Related names in cited records: Ipamorelin acetate↗
FDA's August 2024 assessment distinguishes ipamorelin free base and acetate and evaluates evidence for growth hormone deficiency and postoperative ileus.↗
Citation markers ↗ open the public records supporting the adjacent statements.
Correction · September 15, 2026
We added FDA's dated assessment to distinguish substance forms, evaluated uses and the advisory stage of review. Earlier profile versions remain available. 3
Unapproved new drug in cited enforcement record. At the time of its assessment, FDA reported that neither form was a component of an FDA-approved drug and found insufficient evidence for the evaluated uses. The advisory briefing is not a final compounding determination.↗↗
Review source snapshots checked September 15, 2026 · Integrity checked September 15, 2026.
Four selected reports cover intravenous ipamorelin in bowel-surgery patients and healthy volunteers, plus analytical reports involving nasal exposure. These different purposes and routes do not establish benefit for other proposed uses.↗↗↗↗
What the reviewed sources report
The postoperative-ileus trial found no statistically significant improvement in its key or secondary efficacy analyses. The healthy-volunteer study measured growth hormone responses, which do not establish clinical benefit. The additional urine studies concern detection and receptor binding, not therapeutic benefit.↗↗↗↗
What remains unresolved?
Are there adequately controlled studies for proposed uses outside postoperative bowel recovery?↗↗
How do route, formulation and follow-up affect what can be concluded about harms?↗↗
FDA assessment dated August 19, 2024 · Read September 15, 2026 · Preserved version 1
FDA's evaluation of ipamorelin free base and acetate for growth hormone deficiency and postoperative ileus, prepared for the October 2024 advisory meeting. It is a dated agency assessment, not a final compounding determination. FDA document ↗
Identity and approval scope
FDA distinguishes free base from acetate and states that neither was a component of an FDA-approved drug at the time of its assessment. Study reports did not always identify the form administered. FDA pp. 6, 35 ↗
What did FDA find about effectiveness?
FDA found insufficient evidence supporting the evaluated uses and no clinical effectiveness or safety data for the proposed subcutaneous route. Intravenous postoperative findings do not establish subcutaneous effectiveness. FDA pp. 42, 43 ↗
Serious events require explicit context
FDA reports two deaths among ipamorelin-treated postoperative patients, alongside higher rates of hypokalemia and hyperglycemia. The agency explicitly states that whether the deaths were related to ipamorelin is unclear. FDA pp. 37, 42 ↗
Scope, source pin and remaining work
This summarizes the agency's dated assessment. It is not an independent claim that no evidence exists worldwide or that the briefing is a final regulatory decision. Newer reports and formulation identities require separate screening.
The pharmacology study does not establish chronic treatment benefit
FDA’s October 2024 briefing describes intravenous pharmacology in healthy male volunteers. It found no corresponding pharmacokinetic or pharmacodynamic evidence for the proposed subcutaneous route. FDA PDF pp. 35 ↗
More findings and the sources behind them
Selected FDA advisory-briefing sections, not a final agency ruling. The source date identifies the committee meeting (July 23–24 for the 2026 packages), not a new approval or final decision.
The surgical trial studied a different clinical setting
The safety discussion concerns hospitalized adults after bowel surgery, not a general wellness population or chronic growth-hormone-deficiency treatment. The formulation was not fully specified in the clinical report. FDA PDF pp. 35, 37 ↗
Serious events were reported, with causality unresolved
FDA describes serious postoperative events and two deaths among ipamorelin-treated participants. It explicitly states that their relationship to ipamorelin was unclear, while considering the overall findings a safety concern. FDA PDF pp. 37 ↗
Product quality is part of the uncertainty
FDA raised questions about impurities, aggregates, endotoxins and immunogenicity for the nominated substances. Its staff recommendation against 503A-list inclusion is a pre-decision assessment, not itself a final agency ruling. FDA PDF pp. 1, 40 ↗
What remains to be checked
Check subsequent advisory records and any final FDA action separately from the staff briefing.
