A synthetic growth hormone secretagogue. FDA has raised safety concerns, and it has no 503A pathway.
Key takeaway
Ipamorelin is a five-amino-acid peptide that acts on the ghrelin receptor to trigger growth hormone release. It is often paired with CJC-1295 or sermorelin in clinic menus.
At a glance
| FDA status | Not FDA-approved |
|---|---|
| 503A compounding | No 503A pathway: nomination withdrawn after FDA safety review |
| Body areas | Hormones & pituitary, Muscle, joints & recovery |
| Through ScriptMates | Information only |
| Open questions | None noted |
What is ipamorelin?
Ipamorelin is a five-amino-acid peptide that acts on the ghrelin receptor to trigger growth hormone release. It is often paired with CJC-1295 or sermorelin in clinic menus.
FDA notes it contains unnatural amino acids that make the peptide harder to characterize. A published study reported serious adverse events, including death, when it was given intravenously for gastric motility.
Dosage forms
No FDA-approved dosage form. FDA describes investigational intravenous administration but does not establish an approved or safe dosage form for human use.
Is ipamorelin FDA-approved?
Not FDA-approved. In 503B Category 2 (significant safety risks). Its 503A nomination was withdrawn, so it is not on the 503A list or in any 503A category.
Can it be prescribed through ScriptMates?
No 503A pathway: nomination withdrawn after FDA safety review. A partner pharmacy lists it, but it has no lawful 503A pathway today (nomination withdrawn after FDA safety review).
Sources
- FDA: Bulk substances that may present significant safety risks (Category 2 and withdrawn nominations)
- FDA: Bulk drug substances nominated under 503A, Categories 1–3 (May 14, 2026)
Checked October 27, 2026. FDA updates these pages, so confirm before relying on them.