Sermorelin is the odd one out among the GHRH analogues sold online: it was a real approved drug with a real label, and it was withdrawn from the market for business reasons rather than safety ones. That history is why clinics can offer it through a pharmacy at all. It is also why the evidence for it stops in the 1990s.
What it is
Sermorelin is the first 29 amino acids of human GHRH, which is the shortest fragment with full GHRH activity (PubMed 18031173). It stimulates the pituitary to release the person's own growth hormone. Serono developed it under the brand Geref: first as a diagnostic injection to test pituitary GH reserve, then as a daily subcutaneous treatment for children with idiopathic growth hormone deficiency.
The human evidence
Because sermorelin went through the approval process, its trials look like drug trials:
| Year | Design | Result | PubMed |
|---|---|---|---|
| 1993 | Randomised comparison of GHRH(1-29) against growth hormone in GH-deficient children, multicentre | Both increased growth velocity; GH itself produced the larger response. | 8329826 |
| 1993 | Randomised comparative study, GHRH(1-29) vs GH, children with GH deficiency | Same programme; sermorelin effective in a subset with intact pituitary function. | 8329830 |
| 1996 | Multicentre open-label, 110 previously untreated prepubertal GH-deficient children, one year of nightly injections | Growth velocity accelerated over the year in the 86 children evaluable for efficacy. | 8772599 |
| 1999 | Drug review (BioDrugs) | Summarises the diagnostic-test data (a rapid and relatively specific test for GH deficiency) and the treatment data behind the labels. | 18031173 |
The evidence is for children with a diagnosed deficiency, measuring height. That population responds to any agent that restores GH signalling. It says little about what daily GHRH does to a healthy 45-year-old, and we could find no randomised trial that asks.
Regulatory status
Drugs@FDA records two Geref applications: NDA 019863, approved December 28, 1990 (the diagnostic), and NDA 020443, approved September 26, 1997 (treatment). Both are listed as discontinued. We have not located an FDA determination that either was withdrawn for safety or effectiveness reasons; Drugs@FDA records the marketing status, not the reason.
For compounding, the relevant fact is that sermorelin was the active ingredient of an FDA-approved drug. Section 503A lists "a component of an FDA-approved drug" as one of the routes by which a bulk substance may be used, alongside a USP monograph or a place on the 503A bulks list. Sermorelin does not appear on FDA's 503A category lists (updated May 14, 2026) and is not on the Category 2 safety page. That is a different position from every research peptide on this site. It is not the same as FDA endorsing compounded sermorelin for adults, and a compounded product is not Geref: no compounded sermorelin has been reviewed for potency, purity or stability by FDA. The compounding site explains what a 503A pharmacy may and may not do.
Safety signals
FDA has published no compounding safety concern for sermorelin. We have not reproduced the discontinued Geref label's adverse-reaction list here because it is no longer a current document. The tesamorelin label, the modern GHRH analogue, carries a formal neoplasm warning and a glucose-intolerance warning; there is no reason to assume sermorelin is exempt from either, only that its trials were too short and too young to show them.
Grade: B
B because there are randomised controlled comparisons and a regulator once reviewed the data for a labelled use. Not A, because no approved product is on the market and the current label does not exist. The grade applies to the paediatric deficiency indication; the adult "GH optimisation" use has no trial behind it and receives no grade. See the tesamorelin page for the GHRH analogue that does have a current label and a warnings section.
Questions people ask
Is sermorelin FDA approved?
It was. Geref (sermorelin acetate) was approved as NDA 019863 on December 28, 1990 for diagnostic use and as NDA 020443 on September 26, 1997 to treat growth hormone deficiency in children. Drugs@FDA lists both applications as discontinued. There is no currently marketed FDA-approved sermorelin product.
Can a pharmacy compound sermorelin?
Section 503A allows compounding from a bulk substance that is a component of an FDA-approved drug, among other conditions. Sermorelin was the active ingredient of an approved drug that is now discontinued. It does not appear on FDA's 503A category lists (updated May 14, 2026) or on the Category 2 safety page. Whether a specific pharmacy's sermorelin meets every 503A condition is a question for that pharmacy and its state board; we do not state a status FDA has not published.
Does sermorelin work for anti-ageing in adults?
The controlled trials are in children with growth hormone deficiency, where the question was height velocity. We found no randomised trial of sermorelin for body composition, sleep, energy or ageing in healthy adults. The grade on this page applies to the former labelled use, not to those claims.
Sources
- Drugs@FDA: GEREF (sermorelin acetate), NDA 019863 approved December 28, 1990 and NDA 020443 approved September 26, 1997, marketing status discontinued Accessed September 4, 2026.
- FDA: Bulk Drug Substances Nominated for Use in Compounding Under Section 503A, category lists (updated May 14, 2026) Accessed September 4, 2026.
- Thorner M et al. Once daily subcutaneous growth hormone-releasing hormone therapy accelerates growth in growth hormone-deficient children during the first year of therapy. J Clin Endocrinol Metab 1996. PubMed 8772599 Accessed September 4, 2026.
- Neyzi O et al. Growth response to growth hormone-releasing hormone(1-29)-NH2 compared with growth hormone. Acta Paediatr Suppl 1993. PubMed 8329826 Accessed September 4, 2026.
- Chen RG et al. A comparative study of growth hormone (GH) and GH-releasing hormone(1-29)-NH2 for stimulation of growth in children with GH deficiency. Acta Paediatr Suppl 1993. PubMed 8329830 Accessed September 4, 2026.
- Prakash A, Goa KL. Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency. BioDrugs 1999. PubMed 18031173 Accessed September 4, 2026.
Canonical URL: https://formblendspeptides.com/peptides/sermorelin. Written by the FormBlends editorial team. This page is educational and is not medical advice; see the medical disclaimer.