At a glance
- ACE-031 (ramatercept) is not an FDA-approved drug: Drugs@FDA has no record of it.
- PubMed lists 12 publications mentioning it, including 2 randomized controlled trials and 1 animal-only study.
- ClinicalTrials.gov lists 4 registered studies testing it (0 active).
- FDA's adverse event system (FAERS) holds 1 report mentioning it; 1 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
No application found in Drugs@FDA, FDA's database of approved drugs.
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- ACE-031, a soluble activin type IIB receptor, increases muscle mass and strength in the common marmoset (Callithrix jacchus).
- ACE-031, a Soluble Activin Type IIB Receptor, Increases Muscle Mass and Strength in the Common Marmoset (Callithrix jacchus).
- Gel Electrophoretic Detection of Black Market ACE-031.
- The relationship between myodural bridge, atrophy and hyperplasia of the suboccipital musculature, and cerebrospinal fluid dynamics.
- The relationship between myodural bridges, hyperplasia of the suboccipital musculature, and intracranial pressure.
- Myostatin inhibitor ACE-031 treatment of ambulatory boys with Duchenne muscular dystrophy: Results of a randomized, placebo-controlled clinical trial.
- Emerging drugs affecting skeletal muscle function and mitochondrial biogenesis - Potential implications for sports drug testing programs.
- A single ascending-dose study of muscle regulator ACE-031 in healthy volunteers.
- [Anti-myostatin antibody therapy for myopathies].
- [Myostatin blockade therapy for muscular atrophy].
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 4
- Active
- 0
- With posted results
- 1
Conditions studied
| Study | Status | Phase | Start |
|---|---|---|---|
| Extension Study of ACE-031 in Subjects With Duchenne Muscular Dystrophy | Terminated | Phase 2 | Oct 2010 |
| Study of ACE-031 in Subjects With Duchenne Muscular Dystrophy | Terminated | Phase 2 | Apr 2010 |
| A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 in Healthy Postmenopausal Women | Completed | Phase 1 | Aug 2009 |
| A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 (ActRIIB-IgG1)in Healthy Postmenopausal Volunteers | Completed | Phase 1 | Sep 2008 |
All 4 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 1
- Serious
- 1
- With death outcome
- 0
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
Change history
No changes since monitoring began on October 30, 2026.