Retrieve and appraise the original human reports and proposed formulation or route; agency search findings are dated and do not establish a complete worldwide literature review.
Source dates and review coverage
PDF citations use file page numbers. Named webpage sections and registry fields identify the portions read. These are selected readings, not complete source coverage.
Search and screening record checked 2026-09-15. Counts describe records, not independent trials. Full-text appraisal is separate from an abstract review.
Original human ipamorelin administration and administration-sample reports, including pharmacokinetics. Reviews, other compounds, preclinical and sample-only method studies are separate evidence categories.
50 retrieved · 4 included · 45 excluded · 1 awaiting a decision · 0 full-text appraisals
Eligibility decisions use titles and abstracts from the pinned PubMed results; unavailable details remain unresolved rather than inferred.
Full-text appraisal, study-family reconciliation, registry history and broader alias/jurisdiction searches remain separate open work.
Showing 25 of 50 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
PubMed 26811125 — include: Original human administration or analysis of administration-study samples; analytical exposures do not establish therapeutic benefit or safety.
PubMed 25869809 — include: Original human administration or analysis of administration-study samples; analytical exposures do not establish therapeutic benefit or safety.
PubMed 25331030 — include: Original human administration or analysis of administration-study samples; analytical exposures do not establish therapeutic benefit or safety. Study families: NCT00672074.
PubMed 10496658 — include: Original human administration or analysis of administration-study samples; analytical exposures do not establish therapeutic benefit or safety. Study families: ipamorelin-1999-pharmacology.
PubMed 26472487 — unresolved: The abstract describes urine containing ipamorelin but does not establish whether the samples followed human administration or were fortified; full text is needed.
PubMed 42578445 — exclude: Review of existing peptide evidence; no new ipamorelin human administration reported.
PubMed 42395176 — exclude: Review of existing peptide evidence; no new ipamorelin human administration reported.
PubMed 42160466 — exclude: Review of existing peptide evidence; no new ipamorelin human administration reported.
PubMed 42123471 — exclude: Review of existing peptide evidence; no new ipamorelin human administration reported.
PubMed 42021992 — exclude: Review of existing peptide evidence; no new ipamorelin human administration reported.
PubMed 41966639 — exclude: Review of existing peptide evidence; no new ipamorelin human administration reported.
PubMed 41880199 — exclude: Review of existing peptide evidence; no new ipamorelin human administration reported.
PubMed 41490200 — exclude: Review of existing peptide evidence; no new ipamorelin human administration reported.
PubMed 41476424 — exclude: Review of existing peptide evidence; no new ipamorelin human administration reported.
PubMed 39043357 — exclude: Animal, cell or compound-development study, outside the human-administration subset.
PubMed 38996787 — exclude: Animal, cell or compound-development study, outside the human-administration subset.
PubMed 32801950 — exclude: Animal, cell or compound-development study, outside the human-administration subset.
PubMed 32257855 — exclude: Review of existing peptide evidence; no new ipamorelin human administration reported.
PubMed 30282322 — exclude: Animal, cell or compound-development study, outside the human-administration subset.
PubMed 30168238 — exclude: Animal, cell or compound-development study, outside the human-administration subset.
PubMed 30136411 — exclude: Product/sample-method or nonhuman analytical research; inspected abstracts do not report human ipamorelin administration. Other peptides used in human validation are separate exposures.
PubMed 29864719 — exclude: Product/sample-method or nonhuman analytical research; inspected abstracts do not report human ipamorelin administration. Other peptides used in human validation are separate exposures.
PubMed 27497113 — exclude: Product/sample-method or nonhuman analytical research; inspected abstracts do not report human ipamorelin administration. Other peptides used in human validation are separate exposures.
PubMed 26578461 — exclude: Product/sample-method or nonhuman analytical research; inspected abstracts do not report human ipamorelin administration. Other peptides used in human validation are separate exposures.
