Growth hormone-releasing hormone (GHRH) analog peptide
Sermorelin is a synthetic N-terminal fragment (1-29) of growth hormone-releasing hormone (GHRH) that was formerly FDA-approved as Geref for diagnostic use in pediatric growth hormone deficiency. The manufacturer discontinued Geref, and the product is no longer commercially available under an FDA-approved brand. It is now widely compounded by telehealth clinics for off-label anti-aging and performance use.
Track regulatory history and compounding status. Do not publish dosing, sourcing, or treatment instructions. Distinguish clearly between the former FDA-approved diagnostic indication and current off-label compounding use.
Sermorelin (Geref) was previously FDA-approved as a diagnostic agent for evaluating growth hormone deficiency in children — it was a 29-amino-acid fragment of naturally occurring GHRH.
The manufacturer (EMD Serono) discontinued Geref; the FDA-approved product is no longer commercially available, though the drug was not formally withdrawn for safety reasons.
Sermorelin is now widely prescribed by telehealth and anti-aging clinics via compounding pharmacies for off-label adult use — this compounding is subject to FDA oversight and the bulk substance risk list framework.
Published clinical literature for sermorelin is primarily from the 1990s-2000s era and focuses on pediatric GH deficiency diagnostic testing; modern adult off-label use lacks robust clinical trial data.
Evidence level: Primary regulatory
Sources: U.S. Food and Drug Administration
The FDA approval was for diagnostic use in pediatric GH deficiency, not for treatment or for adult anti-aging use. The brand product (Geref) has been discontinued by the manufacturer. Confirm regulatory status on each review cycle.
Evidence level: Community discussion
Sources: U.S. Food and Drug Administration, U.S. Food and Drug Administration
Track the telehealth compounding trend without endorsing it. Adult anti-aging use is off-label and lacks the clinical trial evidence base that supported the original pediatric diagnostic approval.
Evidence level: Primary regulatory
Sources: U.S. Food and Drug Administration
The discontinuation was a manufacturer business decision, not an FDA safety withdrawal. This distinction matters for accurate regulatory framing.
Source records are stored in the repo and linked from each claim.
FDA page summarizing bulk drug substances that may present significant safety risks in compounding contexts.
FDA warning letter discussing peptide products marketed online and the limits of research-use-only positioning.
PubMed index of clinical literature on sermorelin (Geref) for diagnostic testing of growth hormone deficiency in pediatric patients. Sermorelin was formerly FDA-approved as Geref; the brand product has been discontinued by the manufacturer.
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