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ClinicalMuscleIMTrial-dependentPartial data

ACE-083

Locally acting follistatin-Fc fusion for intramuscular hypertrophy. FSHD and CMT Phase 2 trials failed functional endpoints; discontinued.

§ 01   Overview

Overview

Locally acting follistatin-Fc fusion for intramuscular hypertrophy. FSHD and CMT Phase 2 trials failed functional endpoints; discontinued.

FSHD and CMT Phase 2 failed functional endpoints 2019–2020.

§ 02   Mechanism

Mechanism of action

ACE-083 is a follistatin domain fused to an Fc region. Administered intramuscularly, it traps myostatin and activins locally, producing targeted hypertrophy in the injected muscle.

  • 01Targeted muscle hypertrophy from local injection

§ 03   Dosing

Dosing protocol

Standard Protocol

Dose Range
Historical trial doses
Route
IM
Frequency
Trial-dependent

§ 04   Evidence

Evidence & research

Clinical

FSHD and CMT Phase 2 failed functional endpoints 2019–2020.

FDA Status

Not FDA-approved. Program discontinued.

§ 07   Sourcing

Sourcing & supply

Regulatory status

Investigational, no compounding path

Currently in active clinical trials. No compounding pathway. No brand product. The only US channels are RUO vendors that the FDA has targeted with warning letters. Assume any sourcing carries significant regulatory and quality risk.

No suppliers in our directory currently stock this compound. For investigational or research-only compounds, legitimate channels may not exist outside clinical trials.

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§ 09   Safety

Safety & side effects

Side effects

  • 01Injection site reactions
  • 02Local muscle soreness

Contraindications

None specified.

§ 10   Questions

ACE-083 FAQ

What is ACE-083?
Locally acting follistatin-Fc fusion for intramuscular hypertrophy. FSHD and CMT Phase 2 trials failed functional endpoints; discontinued. ACE-083 is a follistatin domain fused to an Fc region. Administered intramuscularly, it traps myostatin and activins locally, producing targeted hypertrophy in the injected muscle.
What is ACE-083 used for?
Reported uses include targeted muscle hypertrophy from local injection. Evidence strength is rated Clinical — see the evidence section for detail.
How is ACE-083 dosed?
Commonly referenced dosing is Historical trial doses, typically trial-dependent, administered IM. This is educational reference only; consult a licensed clinician before use.
What are the side effects of ACE-083?
Commonly reported side effects include injection site reactions and local muscle soreness. This list is not exhaustive.
Is ACE-083 legal?
Currently in active clinical trials. No compounding pathway. No brand product. The only US channels are RUO vendors that the FDA has targeted with warning letters. Assume any sourcing carries significant regulatory and quality risk. FDA status: Not FDA-approved. Program discontinued..

§ 11   References

Selected references

  1. 01

    Statland FSHD — Neurology 2022

    PMID: 32820014

  2. 02

    FSHD Phase 2

    NCT02927080

  3. 03

    CMT Phase 2

    NCT03124459

This site is for educational and research purposes only. It does not constitute medical advice. Always consult a qualified healthcare provider before using any peptide or supplement.