Reference
Ipamorelin regulatory status
Ipamorelin is not an approved drug. FDA placed it in Category 2 for compounding, and an advisory committee voted against the 503A list in 2024.
By the Ipamorelin Research editorial team · Last reviewed · Scientific review: pending
Short answer
Ipamorelin is not an approved drug in the United States: there is no approved application for it in Drugs@FDA. FDA placed ipamorelin acetate in Category 2 of bulk drug substances that may present significant safety risks when used in compounding on 29 September 2023. On 29 October 2024 the Pharmacy Compounding Advisory Committee voted 12 to 0, with one abstention, against adding either ipamorelin acetate or ipamorelin free base to the 503A Bulks List.
The regulatory record
United States
Checked 2026-11-11
Not an approved drug
Queries of the FDA Drugs@FDA database by generic name and by substance name return no matches for ipamorelin. There is no approved application, and therefore no FDA-approved indication, no approved labelling and no approved dose for any use.
United States
Effective 2023-09-29 · Checked 2026-11-11
Category 2 bulk drug substance for outsourcing-facility compounding (503B)
FDA lists "Ipamorelin acetate" under category 2 of its interim policies, designated 503B, added on September 29, 2023. Category 2 covers substances that may present significant safety risks. The entry states the substance may pose a risk for immunogenicity for certain routes of administration because of the potential for aggregation or peptide-related impurities, notes that it contains unnatural amino acids which add to the complexity of peptide characterisation, references a published study identifying serious adverse events including death after intravenous administration, and states that FDA has not identified safety-related information for certain other injectable routes and lacks sufficient information to know whether the drug would cause harm by those routes.
Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks
United States
Effective 2024-10-29 · Checked 2026-11-11
Advisory committee voted against the 503A Bulks List
At the Pharmacy Compounding Advisory Committee meeting on October 29, 2024 (docket FDA-2024-N-4188), the committee considered ipamorelin acetate and ipamorelin (free base) for inclusion on the 503A Bulks List. The committee voted 12 to 1 to take the two substances individually rather than as a group. It then voted 0 in favour, 12 against, 1 abstention on placing ipamorelin (free base) on the list, and 0 in favour, 12 against, 1 abstention on placing ipamorelin acetate on the list. The minutes record that members voting against agreed there was a lack of information supporting safety and efficacy in the available data for use in growth hormone deficiency and postoperative ileus.
Pharmacy Compounding Advisory Committee Meeting Minutes, October 29, 2024
The 2024 advisory committee vote in detail
FDA convened the Pharmacy Compounding Advisory Committee on 29 October 2024 under docket FDA-2024-N-4188, with ipamorelin acetate and ipamorelin (free base) among the substances considered for the 503A Bulks List[FDA PCAC 2024]. The minutes record three votes [PCAC minutes]:
| Question | Yes | No | Abstain |
|---|---|---|---|
| Vote on the two ipamorelin substances as a group? | 12 | 1 | 0 |
| Should ipamorelin (free base) be placed on the 503A Bulks List? | 0 | 12 | 1 |
| Should ipamorelin acetate be placed on the 503A Bulks List? | 0 | 12 | 1 |
Because one member voted against taking the substances as a group, FDA took individual votes on each. The minutes record that members voting No agreed there was a lack of information supporting safety and efficacy in the available data for the use of ipamorelin in growth hormone deficiency and postoperative ileus, and that one member commented that the high frequency of a drug being prescribed does not necessarily mean it is safe and effective. The member who abstained noted conflicting comments causing confusion between the deliberations on safety and efficacy and the data presented.
Research and regulatory timeline
Every event below carries a verified date and a primary source. Nothing has been added to fill a gap in the chronology, which is why some years are absent.
- research
Ipamorelin described and named
A Novo Nordisk group published the discovery and pharmacology of ipamorelin (NNC 26-0161), a pentapeptide identified from a series lacking the central Ala-Trp dipeptide of GHRP-1. It released GH from rat pituitary cells and in rats and swine, and did not raise ACTH or cortisol in swine at doses more than 200-fold above its GH ED50.
Why it matters: This is the origin of the compound and of the selectivity claim that still dominates how it is described.
- research
Pharmacokinetics compared across routes in rats
A companion study measured clearance, excretion route and nasal bioavailability for ipamorelin against GHRP-2, GHRP-6 and two other NNC peptides in male rats.
