Ipamorelin
Also sold as: Ipamorelin acetate, NNC 26-0161
Ipamorelin is not an FDA-approved drug for any use and is not a component of one, and FDA's Pharmacy Compounding Advisory Committee has already voted it down — 0 yes, 12 no, 1 abstain, voted separately for ipamorelin (free base) and for ipamorelin acetate on 2024-10-29 — against adding either to the 503A bulks list; it is absent from that list today because the committee voted against adding it and the nominators then withdrew the nominations, not because it was cleared, and ipamorelin acetate remains in FDA's Category 2 of bulk drug substances that may present significant safety risks. Ipamorelin genuinely was tested in humans, and it failed: in a 2014 Phase 2 trial of 114 bowel-resection patients, researchers reported no significant differences between ipamorelin and placebo in the key and secondary efficacy analyses, and the development programme was discontinued. FDA has not identified data supporting effectiveness for growth hormone deficiency or for postoperative ileus — the only two uses it evaluated. The uses ipamorelin is actually marketed for, including weight loss, anti-aging and bodybuilding, were never evaluated at all.
Which molecule this is. A synthetic pentapeptide growth hormone secretagogue (ghrelin receptor / GHS-R1a agonist), first identified in 1998. FDA evaluates two distinct substances: ipamorelin (free base) and ipamorelin acetate, and voted on them separately. The distinction is not pedantry — FDA's own briefing document repeatedly flags that the published literature 'does not always clearly identify whether the ipamorelin form administered in the clinical studies was a salt formulation or the free base', and FDA therefore labels the form in the human trials as 'unspecified'. Both nominations were themselves ambiguous about which substance was being nominated. Ipamorelin (free base) is a five-amino-acid peptide containing UNNATURAL amino acids, which FDA treats as a characterisation and immunogenicity concern in its own right.
FDA status
FDA has not approved this and it is not in active development toward approval. That says nothing about whether it is being sold — most substances in this category are.
Not an FDA-approved drug for any indication, and not in active development toward approval. That says nothing about whether it is sold — it is.
“Bulk drug substances nominated but withdrawn”Checked against the source on .
503A compounding
The nominator withdrew the nomination. This is not a legalisation event — the substance is not on the 503A bulks list and remains non-compoundable.
Absent from Categories 1, 2 and 3 of the 503A list updated 2026-05-14 — verified by fetching and text-extracting the document directly. Category 2 there contains exactly six substances, and ipamorelin is not among them. The 503A nominations (Wells Pharmacy Network, FDA-2015-N-3534-0283; LDT Health Solutions, FDA-2018-N-2973-0002) were withdrawn by the nominators. THIS IS NOT A LEGALISATION EVENT and, for ipamorelin specifically, the 'it left Category 2' framing is at its most misleading: ipamorelin acetate REMAINS in Category 2 under the 503B interim policy (added 2023-09-29) and is the only substance FDA lists in both its current category 2 table and its withdrawn table. It is not on the 503A bulks list and remains non-compoundable. Withdrawal also came AFTER the advisory committee had already voted the substance down 0-12-1 — the nomination was not withdrawn from a live process with an open outcome. We did not verify the exact withdrawal date; FDA publishes no date column for the withdrawn table.
“Bulk drug substances nominated but withdrawn”Checked against the source on .
Evidence
There is human data, but efficacy is not established. This includes programmes that were tested and failed.
