U.S. regulatory status
Ipamorelin
Also known as Ipamorelin acetate
Is Ipamorelin legal right now?
Ipamorelin is not on the FDA’s 503A Bulk Drug Substances List, so it is not approved for pharmacy compounding under enforcement discretion.
Its interim-list nomination was withdrawn in 2024, removing it from Category 2 (the “significant safety risks” bucket) around September 2024; however, at the October 29, 2024 advisory committee (PCAC) meeting the committee voted against adding it to the list, citing insufficient human safety data and endocrine concerns. It is not part of the April 2026 peptide batch and does not appear on the July 2026 or February 2027 PCAC agendas, so it sits off both the restricted list and the permitted list, with no separate federal ban.
In limbo: Moved on paper - nominated, removed from a restricted list, or recommended by an FDA committee - but not added to the 503A list. The headline implies a change; the legal status has not moved.
Verified Sep 22, 2026 (ET) · status held since Oct 29, 2024
Where it sits in the process
- Nominated (stalled here - not advancing)
- Under review (not reached)
- Rulemaking (not reached)
- Compounding-legal (not reached)
Not on a path to the 503A list right now. The process stalled or reversed at this stage - read the status above. Sitting at an earlier step is not a sign it will advance.
What changed last
FDA advisory committee voted against adding ipamorelin to the 503A list.
Status elsewhere
| Jurisdiction | Status | Note |
|---|---|---|
| United States (FDA) | In limbo | Removed from Category 2 (~Sept 2024); PCAC voted against 503A inclusion Oct 29, 2024; not on any bulks list; no separate ban. |
| Australia (TGA) | Restricted | Reported as Schedule 4 (prescription-only) under the Poisons Standard. |
| United Kingdom (MHRA) | Restricted | No UK marketing authorisation; supply for human use treated as an unlicensed medicine. |
| European Union (EMA) | Restricted | No EU marketing authorisation; absent from the Union Register, so sale as a medicine is unlawful EU-wide, with enforcement at member-state level. |
| Canada (Health Canada) | Restricted | Not authorized for sale; Health Canada’s April 2026 advisory names ipamorelin as an unauthorized injectable peptide drug that is illegal to sell in Canada. |
| Sport / anti-doping (WADA) | Restricted | Prohibited at all times under S2 as a growth-hormone secretagogue. |
The U.S. status is watched by automation every six hours. Statuses elsewhere change less often and are covered by a monthly wide-net sweep, then re-verified whenever a lead surfaces - this entry’s last-verified date covers every row above. How we track it
Sources & transparency
Sources for this entry
- FDA - 503A bulk drug substances: Category 1 & Category 2 lists FDA · primaryIpamorelin is not on the 503A (Category 1) list; the FDA 503A categories govern compounding eligibility.
- Federal Register - PCAC notice of meeting, Oct 29, 2024 Federal Register · primaryConfirms the Oct 29, 2024 PCAC meeting that reviewed ipamorelin (nomination withdrawn; committee voted against inclusion).
- MHRA Products database - search: ipamorelin UK gov · primaryBasis for the United Kingdom (MHRA) status row.
- Health Canada advisory on unauthorized injectable peptides (Apr 9, 2026) Health Canada · primaryBasis for the Canada (Health Canada) status row.
- Union Register of medicinal products (European Commission) EU · primaryBasis for the European Union (EMA) status row.
- A4PC - PCAC votes against four nominated bulk drug substances AnalysisCommittee voted against adding ipamorelin (among four substances) to the 503A list.
- FDA Law Blog - FDA’s Pep(tide) Rally (Hyman, Phelps & McNamara) AnalysisIpamorelin is not on the July 2026 or February 2027 PCAC agendas.
- Last verified by a human
- Sep 22, 2026 (ET) · how we verify
- Who runs this
- Peptlas Research Team - independent. About us.
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This page reports publicly available regulatory status for information only. It is not medical or legal advice and makes no health claim. See our full disclaimer.
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