ACE-083 Research Reference

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

Researched for: localized muscle-volume modulation

Structural Research protein Lyophilized verified

Also known as: ACE083

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Quick Facts

Reference Sizes

1 mg, 5 mg

Calculator

Preset available

Storage

Use source-label storage wording. Track lot, storage location, and open/reconstitution date.

Solubility

Aqueous recombinant protein solution for IM injection

Catalog Description

ACE-083 is a follistatin-based ligand trap designed for local intramuscular retention and localized skeletal-muscle hypertrophy. In the randomized Phase 2 FSHD study, 150 mg and 240 mg per muscle every three weeks increased total muscle volume, but the 240 mg regimen did not improve functional or patient-reported outcomes versus placebo. The development program for FSHD was discontinued on efficacy grounds. It remains investigational and is not approved.

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

Research Profile

Half-Life

Local and systemic pharmacokinetics are not summarized by a single established half-life in the Phase 2 publication

Onset

Muscle-volume changes were assessed over 3-6 months; functional benefit was not demonstrated

Administration Routes (Research)

Intramuscular (localized injection, per study design)

Reported Research Effects

Localized increase in injected-muscle volume
No demonstrated improvement in strength or function in the randomized Phase 2 FSHD study
Development for FSHD discontinued for lack of functional efficacy

Reported Research Side Effects

Mostly mild or moderate injection-site and musculoskeletal events in Phase 2
Development was discontinued for lack of functional efficacy rather than a new systemic safety signal

Data source: Published randomized Phase 2 FSHD study and ClinicalTrials.gov record

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

Research Protocols Reported in the Literature

150 mg or 240 mg per injected muscle every 3 weeks [IM; Up to 6 months; Every 3 weeks]Source: randomized Phase 2 FSHD study NCT02927080

Sources

Randomized phase 2 study of ACE-083, a muscle-promoting agent, in facioscapulohumeral muscular dystrophy — PubMed Central (NIH)
https://pmc.ncbi.nlm.nih.gov/articles/PMC9321022/

NCT02927080 ACE-083 in FSHD — ClinicalTrials.gov
https://clinicaltrials.gov/study/NCT02927080

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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.