WHERE THE EVIDENCE STANDS
Early human studies established that ipamorelin raises growth-hormone secretion with less effect on cortisol and prolactin than older secretagogues. A clinical programme in post-operative ileus did not progress. Published efficacy data for the uses it is now promoted for are limited.
Ipamorelin acetate was placed in Category 2 in September 2023. Its 503A nomination was withdrawn in September 2024, which took it off the 503A Category 2 table without making it eligible to compound; an advisory committee voted against adding it to the 503A bulks list in October 2024. It remains in Category 2 for 503B outsourcing facilities, where the agency's published concerns are immunogenicity and a literature report of serious adverse events with intravenous use. Earlier versions of this record noted the status as disputed; the FDA table resolves it.
ENTRIES ABOUT Ipamorelin · 2
PUBLIC
A 1 October 2026 Q&A from the Harvard T.H. Chan School of Public Health lists BPC-157, TB-500, MOTS-c, CJC-1295 and ipamorelin among synthetic peptides promoted online for recovery and performance.
REGULATION
In September 2023 the FDA placed nineteen peptides in Category 2. In April 2026 it removed twelve of them after their nominations were withdrawn and scheduled advisory meetings to consider adding them to the 503A bulks list.
SOURCES
- AJMC. Peptide regulation debate intensifies after FDA advisory panel's controversial vote. 25 Sep 2026. News feature. https://www.ajmc.com/view/peptide-regulation-debate-intensifies-after-fda-advisory-panel-s-controversial-vote
- FDA. Certain bulk drug substances for use in compounding that may present significant safety risks (Category 2 table: ipamorelin acetate, 503B, added 29 Sep 2023). Updated 22 Apr 2026. Regulatory document. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
- Superpower. Ipamorelin: mechanism, research, and status (503A withdrawal, Sep 2026 position). Sep 2026. Secondary summary. https://superpower.com/guides/peptides/ipamorelin
REVIEWED 5 Oct 2026 · NEXT REVIEW JAN 2027 · CORRECTIONS ARE LOGGED HERE