PubMed 24574167 — exclude: Product/sample-method or nonhuman analytical research; inspected abstracts do not report human ipamorelin administration. Other peptides used in human validation are separate exposures.
ClinicalTrials.gov search
ClinicalTrials.gov API v2 identity-name search, complete retrieved records. Includes protocols, extensions, combinations and expanded access; these are not all efficacy trials or published outcomes.
3 retrieved · 2 included · 0 excluded · 1 awaiting a decision · 0 full-text appraisals
Registry identity screening is distinct from appraisal of posted results, protocol history and publication linkage.
Other registries and unregistered studies are outside this search.
Showing 3 of 3 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
ClinicalTrials.gov NCT01280344 — include: The intervention record names this molecule or its validated development code. Eligibility here is registry identity matching; outcomes and applicability remain separately unappraised. Study families: NCT01280344.
ClinicalTrials.gov NCT00672074 — include: The intervention record names this molecule or its validated development code. Eligibility here is registry identity matching; outcomes and applicability remain separately unappraised. Study families: NCT00672074.
ClinicalTrials.gov NCT07717866 — unresolved: Broad multicomponent protocol lists nonspecific physiological supplementation; ipamorelin exposure is not resolved.
FDA search
Exact active-ingredient terms in the openFDA Drugs@FDA endpoint, checked September 15. A zero result describes this indexed query only, not worldwide nonapproval or every FDA document.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Search terms, record decisions and remaining work
products.active_ingredients.name:"IPAMORELIN" OR products.active_ingredients.name:"IPAMORELIN ACETATE"
This query does not cover all FDA safety communications, labels, compounding proceedings or other regulatory systems.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
EMA search
Local identity matching in the pinned EMA medicines metadata feed. This feed is not every national European authorization or every agency document; orphan designation is not marketing authorization.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Search terms, record decisions and remaining work
Case-insensitive word-boundary matching of reviewed identity terms: ["ipamorelin", "ipamorelin acetate"]
Complete source-document appraisal and national European sources remain open.
Zero identity matches apply only to these feed fields and terms.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
EMA search
Local identity matching in the pinned EMA documents metadata feed. This feed is not every national European authorization or every agency document; orphan designation is not marketing authorization.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Search terms, record decisions and remaining work
Case-insensitive word-boundary matching of reviewed identity terms: ["ipamorelin", "ipamorelin acetate"]
Complete source-document appraisal and national European sources remain open.
Zero identity matches apply only to these feed fields and terms.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
EMA search
Local identity matching in the pinned EMA orphans metadata feed. This feed is not every national European authorization or every agency document; orphan designation is not marketing authorization.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Search terms, record decisions and remaining work
Case-insensitive word-boundary matching of reviewed identity terms: ["ipamorelin", "ipamorelin acetate"]
Complete source-document appraisal and national European sources remain open.
Zero identity matches apply only to these feed fields and terms.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
Read the full Human Evidence Review
Supervised synthesis
What do selected human studies report about Ipamorelin?