Administration check run on each cited study, and both PASS — unlike MOTS-c and TB-500, ipamorelin really was administered to humans. Beck et al. 2014 (NCT00672074) gave intravenous ipamorelin or placebo to 114 analysed adults after bowel resection; the earlier Phase 1 (PMID 10496658) gave intravenous infusions across five ascending dose levels to healthy male volunteers (FDA describes it as 48 subjects), and FDA reports that ipamorelin 'displayed linear pharmacokinetics based on the two-compartment model' and that 'a linear pharmacodynamic model described the stimulation of GH release in an episodic fashion dependent on the concentration of ipamorelin'. We do not call that release dose-proportional: FDA does not use the term, and it records that the lowest-dose and placebo groups 'were not included in the PK/PD analysis due to negligible GH levels', which cuts against proportionality at the bottom of the range. Neither is an endogenous-biomarker study. THE TIER LABEL FLATTERS THIS COMPOUND AND SHOULD BE READ WITH THE NOTE, NOT WITHOUT IT. 'Promising-but-unproven' is the correct bucket only because the enum defines it to include programmes that were tested and failed. The honest statement is stronger and worse: the one indication ever tested for efficacy in humans was tested properly and the drug did not beat placebo. In a 2014 Phase 2 trial of 114 bowel-resection patients, researchers reported median time to first tolerated meal of 25.3 hours on ipamorelin versus 32.6 hours on placebo (p = 0.15) and no significant differences in the key or secondary efficacy analyses. Limitations, in the authors' own framing: the study was small and enrolled patients with a broad range of underlying conditions. A larger Phase 2 followed (NCT01280344, Helsinn Therapeutics, n=320, completed) and its results were NEVER posted to ClinicalTrials.gov and never published — we searched all 53 PubMed records mentioning ipamorelin and found no publication reporting it. The programme was then abandoned; no Phase 3 exists. There is zero human efficacy evidence for growth hormone deficiency, and zero for any of the uses ipamorelin is actually marketed for (weight loss, anti-aging, sleep, bodybuilding). FDA: 'FDA has not identified data to support the effectiveness of ipamorelin (free base) or ipamorelin acetate for the diagnosis or treatment of GHD in children or adults.' Both Phase 2 trials were sponsored by Helsinn Therapeutics, a legitimate pharmaceutical company — not by a research-peptide vendor — and both are recorded as COMPLETED with zero results posted.
“There were no significant differences between ipamorelin and placebo in the key and secondary efficacy analyses.”Checked against the source on .
What FDA found
FDA’s own words. These are the most citable thing on this site, and the least likely to appear anywhere funded by someone selling the compound.
The Pharmacy Compounding Advisory Committee voted AGAINST placing ipamorelin on the 503A Bulks List on 2024-10-29 — ipamorelin (free base) 0 yes / 12 no / 1 abstain, and ipamorelin acetate 0 yes / 12 no / 1 abstain.
This is the single most important distinction between ipamorelin and every pending peptide in this library. BPC-157, epitalon, KPV, MOTS-c, semax, TB-500 and emideltide are subject to a staff PROPOSAL awaiting the 2026-07-23 PCAC meeting, and for those a proposal is not a final determination. Ipamorelin's committee process ALREADY RAN and it lost, unanimously among voting members, twice. Committee members who voted no 'agreed that there was a lack of information supporting safety and efficacy shown in the available data for the use of Ipamorelin (free base) for GHD and postoperative ileus'. One member noted 'that the high frequency of a drug being prescribed does not necessarily mean the drug is safe and effective'. The single abstention was not a dissent on the merits: that member cited confusion between the deliberations on ipamorelin acetate and the data presented. Note the committee is advisory — the vote is a recommendation, not a rulemaking.
Final Summary Minutes of the Pharmacy Compounding Advisory Committee Meeting, October 29, 2024 — FDA, 29 October 2024“The majority of the Committee members voted against placing Ipamorelin (free base) on the 503A Bulks List.”
Checked against the source on .FDA staff proposed not adding ipamorelin acetate or ipamorelin (free base) to the 503A Bulks List, citing lack of data, safety issues, lack of evidence of effectiveness, and the existence of FDA-approved drugs for both proposed conditions.
The 'existence of FDA-approved drugs' limb matters and is routinely omitted by vendors: FDA's reasoning is partly that patients do not need a compounded ipamorelin because approved options exist (human growth hormone formulations for GHD, and alvimopan, which FDA calls the only approved drug for management of POI), 'particularly in light of these being serious conditions'. Note also the scope, which the next finding records in full: FDA evaluated ipamorelin for growth hormone deficiency and postoperative ileus ONLY, and postoperative ileus was not even nominated — FDA states it 'in its discretion opted to evaluate the unnominated use of postoperative ileus'. None of the uses ipamorelin is actually sold for was evaluated.
