Ipamorelin

Definition

Ipamorelin is a synthetic pentapeptide that mimics ghrelin at the growth hormone secretagogue receptor, producing selective growth hormone release with little effect on cortisol or prolactin; that selectivity built its reputation in the wellness market.

It is routinely sold in combination with CJC-1295, a pairing invented by the market rather than by any trial.

Evidence

Ipamorelin's clinical record is nearly singular: a randomized, placebo-controlled proof-of-concept trial in 114 patients with postoperative ileus found a median time to first tolerated meal of 25.3 hours against 32.6 with placebo, a difference that did not reach statistical significance (p = 0.15) ^[1]. Reviews of the GH-axis peptides find no completed efficacy trial supporting the uses it is marketed for today ^[2].

One neutral trial in an unrelated indication is the entire human record; everything else is extrapolated pharmacology.

That description is now a measurement. Searched in August 2026 the molecule returns 54 indexed papers, 28 carrying the Humans subject heading, and exactly 2 under the clinical-trial publication type, both of which also carry the randomized-controlled-trial type ^[4]. Both were read. One is the postoperative ileus study above; the other is a dose-escalation pharmacokinetic and pharmacodynamic study in healthy male volunteers, eight subjects at each of five 15-minute infusion rates, which measured concentrations of the peptide and of growth hormone and modeled the relation between them ^[3].

A pharmacokinetic study is not an outcome trial. Read together, the two records say that the compound reaches the bloodstream and releases growth hormone in a dose-related way, and that the single time anyone measured whether it changed a clinical outcome, it did not.

Lawful access

Ipamorelin has no lawful compounding route under either section of the law. Its nominations for the 503A list, which governs pharmacies filling individual prescriptions, were withdrawn on September 19, 2024, and it sits in no 503A category. FDA presented its evaluation to the advisory committee on October 29, 2024 regardless, and the committee voted 0–12, with one abstention, against listing it ^[6].

Under the separate 503B policy for outsourcing facilities, FDA has kept ipamorelin acetate in Category 2 since September 29, 2023, the file for substances with identified significant safety risks. FDA's page, content current April 22, 2026, still lists it there, citing immunogenicity risk and a published report of serious adverse events, including a death, when it was given intravenously for gastric motility ^[5]. It was not among the peptides reviewed at the July 2026 PCAC meeting.

Material sold online is research-use-only supply, outside pharmacy oversight.

The substance also appears in a criminal case. In October 2020 Tailor Made Compounding, a Kentucky pharmacy, pleaded guilty in federal court to distributing unapproved new drugs between October 2018 and April 2020; the Justice Department's account of the plea agreement names Ipamorelin among them, and the company agreed to forfeit $1,788,906.82, its 2019 sales of those products ^[8].

Related molecules

Its constant commercial partner CJC-1295 shares the withdrawn status; sermorelin shows what a lawful position in the GH secretagogues class looks like. A withdrawal is not the only way to leave the list without a route: GHRP-2 reached Category 3 instead, which is where a nomination lands when the submission behind it was inadequate to review.

The pairing with CJC-1295 has never been tested as a pair. CJC-1295 with ipamorelin reads the two human records together, including the second postoperative trial that closed in 2014 without posted results ^[7].

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