Why it matters: Established the basic disposition of the compound and the interest in non-injectable routes.
- clinical
First human pharmacokinetic and pharmacodynamic study
Healthy male volunteers received 15-minute intravenous infusions across five dose levels, eight subjects per level. Half-life was about 2 hours, and each dose produced a single episode of GH release peaking at 0.67 hours.
Why it matters: The only indexed study measuring what ipamorelin does to growth hormone in people. It remains the basis for every statement about human GH response.
- research
Longitudinal bone growth measured in rats
Fifteen days of subcutaneous dosing increased tibial growth rate dose-dependently, while total IGF-I, IGF binding proteins and bone turnover markers were unchanged.
Why it matters: An early demonstration that a growth effect in this model did not travel with a measurable change in circulating IGF-1.
- research
Secretagogues increase body fat in mice
In GH-deficient and GH-intact mice, ipamorelin increased relative fat mass, serum leptin and food intake, while GH itself decreased relative fat mass.
Why it matters: The direction of this result is the opposite of the fat-loss claim commonly made for the compound class, and it was reported by the researchers themselves.
- clinical
Phase 2 trial in postoperative ileus begins
Helsinn Therapeutics registered NCT00672074, a randomised, quadruple-masked, placebo-controlled trial at 19 sites, which enrolled 117 patients after bowel resection.
Why it matters: The start of the only ipamorelin trial programme to reach published human results.
- clinical
First phase 2 trial completes
NCT00672074 completed in December 2009. No results were posted to the registry.
Why it matters: Publication followed five years later.
- clinical
Larger dose-finding phase 2 trial begins
NCT01280344 began at 45 sites with four arms and an eventual enrolment of 320 patients, nearly three times the first trial.
Why it matters: The largest ipamorelin trial ever conducted.
- clinical
The one randomised trial is published
The proof-of-concept trial reported a median time to first tolerated meal of 25.3 hours against 32.6 hours for placebo (P = 0.15), and no significant differences in the key and secondary efficacy analyses.
Why it matters: This is the entire published randomised human evidence base for ipamorelin, and its primary efficacy result was null.
- clinical
The larger trial completes, and is never reported
NCT01280344 completed in May 2014. No results have been posted to the registry and no publication was found in the PubMed search behind this database.
Why it matters: The largest body of human ipamorelin data that exists is not in the public record. Any account of the human evidence that omits this is incomplete.
- product
A modified ipamorelin is identified in market products
Analysis of black-market growth-promoting products identified Gly-Ipamorelin, the peptide extended by an N-terminal glycine, with its identity confirmed by custom synthesis.
Why it matters: Material sold as ipamorelin is not always ipamorelin. This is a product-identity finding, separate from anything about the compound itself.
- product
Glycine-extended analogues found in seized material
Preparations seized by Danish customs were identified as glycine-extended analogues of GHRP-2, GHRP-6, ipamorelin and modified GRF (1-29).
Why it matters: A second independent finding of the same substitution, and a recommendation that testing methods be updated to detect it.
- regulatory
FDA places ipamorelin acetate in Category 2
Ipamorelin acetate was added to FDA’s list of bulk drug substances that may present significant safety risks when used in compounding, under the 503B interim policy.
Why it matters: The formal US regulatory position on the substance, citing immunogenicity, peptide-related impurities and unnatural amino acids.
Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks
- regulatory
Advisory committee votes against the 503A Bulks List
The Pharmacy Compounding Advisory Committee voted 0 for, 12 against, 1 abstaining on placing each of ipamorelin (free base) and ipamorelin acetate on the 503A Bulks List, citing a lack of information supporting safety and efficacy.
Why it matters: An independent expert committee reviewed the same evidence summarised on this site and reached a unanimous negative view.
Pharmacy Compounding Advisory Committee Meeting Minutes, October 29, 2024
What this site has not verified
Regulatory information is only useful if the jurisdiction and the date are explicit. The following are gaps, shown rather than filled:
World Anti-Doping Agency
Ipamorelin is a growth hormone secretagogue, a class addressed in section S2 of the WADA Prohibited List. The current List PDF could not be retrieved from wada-ama.org at the time of writing, so the exact section wording and whether ipamorelin is named explicitly are not verified here. Athletes should consult the official List directly rather than rely on any secondary summary, including this one.