Ipamorelin-Related Bulk Drug Substances (Ipamorelin (free base) and Ipamorelin Acetate) — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, October 29, 2024 — FDA, 29 October 2024“Accordingly, we propose not adding ipamorelin acetate or ipamorelin (free base) to the 503A Bulks List.”
Checked against the source on .FDA evaluated ipamorelin for exactly two uses — growth hormone deficiency and postoperative ileus — and only the first was nominated. None of the uses ipamorelin is actually marketed for was evaluated, so FDA made no effectiveness finding on any of them.
Three FDA sentences fix the scope. The nominated use: 'The nominators' proposed use for ipamorelin is to treat GHD.' The second condition, added by FDA itself: 'Consistent with past practice, FDA in its discretion opted to evaluate the unnominated use of postoperative ileus.' And the marketed uses, which FDA merely LISTS and never evaluates: 'It has been marketed for use in weight loss management, anti-aging, inflammatory conditions, sleep cycle improvement, and bodybuilding.' FDA's two effectiveness conclusions are scoped word-for-word to GHD and to POI respectively and to nothing else. We do not know why no marketed use was evaluated and FDA does not say, so we do not assert a reason.
Ipamorelin-Related Bulk Drug Substances (Ipamorelin (free base) and Ipamorelin Acetate) — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, October 29, 2024 — FDA, 29 October 2024“Ipamorelin (free base) and ipamorelin acetate were evaluated for the following uses: growth hormone deficiency (GHD) and postoperative ileus (POI).”
Checked against the source on .FDA found no effectiveness data for ipamorelin via the subcutaneous route — the very route proposed in the nominations and the one used by the market.
The nominated product was a 2000 mcg/mL lyophilised powder for SUBCUTANEOUS injection, yet every human study FDA could find used the INTRAVENOUS route. In FDA's words: 'We do not have nonclinical and clinical safety data or effectiveness data for GHD or POI for the proposed SC ROA.' So the human evidence base, such as it is, does not even cover how the substance is administered in practice. FDA's compounding-history finding cuts the same way: outsourcing-facility reporting shows compounding with ipamorelin from 2017, but it 'appears to have stopped in 2020', while FDA separately records that ipamorelin 'formulations are increasingly being marketed by medical spas and wellness clinics' for weight loss management, anti-aging, inflammatory conditions, sleep cycle improvement and bodybuilding. FDA made no effectiveness finding on any of those uses — as the scope finding above records, it did not evaluate them.
Ipamorelin-Related Bulk Drug Substances (Ipamorelin (free base) and Ipamorelin Acetate) — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, October 29, 2024 — FDA, 29 October 2024Checked against the source on .FDA states that neither ipamorelin (free base) nor ipamorelin acetate has a USP or NF drug substance monograph, and that neither is a component of an FDA-approved drug.
These are the first two of the three statutory doors into 503A compounding; the bulks list is the third, and the advisory committee shut it 0-12-1. FDA also closed the foreign-recognition route: a search of the National Medical Registries, the European Medicines Agency website, and the European, Chinese, Indian and Japanese Pharmacopeias 'did not show any monograph listings for either ipamorelin or ipamorelin acetate'. The one national authority FDA found that HAD acted, acted against it — Australia's Advisory Committee on Medicines Scheduling recommended and confirmed adding ipamorelin to the Poisons Standard under performance and image enhancing drugs, 'for which possession without authority is illegal'.
Ipamorelin-Related Bulk Drug Substances (Ipamorelin (free base) and Ipamorelin Acetate) — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, October 29, 2024 — FDA, 29 October 2024“There is no applicable United States Pharmacopeia (USP) or National Formulary (NF) drug substance monograph for ipamorelin (free base) or its acetate form, and neither is a component of an FDA-approved drug.”
Checked against the source on .FDA records that clinical development of ipamorelin for postoperative ileus was discontinued because of the Phase 2 trial's results.
