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Sermorelin Reference

Educational, not medical advice reference for Sermorelin: GH Release; regulatory status, evidence posture, source review, and schedule notes. Al…

Reference summary

Older US pediatric and adult studies documented growth hormone release following sermorelin administration during its approved-product era, and it was widely used for GH provocative testing. The Vittone 1997 study reported that nightly subcutaneous GHRH 1-29 in healthy elderly men increased nocturnal pulsatile GH release over 6 weeks, with no change in IGF-1. Independent modern clinical outcome data on body composition, sleep, and quality of life are limited compared with current approved GH-axis therapies; most current community use rests on the pulsatile-GH mechanism rather than fresh randomized data.

Regulatory and posture

Categories
GH Release
Aliases
GRF 1-29, GHRH(1-29), Sermorelin acetate, Geref, Geref Diagnostic
Evidence posture
human - Original US label was withdrawn in 2008. Current use is via compounding and falls outside FDA oversight.
Regulatory status
Sermorelin acetate was FDA-approved as Geref (pediatric idiopathic GH deficiency) and Geref Diagnostic (GH provocative testing), and the last sermorelin product was discontinued from the US market around 2008 (the FDA discontinuation was for commercial reasons rather than a safety withdrawal). No FDA-approved sermorelin drug label is currently on the US market; present clinical use is via compounding pharmacies. FDA lists sermorelin among bulk drug substances with safety-risk concerns for compounding. WADA prohibits GHRH analogs (including sermorelin) at all times under category S2.
Content review status
research reference

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