Ipamorelin

FDA's compounding safety review states that ipamorelin acetate may pose a risk for immunogenicity for certain routes due to potential aggregation or peptide-related impurities, and that it contains unnatural amino acids adding to characterization complexity. The review states a published study identified serious adverse events, including death, when ipamorelin was given intravenously to improve gastric motility, and that FDA lacks safety information for other injectable routes.^[3]

• FDA's own page links the ipamorelin entry to the intravenous postoperative-ileus trial already cited for outcomes (peptide-pmid-25331030). That trial's abstract does not display a mortality figure, and its full text is paywalled, so whether FDA's statement rests on a death reported only in the full text could not be confirmed in this pass.
• This is a regulatory characterization, not an independently verified case description; it does not establish that ipamorelin caused any reported death.

A healthy-volunteer study reported an approximately two-hour terminal half-life after intravenous ipamorelin infusion. This cannot establish the absorption or half-life of subcutaneous products or peptide mixtures.^[2]

• Route-specific estimate from a small experimental study.

A postoperative phase 2 trial did not find a statistically significant improvement in time to tolerate a meal with intravenous ipamorelin compared with placebo. It does not establish benefits for muscle growth or recovery in healthy users.^[1]

• The indication, formulation and route differ from research-market subcutaneous use.
• A separate FDA compounding-safety communication describes a published intravenous ipamorelin gastric-motility study reporting deaths; this dossier could not confirm from this abstract whether that statement refers to this same 114-117 patient trial.