§ 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
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.
Browse full supplier directory§ 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
- 01
Statland FSHD — Neurology 2022
PMID: 32820014
- 02
FSHD Phase 2
NCT02927080
- 03
CMT Phase 2
NCT03124459