Last updated October 21, 2026. Approval line checked October 21, 2026. Compounding sources checked October 10, 2026.
FDA status
Not approved
Not approved. This record is not an FDA-approved drug product. Approval, where it exists, is specific to a drug product, indication, and route.
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Evidence tier
Human Observational. The tier is the highest indexed study type. It is not a safety rating and it is not an FDA approval. Confidence score 2/5. 48 PubMed citations indexed.
Products sold as "research use only" are not approved for human use. FDA warning.
Ghrelin receptor (GHSR-1a) agonist stimulating pulsatile GH release with minimal cortisol/prolactin spillover; complements longer-acting GHRH analogs.
What the literature studies
Selective GH Secretagogue
Evidence tier
Human Observational
Compounding record
Status not verified
Status not verified. Status not verified. Exact FDA substance context: Ipamorelin acetate: 503A withdrawn / 503B Category 2. This record does not specify acetate; other forms are not verified. Previously in Category 2; FDA still identifies potential significant safety risks for the named withdrawn substance. Withdrawal is not FDA approval or a determination of safety or compounding eligibility. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route.
Regulatory source checked October 10, 2026. This compounding label is separate from the approval line above.
IV use associated with serious adverse events.
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Educational only. Not medical advice. This page does not give doses or sourcing. See the medical and editorial disclaimer.
Ipamorelin is a selective ghrelin-receptor (GHS-R) agonist that raises growth hormone in animals and was tested in people for postoperative ileus - where it failed its key endpoints - and FDA lists it among compounding substances that may present significant safety risks.
A pentapeptide growth hormone secretagogue designed for GH selectivity with less cortisol/prolactin rise than earlier GHRPs [R1].
Not FDA-approved for any use. FDA lists ipamorelin acetate under Category 2 of the 503B interim policy (added Sep 29 2023) and also under "nominated but withdrawn" for 503A context; FDA cites immunogenicity risk from aggregation/impurities, unnatural amino acids that complicate characterization, and a published IV gastric-motility study with serious adverse events including death (causality not established for all events). FDA states it lacks sufficient information to know whether the drug would cause harm via certain other injectable routes [FDA-RISK].
Selective GH release in animal models with relatively little ACTH/cortisol stimulation compared with older secretagogues [R1]. Animal results are not evidence of clinical benefit in people.
FDA-cited immunogenicity and impurity concerns; serious adverse events in an IV motility study [FDA-RISK][R2]. Gray-market quality unverified. Often marketed in "stacks" with CJC-1295; stacking has no approved indication.
No pending FDA approval identified. Interim peptide compounding policy under White House review may or may not touch GH secretagogues; text not public [OIRA].
Last checked 2026-10-27
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