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Investigational / not FDA-approved

ACE-031

ActRIIB–IgG1 Fc fusion — development discontinued; no monomer CID; refuse PE glow.

Editorial review:
What evidence says

Evidence snapshot

This drawer marks papers. It is not a plan, a dose, or a source. A paper is a bounded report. It is not a protocol. Grades name the object. They are not a safety rating.

Identity lock. ACE-031 (also discussed as a soluble activin type IIB receptor–IgG1 Fc fusion / ActRIIB-Fc class agent; sometimes named in development narratives alongside ramatercept-class framing) is a fusion protein, not a short peptide monomer. No clean PubChem small-molecule CID is locked in this pack (expected for a recombinant Fc fusion). It was developed to bind myostatin / activin ligands and increase muscle mass. Clinical development stopped after safety signals (including epistaxis / telangiectasia narratives) in the Duchenne program. Black-market ACE-031 detections appear in anti-doping literature — detecting a seized vial ≠ clinical efficacy. No approved indication. Off-label does not apply. There is no label to be off of. Refuse physique / performance-enhancement glow. This drawer marks papers. It is not use advice.

Bottom line

Human data include a single ascending-dose healthy-volunteer study and a randomized placebo-controlled trial in ambulatory boys with Duchenne muscular dystrophy that did not become an approved therapy. Preclinical ActRIIB-Fc muscle-growth papers (mouse, marmoset) are not human grades. Refuse bodybuilding / “myostatin blocker” glow from this set.

Papers

Human clinical (development stopped)

PMID 23169607 — Attie 2013

Tested: single ascending-dose study of ACE-031 in healthy volunteers (pharmacodynamic muscle/biomarker framing).

Does not show: an approved indication, long-term safety in athletes, or that gray-market vials match trial material.

PMID 27462804 — Campbell 2017

Tested: randomized, placebo-controlled clinical trial of ACE-031 in ambulatory boys with Duchenne muscular dystrophy.

Does not show: a marketed DMD therapy; development was discontinued amid safety concerns — trial result ≠ consumer use claim.

Preclinical ActRIIB-Fc / muscle mass (not human grades)

PMID 20466801 — Cadena 2010

Tested: soluble activin type IIB receptor administration promoting skeletal muscle growth independent of fiber type (rodent framing).

Does not show: human hypertrophy efficacy or safety for unlabeled use.

PMID 41256654 — Cadena 2025

Tested: ACE-031 increasing muscle mass and strength in the common marmoset.

Does not show: a human body-composition RCT or approved sports indication.

Detection / anti-doping context (identity ≠ efficacy)

PMID 40312924 — Reichel 2025

Tested: gel electrophoretic detection methods for black-market ACE-031.

Does not show: clinical benefit; analytical detection of illicit product is not an efficacy grade.

PMID 26842585 — Thevis 2016

Tested: review of emerging drugs affecting skeletal muscle function / mitochondrial biogenesis and sports drug-testing implications (includes myostatin-pathway agents in class discussion).

Does not show: ACE-031 human therapeutic approval.

What is not established

Any approved human indication for ACE-031. That preclinical muscle mass increases equal safe human performance enhancement. Equivalence of unlabeled “ACE-031” research chemicals to clinical-batch ActRIIB-Fc. A PubChem monomer CID for this fusion protein. This drawer does not provide use advice, schedules, or sourcing.

Selected sources

23169607 27462804 20466801 41256654 40312924 26842585

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