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MONOGRAPH No. 067
TYPE
Fusion protein / not a peptide
MW
~110 kDa (protein)
CAS
Not assigned
EU STATUS
Research only
WADA
Prohibited S2/S4
MIN PURITY
By SDS-PAGE / bioassay
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💪 Muscle, IGF & Body Composition

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.

Last reviewed:

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.

WADA-prohibited. Clinical development halted due to adverse bone/vascular effects. Fusion protein — not a simple peptide. Requires protein handling and cold chain. Not for human use. This is a research compound, not a medication.
✓ PeptideCompare lists ACE-031 from specialist EU research vendors. Protein stability and cold-chain documentation are essential — standard peptide COA criteria do not fully apply.

Molecular information

Molecular weight
~110 kDa (protein)
CAS number
Not assigned

Pharmacokinetics

Half-life (t½)
≈ 12 days
Source: Fc-fusion estimate (~10–15 days)

Potency retained over time

Each line is one storage condition: it starts at 100% and falls as potency is lost. Above the dashed 80% line the material is considered reliable — hover for exact values.

Freezer −20 °C
36+ mo
Stable · >95% potency
Fridge 4 °C
4-5 wks
In use · after recon
Room 20 °C
5-6 days
Avoid · increased loss
Warm 37 °C+
<1 day
Critical · rapid degradation

⚠ A structural estimate, derived from each compound's sequence length, cyclisation and oxidation-, deamidation- and light-sensitive residues. Indicative only — not lab-measured per batch.

ACE-031 across EU suppliers

COA-verified EU vendors · Updated monthly

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