FDA is quoting Ishida et al. 2020, a published review of POI drug development, reporting on the Beck et al. 2014 trial. The reviewers' full statement as FDA reproduces it: 'in patients undergoing bowel resection, ipamorelin did not shorten the time to first meal intake compared with placebo. This phase II clinical trial did not show any significant difference in measurable colonic functions between ipamorelin and placebo. Due to these disappointing results, its development was discontinued.' Read against the marketing, this is the whole record: the only people who ever spent money finding out whether ipamorelin does something in humans stopped when they found out.
Ipamorelin-Related Bulk Drug Substances (Ipamorelin (free base) and Ipamorelin Acetate) — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, October 29, 2024 — FDA, 29 October 2024“Due to these disappointing results, its development was discontinued.”
Checked against the source on .FDA's overall effectiveness conclusion: evidence is limited for any route, and there are NO data supporting effectiveness by the subcutaneous route that was nominated.
Two distinct claims in one sentence, and vendors quote neither. 'Limited for any ROA' is the verdict on the intravenous Phase 1 and Phase 2 data that actually exist; 'no data ... for the proposed SC route' is the verdict on the route people are sold. FDA adds that 'professional society guidelines do not discuss use of ipamorelin-related bulk drug substance for GHD or POI' — the specialty bodies that write the standard of care for both evaluated conditions do not mention it at all.
Ipamorelin-Related Bulk Drug Substances (Ipamorelin (free base) and Ipamorelin Acetate) — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, October 29, 2024 — FDA, 29 October 2024“We conclude based on available clinical information that the evidence of effectiveness for GHD or POI is limited for any ROA, and there are no data to support the effectiveness of ipamorelin (free base) or ipamorelin acetate for the proposed SC route of administration for these medical conditions.”
Checked against the source on .FDA identified, from ipamorelin's ghrelin-receptor mechanism, potential for behavioural reinforcement and addiction and for negative effects on reproductive health and pregnancy — and states the nonclinical studies were too limited to resolve either.
MAY, not DOES — and FDA says so itself in the same document: 'nonclinical studies were insufficient to demonstrate whether ipamorelin (free base or acetate) has reinforcing and addictive properties', and 'it remains to be determined whether ipamorelin (free base) or ipamorelin acetate ... can negatively impact fertilization and embryofetal development as ghrelin did'. The concern is class-based: in a 2014 mouse study (Luque et al.), researchers reported that systemic treatment with either a ghrelin receptor agonist or a ghrelin receptor antagonist negatively affected fertilization and embryofetal development, and in a 2008 fMRI study (Malik et al.) researchers reported that intravenous ghrelin increased activity in reward-processing brain regions of healthy human subjects during exposure to food images. FDA states outright that at the time of the evaluation it identified NO published nonclinical developmental and reproductive toxicity studies with ipamorelin, and 'did not identify in the publicly available literature nonclinical studies to inform the carcinogenic potential of ipamorelin (free base) or ipamorelin acetate' — for a substance marketed for open-ended anti-aging use. Its closing nonclinical line: 'nonclinical toxicity studies were too limited in scope and duration to inform safety considerations for potential clinical uses'.
Ipamorelin-Related Bulk Drug Substances (Ipamorelin (free base) and Ipamorelin Acetate) — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, October 29, 2024 — FDA, 29 October 2024“From the nonclinical pharmacological perspective, due to its primary mechanism of action as a ghrelin receptor agonist, ipamorelin (free base) or ipamorelin acetate may have behavioral reinforcing properties, which can contribute to development of addiction, and may also negatively affect reproductive health and pregnancy outcomes.”
Checked against the source on .Ipamorelin is a World Anti-Doping Agency prohibited substance, listed under section S2.4, and FDA records it has been detected in vials confiscated from athletes.
Recorded because it is the one question about ipamorelin with a hard, checkable, consequential answer, and because the bodybuilding market is a substantial share of the demand FDA describes. FDA cites Cox et al. 2015 for detection of ipamorelin in vials confiscated from athletes in Germany, Belgium and Australia, and states 'in the USA, ipamorelin has been detected in confiscated vials'. Prohibited-list status is an anti-doping sanction matter, not a criminal or FDA one — three separate systems, and a substance can be in trouble under all of them at once.
