U.S. Food and Drug Administration (FDA)
Is Ipamorelin legal in United States?
Not approvedNo FDA approval; FDA keeps ipamorelin in Category 2 for 503B outsourcing facilities because of immunogenicity and safety concerns
Not approved as a medicine here.
Ipamorelin is not approved for any use. FDA added ipamorelin acetate to the 503B Category 2 list on 29 September 2023, citing immunogenicity risk for some routes, its unnatural amino acids, and a published study that found serious adverse events including death when it was given intravenously. FDA also lists it among 503A nominations that were withdrawn, so it is not on the 503A bulks list either and is not in the Category 1 policy. FDA could consider enforcement against compounders under its general policies.
Last verified 2026-09-29 · how we verify
Ipamorelin elsewhere
Sources (3)
- 01Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (Category 2 and withdrawn nominations)U.S. Food and Drug Administration · 2026-04-22 · accessed 2026-09-29
- 02Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (Categories 1, 2 and 3)U.S. Food and Drug Administration · 2026-05-14 · accessed 2026-09-29
- 03Bulk Drug Substances Nominated for Use in Compounding Under Section 503B (Categories 1, 2 and 3)U.S. Food and Drug Administration · 2025-03-21 · accessed 2026-09-29