Consult the primary source directly
Checked 2026-11-11
United Kingdom, European Union, Australia, Canada
No primary regulatory record for ipamorelin in these jurisdictions has been verified for this site. Their absence here means it has not been checked, not that no record exists.
Checked 2026-11-11
Legality is not the same question as approval
“Is ipamorelin legal?” and “is ipamorelin approved?” are different questions with different answers, and the second is the one this page can answer from primary sources: it is not approved, and FDA has twice declined to treat it as suitable for compounding. Questions of legality depend on jurisdiction, on the capacity in which a substance is held, and on rules this site has not verified. It is also worth separating both questions from a third: whether material sold under the name is the compound at all, which two analytical studies have found it sometimes is not [Krug 2018] [Gajda 2019].
Regulatory records on this page were last checked on 2026-11-11. The safety findings behind them are set out on the safety page.
References
- Beck DE, Sweeney WB, McCarter MD et al. (2014). Prospective, randomized, controlled, proof-of-concept study of the Ghrelin mimetic ipamorelin for the management of postoperative ileus in bowel resection patients. Int J Colorectal Dis. PubMed 25331030 · doi:10.1007/s00384-014-2030-8[Human, grade A]
- Krug O, Thomas A, Malerød-Fjeld H et al. (2018). Analysis of new growth promoting black market products. Growth Horm IGF Res. PubMed 29864719 · doi:10.1016/j.ghir.2018.05.001[Analytical, grade D]
- Gajda PM, Holm NB, Hoej LJ et al. (2019). Glycine-modified growth hormone secretagogues identified in seized doping material. Drug Test Anal. PubMed 30136411 · doi:10.1002/dta.2489[Analytical, grade D]
- Raun K, Hansen BS, Johansen NL et al. (1998). Ipamorelin, the first selective growth hormone secretagogue. Eur J Endocrinol. PubMed 9849822 · doi:10.1530/eje.0.1390552[Animal, grade C]
- Johansen PB, Nowak J, Skjaerbaek C et al. (1999). Ipamorelin, a new growth-hormone-releasing peptide, induces longitudinal bone growth in rats. Growth Horm IGF Res. PubMed 10373343 · doi:10.1054/ghir.1999.9998[Animal, grade C]
- Lall S, Tung LY, Ohlsson C et al. (2001). Growth hormone (GH)-independent stimulation of adiposity by GH secretagogues. Biochem Biophys Res Commun. PubMed 11162489 · doi:10.1006/bbrc.2000.4065[Animal, grade C]
- Gobburu JV, Agersø H, Jusko WJ et al. (1999). Pharmacokinetic-pharmacodynamic modeling of ipamorelin, a growth hormone releasing peptide, in human volunteers. Pharm Res. PubMed 10496658 · doi:10.1023/a:1018955126402[Human, grade B]
- U.S. Food and Drug Administration, openFDA. openFDA Drugs@FDA and NDC directory queries for ipamorelin. Source[retrieved 2026-11-11]
- U.S. Food and Drug Administration (2026-04-22). Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. Source[retrieved 2026-11-11]
- U.S. Food and Drug Administration (2024-10-29). October 29, 2024: Meeting of the Pharmacy Compounding Advisory Committee. Source[retrieved 2026-11-11]
- U.S. Food and Drug Administration (2024-10-29). Pharmacy Compounding Advisory Committee Meeting Minutes, October 29, 2024. Source[retrieved 2026-11-11]
- U.S. Food and Drug Administration (2024-10-29). FDA Briefing Document, Pharmacy Compounding Advisory Committee: Ipamorelin. Source[retrieved 2026-11-11]
- FDA Global Substance Registration System. IPAMORELIN, UNII Y9M3S784Z6. Source[retrieved 2026-11-11]
- ClinicalTrials.gov, U.S. National Library of Medicine (2011-04). Phase II Double-Blind Placebo-Controlled Dose Finding Study to Evaluate Safety/Efficacy of Ipamorelin Compared to Placebo for Recovery of Gastrointestinal Function Following Bowel Resection (NCT01280344). Source[retrieved 2026-11-11]
- ClinicalTrials.gov, U.S. National Library of Medicine (2008-04). A Phase II, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety and Efficacy of Ipamorelin Compared to Placebo for the Management of Post-Operative Ileus (NCT00672074). Source[retrieved 2026-11-11]