Ipamorelin-Related Bulk Drug Substances (Ipamorelin (free base) and Ipamorelin Acetate) — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, October 29, 2024 — FDA, 29 October 2024“Ipamorelin is on the list of prohibited substances under section S2.4 of the World Anti-Doping Agency (WADA).”
Checked against the source on .
Documented safety signals
Two deaths occurred among ipamorelin-treated subjects in the Phase 2 postoperative-ileus trial. FDA states it is UNCLEAR whether the deaths were related to ipamorelin.
THE CAUSALITY CAVEAT IS PART OF THE FINDING, NOT A FOOTNOTE TO IT, AND MUST NEVER BE DROPPED. FDA does not say ipamorelin killed anyone. The two subjects had undergone bowel resection for colon cancer and developed anastomotic leak, a complication reported in about 5% of anastomosis surgeries; FDA records the primary causes of death as hyperkalemia in a subject with aortic clots, sepsis, perforated ulcer, and renal failure and sepsis in a subject with pneumonia. Most SAEs occurred after subjects completed therapy. The population was gravely ill at baseline and both arms had SAEs. Note the tension a careless reader will miss: the Beck 2014 abstract says ipamorelin 'was well tolerated' and does not mention the deaths at all — FDA's reading of the same study is where the fatal SAEs surface. Reading only the abstract, or only FDA's public one-line summary, gives two different and equally incomplete pictures. FDA's public safety-risks page compresses this to 'A study published in literature identified serious adverse events including death when ipamorelin was administered intravenously for improving gastric motility' without naming the study or the causality caveat; the study is Beck et al. 2014. We could not read the Beck full text (paywalled) to confirm FDA's per-arm figures independently.
Ipamorelin-Related Bulk Drug Substances (Ipamorelin (free base) and Ipamorelin Acetate) — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, October 29, 2024 — FDA, 29 October 2024“Although it is unclear whether the deaths reported in the above study were related to ipamorelin, their occurrence in ipamorelin-treated subjects, along with the higher rates of hypokalemia and hyperglycemia reported in ipamorelin-treated subjects, raises safety concerns about the use of ipamorelin in compounding.”
Checked against the source on .Higher rates of hypokalemia and hyperglycemia in ipamorelin-treated subjects than placebo; reported adverse events also included insomnia, nausea, vomiting and abdominal distention.
Directionally relevant to how ipamorelin is actually sold. It is marketed for body composition and anti-aging on the strength of growth hormone release, and growth hormone release is exactly the mechanism that drives the glucose signal. FDA makes this explicit as a separate finding: the nomination did not include, and FDA did not identify, sufficient data to conclude that ipamorelin would not present safety concerns similar to those associated with approved products that stimulate GH release, 'such as glucose intolerance and diabetes mellitus'. The absence of a documented harm is not evidence of safety here — it is absence of data.
Ipamorelin-Related Bulk Drug Substances (Ipamorelin (free base) and Ipamorelin Acetate) — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, October 29, 2024 — FDA, 29 October 2024Checked against the source on .FDA identified only two FAERS reports for ipamorelin through 2023-09-30, both NON-SERIOUS.
Recorded to pre-empt the inference vendors draw from it. A thin FAERS file is not a safety record — FAERS is passive surveillance, and a substance sold outside the prescription system by medical spas and research-chemical sellers has almost no reporting pathway into it. One of the two reports involved ipamorelin combined with sermorelin. Ipamorelin is not a component of any FDA-approved drug and has no USP or NF monograph.
Ipamorelin-Related Bulk Drug Substances (Ipamorelin (free base) and Ipamorelin Acetate) — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, October 29, 2024 — FDA, 29 October 2024Checked against the source on .FDA identified immunogenicity and characterisation risk: ipamorelin contains unnatural amino acids and may aggregate, and ipamorelin (free base) is not well-characterised.
