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.
Growth hormone-releasing hormone (GHRH) analog peptide
Sermorelin
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.
Evidence review
Last reviewed Jul 1, 2026
Next review Jul 29, 2026
Evidence snapshot
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discontinued Geref; the FDA-approved product is no longer commercially available, though the drug was not formally withdrawn for safety reasons.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.
Research record
What the evidence record says
- Evidence grade
- Not Graded
- Regulatory status
- Sermorelin regulatory status has not been fully reviewed by Peptide Report editorial team. See company profiles and regulatory watch for current status.
Evidence records
Studies, registries, reviews, and regulatory records
Evidence review pending
- Detailed evidence review for Sermorelin is pending editorial assessment. Current summary reflects available public records.
Records: FDA BPC-157 compounding safety risk: immunogenicity, Warning Letter: Gram Peptides, Sermorelin (Geref) for Diagnosis of Growth Hormone Deficiency
Evidence timeline
What changed, and when
Peptide Report last reviewed Sermorelin on 2026-07-01.
Records: FDA BPC-157 compounding safety risk: immunogenicity
Direct answers
Frequently asked questions
What is Sermorelin?
Sermorelin is a growth hormone-releasing hormone (ghrh) analog peptide tracked by Peptide Report. See the full profile for current editorial assessment.
Open research questions
What is still unknown
- What is the complete human evidence base for Sermorelin?
- What are the long-term safety considerations for Sermorelin?
Tracked claims
Sermorelin was formerly FDA-approved as Geref for diagnostic testing of growth hormone deficiency in children.
Evidence level: Primary regulatory
Sources: FDA BPC-157 compounding safety risk: immunogenicity
How to read this: 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.
Sermorelin is widely compounded by telehealth clinics for off-label adult anti-aging use.
Evidence level: Community discussion
Sources: FDA BPC-157 compounding safety risk: immunogenicity, Warning Letter: Gram Peptides
How to read this: 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.
The original FDA-approved brand product (Geref) was discontinued by the manufacturer.
Evidence level: Primary regulatory
Sources: FDA BPC-157 compounding safety risk: immunogenicity
How to read this: The discontinuation was a manufacturer business decision, not an FDA safety withdrawal. This distinction matters for accurate regulatory framing.
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Sources on this page
Each source record is linked to the claim or evidence note it supports.
Certain bulk drug substances for use in compounding may present significant safety risks
FDA risk page lists BPC-157: compounded BPC-157 may pose immunogenicity risk and peptide-related impurity concerns for certain routes of administration.
41 linked pagesOpen original ·
fda-bulk-risk-listWarning Letter: Gram Peptides
FDA warning letter discussing peptide products marketed online and the limits of research-use-only positioning.
35 linked pagesOpen original ·
fda-gram-peptides-warning-2026Sermorelin (Geref) for Diagnosis of Growth Hormone Deficiency
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.
6 linked pagesOpen original ·
pubmed-sermorelin-gh-deficiency-1997Related compounds
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