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Historical approval / published human studies
This page is reference information about Sermorelin: its U.S. regulatory history — the discontinued Geref product and the absence of any current FDA-approved anti-aging or 'wellness' indication — the fact that no current dose is established, and the safety questions to raise with a licensed clinician. It is informational only and contains no dosing guidance.
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Sermorelin: reference record
| Regulatory status | Former U.S. Geref products discontinued; no current FDA-approved anti-aging indication |
|---|---|
| Route | Subcutaneous historically |
| Dosing frequency | No current established regimen |
| Published range | No established range |
| Evidence basis | Historical approval / published human studies |
| Common vial sizes | 5, 10, 15 |
Sources
- FDA archived new drug application document (Sermorelin) - accessdata.fda.govBasis for the regulatory status, route, frequency and published range in the table above. Source last checked 2026-06-24
What is Sermorelin?
Sermorelin is a synthetic fragment corresponding to the first 29 amino acids of growth-hormone-releasing hormone. Its history is distinctive: it was once an approved U.S. product, marketed as Geref, and that product line was discontinued.
Is Sermorelin FDA-approved?
Not currently. Sermorelin previously held U.S. approval as Geref, but those products were discontinued and there is no current FDA-approved anti-aging or general wellness indication. It is best described as prior-approved and withdrawn rather than never-approved.
How is Sermorelin given?
Historically it was given subcutaneously under its former labeling. There is no current established regimen, and no current approved adult dose exists.
What are the known safety concerns with Sermorelin?
A historical approval does not validate present-day compounded formulations or adult anti-aging use. The discontinued label described a different product, prepared and supervised under different conditions.
Historical pediatric and adult studies used weight-based regimens; no current FDA-approved adult 'wellness' dose
No default dose. Follow the exact current prescriber/pharmacy instructions if a lawful compounded product is used.
Historical approval does not validate current compounded formulations or adult anti-aging use.
Supply-chain quality · Finnrick
Avg quality score
6.2
/10
Purity range
96.58
–
99.95
%
Qty divergence
±
50
%
Vendors · samples
5
·
23
Common vial sizes
5, 10, 15
mg
Test window
Apr 2025 - Mar 2026
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