ACE-031 (ramatercept) regulatory status
Current status of ACE-031 (ramatercept) in the United States: Unscheduled. In sport: WADA prohibited. Details, sources, and the dated timeline follow.
By the PeptideAgent Editorial Team. Draft, pending editorial review. Last verified
What is the current status of ACE-031 (ramatercept)?
- FDA and compounding
- ACE-031 is an investigational biologic that was never submitted for FDA approval; its sponsor ended development in 2011 after the Duchenne trial was halted. It is not on the FDA 503A bulks list, has not been nominated or reviewed by the Pharmacy Compounding Advisory Committee, and as a recombinant fusion protein it is not a candidate for 503A compounding. Products sold under this name are not lawful for human use and their identity cannot be verified.
- WADA
- WADA prohibited
- Access path
- Not legally available: no approved product, no active clinical trials, and not eligible for compounding.
- Products labeled research use only are not lawful for human use and are not verified for identity or purity.
Full ACE-031 (ramatercept) page: evidence, dosing in the literature, and sources
How has the status of ACE-031 (ramatercept) changed over time?
- WADA
WADA publishes the 2027 Prohibited List
WADA published the 2027 Prohibited List on September 21, 2026, and it takes effect January 1, 2027. The S2 peptide hormone and growth factor classes are unchanged. BPC-157 is still named under S0, and MOTS-c is still named under S4.4 as an activator of AMP-activated protein kinase. WADA added a note that many peptides without approval for human use fall under S0 or another section, and that a peptide not named on the list may still be prohibited. GLP-1 receptor agonists such as semaglutide and tirzepatide are still not on the list.
- WADA
WADA 2026 Prohibited List takes effect
The 2026 WADA Prohibited List took effect on January 1, 2026 and continues to prohibit the S2 peptide hormone and growth factor classes (GHRH analogs, growth hormone secretagogues, GH fragments, IGF-1 and analogs, MGF, thymosin beta-4 and derivatives, hCG and GnRH-class releasing factors in males), myostatin inhibitors, insulin and the AMPK activator MOTS-c under S4, desmopressin under S5, and BPC-157 under S0. GLP-1 receptor agonists such as semaglutide and tirzepatide are not on the list.
- WADA
WADA 2025 Prohibited List keeps peptide hormones and growth factors banned at all times
The 2025 WADA Prohibited List took effect on January 1, 2025. Section S2 (peptide hormones, growth factors, related substances and mimetics) covers GHRH analogs such as CJC-1295, sermorelin, and tesamorelin, growth hormone secretagogues such as ipamorelin, GHRP-2, GHRP-6, hexarelin, and ibutamoren (MK-677), growth hormone fragments such as AOD-9604, growth factors including IGF-1 and its analogs, MGF, and thymosin beta-4 (TB-500), and chorionic gonadotropin and releasing factors such as gonadorelin and kisspeptin (prohibited in males). Myostatin inhibitors such as ACE-031 fall under S4, insulin under S4 metabolic modulators, desmopressin under S5, and BPC-157 remains an S0 non-approved substance.
Sources
Numbered citations in the answers above point here, followed by the regulatory sources on record for ACE-031 (ramatercept) and the source of each dated event.
- [1]FDA: Bulk drug substances used in compounding under section 503A of the FD&C Act (links to the Category 1, 2, and 3 lists and the bulks list)FDA, 2026
- [2]WADA Prohibited List, section S4 (hormone and metabolic modulators, including myostatin inhibitors)WADA, 2026
- [3]WADA 2027 Prohibited ListWADA, 2026