ACE-031 (Ramatercept)
Aliases: Ramatercept · ActRIIB-Fc
Last verified: 2026-09-23
The short version
A soluble fusion protein (ActRIIB receptor + IgG Fc) — a decoy that traps myostatin and related ligands. In Phase II for Duchenne muscular dystrophy it produced significant lean-mass gains. Key fact: Human data are limited: small trials or case-series reports exist, without large randomized studies. Acceleron/Shire Phase I/II; discontinued. Status: discontinued. Not approved; WADA-banned.
Identity & type
- Molecular type
- peptide
- Origin
- A soluble fusion protein (ActRIIB receptor + IgG Fc) — a decoy that traps myostatin and related ligands.
Mechanism of action
Binds TGF-β-family ligands (myostatin, activin, GDF11) before they activate ActRIIB → blocks muscle-growth-limiting signals.
not confirmed in humans
Dosing & routes
Official / clinical context
Development was abandoned; no active regulatory document exists. There are no official indications.
Regulator-approved labeling and published study designs — never a recommendation.
Community-reported practice
In trials: 1–3 mg/kg SC every 2–4 weeks. Experiences are rare and old (gray market pre-2013): rapid muscle growth, but also nose/gum bleeding and mild telangiectasia — the very reasons development was halted.
Unverified self-reports. Not medical advice. Not endorsement.
Expected effects (community)
Experiences are rare and old (gray market pre-2013): rapid muscle growth, but also nose/gum bleeding and mild telangiectasia — the very reasons development was halted.
Protocol — official vs community
Official / label
No approved protocol exists — development was discontinued. In the Acceleron/Shire Phase I/II program, doses of 1–3 mg/kg SC every 2–4 weeks were studied in DMD patients.
Duration: Trial-defined; the DMD program was halted in 2013 over safety signals (nosebleeds, telangiectasias, hypoglycemia).
The soluble-receptor concept survived in related molecules — luspatercept uses the same ActRIIB-ligand-trap logic and is approved for anemias — which is why the approach is credible even though this specific drug is not.
Community (anecdotal)
Gray-market vials appear sporadically at doses far below the mg/kg trial range, reflecting the drug's cost and scarcity rather than a considered protocol.
- Cycle:
- No standardized pattern.
- Break:
- —
The only real dosing data is the discontinued trial above. Anything sold today as 'ACE-031' is unverifiable, and the safety signals that killed the program apply to the mechanism, not just the formulation.
Human evidence
Human data are limited: small trials or case-series reports exist, without large randomized studies. Acceleron/Shire Phase I/II; discontinued.
Preclinical evidence
Acceleron/Shire Phase I/II; discontinued. Related molecules (e.g., Luspatercept, same concept) later approved for anemias.
Known risks
- Nosebleeds, telangiectasias, hypoglycemia — DMD development halted in 2013 over safety signals.characterized
- zbog sigurnosnih signala.characterized
- Unregulated injectable supply — sterility, purity and accurate dose not assuredtheoretical
Teal: characterized in clinical/labeling contexts. Amber: theoretical or reported outside controlled settings.
Unknowns & evidence gaps
- Long-term human safety
- Optimal dose and pharmacokinetics
Frequently asked questions
References
Systematic references are being expanded; verify sources directly before any decision.