Ipamorelin official evidence assessment · version 1
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What does the official evidence assessment say?
FDA assessment dated August 19, 2024 · Read September 15, 2026 · Preserved version 1
FDA's evaluation of ipamorelin free base and acetate for growth hormone deficiency and postoperative ileus, prepared for the October 2024 advisory meeting. It is a dated agency assessment, not a final compounding determination. FDA document ↗
Identity and approval scope
FDA distinguishes free base from acetate and states that neither was a component of an FDA-approved drug at the time of its assessment. Study reports did not always identify the form administered. FDA pp. 6, 35 ↗
What did FDA find about effectiveness?
FDA found insufficient evidence supporting the evaluated uses and no clinical effectiveness or safety data for the proposed subcutaneous route. Intravenous postoperative findings do not establish subcutaneous effectiveness. FDA pp. 42, 43 ↗
Serious events require explicit context
FDA reports two deaths among ipamorelin-treated postoperative patients, alongside higher rates of hypokalemia and hyperglycemia. The agency explicitly states that whether the deaths were related to ipamorelin is unclear. FDA pp. 37, 42 ↗
Scope, source pin and remaining work
This summarizes the agency's dated assessment. It is not an independent claim that no evidence exists worldwide or that the briefing is a final regulatory decision. Newer reports and formulation identities require separate screening.
Source: FDA evaluation of ipamorelin-related bulk substances, August 19, 2024. SHA-256: 751d3a46471342fd83a14540bd4ed7fb2f802df89c71f1792c4d0abb2b7c671e.