ACE-031

Fat LossSoluble activin receptor IIB fusion protein / discontinuedExperimental

ACE-031 is a soluble activin receptor IIB fusion protein in the Myostatin Inhibitor class. ACE-031 acts as a decoy receptor, binding myostatin and related TGF-beta superfamily ligands in the circulation before they can engage cell-surface activin receptors. Removing that inhibitory signal relieves suppression of muscle growth.

Calculate Dose

For research use only.

Key Facts

CAS
—
Molecular Weight (MW)
—
Half-life
Mean 10–15 days after a single subcutaneous dose in healthy postmenopausal women (Attie et al. 2013)
FDA status
Not Approved
Evidence level
Clinical Trial Evidence
Human dose established
No
Administration Route
Not established in humans
Frequency
Not established in humans
Last updated
Nov 7, 2026
Reviewed
Nov 7, 2026

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Vendors listing this peptide
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3
Price per mg
$37.59–$139.00/mg

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Research summary

Fusion protein of the activin receptor type IIB extracellular domain with an IgG1 Fc region, developed as a myostatin pathway inhibitor for muscular dystrophy. Clinical development was discontinued after vascular adverse events. Not FDA-approved.

Research evidence

  • Regulatory review (FDA label)None in reviewed sources
  • Controlled human trials4 reviewed sources
  • Early or uncontrolled human studies1 reviewed source
  • Lab & animal studiesNone in reviewed sources
How it works

Each step shows whether the sources Peptide Library has reviewed include that kind of research. Counts are reviewed sources, not every study ever published. Reviews and programme summaries that describe human use are shown as "reported", not as trials, and registered trials without published results are listed but not counted. A higher step means research has progressed further; it does not mean a compound works better or is safer. Compounds whose evidence has not been reviewed yet show "Not reviewed" instead of a guess.

Peptide Library's ACE-031 profile summarises 5 cited studies listed in the Science section, the compound's regulatory status, and research-protocol parameters reported for it. It is a research reference, not medical advice.

ACE-031 dosage: no established human dose

ACE-031 (ramatercept) has no established human dosage. It was given to people in the trials of its development programme: single subcutaneous doses of 0.02–3 mg/kg in healthy postmenopausal women, and 0.5 mg/kg every 4 weeks or 1.0 mg/kg every 2 weeks for 12 weeks in boys with Duchenne muscular dystrophy. The Duchenne trial and its extension were stopped because of safety concerns, nosebleeds and small dilated blood vessels (telangiectasias), and no later trial is registered on ClinicalTrials.gov.

Clinical Trial Evidence

No established human dosage.

Human clinical evidence: None identified.

Preclinical research: ACE-031 is a fusion of the activin receptor type IIB with an antibody Fc fragment, made to soak up myostatin and related signals. In people it was tested only in its own company trials, and the Duchenne programme stopped for safety reasons before any dose was shown to work. Animal work, including a 14-week study in marmosets that increased lean mass and muscle force, does not establish a human dose.

Animal dosing is not converted into a human dose anywhere on this page. Where research figures appear below, they are reported as studied, not recommended.

Dosage evidence summary for ACE-031
Human dosing establishedNo
RouteSubcutaneous (in the halted trial programme)
Half-lifeMean 10–15 days after a single subcutaneous dose in healthy postmenopausal women (Attie et al. 2013)
Evidence levelClinical Trial Evidence
Last reviewed2026-11-07

Human research reported

Doses as studied, one row per regimen. Different trials used different regimens; they are listed separately rather than averaged.

Research-reported dosing for ACE-031, one row per studied regimen
Study / contextPopulationDoseRouteFrequencyDurationOutcome studiedSource
Phase 1 single ascending-dose study in healthy volunteers (2013)Clinical trial · Double-blind, placebo-controlled phase 1 studyHealthy postmenopausal women (n=48, randomised 3:1 to ACE-031 or placebo)0.02–3 mg/kg as one doseSubcutaneousSingle doseSingle dose; lean mass and thigh muscle measured at day 29Generally well tolerated, with injection-site redness; at 3 mg/kg, total lean mass rose 3.3% and thigh muscle volume 5.1% at day 29A single ascending-dose study of muscle regulator ACE-031 in healthy volunteers. Muscle Nerve. 2013.
NCT00952887 — phase 1 multiple-dose study in healthy volunteersClinical trial · Placebo-controlled phase 1 trial (registry record)Healthy postmenopausal women (n=70, 8 dosing groups)Dose levels not stated in the registry recordSubcutaneous2 or 3 doses over one month, or 7 doses over 3 months1 or 3 monthsSafety, tolerability, pharmacokinetics and pharmacodynamics; completed, no results postedNCT00952887 — A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 in Healthy Postmenopausal Women
NCT01099761 — phase 2 trial in Duchenne muscular dystrophy, terminatedClinical trial · Randomised, placebo-controlled, ascending-dose phase 2 trial; results postedAmbulant boys aged 4 and over with Duchenne muscular dystrophy on steroids (n=24: 9, 9 and 6 on placebo)0.5 mg/kg every 4 weeks or 1.0 mg/kg every 2 weeks; a planned 2.5 mg/kg every 4 weeks group enrolled no oneSubcutaneousEvery 4 weeks or every 2 weeks12 weeksTerminated based on preliminary safety dataNCT01099761 — Study of ACE-031 in Subjects With Duchenne Muscular Dystrophy
Published results of the Duchenne trial (Campbell et al. 2017)Clinical trial · Randomised, double-blind, placebo-controlled trialAmbulatory boys with Duchenne muscular dystrophyAscending doses every 2–4 weeks; amounts not stated in the indexed abstractSubcutaneousEvery 2–4 weeks—No serious or severe adverse events; stopped after the second dosing regimen because of nosebleeds and telangiectasias. Trends, not statistically significant, toward a stable 6-minute walk distance, more lean mass and bone density and less fatMyostatin inhibitor ACE-031 treatment of ambulatory boys with Duchenne muscular dystrophy: Results of a randomized, placebo-controlled clinical trial. Muscle Nerve. 2017.
NCT01239758 — extension study in Duchenne muscular dystrophy, terminatedClinical trial · Phase 2 extension study (registry record)Boys with Duchenne muscular dystrophy from the core study (n=11)0.5 mg/kg every 4 weeks, up to 1.0 mg/kg every 2 weeks, or up to 2.5 mg/kg every 4 weeksSubcutaneousEvery 2 or 4 weeks24 weeks plannedTerminated based on preliminary safety data; no results postedNCT01239758 — Extension Study of ACE-031 in Subjects With Duchenne Muscular Dystrophy

