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Published Phase 2 human RCT; negative primary endpoint
Ipamorelin is an investigational, non-FDA-approved peptide studied as a growth-hormone secretagogue; here's its regulatory status, what the intravenous trial tested, and the safety signals to know.
Ipamorelin dosage calculator →
Arithmetic only, not medical advice.
Ipamorelin: reference record
| Regulatory status | Investigational/discontinued; not FDA-approved |
|---|---|
| Route | Intravenous in cited trial |
| Dosing frequency | Twice daily (IV study) |
| Published range | 0.03 mg/kg |
| Evidence basis | Published Phase 2 human RCT; negative primary endpoint |
| Common vial sizes | 5, 10 |
Sources
- PubMed - PMID 25331030Basis for the regulatory status, route, frequency and published range in the table above. Source last checked 2026-06-24
What is Ipamorelin?
Ipamorelin is a synthetic pentapeptide studied as a growth-hormone secretagogue. It was investigated but never brought to market, and it is best described as a legacy research compound rather than an active pipeline candidate.
Is Ipamorelin FDA-approved?
No. Ipamorelin is investigational and discontinued, with no FDA approval for any use. Development did not proceed to an approved product.
How is Ipamorelin given?
The only published human dosing came from a postoperative-ileus trial that used an intravenous route, twice daily. That trial did not meet its primary endpoint. There is no established subcutaneous route or outpatient regimen.
What are the known safety concerns with Ipamorelin?
The FDA has noted immunogenicity and impurity concerns, and serious adverse events including death were reported in the intravenous study context. An intravenous study figure cannot be carried across to subcutaneous self-use.
Postoperative ileus trial used 0.03 mg/kg IV twice daily up to 7 days; primary endpoint not met
Do not use the IV study value as a subcutaneous protocol. No established outpatient injectable dose.
FDA notes immunogenicity/impurity concerns and serious adverse events including death in IV study context.
Supply-chain quality · Finnrick
Avg quality score
7
/10
Purity range
97.1
–
99.96
%
Qty divergence
±
65
%
Vendors · samples
56
·
311
Common vial sizes
5, 10
mg
Test window
Feb 2025 - May 2026
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