At a glance
- Ipamorelin is not an FDA-approved drug: Drugs@FDA has no record of it.
- FDA lists it in Category 2, bulk substances that may present significant safety risks in compounding (since September 29, 2023).
- PubMed lists 51 publications mentioning it, including 2 randomized controlled trials and 20 animal-only studies.
- ClinicalTrials.gov lists 3 registered studies testing it (1 active).
- FDA's adverse event system (FAERS) holds 11 reports mentioning it; 4 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
No application found in Drugs@FDA, FDA's database of approved drugs.
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
FDA's stated risk · Original FDA text (English) 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. Ipamorelin acetate also contains unnatural amino acids, which add to the complexity of peptide characterization. A study published in literature identified serious adverse events including death when ipamorelin was administered intravenously for improving gastric motility. FDA has not identified safety-related information regarding ipamorelin acetate via certain other injectable routes of administration. Therefore, the agency lacks sufficient information to know whether the drug would cause harm if administered to humans via those routes. FDA's stated risk · Original FDA text (English) 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. Ipamorelin acetate also contains unnatural amino acids, which add to the complexity of peptide characterization. A study published in literature identified serious adverse events including death when ipamorelin was administered intravenously for improving gastric motility. 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. Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Peptides in urology and sexual medicine: clinical effectiveness, dosing, indications, and safety: a narrative review.
- Peptide Supplements and Their Therapeutic Applications in Sports Medicine.
- The emerging landscape of performance-enhancing peptides modulating GH-IGF1 axis: bridging the gap between clinical evidence and patient self-administration.
- Injectable Peptides in Sports Medicine: A Structured Narrative Review of Evidence, Safety, and Antidoping Implications.
- Therapeutic Peptides in Aesthetic, Metabolic and Endocrine Conditions: Effects, Safety, Clinical Applications, and Future Perspectives.
- Therapeutic peptides in gerontology: mechanisms and applications for healthy aging.
- Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance.
- A new era of doping? Use of peptide and peptide-analog drugs in recreational and professional sport and bodybuilding: a critical review.
- Therapeutic Peptides in Orthopaedics: Applications, Challenges, and Future Directions.
- Injectable Peptide Therapy: A Primer for Orthopaedic and Sports Medicine Physicians.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 3
- Active
- 1
- With posted results
- 0
Conditions studied
| Study | Status | Phase | Start |
|---|---|---|---|
| Trifecta Research Study | Active, not recruiting | — | August 1, 2022 |
| Safety and Efficacy of Ipamorelin Compared to Placebo for the Recovery of Gastrointestinal Function | Completed | Phase 2 | Apr 2011 |
| Safety and Efficacy of Ipamorelin for Management of Post-Operative Ileus | Completed | Phase 2 | Apr 2008 |
All 3 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 11
- Serious
- 4
- With death outcome
- 0
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
Change history
No changes since monitoring began on October 30, 2026.