Ipamorelin
Evidence: C/DGH Axis / Body Composition
Evidence Snapshot
What this grade covers
C for acute human growth-hormone pharmacology, pharmacokinetic characterization, official regulatory review, and FDA compounding-safety context; D for human endocrine selectivity, therapeutic efficacy, postoperative recovery benefit, treatment of growth-hormone deficiency, body-composition improvement, muscle or strength gain, fat loss, athletic performance, sleep or recovery benefit, anti-aging or longevity effects, pediatric use, chronic or repeated-endocrine use, and long-term safety because adequate controlled human outcome evidence is absent or the available randomized trial had a null primary endpoint.
Regulatory Context
No FDA-approved ipamorelin product is established in the official materials reviewed. In October 2024, the Pharmacy Compounding Advisory Committee voted against adding ipamorelin free base and acetate to the 503A Bulks List. FDA also identifies aggregation, impurity, immunogenicity, unnatural-amino-acid characterization, and serious adverse-event concerns.
Research Takeaway
Ipamorelin is a ghrelin/GHS-receptor agonist and growth-hormone secretagogue; preclinical selectivity findings should not be converted into claims of superior human safety.
See all 10 evidence claims →Quick Summary
Ipamorelin is a ghrelin-receptor agonist and growth-hormone secretagogue. Human research confirms that it can trigger an acute GH pulse, but the principal phase 2 clinical trial for postoperative ileus did not meet its primary efficacy endpoint. Evidence does not establish common claims involving sleep, recovery, body composition, or anti-aging, and FDA has highlighted serious safety and product-characterization concerns for compounded injectable use.
Mechanism & Research Overview
Ipamorelin activates the growth-hormone secretagogue receptor and stimulates pituitary GH release. Preclinical experiments described greater hormonal selectivity than older secretagogues tested in the same models. That selectivity finding is not equivalent to proven human safety, superior clinical outcomes, or evidence for popular wellness uses.
Evidence Grade Breakdown
A single letter grade can't capture how evidence quality differs across approved use, off-label use, and unsupported claims. The categories below break that down -- none of them grade this compound "overall."
Overall Research Grade
Ipamorelin has limited direct human evidence establishing acute growth-hormone release and pharmacokinetic activity, together with official FDA regulatory and compounding-safety assessments. Its commonly cited endocrine selectivity remains supported only by preclinical experiments, the only randomized therapeutic trial had a null primary endpoint, and adequate evidence is absent for broad therapeutic outcomes, repeated endocrine use, and long-term safety.
CAcute Human Pharmacology
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Acute Human Pharmacology
One human dose-escalation PK/PD study establishes an acute growth-hormone pulse and an approximately two-hour pharmacokinetic half-life. The study was short, mechanistic, and single-session; it does not establish repeated-use effects or therapeutic clinical outcomes.
DHuman Endocrine Selectivity
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Human Endocrine Selectivity
No direct human Ipamorelin source in the reviewed evidence measures ACTH, cortisol, or prolactin. The selectivity characterization rests entirely on preclinical rat-pituitary-cell, rat, and swine experiments and does not establish human endocrine selectivity or superior safety.
DPostoperative-Ileus Clinical Efficacy
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Postoperative-Ileus Clinical Efficacy
One randomized controlled phase 2 trial evaluated postoperative ileus in 114 adults, but the numerical difference in the primary endpoint was not statistically significant. The ClinicalTrials.gov record and journal publication describe the same underlying trial and must not be interpreted as two independent randomized trials.
DBroader Therapeutic Outcomes
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Broader Therapeutic Outcomes
The reviewed evidence does not establish treatment efficacy for adult growth-hormone deficiency, body-fat reduction, lean-mass or muscle gain, strength, athletic performance, recovery, injury healing, sleep improvement, anti-aging, longevity, obesity, diabetes, pediatric growth, or chronic disease outcomes.
CPreclinical and Mechanistic Evidence
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Preclinical and Mechanistic Evidence
Two preclinical sources support growth-hormone-secretagogue pharmacology, comparative selectivity in animal and cell models, and a gastrointestinal-motility rationale. These findings provide mechanistic context but do not establish human therapeutic efficacy or safety.
