A

Tier

Sermorelin

Sermorelin

Sermorelin

GHRH(1-29) analog for natural GH stimulation.

Muscle & Performance

Peptide

WADA Status:

Prohibited at all times (S2)

Human Trial Scoreboard

Completed human RCTs

0
0
0

Count not verified

Largest Human Study

0
0
0

Size not verified

Longest exposure

0
0
0

Duration not verified

Most Recent Trial

0
0
0

Year not verified

Description

Sermorelin is the first twenty nine amino acids of the natural growth hormone releasing hormone, which is the active portion. It has an unusual history for this database in that it was once a properly approved medicine, sold as Geref, used to diagnose growth hormone deficiency and to treat it in children. The product was later withdrawn from the US market, and the available reporting indicates a commercial decision rather than a safety problem, though the precise stated reason is not well documented publicly. It now sits in the unapproved compounding category. It is worth distinguishing from the modified analogues it gets grouped with: sermorelin is the unmodified natural sequence, which is why it breaks down quickly, and the modifications in compounds like CJC-1295 exist specifically to slow that breakdown.

What Are The Claims

Claims made for this compound: Stimulates natural, pulsatile GH release; Proposed improvements in sleep, recovery, and body composition; Feedback-regulated mechanism may reduce overshoot versus direct GH

Evidence

The withdrawal reason is frequently misrepresented in both directions, so here it is precisely. Per the Federal Register notice of 4 March 2013, Geref was not withdrawn for reasons of safety or effectiveness. The manufacturer ceased production of the active ingredient. It was a commercial decision. That cuts against the implication sometimes made that sermorelin was pulled as dangerous. It also cuts against the more common marketing move of treating a lapsed approval as an ongoing endorsement. The original approval covered diagnostic use and pediatric deficiency, not the adult anti-aging and body-composition applications it is now sold for.

Evidence Strength

Moderate (historically FDA-approved diagnostic/pediatric)

Caveats

Geref was withdrawn from the US market in 2008 for commercial reasons; anti-aging use is off-label/compounded.

Safety
Alternative Measures
Legal Status

US

Prior product withdrawn; unapproved, compounding category only

UK

Not approved

EU

Not approved

AU

Not approved

WADA

Prohibited at all times (S2)

Formerly FDA-approved as Geref, first as a diagnostic agent in 1990 and subsequently for pediatric growth hormone deficiency in 1997. EMD Serono discontinued the product in 2008 and the FDA withdrew marketing approval effective 2009. Currently available only through compounding.

Citations

Federal Register, 4 March 2013: Geref withdrawal not for reasons of safety or effectiveness. | FDA approval as diagnostic agent 1990; pediatric growth hormone deficiency 1997; discontinued by EMD Serono 2008, marketing approval withdrawn 2009.

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