ACE-031 — EU research guide.
ACE-031 (sotatercept precursor) is a fusion protein of ActRIIA (activin receptor type IIA) and IgG1-Fc that acts as a ligand trap for myostatin, activin A and other TGF-β family members that inhibit muscle growth.
What is ACE-031?
ACE-031 is a recombinant fusion protein consisting of the extracellular domain of ActRIIA linked to an IgG1-Fc region. It sequesters myostatin, activin A, activin B, GDF11 and other negative regulators of muscle growth, releasing their brake on muscle anabolism. It is structurally related to Sotatercept (approved for PAH) and Luspatercept (approved for beta-thalassaemia), which target related ligands.
What does the research show?
Phase 2 trials in healthy volunteers and in Duchenne Muscular Dystrophy showed significant increases in lean mass and thigh muscle volume. Development was halted due to adverse effects on bone and vascular biology at higher doses. The muscle-building efficacy data is robust; the safety signal led to reprioritisation toward related compounds.
EU legal status
Not approved. Clinical development halted. Available as a research-use biologics for in-vitro and animal model research into the ActRIIA/myostatin pathway. WADA-prohibited.
Molecular information
Pharmacokinetics
ACE-031 across EU suppliers
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