Where sources disagree

  • The doses above were weight-based and given under trial monitoring. The Duchenne trial was stopped because of nosebleeds and telangiectasias, which were not muscle-related, so these doses are not a tested safe regimen.
  • ACE-031 binds myostatin and related signalling proteins, not myostatin alone, and the events that stopped the Duchenne trial were not muscle-related. Results with other myostatin blockers do not describe ACE-031.

Reconstitution

Common research vial sizes: 1 mg.

Reconstitution arithmetic for ACE-031
VialBacteriostatic waterConcentrationPer 0.01 mL
1 mg1 mL1 mg/mL10 mcg per 0.01 mL

These figures are arithmetic only — they convert a vial and a volume into a concentration. They are not a recommendation to take any dose.

Calculate reconstitution & dose →

Science

Mechanism of Action

ACE-031 acts as a decoy receptor, binding myostatin and related TGF-beta superfamily ligands in the circulation before they can engage cell-surface activin receptors. Removing that inhibitory signal relieves suppression of muscle growth. Because the receptor domain binds several ligands rather than myostatin alone, off-target effects on vascular and haematological pathways were observed, which is why development stopped.

Research statistics

7 PubMed publications · 28.6% human clinical research · 4 registered trials

Counts of published research through 2026-11-01, not evidence that it works. Publications by year, study types and trials · How publications are counted

Regulatory & research status

ACE-031 is not an FDA-approved product. It is sold for laboratory research and has no approved medical use.

Regulatory and research status for ACE-031
FDA statusNot Approved
Research statusDevelopment discontinued
AvailabilityResearch-Only
WADA (sport)Unknown / Not Listed
Library classificationResearch-Only

How FDA approval, compounding and research-only status differ

Benefits

—

ACE-031 side effects

No side effects listed yet for this entry.

Storage & stability

Lyophilized (freeze-dried) peptide powder is far more stable than the reconstituted solution. Keep sealed vials cold, dry and away from light; long-term storage is typically frozen, with short-term refrigeration for vials in use.

Once reconstituted in bacteriostatic water, keep the solution refrigerated, avoid repeated freeze–thaw cycles and agitation, and label the vial with the reconstitution date and concentration. Discard any solution that turns cloudy or shows particulates.

Degradation rates differ by sequence: peptides containing methionine, cysteine, asparagine or glutamine are more prone to oxidation and deamidation, so shelf life after reconstitution is compound-specific rather than universal.

Read the full guide: how to store peptides before and after reconstitution →

Source: Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS. Stability of protein pharmaceuticals: an update. Pharm Res. 2010;27(4):544–575. (PMID 20143256). General guidance for research handling; not product-specific instructions.

ACE-031: frequently asked questions

What is ACE-031?

Fusion protein of the activin receptor type IIB extracellular domain with an IgG1 Fc region, developed as a myostatin pathway inhibitor for muscular dystrophy. Clinical development was discontinued after vascular adverse events. Not FDA-approved.

How does ACE-031 work?

ACE-031 acts as a decoy receptor, binding myostatin and related TGF-beta superfamily ligands in the circulation before they can engage cell-surface activin receptors. Removing that inhibitory signal relieves suppression of muscle growth.

Is ACE-031 FDA approved?

No. ACE-031 is not currently FDA-approved. Its development or marketing was discontinued, which can happen for commercial reasons as well as safety or efficacy ones. Any material available today is not an approved product.

What peptides are similar to ACE-031?

Compounds most often compared with ACE-031 include Follistatin-344, GDF-11, MGF and Anamorelin. They are grouped by shared mechanism or research area rather than by equivalence, and their regulatory status and evidence base differ.

References

Related research, comparisons & guides

Related peptides

Compiled by Peptide Library Editorial · Reviewed Aug 30, 2026 · Updated Nov 7, 2026 · Version 3

This ACE-031 profile is compiled from published literature (5 cited studies linked above), public regulatory records and chemical registries. It describes what research reports; it is not medical advice, and nothing here is a dosing recommendation for humans. Peptide Library does not sell peptides. Editorial policy · How profiles are compiled · Report an error

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