Sermorelin

Growth Hormone Secretagogues

aka Geref · GHRH(1-29)NH2 · GRF(1-29)NH2

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Formula

MW (Da)

Half-life

~11–12 min (IV)

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Overview

Sermorelin is a synthetic analog of the first 29 amino acids of human growth hormone-releasing hormone (GHRH(1-29)NH2). It was FDA-approved as Geref for both GH-reserve diagnostic testing and pediatric growth hormone deficiency treatment; the FDA documented that the products were later withdrawn from sale, but not for reasons of safety or effectiveness.

Mechanism

Sermorelin acts as a GHRH receptor agonist at pituitary somatotrophs, stimulating endogenous GH release and downstream IGF-1 signaling. Per the Irish SPC, plasma half-life is 6–7 minutes after IV administration, with a peak GH response around 30 minutes and a duration of 2–3 hours. The physiology distinguishes sermorelin as a secretagogue that preserves endogenous pulsatility rather than replacing GH directly.

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Reported benefits

Accelerated growth in pediatric GH deficiency

The multinational Geref International Study Group treated 110 previously untreated prepubertal GH-deficient children with 30 μg/kg/day SC at bedtime for up to 1 year; 86 were evaluable for efficacy. Once-daily therapy accelerated growth in the first treatment year.

[sermorelin-thorner-1996]

clinical

Reliable diagnostic for GH-reserve testing

Diagnostic regimen: 1 μg/kg IV once after overnight fast with serial GH sampling over 60 minutes. Reported fewer false positives than several older provocative tests in children without GH deficiency.

[sermorelin-spc-ireland]

clinical

Preserved endogenous GH pulsatility

Plasma half-life 6–7 minutes after IV; peak response around 30 minutes; effect lasts 2–3 hours. Sermorelin promotes physiologic pulsatile GH secretion rather than continuous exposure.

[sermorelin-spc-ireland]

clinical

Reported side effects

Transient facial heat, flushing, and injection-site pain
clinical
The Irish SPC lists facial heat, facial flushing, and injection-site pain as occasional and transient undesirable effects.
Contraindicated in pregnancy / lactation; caution in diabetes and epilepsy
clinical
Pregnancy and lactation are contraindications. Use with caution in diabetes mellitus or epilepsy.
Discontinuation not for safety reasons
clinical
FDA's 2013 Federal Register notice states the discontinued Geref products were not withdrawn for safety or effectiveness reasons, supporting moderate confidence rather than low.

Dosing notes

Diagnostic use: 1.0 μg/kg IV once after overnight fast. Historical pediatric treatment: 30 μg/kg/day SC at bedtime. Both regimens come from approved-product labeling.

Research use only. Information on this page is editorial reference, not medical or dosing advice. Always consult qualified medical guidance before use.

Storage

Per Geref label: store at 2–8 °C, protect from light, shelf life 2 years. Reconstitute immediately before use and discard remainder.

Vendors carrying Sermorelin

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Discussion

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References

[sermorelin-fda-federal-register]
Determination that Geref (sermorelin acetate) products were not withdrawn for safety or effectiveness
FDA Federal Register · 2013 · FDA Federal Register
Source
[sermorelin-spc-ireland]
Geref SPC (Ireland HPRA)
Health Products Regulatory Authority (Ireland) · Irish HPRA SPC
Source
[sermorelin-thorner-1996]
Thorner et al. 1996 — Geref International Study Group pediatric GHD trial
Thorner MO et al. · 1996 · Journal of Clinical Endocrinology & Metabolism
Source
[sermorelin-fda-medr]
FDA medical review for sermorelin (NDA 022505)
FDA · 2010 · FDA accessdata
Source

Reported benefits

Accelerated growth in pediatric GH deficiency

Reliable diagnostic for GH-reserve testing

Preserved endogenous GH pulsatility

Transient facial heat, flushing, and injection-site pain

Contraindicated in pregnancy / lactation; caution in diabetes and epilepsy

Discontinuation not for safety reasons

Discussion