Is Ipamorelin legal in the US?
No. It is not approved and is sold as a research chemical.
Ipamorelin is not approved by the FDA for any use and is sold online as a research chemical; its development for post-operative ileus was abandoned after a negative phase 2 trial. In 2023 the FDA placed it in Category 2 of its compounding lists, the category for substances with significant safety risks, and it remains there for outsourcing facilities (503B) although the nominations for pharmacy compounding (503A) were withdrawn in 2024. In October 2024 the Pharmacy Compounding Advisory Committee voted 12 to 0, with one abstention, against adding it to the 503A bulks list.
No. Novo Nordisk developed it and took it to a phase 2 trial for post-operative ileus. The trial failed, and the company stopped. It has no approved use anywhere. 6
In September 2023 the FDA put ipamorelin in Category 2. This means compounding pharmacies may not use it, because of significant safety concerns. In 2024 the nominations for pharmacy compounding (503A) were withdrawn, but it remains in Category 2 for outsourcing facilities (503B). In October 2024 the Pharmacy Compounding Advisory Committee voted 12 to 0, with one abstention, against adding it to the 503A bulks list. Withdrawing a nomination is not approval. 710
More on Ipamorelin
Citations
- Cleveland Clinic: ghrelin overview my.clevelandclinic.org
- Raun 1998, European Journal of Endocrinology: ipamorelin, the first selective growth hormone secretagogue pubmed.ncbi.nlm.nih.gov
- Growth Hormone and IGF Research 2001: ipamorelin study doi.org
- Gobburu 1999, Pharmaceutical Research: pharmacokinetic-pharmacodynamic modeling of ipamorelin in human volunteers pubmed.ncbi.nlm.nih.gov
- Venkova 2009, Journal of Pharmacology and Experimental Therapeutics: ipamorelin in a rat model of post-operative ileus doi.org
- Beck 2014, International Journal of Colorectal Disease: randomised proof-of-concept study of ipamorelin for post-operative ileus pubmed.ncbi.nlm.nih.gov
- FDA: certain bulk drug substances for use in compounding may present significant safety risks fda.gov
- Ghigo 1997, European Journal of Endocrinology: growth hormone-releasing peptides, review pubmed.ncbi.nlm.nih.gov
- Arvat 1997, Peptides: effects of GHRP-2 and hexarelin on GH, prolactin, ACTH and cortisol in man pubmed.ncbi.nlm.nih.gov
- FDA: bulk drug substances nominated for use in compounding under section 503A, category list fda.gov
- Thomas 2012, Journal of Chromatography A: determination of prohibited small peptides in urine for sports drug testing pubmed.ncbi.nlm.nih.gov
Reference information only, not medical advice. Drawn from the Ipamorelin article, fact-checked against the cited sources. No dosing anywhere on this site.