Sermorelin
Growth hormone-releasing hormone (GHRH) analogue
Status
Withdrawn
FDA approved sermorelin as Geref (1990 for diagnosis, 1997 for growth failure in children), but the maker stopped selling it in 2008 and FDA withdrew both approvals in 2009, later confirming this was not for safety or effectiveness reasons; sermorelin sold in the US since then is compounded or research-grade and has no current FDA approval.
Evidence
Moderate
Open-label trials in growth hormone-deficient children supported its former approval, but there are no large randomized trials, and adult use rests on small short studies.
In sport
WADAProhibited (WADA)
Sermorelin is a lab-made copy of the first 29 amino acids of growth hormone-releasing hormone, the signal that makes the pituitary release growth hormone. FDA once approved it for children with growth hormone deficiency, but no approved product has been sold since 2008.
Structure
29 residuesPoint at a bead, or focus the chain and use the arrow keys, to name it. Pick a chemistry to highlight it.
Sequence as text
H-Y-A-D-A-I-F-T-N-S-Y-R-K-V-L-G-Q-L-S-A-R-K-L-L-Q-D-I-M-S-R-NH2
What it is used for
- Growth failure from idiopathic growth hormone deficiency in children, the former Geref indication (studied)
- Testing the pituitary's ability to release growth hormone, the former diagnostic indication (studied)
- Raising growth hormone in healthy older adults (studied)
- Anti-ageing, body composition, sleep or recovery (claimed, unproven)
How it works
Sermorelin binds the GHRH receptor on somatotroph cells of the anterior pituitary, prompting release of the body's own growth hormone, which in turn raises IGF-1 (insulin-like growth factor 1) from the liver. Because it acts upstream, the body's normal brakes on growth hormone (somatostatin and IGF-1 feedback) still limit the response, and it only works if the pituitary can still make growth hormone.
How strong the evidence is
Moderate
In an open-label study by the Geref International Study Group, 110 previously untreated growth hormone-deficient children received nightly injections for up to a year; mean height velocity rose from 4.1 to 7.2 cm per year at 12 months, and treatment was well tolerated (Thorner 1996). In a 6-week study of 11 healthy men aged 64 to 76, nightly GHRH(1-29) increased night-time growth hormone release but did not change IGF-1, weight or body composition, with small gains in some strength tests (Vittone 1997). Recombinant growth hormone displaced it for children, and no large randomized trial supports use for ageing or body composition.
Risks and side effects
- No approved product exists: compounded or research-grade sermorelin is not FDA-reviewed for identity, purity or strength
- Raises growth hormone and IGF-1; the label of the related GHRH analogue tesamorelin warns of fluid retention, joint pain, glucose intolerance and caution with any history of cancer
- Long-term safety in adults has not been tested in controlled trials
- Prohibited in sport at all times (WADA S2)
Regulatory status
| Region | Year | Approved for |
|---|---|---|
| USFDA | 1990Withdrawn 2009 | Diagnostic test of pituitary growth hormone secretion |
| USFDA | 1997Withdrawn 2009 | Growth failure in children with idiopathic growth hormone deficiency |
Status by country
| Jurisdiction | Status | Source |
|---|---|---|
| USUnited States | Withdrawn | Source 1 |
| EUEuropean Union | No authorised medicine | Source 9 |
| UKUnited Kingdom | No authorised medicine | Source 10 |
| AUAustralia | No authorised medicine | Source 11 |
| CACanada | No authorised medicine | Source 12 |
Timeline
2009
- Withdrawn, US (FDA)Diagnostic test of pituitary growth hormone secretion
- Withdrawn, US (FDA)Growth failure in children with idiopathic growth hormone deficiency
1997
- Approved, US (FDA)Growth failure in children with idiopathic growth hormone deficiency
1990
- Approved, US (FDA)Diagnostic test of pituitary growth hormone secretion
Sources
- 01Determination That GEREF (Sermorelin Acetate) Injection Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness(opens the source in a new tab)
- 02GEREF (sermorelin acetate) NDA 020443: product and approval history(opens the source in a new tab)
- 03Sermorelin (CID 16132413)(opens the source in a new tab)
- 04Somatoliberin (human GHRH) (P01286)(opens the source in a new tab)
- 05Once daily subcutaneous growth hormone-releasing hormone therapy accelerates growth in growth hormone-deficient children during the first year of therapy(opens the source in a new tab)
- 06Effects of single nightly injections of growth hormone-releasing hormone (GHRH 1-29) in healthy elderly men(opens the source in a new tab)
- 07EGRIFTA WR (tesamorelin) for injection: prescribing information(opens the source in a new tab)
- 08World Anti-Doping Code International Standard: Prohibited List 2026(opens the source in a new tab)
- 09Find medicine: centrally authorised medicines(opens the source in a new tab)
- 10MHRA Products: active substances beginning with S(opens the source in a new tab)
- 11Australian Register of Therapeutic Goods (ARTG)(opens the source in a new tab)
- 12Unauthorized injectable peptide drugs seized and sold by Canada Peptide may pose serious health risks(opens the source in a new tab)
Educational information, not medical advice. Talk to a licensed clinician before starting, stopping or changing any medicine.