← All compounds · evidence tier first, by design
| Use | E1 | E2 | E3 | E4 | E5 | E6 | E7 | E8 |
|---|---|---|---|---|---|---|---|---|
| E4 Idiopathic growth hormone deficiency in children (former US-approved use) | E4 | |||||||
| E4 Age-related decline in growth hormone, body composition and strength in older adults (anti-ageing claims) | E4 |
Sermorelin
YADAIFTNSYRKVLGQLSARKLLQDIMSR
Residues 1-29 of human growth hormone-releasing hormone with a C-terminal amide.
Also: Sermorelin acetate, GHRH(1-29)NH2, GRF(1-29)
A synthetic copy of the first 29 amino acids of human growth hormone-releasing hormone (GHRH). In the US it was approved as Geref, for testing pituitary growth hormone release (1990) and for idiopathic growth hormone deficiency in children (1997). The manufacturer discontinued Geref in 2008 and FDA withdrew both approvals in 2009; FDA later determined the withdrawal was not for safety or effectiveness reasons. No sermorelin product is currently approved in the US. It is offered by compounders and "anti-ageing" clinics for adult uses never tested in an approval trial.
- US C gray market
- EU ? not verified
- UK ? not verified
- CA C gray market
- AU ? not verified
- JP ? not verified
- CN ? not verified
01Regulatory status, by jurisdiction
| Jurisdiction | Status | Detail and primary source |
|---|---|---|
| US | Withdrawn / discontinued | Geref (sermorelin acetate; NDA 19-863 diagnostic, approved 28 Dec 1990; NDA 20-443 for idiopathic GH deficiency in children, approved 26 Sept 1997; EMD Serono) was discontinued by the sponsor in 2008, and FDA withdrew approval of both NDAs effective 18 June 2009 at the sponsor's request. In 2013 FDA determined the products were not withdrawn for reasons of safety or effectiveness. Drugs@FDA lists both as Discontinued. Sermorelin does not appear in any category of FDA's 503A nominated bulk-substance list (updated 14 May 2026); this record does not determine whether compounding with it is lawful under another 503A pathway.“In the Federal Register of May 19, 2009 (74 FR 23407), FDA announced that it was withdrawing approval of NDA 19-863 and NDA 20-443, effective June 18, 2009.”Determination That GEREF (Sermorelin Acetate) Injection ... Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness (Federal Register, 4 March 2013) · retrieved 2026-10-10 |
| CA | Not approved | A query of Health Canada's Drug Product Database for the active ingredient sermorelin returned no products under any status (including cancelled products) on the retrieval date.“Search by drug identification number”Drug Product Database online query · retrieved 2026-10-10 |
| EU UK AU JP CN | Not yet verified from a primary source. No status is shown rather than an unsourced one. | |
Sport (WADA): Prohibited · class S2.2.4. “growth hormone-releasing hormone (GHRH) and its analogues (e.g. CJC-1293, CJC-1295, sermorelin and tesamorelin)” WADA source
02What the human evidence shows
Idiopathic growth hormone deficiency in children (former US-approved use)
n/c: not counted here; see the cited review.
The principal published efficacy study was an open-label, uncontrolled multicentre study in 110 previously untreated prepubertal children with GH deficiency; mean height velocity rose over 12 months, and 74% were classed as good responders at 6 months. No randomised controlled trial against placebo or growth hormone was identified in this review. The product has not been marketed in the US since 2008.
- [1] Mean height velocity increased over 12 months in an open-label study of 110 prepubertal GH-deficient children
Registered-study counts: ClinicalTrials.gov intervention search “sermorelin”, fetched 2026-10-10. Registered studies include trials of other uses; the gap between registered and reported is itself a finding.
Age-related decline in growth hormone, body composition and strength in older adults (anti-ageing claims)
No randomised controlled trial in humans has been published for this use.
Evidence is limited to very small, short studies in healthy older men, without a placebo group. In 10 older men, two weeks of GHRH(1-29) raised GH and IGF-1 to levels seen in young men (dose order randomised, no placebo). In 11 older men over six weeks, GH rose but IGF-1, body weight, muscle and fat by DEXA did not change; two of six strength measures improved. No trial has tested body composition, function, frailty or any clinical outcome against placebo. Trials of tesamorelin, a different GHRH analogue, are not evidence for sermorelin.
- [2] Raised 24-hour GH and IGF-1 over 14 days in 10 healthy older men
- [3] Raised nocturnal GH without change in IGF-1, lean or fat mass over 6 weeks in 11 older men; 2 of 6 strength measures improved
Registered-study counts: ClinicalTrials.gov intervention search “sermorelin”, fetched 2026-10-10. Registered studies include trials of other uses; the gap between registered and reported is itself a finding.
03Safety signals
There are no adequate human safety data. The absence of reported harm is not evidence of safety.
04What is unknown
- No placebo-controlled trial of sermorelin in adults for body composition, strength, sleep, cognition or any other outcome claimed by anti-ageing clinics
- No long-term safety data in adults; the published adult studies lasted two to six weeks
- Quality and identity of compounded sermorelin are not covered by any current FDA approval
- Whether stimulating GH and IGF-1 over long periods in older adults alters cancer or metabolic risk has not been studied for sermorelin
- Post-marketing safety data from the Geref era are not published in a form that allows exposure-adjusted rates; FDA's 2013 notice reported only that its review found no safety reason for withdrawal
- EU, UK, Australian, Japanese and Chinese status (including any historic national authorisations) was not verified from regulator sources for this record
05Product quality
No independent purity results have been published for this compound yet. The purity programme will publish full methods and vendor-named results, passes and failures, once its protocol has had legal review.
06Citations
- Once daily subcutaneous growth hormone-releasing hormone therapy accelerates growth in growth hormone-deficient children during the first year of therapy. Geref International Study Group. (1996). doi:10.1210/jcem.81.3.8772599
- Growth hormone (GH)-releasing hormone-(1-29) twice daily reverses the decreased GH and insulin-like growth factor-I levels in old men. (1992). doi:10.1210/jcem.75.2.1379256
- Effects of single nightly injections of growth hormone—releasing hormone (GHRH 1–29) in healthy elderly men (1997). doi:10.1016/s0026-0495(97)90174-8
Every DOI is resolved against Crossref and every NCT number against ClinicalTrials.gov, title for title, before publication. Regulatory sources are cited inline above with a verbatim quote and retrieval date.
07Mechanism
Sermorelin binds pituitary GHRH receptors; in human studies it acutely and repeatedly increased growth hormone secretion.
Mechanism is placed last on purpose: a plausible mechanism is not evidence that a compound works in people.
Reviewed by OSMF research team (AI-assisted, source-verified) on 2026-10-10. Found an error? It goes in the corrections log: report it.