Ipamorelin Compounding Pharmacy FDA and State Board Enforcement History

What is ipamorelin's regulatory status?

Ipamorelin is a five-amino-acid synthetic peptide that stimulates growth hormone release at the ghrelin/GH-secretagogue receptor rather than the GHRH receptor, and it contains unnatural amino acids [4][7]. It was developed as an investigational drug for postoperative ileus, but that development was reportedly discontinued after disappointing phase 2 results [4][7]. It is not a component of any FDA-approved drug and has no US Pharmacopeia monograph [4].

What has FDA done about compounded ipamorelin?

FDA added ipamorelin acetate to category 2, its list of bulk substances that may present significant safety risks for compounding by outsourcing facilities, on September 29, 2023. It was still on that list on FDA's page dated 04/22/2026 and on the outsourcing-facility version updated March 21, 2025 [1][2].

FDA's stated concerns are possible immunogenicity for certain routes because of aggregation and peptide-related impurities, unnatural amino acids that complicate characterization, and a published study that identified serious adverse events, including death, when ipamorelin was given intravenously to improve gastric motility. FDA says it has not identified safety-related information for other injectable routes [1].

For state-licensed pharmacies and physicians, ipamorelin sits in the table of withdrawn nominations and in none of the three categories on FDA's list updated May 14, 2026, and the agency's category 1 policy does not apply to it [1][5].

What did FDA's advisers conclude?

On October 29, 2024 the Pharmacy Compounding Advisory Committee voted 0 yes, 12 no, 1 abstention on ipamorelin free base and 0 yes, 12 no, 1 abstention on ipamorelin acetate, citing a lack of information supporting safety and efficacy for growth hormone deficiency and postoperative ileus; FDA's reviewers had proposed that ipamorelin not be added to the pharmacy bulks list [3]. HHS's October 2026 draft enforcement-discretion policy names six peptides — BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500 — and ipamorelin is not one of them [6].

What human data exist?

The one published ileus study FDA identified was a phase 2 trial in postoperative ileus: 117 adults enrolled, 114 analyzed after bowel resection, given 0.03 mg/kg intravenous ipamorelin or placebo twice daily from day 1 to day 7 or discharge. Median time to first tolerated solid meal was 25.3 hours versus 32.6 hours (p=0.15, not significant) [4][8]. Per FDA's summary, low potassium occurred in 12.5% versus 3.4% and high blood sugar at discharge in 14.3% versus 8.6%; two ipamorelin-treated patients died of surgical complications, and FDA said it is unclear whether the deaths were related to the drug [4][8].

A separate published study evaluated intravenous ipamorelin in healthy men for pharmacokinetics and growth hormone response rather than efficacy: half-life was about 2 hours, with GH peaking about 0.67 hours after a 15-minute infusion [9]. No FDA-approved dose exists, and FDA found no human pharmacokinetic, safety or efficacy data for subcutaneous ipamorelin [4].