Performance · Investigational
ACE-031 (Ramatercept)
No lawful US pathway
01 · Overview
ACE-031 is a recombinant fusion protein combining the extracellular domain of activin receptor type IIB with a human IgG1 Fc domain. The soluble receptor acts as a decoy that binds myostatin and other negative regulators of muscle mass (PMID 23169607).
By neutralizing these TGF-beta superfamily ligands it was designed to promote muscle growth in conditions involving muscle wasting, such as Duchenne muscular dystrophy (PMID 27462804).
02 · Research summary & key findings
A phase 1 single ascending dose study in 48 healthy postmenopausal women found ACE-031 generally well tolerated, with a mean half-life of about 10 to 15 days and statistically significant increases in total body lean mass and thigh muscle volume at the highest dose, together with biomarker changes suggesting effects on bone and fat metabolism (PMID 23169607). A randomized, double-blind, placebo-controlled trial in ambulatory boys with Duchenne muscular dystrophy was stopped after the second dosing regimen because of epistaxis and telangiectasias; trends toward preserved 6-minute walk distance, increased lean mass and bone mineral density and reduced fat mass did not reach statistical significance (PMID 27462804). Both Duchenne studies are registered as terminated on ClinicalTrials.gov and no later ACE-031 trials have been registered or published.
03 · Regulatory status
ACE-031 (Ramatercept) is in the investigational stage. While preclinical and early-phase data exist, it has not received regulatory approval for clinical use in the United States.
No lawful pathway today
ACE-031 (Ramatercept) is not FDA-approved and does not currently have a lawful prescription or compounding pathway in the United States, so we do not sell it and will not book a consultation for it. That can change: in 2026 FDA began reviewing several peptides for compounding. If you are working on the goal it is studied for, a licensed clinician can tell you what is lawfully available, which may be something else.
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Looking for a lawful, clinician-prescribed option for athletic performance?
ACE-031 (Ramatercept) is an investigational compound, is not FDA-approved, and has no lawful US compounding pathway, so we do not offer it and no clinician we work with will prescribe it. Products sold online as “research chemicals” are not made or tested to the standards required of medicines. If you are working on athletic performance, a licensed clinician can tell you at a free consultation whether an FDA-approved or lawfully compounded treatment fits you, or whether nothing does.
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04 · Administration routes
- Subcutaneous injection
References
- [1]A single ascending-dose study of muscle regulator ACE-031 in healthy volunteers Muscle Nerve, 2013. PMID 23169607
- [2]Myostatin inhibitor ACE-031 treatment of ambulatory boys with Duchenne muscular dystrophy: Results of a randomized, placebo-controlled clinical trial Muscle Nerve, 2017. PMID 27462804
Primary literature
- PubMed: "ACE-031"
Peer-reviewed literature indexed by the National Library of Medicine.
- ClinicalTrials.gov: "ACE-031"
Registered interventional and observational studies, including status and phase.
- PubChem: "ACE-031"
Chemical structure, molecular properties, and bioactivity data.
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