ACE-083: dosing from clinical trials
> Updated:
Human schedule
ACE-083 is a locally acting follistatin-based ligand trap that was injected intramuscularly directly into a target muscle (tibialis anterior or biceps brachii). The figures below generalize the regimens described in published phase 2 studies.
This is a concise reference to regimens described for adults; it is not an individual prescription.
ACE-083 dosing in the clinical trials is always tied to a specific muscle rather than body weight: the same milligram dose is injected into one muscle regardless of the participant's weight.
| Period / condition | Dose | Escalation |
|---|---|---|
| Starting cohort (IM, every 3 weeks) | 150 mg per muscle | Starting dose |
| Escalation (IM, every 3 weeks) | 200 mg per muscle | Increase if needed |
| Main regimen (IM, every 3 weeks) | 240 mg per muscle | Maximum in this schedule |
Practical dosing and effect details
In a study by Statland and colleagues (Muscle & Nerve, 2022) in patients with facioscapulohumeral muscular dystrophy, the ACE-083 dose was escalated stepwise: 150, then 200, then 240 mg per muscle, injected every three weeks for up to 5 doses (about 3 months). At the 200-240 mg doses, total muscle volume (TMV) rose more than 15% from baseline on MRI. In the second part of the study, participants received a fixed 240 mg per muscle dose bilaterally every three weeks for 27 weeks (9 doses); the increase in contractile muscle volume (CMV) versus placebo was statistically significant, though that did not always translate into a clinically noticeable gain in strength or function. The schedule on this page (150, 200, 240 mg, every 3 weeks intramuscularly into the target muscle) reproduces that same studied escalation. This is reference information for planning a research protocol, not a medical recommendation and not instructions for self-administration.
This reference is research-use material. The information is not medical advice and is not intended for diagnosis, treatment or prevention of disease.