CRegulatory and Compounding-Safety Evidence
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Regulatory and Compounding-Safety Evidence
Official FDA materials document the advisory committee's 0 yes, 12 no, and 1 abstention vote concerning Ipamorelin free base and acetate, the absence of an FDA-approved product, insufficient evidence for proposed compounded uses, and concerns involving aggregation, impurities, immunogenicity, characterization, and serious adverse-event reports. These regulatory findings do not establish therapeutic efficacy.
DLong-Term and Repeated-Use Safety
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Long-Term and Repeated-Use Safety
The human PK/PD study was single-session and the longest human exposure in the reviewed evidence was seven days. No adequate evidence establishes chronic-use safety, repeated endocrine response, desensitization, tachyphylaxis, pediatric safety, pregnancy safety, or long-term organ-system outcomes.
Evidence reviewed
- Randomized human trials
- 1
- Observational human studies
- 1
- Regulatory documents
- 4
- Preclinical studies
- 2
- Primary sources reviewed
- 8
Study counts describe the reviewed evidence base. They do not independently determine evidence quality.
How MitoCore grades evidence
Grade definitions
- A
- Strong and directly applicable evidence, generally including regulatory support or multiple high-quality replicated human trials for the exact claim and population.
- A-
- Strong human evidence with limited uncertainty, narrower applicability, or incomplete replication.
- B+
- Moderately strong evidence with meaningful human support but important scope, duration, safety, or generalizability limitations.
- B
- Credible evidence with notable uncertainty, limited replication, or mixed results.
- C
- Preliminary or inconsistent evidence, usually limited human data or strong indirect evidence.
- D
- Weak, indirect, population-limited, or largely unsupported evidence for the specific use being graded.
- F
- No credible supporting evidence, evidence contradicting the claim, or claims based primarily on speculation or marketing.
Confidence definitions
- High
- The evidence classification is unlikely to change substantially with ordinary additional research.
- Moderate
- The classification is reasonably supported but could change with additional high-quality evidence.
- Low
- The evidence base is sparse, indirect, inconsistent, or dependent on uncertain assumptions.
- Very Low
- The evidence base is extremely limited, speculative, or unsuitable for firm conclusions.
Scope
The grade evaluates the evidence supporting the specific category or claim. A grade does not evaluate product purity, supplier quality, personal suitability, treatment appropriateness, individual outcomes, legality, or medical safety for a specific person.
These grades and confidence levels describe the research evidence itself. They are not medical recommendations, and they do not evaluate any specific product, supplier, or individual's situation.
Evidence Claims
Individual scientific statements drawn from the sources cited below, each shown with the specific evidence boundary that statement does not establish.
Supported
Ipamorelin is a ghrelin/GHS-receptor agonist and growth-hormone secretagogue; preclinical selectivity findings should not be converted into claims of superior human safety.
Sources: Ipamorelin, the first selective growth hormone secretagogue; Pharmacokinetic-pharmacodynamic modeling of ipamorelin, a growth hormone releasing peptide, in human volunteers
Supported
A human dose-escalation PK/PD study showed an acute growth-hormone pulse and an approximately two-hour pharmacokinetic half-life, but it did not test sleep, recovery, muscle gain, fat loss, or anti-aging outcomes.
Supported
The completed phase 2 postoperative-ileus trial did not meet its primary efficacy endpoint: the numerical difference in time to first tolerated meal was not statistically significant.
Sources: Prospective, randomized, controlled, proof-of-concept study of the ghrelin mimetic ipamorelin for the management of postoperative ileus in bowel resection patients; Safety and Efficacy of Ipamorelin for Management of Post-Operative Ileus
Supported
Rodent postoperative-ileus experiments reported improved gastric emptying and transit, but these findings do not establish human efficacy or wellness benefits.
Supported
FDA states that compounded ipamorelin acetate may pose immunogenicity risks related to aggregation and impurities and that available information is insufficient to establish safety for proposed compounded uses. FDA's 2024 review also identified serious adverse events, including deaths, in the intravenous development literature; those reports do not establish a broad safety profile for compounded use.