This is the finding that keeps ipamorelin acetate in Category 2 under the 503B interim policy to this day, and it is why the 503A withdrawal changed less than the market claims. FDA's stated position on these routes is an information gap, not a clean bill: 'FDA has not identified safety-related information regarding ipamorelin acetate via certain other injectable routes of administration. The agency lacks sufficient information to know whether the drug would cause harm if administered to humans via those routes.' Neither Category status nor a withdrawn nomination is the criminal line: the Watkins indictment (D. Utah, 1:26-cr-00015, 2026-04-01) charges misbranding under 352(b), which is why Category 1 substances sit in the same indictment as BPC-157.
Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks — FDA, 22 April 2026“Compounded drugs containing Ipamorelin acetate may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation or peptide-related impurities.”
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Questions people actually ask
Every answer cites the document behind it. Where the honest answer is “nobody knows”, that is the answer you will get.
- Is ipamorelin legal in 2026?
Ipamorelin is not eligible for use in pharmacy compounding under section 503A. A bulk drug substance qualifies by only three routes — a USP or NF monograph, being a component of an FDA-approved drug, or appearing on FDA's 503A bulks list — and FDA's briefing document states that ipamorelin (free base) and ipamorelin acetate meet none of them: there is no USP or NF monograph for either, neither is a component of an FDA-approved drug, FDA staff proposed not adding either to the bulks list, and the Pharmacy Compounding Advisory Committee voted 0-12-1 against adding each of them on 2024-10-29. Ipamorelin's absence from the 503A list is not permission — the two nominations that could have placed it there were withdrawn by the nominators after that vote — and ipamorelin acetate remains on FDA's list of bulk drug substances that may present significant safety risks. Separately, no list or category status is itself a statement about whether selling or possessing a substance is lawful; ipamorelin is also on the World Anti-Doping Agency prohibited list under section S2.4, and Australia has scheduled it under performance and image enhancing drugs, for which possession without a prescription is illegal there.
Ipamorelin-Related Bulk Drug Substances (Ipamorelin (free base) and Ipamorelin Acetate) — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, October 29, 2024 — FDA, 29 October 2024Checked against the source on .- Did ipamorelin become legal again when FDA removed it from Category 2?
No. Ipamorelin acetate has not left FDA's Category 2 — it is still listed among the bulk drug substances FDA has identified as potentially presenting significant safety risks, added under the 503B interim policy on 2023-09-29, and it is the one substance that appears both in FDA's current Category 2 table and in the table of substances whose nominations were withdrawn. What changed is only that the two 503A nominations for ipamorelin were withdrawn by the nominators, and withdrawal moves a substance sideways rather than toward legality: ipamorelin did not enter Category 1, is not on the 503A bulks list, and remains ineligible for compounding under section 503A. For ipamorelin the sequence also matters — FDA's advisory committee had already voted 0 yes, 12 no, 1 abstain against adding both ipamorelin (free base) and ipamorelin acetate to the 503A list on 2024-10-29, so the nominations were not withdrawn from a live process with an open outcome.
Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks — FDA, 22 April 2026Checked against the source on .- Did FDA approve ipamorelin?
No. There is no FDA-approved drug product containing ipamorelin, and FDA's briefing document for the October 29, 2024 Pharmacy Compounding Advisory Committee meeting states that neither ipamorelin (free base) nor ipamorelin acetate is a component of an FDA-approved drug. Ipamorelin was investigated by a pharmaceutical sponsor, Helsinn Therapeutics, in two Phase 2 trials for postoperative ileus and never advanced to Phase 3; no marketing application for it has ever been approved. FDA also found no approval or pharmacopeial recognition abroad — a search of the National Medical Registries, the European Medicines Agency website and the European, Chinese, Indian and Japanese Pharmacopeias returned no monograph listings for ipamorelin or ipamorelin acetate. For both conditions FDA evaluated, approved alternatives already exist: human growth hormone formulations for growth hormone deficiency, and alvimopan, which FDA describes as the only approved drug for accelerating gastrointestinal recovery following bowel resection.
Ipamorelin-Related Bulk Drug Substances (Ipamorelin (free base) and Ipamorelin Acetate) — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, October 29, 2024 — FDA, 29 October 2024Checked against the source on .- Is there any human evidence that ipamorelin works?
