A chain inhibitor” CHEMBL1743073

Modality Protein / enzyme biologic “ACE-011 (ActRIIA-IgG1)” NCT00709540
Route Subcutaneous “ACE-011 given subcutaneously” NCT00709540
Target BMPR2 “Sotatercept is a novel medication which targets the BMPR2/TGF-β pathway” NCT06658522
Target INHBA “Inhibin beta A chain inhibitor” CHEMBL1743073