Sources: FDA Briefing Document — Pharmacy Compounding Advisory Committee (Ipamorelin Bulk Substances); Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks
Supported
At the October 29, 2024 Pharmacy Compounding Advisory Committee meeting, the committee voted separately 0 yes, 12 no, and 1 abstention on including ipamorelin free base and ipamorelin acetate on the 503A Bulks List.
Sources: October 29, 2024 Pharmacy Compounding Advisory Committee Meeting — Vote Results
Supported
Available human evidence is insufficient to establish ipamorelin as an effective treatment for adult growth hormone deficiency; FDA's 2024 compounding review concluded that available evidence did not support effectiveness for this use.
Sources: FDA Briefing Document — Pharmacy Compounding Advisory Committee (Ipamorelin Bulk Substances)
Supported
The reviewed human studies evaluated acute growth-hormone pharmacology and postoperative ileus; they did not test fat loss or muscle gain in healthy adults.
Sources: Pharmacokinetic-pharmacodynamic modeling of ipamorelin, a growth hormone releasing peptide, in human volunteers; Prospective, randomized, controlled, proof-of-concept study of the ghrelin mimetic ipamorelin for the management of postoperative ileus in bowel resection patients; Safety and Efficacy of Ipamorelin for Management of Post-Operative Ileus
Supported
The reviewed human studies evaluated acute growth-hormone pharmacology and postoperative ileus; they did not test sleep quality or recovery in healthy adults.
Sources: Pharmacokinetic-pharmacodynamic modeling of ipamorelin, a growth hormone releasing peptide, in human volunteers; Prospective, randomized, controlled, proof-of-concept study of the ghrelin mimetic ipamorelin for the management of postoperative ileus in bowel resection patients; Safety and Efficacy of Ipamorelin for Management of Post-Operative Ileus
Supported
In a rat model, ipamorelin produced growth-hormone-related biological effects, including stimulation of longitudinal bone growth.
Does not establish
Evidence boundary: This is rodent preclinical evidence only; it does not establish human efficacy, anti-aging benefit, muscle-gain benefit, fat-loss benefit, or recovery benefit.
Sources: Ipamorelin, a new growth-hormone-releasing peptide, induces longitudinal bone growth in rats
Safety & Evidence Limitations
Considerations reported in the sources cited on this page — not a complete list of every possible risk, and not medical advice.
Safety Consideration
FDA highlights serious adverse events, including death, in the intravenous development literature.Safety Consideration
Compounded products may present aggregation, impurity, immunogenicity, identity, and characterization risks.Safety Consideration
Human PK/PD evidence does not establish long-term clinical benefit or safety.Safety Consideration
The principal phase 2 trial did not meet its primary efficacy endpoint.
Research Areas Being Studied
Research areas discussed on this page reflect the GH Axis / Body Composition category and the sources cited below.
Findings Reported in Studies
Educational summary only — reported in cited studies, not a claim of proven benefit.
- Prospective, randomized, controlled, proof-of-concept study of the ghrelin mimetic ipamorelin for the management of postoperative ileus in bowel resection patients (2014): 0.03 mg/kg intravenously twice daily for up to seven days; the numerical difference in the primary endpoint was not statistically significant (p=0.15).
- Pharmacokinetic-pharmacodynamic modeling of ipamorelin, a growth hormone releasing peptide, in human volunteers (1999): Five escalating 15-minute intravenous infusion rates; approximately two-hour pharmacokinetic half-life.
