RM-TRS / Tissue, repair and matrix signalling
ACE-031
Also known as: Ramatercept · ActRIIB-Fc · Soluble activin receptor type IIB fusion protein
Grade describes the published research on the molecule. It is not a quality score, a safety score, or a release state.
What this is
ACE-031 is a dimeric fusion protein combining part of activin receptor type IIB with an IgG1 Fc region. Catalogs often place it beside peptides, but its identity and analytical controls are those of a much larger recombinant protein.
Evidence position
Sponsor-manufactured ACE-031 reached controlled human studies. One Duchenne muscular dystrophy study was stopped after epistaxis and telangiectasia safety concerns.
What the record does not establish
The clinical record does not validate a vial sold under the same name. Published testing of black-market samples makes intact-protein identity, Fc confirmation, aggregation and lot-specific analysis especially important.
Sources
- 01Single ascending-dose ACE-031 study in healthy volunteersPubMed
- Shows
- Double-blind, placebo-controlled human pharmacology data for sponsor-manufactured ACE-031
- Does not show
- Single-dose study in 48 participants; does not authenticate commercial research material
- 02Randomized ACE-031 trial in Duchenne muscular dystrophyPubMed
- Shows
- Controlled human trial and the safety concerns that contributed to discontinuation
- Does not show
- Early terminated development program; no approval or supplier-lot validation
- 03Gel electrophoretic detection of black-market ACE-031PubMed
- Shows
- Analytical examination found that tested black-market products did not contain the expected ACE-031 Fc-fusion protein
- Does not show
- Applies to the examined samples, not every seller or lot
External database index
LIVE DATABASE INDEX / SEPARATE FROM CURATED EVIDENCE
Records below come directly from public scientific databases. They help find relevant material, but do not affect the evidence grade until they are matched to the molecule and added to the curated source list.
PUBMED / FOUND RECORDS
- Gel Electrophoretic Detection of Black Market ACE-031.Drug testing and analysis / 2025 OctPMID 40312924 / DOI 10.1002/dta.3898
- Gateways to clinical trials.Methods and findings in experimental and clinical pharmacology / 2010 Jan-FebPMID 20383346
- [Anti-myostatin antibody therapy for myopathies].Rinsho shinkeigaku = Clinical neurology / 2011 NovPMID 22277518 / DOI 10.5692/clinicalneurol.51.1157
- A single ascending-dose study of muscle regulator ACE-031 in healthy volunteers.Muscle & nerve / 2013 MarPMID 23169607 / DOI 10.1002/mus.23539
- The relationship between myodural bridges, hyperplasia of the suboccipital musculature, and intracranial pressure.PloS one / 2022PMID 36054096 / DOI 10.1371/journal.pone.0273193
CLINICALTRIALS.GOV / FOUND RECORDS
- Extension Study of ACE-031 in Subjects With Duchenne Muscular DystrophyTERMINATED / PHASE2 / Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USANCT01239758 / DIRECT intervention MATCH: ACE-031
- A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 (ActRIIB-IgG1)in Healthy Postmenopausal VolunteersCOMPLETED / PHASE1 / Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USANCT00755638 / DIRECT intervention MATCH: ACE-031
- A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 in Healthy Postmenopausal WomenCOMPLETED / PHASE1 / Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USANCT00952887 / DIRECT intervention MATCH: ACE-031
- Study of ACE-031 in Subjects With Duchenne Muscular DystrophyTERMINATED / PHASE2 / Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USANCT01099761 / DIRECT intervention MATCH: ACE-031