ACE-031 Research Reference

Catalog classification, reference sizes, lab math links, and source-backed data. Educational use only — not medical advice.

Researched for: myostatin signaling and muscle mass

Structural Research protein Lyophilized verified

Also known as: ActRIIB-Fc

Quick Facts

Reference Sizes
1 mg, 5 mg
Calculator
Preset available
Storage
Development was discontinued due to safety findings (nosebleeds, hormonal changes) - research-grade material only; follow source COA guidance and note this history before recording.
Solubility
Recombinant Fc-fusion protein supplied as a study-specific aqueous formulation for SC administration

Catalog Description

ACE-031 is an activin receptor type IIB (ActRIIB)-Fc fusion protein with broad ligand specificity, blocking myostatin, GDF-11, and activin A signaling. In clinical trials, subjects gained measurable lean mass within 2-4 weeks without exercise, and thigh muscle volume increased 5-9%. However, development was discontinued after safety concerns emerged: postmenopausal women showed undesired increases in hemoglobin and decreased FSH levels, and a Phase II pediatric muscular dystrophy trial was halted due to adverse effects including nosebleeds and gum bleeding (attributed to off-target vascular/activin effects).

Catalog descriptions reflect research context only. Not a medical claim or treatment recommendation.

Research Profile

Half-Life
Approximately 10-15 days after SC dosing in the Phase 1 program
Onset
Lean-mass gains reported within 2-4 weeks in trials
Administration Routes (Research)
Subcutaneous (SC)

Reported Research Effects

Reported Research Side Effects

Data source: Published Phase I/II trial safety data

Reflects preclinical/research literature context only. Not a medical claim, dosing instruction, or treatment recommendation.

Route-Specific Research Protocols

Amounts and schedules are separated by administration route. Evidence badges distinguish labels, human studies, preclinical work, community reports, and evidence gaps.

Label / guideline Human study Community only Preclinical only Not established
Subcutaneous (SC) Human study only

0.02-3 mg/kg single dose

Frequency / timing
Study day 1
Duration / setting
Single dose
Technique
SC
Evidence
Human study protocol

Context: published Phase 1 healthy-volunteer trial

Formulation: Route-specific sterile formulation and professional handling requirements apply; concentration cannot be inferred from an oral or topical product.

Route safety: Research-study protocol only; it is not an approved or individualized instruction and should not be extrapolated to another route.

Subcutaneous (SC) Human study only

0.5-1.0 mg/kg every 2-4 weeks

Frequency / timing
Every 2-4 weeks
Duration / setting
Up to 12 weeks
Technique
SC
Evidence
Human study protocol

Context: published Phase 2 Duchenne muscular dystrophy trial

Formulation: Route-specific sterile formulation and professional handling requirements apply; concentration cannot be inferred from an oral or topical product.

Route safety: Research-study protocol only; it is not an approved or individualized instruction and should not be extrapolated to another route.

Do not convert an amount between routes. Bioavailability, formulation, sterility, monitoring, and clinical context differ by route. Research-use context only; independently verify every cited source.

Sources

A single ascending-dose study of muscle regulator ACE-031 in healthy volunteers — PubMed (NIH)
https://pubmed.ncbi.nlm.nih.gov/23169607/
Myostatin inhibitor ACE-031 treatment of ambulatory boys with Duchenne muscular dystrophy: Results of a randomized placebo-controlled clinical trial — Muscle & Nerve
https://onlinelibrary.wiley.com/doi/full/10.1002/mus.25268

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Research Use Only. All content is for educational and research reference only. Not medical advice, a treatment recommendation, or guidance on human use. Compounds are not FDA-approved drugs unless specifically noted.

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