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Compounds / ACE-031

ACE-031

Full name
ACE-031 (ACVR2B-Fc; soluble activin receptor)
Mechanism
Soluble form of activin receptor type IIB fused to an Fc domain; acts as a ligand trap for myostatin/activin, increasing muscle mass in preclinical and early clinical work.
Half-life
long (Fc-fusion)
Administration
subcutaneous (trials)
Typical dosage*
low: trial-defined · typical: investigational · high: trial-defined
Researched for
muscular dystrophy research (clinical trials, since discontinued for that program)
Reported side effects
trial-observed: epistaxis/gum bleeding, telangiectasia (off-target vascular effects)
Interactions
not characterised
Commonly combined
investigational monotherapy
Scheduling
🇦🇺 AUInvestigational — not approved
🇺🇸 USInvestigational — not FDA-approved (program discontinued)
🇬🇧 UKInvestigational — not licensed
Regulatory status
Clinical development for muscular dystrophy was discontinued partly over off-target bleeding/vascular effects. Not approved.

*Doses are commonly-reported figures from public sources, not a recommendation. Educational only.

10studies
9faqs
myostatin-inhibitionbody-compositioninvestigational

Studies (10)

YearTitle / venueSource
2026ACE-031, a soluble activin type IIB receptor, increases muscle mass and strength in the common marmoset (Callithrix jacchus)
PloS one · preclinical
PMID 41686840
2025Molecular mechanism of Activin receptor inhibition by DLK1
Nature communications · preclinical
PMID 40593645
2025ACE-031, a Soluble Activin Type IIB Receptor, Increases Muscle Mass and Strength in the Common Marmoset (Callithrix jacchus)
bioRxiv : the preprint server for biology · preclinical
PMID 41256654
2022Myostatin/Activin Receptor Ligands in Muscle and the Development Status of Attenuating Drugs
Endocrine reviews · preclinical
PMID 34520530
2022Sex specificity of pancreatic cancer cachexia phenotypes, mechanisms, and treatment in mice and humans: role of Activin
Journal of cachexia, sarcopenia and muscle · preclinical
PMID 35510530
2021The association between sarcopenia susceptibility and polymorphisms of FTO, ACVR2B, and IRS1 in Tibetans
Molecular genetics & genomic medicine · preclinical
PMID 34302448
2018Prevention of chemotherapy-induced cachexia by ACVR2B ligand blocking has different effects on heart and skeletal muscle
Journal of cachexia, sarcopenia and muscle · preclinical
PMID 29230965
2017ACVR2B/Fc counteracts chemotherapy-induced loss of muscle and bone mass
Scientific reports · preclinical
PMID 29089584
2013A single ascending-dose study of muscle regulator ACE-031 in healthy volunteers
Muscle & nerve · human
PMID 23169607
2007Activin-type II receptor B (ACVR2B) and follistatin haplotype associations with muscle mass and strength in humans
Journal of applied physiology (Bethesda, Md. : 1985) · preclinical
PMID 17347381

Questions (9)

What is ACE-031?

ACE-031 (ACE-031 (ACVR2B-Fc; soluble activin receptor)). Soluble form of activin receptor type IIB fused to an Fc domain; acts as a ligand trap for myostatin/activin, increasing muscle mass in preclinical and early clinical work.

What is ACE-031 used for?

Commonly discussed uses: muscular dystrophy research (clinical trials, since discontinued for that program). There is both human and animal/preclinical research, though the depth and quality vary by indication. Note: most uses are not approved indications.

How does ACE-031 work?

Mechanism: Soluble form of activin receptor type IIB fused to an Fc domain; acts as a ligand trap for myostatin/activin, increasing muscle mass in preclinical and early clinical work.

Is ACE-031 safe?

Reported considerations: trial-observed: epistaxis/gum bleeding, telangiectasia (off-target vascular effects). There is both human and animal/preclinical research, though the depth and quality vary by indication. Clinical development for muscular dystrophy was discontinued partly over off-target bleeding/vascular effects. Not approved. This is not a safety endorsement; safety data for unapproved compounds is incomplete.

What is the typical dose of ACE-031?

Commonly cited ranges (educational reference, not a recommendation): low trial-defined, typical investigational, high trial-defined. Administration: subcutaneous (trials). Half-life: long (Fc-fusion).

Is ACE-031 legal in Australia?

Australian status: Investigational — not approved. Clinical development for muscular dystrophy was discontinued partly over off-target bleeding/vascular effects. Not approved. General regulatory context: most active peptides are Schedule 4 and require a prescription; import via the Personal Importation Scheme requires a valid Australian prescription for prescription-only goods.

How do you store ACE-031?

Reconstitution/storage reference: research vials vary; storage: refrigerated.

What is ACE-031 commonly stacked with?

Commonly discussed combinations (anecdotal for unapproved compounds): investigational monotherapy. Stacking increases interaction/safety uncertainty.