Ipamorelin is not FDA-approved, and no FDA-approved product contains it. When it becomes available through Promise, it will be a compounded medication, prepared by a pharmacy for an individual prescription. Compounded medications are not reviewed by the FDA for safety, effectiveness, or quality.
The acetate form entered 503A Category 2 in 2023, a safety-concern category for ingredients considered for patient-specific compounding. Those nominations were later withdrawn. It remains in 503B Category 2, the separate safety-concern category for registered outsourcing facilities that compound medications.
FDA's safety summary for ipamorelin acetate reports serious adverse events, including death, in a study of intravenous ipamorelin for stomach movement. Its detailed review describes two deaths among ipamorelin-treated patients after bowel surgery and says it is unclear whether they were related to ipamorelin. FDA also flags possible immune reactions from peptide clumping or impurities. It has not identified safety information for certain other injection routes.
A licensed provider may still prescribe — that decision is between you and your doctor.
The side-effects guide discusses why short hospital studies cannot supply a reliable picture of longer outpatient use.