For clinicians
Ipamorelin for prescribers: status, evidence and what FDA has said
A neutral reference. It reports Ipamorelin's regulatory status, the quality of its human evidence and what FDA has said about it. It does not suggest a dose, a protocol or a source.
Status reviewed 2026-10-01 · By the Grey Peptides Editorial Board · Regulatory fields generated from our tracker
| Also known as | — |
| FDA approval | Not FDA-approved |
| Compounding (503A) | Not compoundable (nomination withdrawn; on no FDA list); 503B Category 2 |
| Outsourcing (503B) | 503B Category 2: FDA has identified significant safety risks |
| WADA 2026 List | Prohibited (S2.2.4) |
| WADA 2027 List | Prohibited (S2.2.4) |
| Evidence grade | Medium |
| Status reviewed | 2026-10-01 |
What FDA has said
FDA lists Ipamorelin acetate in Category 2, the substances it has found may present significant safety risks (page current as of 2026-04-22). In FDA's words:
Compounded drugs containing Ipamorelin acetate may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation or peptide-related impurities. Ipamorelin acetate also contains unnatural amino acids, which add to the complexity of peptide characterization. A study published in literature identified serious adverse events including death when ipamorelin was administered intravenously for improving gastric motility. FDA has not identified safety-related information regarding ipamorelin acetate via certain other injectable routes of administration. Therefore, the agency lacks sufficient information to know whether the drug would cause harm if administered to humans via those routes.
Monitoring: what the literature does and does not say
- No label. Ipamorelin has no FDA-approved label, and therefore no labelled guidance on monitoring.
- What FDA has said about its risks is quoted above, from its list of bulk substances that may present significant safety risks.
These are gaps, not a monitoring schedule. This page does not supply one, and for a compound in this position the human evidence would not support one.
Compounding: where it stands
Today's position for Ipamorelin: Not compoundable (nomination withdrawn; on no FDA list); 503B Category 2. An FDA advisory committee's vote is a non-binding recommendation; until FDA acts, a vote does not change what may be compounded. Our explainer on the 503A and 503B categories sets out what each status means, and the regulatory tracker is updated as FDA acts.
The evidence
A pentapeptide (Aib-His-D-2-Nal-D-Phe-Lys-NH2) from Novo Nordisk's 1990s growth hormone programme, code NNC 26-0161, that released growth hormone without raising ACTH or cortisol in pigs; its human record is one dosing study and a negative phase 2 trial.
The encyclopedia entry lists the human and animal studies we hold, each with its PMID.
What this page leaves out
Doses, regimens, cycle lengths and sources. That is deliberate. A reference that reports status and evidence is useful only if it is not also a protocol, and for a compound in this position there is no approved one to report.
Sources
- US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. Content current as of 2026-04-22; read 2026-10-01. FDA
- Grey Peptides regulatory tracker, row for Ipamorelin, reviewed 2026-10-01. Tracker · dataset
- World Anti-Doping Agency. Prohibited List 2027, dated August 26, 2026, in force January 1, 2027. WADA
This page is a reference for qualified professionals. It is not medical advice, it does not recommend any treatment, and it is not a substitute for the prescriber's own judgement and their state and federal obligations.
Others in this group: AOD-9604 · Cathelicidin (LL-37) · Cerebrolysin · CJC-1295 · Dihexa · GHK-Cu (injectable) · GHRP-6 · Hexarelin · Melanotan II · MK-677 (ibutamoren) · Noopept · PEG-MGF · Pralmorelin (GHRP-2) · Selank · Sermorelin · Tesofensine · Thymopentin · Thymosin α-1