HormonalNot FDA ApprovedAnimal Studies

ACE-031

Also known as ACVR2B-Fc, Myostatin Inhibitor

A fusion protein combining the activin IIB receptor with antibody Fc domain. Phase II trials in Duchenne MD showed significant muscle mass increase but were halted due to nosebleeds and gum bleeding.

Development halted - Safety concerns

Regulatory Pathway

Preclinical
Phase I
Phase II
Phase III
Phase IV
Approved

Dosing Protocol

Typical Dose

0.5-3 mg/kg every 2 weeks (from discontinued trials)

Frequency

Every 2 weeks (research protocol)

Duration

Trials discontinued

Community-reported dosing. Individual results vary. Not a medical recommendation.
Typical community protocol: 0.5-3 mg/kg every 2 weeks (from discontinued trials) via Subcutaneous injection, Every 2 weeks (research protocol). Dose range: 0.5-3 mg/kg per dose. Duration: Trials discontinued.

Timing & Administration

Administer via Subcutaneous injection. Frequency: Every 2 weeks (research protocol).

Mechanism of Action

Acts as a decoy receptor, binding and neutralizing myostatin, GDF11, and activins to promote muscle growth.

Research Summary

Evidence level: animal studies. Clinical status: Development halted - Safety concerns.

Side Effects & Safety

Important Warnings

  • Clinical trials discontinued due to bleeding safety concerns
  • Broad ligand binding may cause unwanted vascular effects.
Nosebleeds
gum bleeding
spider veins (telangiectasias)
injection site reactions
FSH level decrease

References

No references available.