Sermorelin Reference
Educational, not medical advice reference for Sermorelin: GH Release; regulatory status, evidence posture, source review, and schedule notes. Al…
Plain English
- What it is
- Sermorelin is a lab-made copy of the active part of a natural body signal called growth-hormone-releasing hormone, which tells the brain's pituitary gland to release the body's own growth hormone in a natural pulse. It used to be an approved US medicine sold as Geref, but that product was pulled from the market in 2008 and no approved sermorelin medicine is sold here today. The sermorelin people get now is made by compounding pharmacies and is not an FDA-approved product.
- What people use it for
- People, often in their forties and older, reach for it to gently nudge their natural growth hormone without using actual HGH. The most common feedback is deeper sleep, with some reporting slow body-composition changes and quicker recovery from workouts over months. It is also popular at anti-aging and hormone clinics, and the effects tend to be subtle rather than dramatic.
- What the science shows
- Older human studies from its approved-drug days showed it can raise the body's own growth-hormone pulses, and it was widely used in tests of how well the pituitary makes growth hormone. One study in healthy older men found nightly injections increased nighttime growth-hormone release over about six weeks, but blood IGF-1, a longer-term growth marker, did not change. Modern, high-quality studies on real-world results like body composition, sleep, and quality of life are limited, so most current use rests on the mechanism rather than fresh trial data.
- The catch
- Because there is no FDA-approved sermorelin medicine, the compounded versions sold today do not come with the FDA's review of quality and safety. The World Anti-Doping Agency bans this whole class of growth-hormone-releasing peptides at all times, so tested athletes can face a doping violation. Like other growth-hormone-axis products it carries a caution for people with active cancer, and its safety in pregnancy is not known.
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 products (Geref injection) were discontinued from the US market in 2008 and moved to the FDA Orange Book Discontinued Drug Product List, and FDA later determined they were not withdrawn for reasons of safety or effectiveness. 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
Selected public sources
- FDA bulk drug substances with significant safety risks
- PubMed: Vittone 1997 sermorelin (GHRH 1-29) nightly-injection study in healthy elderly men (Metabolism)
- FDA accessdata Drugs@FDA search: sermorelin (Geref) discontinued-product record
- FDA Federal Register notice (Mar 4, 2013): GEREF (sermorelin acetate) injection was not withdrawn from sale for reasons of safety or effectiveness
- WADA prohibited list and resources
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- Peptide half-life calculator - Estimate single-dose decay from cited half-life constants.
- Injection-site rotation overview - Public overview of the Pro site-rotation planner.
For research and educational purposes only. Not medical advice.