RetaCalc
Protocol library
SingleInvestigationalEarly HumanLow confidenceSourced

ACE-031

An activin receptor fusion protein studied in early human trials. Development in Duchenne muscular dystrophy stopped after vascular safety concerns.

Evidence context, not a personal protocol

Quantities below reproduce their stated source context—label, human study, laboratory work or educational guide. They do not assess suitability, product equivalence or individual risk.

Dosage and protocol evidence

Each card states what the quantities are based on. A third-party or animal schedule is not a validated human dose.

Human StudySubcutaneousSingle exposure
Healthy postmenopausal women

A single subcutaneous dose across 0.02 mg/kg to 3 mg/kg cohorts

This ascending-dose study assessed short-term safety, pharmacokinetics and body composition.

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Human StudySubcutaneousEvery 2 or 4 weeks
Ambulatory boys with Duchenne muscular dystrophy

0.5 mg/kg subcutaneously every 4 weeks or 1 mg/kg every 2 weeks for 12 weeks

The controlled study stopped early because of potential safety concerns and did not establish routine use.

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Evidence summary

An activin receptor fusion protein studied in early human trials. Development in Duchenne muscular dystrophy stopped after vascular safety concerns.

Protocol basis

The protocol page is anchored to two early clinical programmes and foregrounds why a study interval should not be interpreted as a continuing-use plan.

What remains uncertain

A favourable benefit-risk profile, authorised indication, long-term safety and commercial product equivalence are not established.

Warnings and contraindications

ACE-031 clinical development was stopped after epistaxis and telangiectasia concerns.
It is a fusion protein rather than a short peptide.
Early changes in body composition did not establish an authorised therapeutic protocol.