Four selected reports cover intravenous ipamorelin in bowel-surgery patients and healthy volunteers, plus analytical reports involving nasal exposure. These different purposes and routes do not establish benefit for other proposed uses.1234
Bottom line from this bounded source set
The postoperative-ileus trial found no statistically significant improvement in its key or secondary efficacy analyses. The healthy-volunteer study measured growth hormone responses, which do not establish clinical benefit. The additional urine studies concern detection and receptor binding, not therapeutic benefit.1234
Reviewed study record
Postoperative ileus: a placebo-controlled phase 2 trial
Design
A multicenter blinded randomized placebo-controlled study assessed recovery after bowel resection.1
Population
The trial enrolled 117 adults; 114 were included in its safety and modified intent-to-treat populations.1
Outcomes reported
Time to a tolerated solid meal was not significantly different between groups. Treatment-emergent adverse events occurred in 87.5% with ipamorelin and 94.8% with placebo.1
Limitations
The study was small and included varied underlying conditions. A nonsignificant result does not prove equivalence, and these postoperative findings do not establish safety for other uses or routes.1
Reviewed study record
Healthy-volunteer pharmacokinetics and hormone response
Design
An escalating-exposure study modeled drug concentrations and growth hormone responses.2
Population
The report describes eight healthy men at each of five exposure levels.2
Outcomes reported
The study observed an episode of growth hormone release and substantial between-person variability in pharmacodynamic responses.2
Limitations
The endpoints were pharmacology and hormone measurements, not clinical benefits. The abstract does not provide enough adverse-event detail for a safety conclusion.2
Reviewed study record
Analytical study after nasal exposure
Design
An analytical study examined urine collected over two days after administration of several growth-hormone-releasing peptides.3
Population
The report states that each compound was administered to one volunteer.3
Outcomes reported
The study identified ipamorelin and metabolites in urine using mass spectrometry.3
Limitations
This establishes an analytical human-exposure report, not evidence of therapeutic efficacy or adequately assessed safety. Results for the other compounds cannot be transferred to ipamorelin.3
Reviewed study record
Receptor assay using excretion-study samples
Design
Researchers tested receptor binding of peptides and metabolites and applied the assay to urine from nasal-administration studies.4
Population
The abstract does not state the participant count or establish whether these samples overlap the earlier analytical report.4
Outcomes reported
The assay detected receptor-binding activity in excreted urine from studies that included ipamorelin.4
Limitations
Receptor binding in a sample is not a patient health outcome. Cohort overlap remains unresolved, so this report should not be counted as independent clinical replication.4
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1007/s00384-014-2030-8. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1023/a:1018955126402. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1002/dta.1787. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1002/dta.1947. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
Explore status sources, recent additions, and coverage gaps
Living status brief
What is the current status of Ipamorelin?
Unapproved new drug in cited enforcement record. At the time of its assessment, FDA reported that neither form was a component of an FDA-approved drug and found insufficient evidence for the evaluated uses. The advisory briefing is not a final compounding determination.↗↗
The cited status sources were checked through July 22, 2026. This answer changes only through the profile’s visible version and correction history.
PeptideScanner currently has no selected safety records connected to this profile. That is a collection gap, not evidence that no such records exist.
PeptideScanner does not infer an answer where the cited records do not provide one. Open the source-linked records below to inspect their scope and limits.
This map describes PeptideScanner’s selected, source-linked collection. It is not an evidence grade and does not establish research quality, safety, effectiveness, or medical relevance.
1 exact source-declared trial-publication link connects selected NCT and PMID records. Open the exact graph →
A phase value is unavailable here for 2 selected records; this is not counted as “no phase.”
A status value is unavailable here for 2 selected records; this is not counted as a trial status.
PubMed bibliography
Publication composition
1 of 14 selected PubMed records include attributed title, venue, publication date, and publication-type fields.
Publication typesJournal Article 1
Bibliography fields unavailable here for 13 selected records; the records remain visible as metadata observations.
Regulatory and publication surfaces
What is structurally connected?
Drugs@FDA applications
0
FDA Federal Register documents
1
DailyMed SPL versions
0
Canonical profile
Published
Profile structured data
Published
Linked dated records
17
Application counts reflect exact reviewed ingredient connections; Federal Register counts reflect exact reviewed peptide-name matches; DailyMed counts reflect listed SPL versions with retained ZIP receipts. “Published” describes this page’s indexing surface, not the state of scientific evidence.
These links come only from structured NCT and PMID identifiers declared by PubMed or ClinicalTrials.gov. They do not summarize the publications or establish findings.
We added FDA's dated assessment to distinguish substance forms, evaluated uses and the advisory stage of review. Earlier profile versions remain available.
The Federal Register published notice 2024-21241, attributed to FDA and its parent HHS department, on 2024-09-18. Its official title is “Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List; Revisions to the Withdrawn or Removed List,” and PeptideScanner's exact reviewed identity mapping connects the document to Ipamorelin.