There is real human data on ipamorelin, and it is negative. Ipamorelin was administered to humans in a Phase 1 study in healthy male volunteers (FDA describes it as 48 subjects), where FDA reports a model showed ipamorelin induced growth hormone release at all dose levels analysed, in a manner dependent on the concentration of ipamorelin — though the lowest-dose group was excluded from that analysis for negligible growth hormone levels — and in a Phase 2 randomised placebo-controlled trial in 114 analysed adults after bowel resection published by Beck et al. in 2014, where researchers reported 'no significant differences between ipamorelin and placebo in the key and secondary efficacy analyses'. A larger Phase 2 trial (NCT01280344, 320 participants) is recorded as completed with no results ever posted or published, and the development programme was then discontinued — FDA quotes a published review stating that, because of the trial's disappointing results, development was discontinued. Both human studies used the intravenous route, not the subcutaneous injection that is sold. FDA states it has not identified data supporting effectiveness of ipamorelin (free base) or ipamorelin acetate for growth hormone deficiency or postoperative ileus — the only two uses FDA evaluated. The uses ipamorelin is actually marketed for, such as weight loss, anti-aging, sleep and bodybuilding, FDA did not evaluate at all, so no FDA finding exists either way on them; searching the published literature ourselves, we found no human efficacy evidence for any of those uses either.
Prospective, randomized, controlled, proof-of-concept study of the Ghrelin mimetic ipamorelin for the management of postoperative ileus in bowel resection patients — PubMed, 21 October 2014“There were no significant differences between ipamorelin and placebo in the key and secondary efficacy analyses.”
Checked against the source on .- Is ipamorelin safe?
Nobody knows, and FDA has documented specific reasons for concern rather than reassurance. In the Phase 2 postoperative-ileus trial, two deaths occurred among ipamorelin-treated subjects; FDA states it is unclear whether those deaths were related to ipamorelin — the subjects had undergone bowel resection for colon cancer and developed anastomotic leak — but FDA concluded that their occurrence in ipamorelin-treated subjects, together with higher rates of hypokalemia and hyperglycemia in ipamorelin-treated subjects, 'raises safety concerns about the use of ipamorelin in compounding'. FDA further identified, from ipamorelin's ghrelin-receptor mechanism, potential for behavioural reinforcement and addiction and for negative effects on reproductive health and pregnancy outcomes, and stated that the nonclinical studies were too limited in scope and duration to resolve either; it identified no published developmental and reproductive toxicity studies and no studies informing carcinogenic potential for a substance marketed for open-ended use. FDA also flagged immunogenicity risk from potential aggregation and peptide-related impurities. FDA found only two adverse-event reports for ipamorelin in its FAERS database through 2023-09-30, both non-serious, but FAERS is passive surveillance and a substance sold outside the prescription system has almost no reporting pathway into it — a thin file is absence of data, not evidence of safety.
Ipamorelin-Related Bulk Drug Substances (Ipamorelin (free base) and Ipamorelin Acetate) — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, October 29, 2024 — FDA, 29 October 2024Checked against the source on .- Will ipamorelin make me fail a drug test?
Ipamorelin is a prohibited substance in sport. FDA's briefing document states that ipamorelin is on the World Anti-Doping Agency's prohibited list under section S2.4, which means it is banned for athletes competing under a WADA-compliant anti-doping programme. FDA also records that ipamorelin has been detected in vials confiscated from athletes in Germany, Belgium and Australia, and in confiscated vials in the United States. Whether any given laboratory screen detects it depends on the panel used, and standard employment or clinical drug screens are not anti-doping panels; prohibited-list status is an anti-doping matter and is separate from FDA's compounding determinations and from criminal law.
Ipamorelin-Related Bulk Drug Substances (Ipamorelin (free base) and Ipamorelin Acetate) — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, October 29, 2024 — FDA, 29 October 2024“Ipamorelin is on the list of prohibited substances under section S2.4 of the World Anti-Doping Agency (WADA).”
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