Study Tables by Evidence Type
Human Studies & Clinical Data
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| Prospective, randomized, controlled, proof-of-concept study of the ghrelin mimetic ipamorelin for the management of postoperative ileus in bowel resection patients | 2014 | 114 adults in the safety and modified intention-to-treat analyses | 0.03 mg/kg intravenously twice daily for up to seven days; the numerical difference in the primary endpoint was not statistically significant (p=0.15). | The primary efficacy endpoint was not statistically significant. Do not present this study as proof of clinical benefit, general safety, recovery enhancement, or broader therapeutic efficacy. | |
| Pharmacokinetic-pharmacodynamic modeling of ipamorelin, a growth hormone releasing peptide, in human volunteers | 1999 | Healthy male volunteers; eight subjects per dose level | Five escalating 15-minute intravenous infusion rates; approximately two-hour pharmacokinetic half-life. | Short mechanistic study; does not establish long-term or non-IV safety. |
Animal / Cell / Preclinical Data
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| Efficacy of ipamorelin, a ghrelin mimetic, on gastric dysmotility in a rodent model of postoperative ileus | 2012 | Rodent postoperative-ileus model | Preclinical gastric-emptying and intestinal-transit study. | Animal findings do not establish human efficacy, clinical recovery benefit, or safety. | |
| Ipamorelin, a new growth-hormone-releasing peptide, induces longitudinal bone growth in rats | 1999 | Rats | Ipamorelin stimulated GH release and induced longitudinal bone growth in rats via tibial growth-plate measurement. | Rodent bone-growth pharmacology finding; does not establish human efficacy for anti-aging, muscle gain, fat loss, or recovery, and must not be used as such. | |
| Ipamorelin, the first selective growth hormone secretagogue | 1998 | Rat pituitary cells, rats, and swine | Preclinical in vitro and in vivo pharmacology experiments described high growth-hormone-releasing potency and comparative hormone selectivity. | Preclinical selectivity does not establish human endocrine selectivity, clinical safety, therapeutic efficacy, or wellness benefit. |
Regulatory Documents & Official Trial Registries
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks | 2026 | FDA safety and compounding review | Current FDA summary of ipamorelin compounding and safety concerns. | This official warning limits any broad claim that ipamorelin was generally well tolerated. | |
| FDA Briefing Document — Pharmacy Compounding Advisory Committee (Ipamorelin Bulk Substances) | 2024 | No finding reported for this source yet. | |||
| October 29, 2024 Pharmacy Compounding Advisory Committee Meeting — Vote Results | 2024 | FDA advisory-committee vote | 0 yes, 12 no, 1 abstention for both ipamorelin free base and acetate. | Committee vote is regulatory evidence, not a clinical trial. | |
| Safety and Efficacy of Ipamorelin for Management of Post-Operative Ileus | 2009 | Adults after bowel resection | Completed phase 2 trial registry record; ClinicalTrials.gov identifier NCT00672074. | This registry record and the journal publication PMID 25331030 describe the same underlying clinical trial. They may be retained as separate catalogued sources but must not be interpreted or counted as two independent randomized trials. |
Anecdotal Reported Patterns — Not Medical Advice
Anecdotal Reported Patterns — Not Medical Advice
Reported dosing patterns are included for educational context only. They are self-reported, unverified, not medical advice, and not instructions for human use. Community-submitted patterns are not yet available in this Phase 1 prototype; this section is a placeholder reserved for moderated, aggregated community data.
Lab Markers to Discuss With a Clinician
Educational topics only — not self-monitoring instructions.
FAQ
Disclaimer
Ipamorelin's ability to produce an acute GH pulse does not establish benefits for sleep, recovery, fat loss, muscle gain, or anti-aging. The postoperative-ileus trial's primary result was not statistically significant.
Educational use only. This content is provided for informational and research-summary purposes only. It is not medical advice, not a treatment recommendation, not a dosing guide, and not a substitute for care from a licensed medical professional. Nothing here is intended to diagnose, treat, cure, prevent, or mitigate disease. Reported dosing patterns, when shown elsewhere on the site, must be labeled either as Study / Trial Dosing or Anecdotal Reported Patterns — Not Medical Advice. Community reports are self-reported, unverified, and not scientific proof.
Community-reported experiences, once enabled, must be displayed only as moderated, anonymized, or aggregated data. They are anecdotal, self-reported, unverified, and should never be presented as proof of safety, efficacy, or expected results.
Content status: Website/CMS content draft; source verification and legal/privacy review required before public launch. Last updated 2026-07-08.
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