PubMed lists PMID 38996787 in Animal reproduction science as Journal Article, with publication-date metadata of 2024-07-05 (day precision). PeptideScanner associated the retained record with the identity slug ipamorelin. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.
Counts and links describe PeptideScanner’s selected records. They are not rankings and do not establish research quality, safety, effectiveness, or medical relevance.
These links are based only on overlapping years and evidence lanes in PeptideScanner’s selected records. They do not imply that the peptides are medically or scientifically similar.
These dates come from selected source records and PubMed metadata. They are not a complete or continuous timeline of research, safety, approval, or effectiveness.
Evidence summary
What the cited records say
At the time of its assessment, FDA reported that neither form was a component of an FDA-approved drug and found insufficient evidence for the evaluated uses. The advisory briefing is not a final compounding determination.↗
This is a source summary, not a medical recommendation. Status may differ by jurisdiction and product.
PeptideScanner retained PubMed bibliographic metadata for PMID 39043357 at 2026-07-30T16:20:38.933Z. PubMed recorded a metadata revision date of 2026-05-24 and an Entrez history date of 2024-07-23. PeptideScanner associated this retained record with the identity slug ipamorelin. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 25331030 at 2026-07-30T16:20:34.456Z. PubMed recorded a metadata revision date of 2026-05-18 and an Entrez history date of 2014-10-22. PeptideScanner associated this retained record with the identity slug ipamorelin. These dates describe PubMed metadata history, not the article's original publication date.↗
The Federal Register published notice 2024-21241, attributed to FDA and its parent HHS department, on 2024-09-18. Its official title is “Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List; Revisions to the Withdrawn or Removed List,” and PeptideScanner's exact reviewed identity mapping connects the document to Ipamorelin.↗
PubMed lists PMID 38996787 in Animal reproduction science as Journal Article, with publication-date metadata of 2024-07-05 (day precision). PeptideScanner associated the retained record with the identity slug ipamorelin. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 25869809 at 2026-07-30T20:43:08.964Z. PubMed recorded a metadata revision date of 2019-12-10 and an Entrez history date of 2015-04-15. PeptideScanner associated this retained record with the identity slug ipamorelin. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 9879640 at 2026-07-30T20:46:59.653Z. PubMed recorded a metadata revision date of 2019-09-09 and an Entrez history date of 1999-01-08. PeptideScanner associated this retained record with the identity slug ipamorelin. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 9849822 at 2026-07-30T20:46:59.652Z. PubMed recorded a metadata revision date of 2019-09-05 and an Entrez history date of 1998-12-16. PeptideScanner associated this retained record with the identity slug ipamorelin. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 11459660 at 2026-07-30T20:48:24.201Z. PubMed recorded a metadata revision date of 2019-08-19 and an Entrez history date of 2001-07-19. PeptideScanner associated this retained record with the identity slug ipamorelin. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 10496658 at 2026-07-30T20:48:24.176Z. PubMed recorded a metadata revision date of 2019-08-18 and an Entrez history date of 1999-09-25. PeptideScanner associated this retained record with the identity slug ipamorelin. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 10828840 at 2026-07-30T20:50:07.370Z. PubMed recorded a metadata revision date of 2019-07-09 and an Entrez history date of 2000-06-01. PeptideScanner associated this retained record with the identity slug ipamorelin. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 15665799 at 2026-07-30T21:09:05.701Z. PubMed recorded a metadata revision date of 2018-12-17 and an Entrez history date of 2005-01-25. PeptideScanner associated this retained record with the identity slug ipamorelin. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 9733495 at 2026-07-30T21:08:59.367Z. PubMed recorded a metadata revision date of 2018-12-01 and an Entrez history date of 1998-09-11. PeptideScanner associated this retained record with the identity slug ipamorelin. These dates describe PubMed metadata history, not the article's original publication date.↗