Peptide Evidence Index
Sermorelin
Quick answers
- What is it?
- Sermorelin is a synthetic copy of the first 29 amino acids of human growth-hormone-releasing hormone (GHRH), the hypothalamic signal that tells the pituitary gland to release growth hormone.
- Why are people interested in it?
- It is the rare case of an unapproved research-chemical product today built around a molecule that was, decades ago, an FDA-approved prescription drug for growth hormone deficiency.
- What has actually been studied?
- Randomized controlled trials in children with confirmed growth hormone deficiency, run mostly in the late 1980s and 1990s, comparing sermorelin injections (and an intranasal form) directly against growth hormone treatment.
- How strong is the evidence?
- Real randomized human trial evidence exists, but only in a narrow pediatric population using an approved product no longer sold; today's compounded versions have never been tested in a trial.
- What don't we know yet?
- Whether sermorelin has any benefit in healthy adults, and whether today's compounded product matches the discontinued approved drug, are both unstudied.
- Where can I read the original research?
- Sources at the bottom of this page: Wilton et al., Acta Paediatr Suppl 1993; Neyzi et al., Acta Paediatr Suppl 1993.
Plain-English overview
Sermorelin is a synthetic 29-amino-acid fragment of human growth-hormone-releasing hormone (GHRH), the natural hypothalamic signal that prompts the pituitary gland to release growth hormone. It holds a regulatory history unlike any other compound in this library: it was once an FDA-approved prescription medicine, marketed in the United States as Geref, specifically for growth hormone deficiency in children. That approved product was withdrawn from the market by its manufacturer for business reasons, not a safety or efficacy finding, and no FDA-approved sermorelin product currently exists. What is sold today under the sermorelin name, including through compounding pharmacies for adult "anti-aging" use, is a different, unapproved product that has not itself been through FDA review or been tested in the randomized trials described below.
What researchers are studying it for
- growth hormone deficiency in children (the historic FDA-approved indication)
- diagnostic testing of growth hormone reserve
Current evidence level
Regulatory status: Approved medicine. Evidence strength and approval are scored separately; approval is a regulatory decision about a specific use, not a measure of how much research exists.
Human research
Sermorelin's real trial evidence dates to the late 1980s and 1990s, in children with confirmed growth hormone deficiency, the population the drug was approved to treat. A comparative trial of 60 children randomized to two sermorelin doses or growth hormone injections over six months found growth hormone produced significantly better height velocity (14.6 cm/year) than either the low-dose (9.2 cm/year) or high-dose (9.3 cm/year) sermorelin groups (Chen et al., 1993, Acta Paediatr Suppl). A separate multicenter trial of 43 children with growth hormone deficiency found similar results: height velocity was lowest in the low-dose sermorelin group and comparable between the high-dose sermorelin and growth hormone groups, but only the growth hormone group showed an increase in height standard deviation score for bone age (Neyzi et al., 1993, Acta Paediatr Suppl). A pharmacokinetic study in 30 healthy adult men found intravenous sermorelin reliably raised growth hormone, but intranasal absorption was poor, with only 3-5% bioavailability, requiring roughly 50-fold higher doses than an injection to produce a comparable effect (Wilton et al., 1993, Acta Paediatr Suppl). An 8-child pilot study of that intranasal form found the growth-hormone response and growth rate declined within weeks, alongside antibody formation against the drug in three of eight children, and it was judged unsuitable in the form tested (Hümmelink et al., 1993, Acta Paediatr Suppl). In the 60-child comparative trial, nearly all sermorelin-treated children developed antibodies against the drug by the end of treatment, though these were not correlated with height outcomes and had largely disappeared within 9 months of stopping. An earlier 1986 review of clinical experience with the fragment (then studied as GRF) described its use as a diagnostic test for growth hormone deficiency, distinguishing hormone-deficient children by their blunted growth hormone response (Ranke, 1986, Acta Paediatr Scand Suppl). No trial of sermorelin for weight loss, sleep, libido, or general anti-aging use in adults without growth hormone deficiency was found.
Animal and preclinical research
The material reviewed for this entry does not describe a dedicated animal literature for sermorelin; its key evidence base is instead a set of direct pediatric and adult human trials run in the 1980s and 1990s, predating the modern norm of extensive preclinical testing before human trials. No animal study of sermorelin was identified in this review.
Major findings
- In a 60-child randomized trial, growth hormone produced significantly greater height velocity (14.6 cm/year) than either sermorelin dose (9.2-9.3 cm/year) over six months (Chen et al., 1993).
- A separate 43-child trial found comparable growth with high-dose sermorelin and growth hormone, but only growth hormone improved height-for-bone-age (Neyzi et al., 1993).
- Nearly all children on sermorelin developed antibodies against the drug within months of treatment, and the growth-hormone-releasing effect faded as antibody levels rose.
- Intranasal sermorelin had only 3-5% bioavailability and required roughly 50 times the intravenous dose to achieve a comparable growth-hormone release (Wilton et al., 1993).
- An intranasal pilot study in 8 children found declining hormone response and growth effect within weeks, alongside antibody formation and nasal irritation (Hümmelink et al., 1993).
- Sermorelin was used successfully as a diagnostic test to distinguish growth-hormone-deficient children by their blunted response (Ranke, 1986).
What has not been established
- Whether sermorelin provides any measurable benefit in healthy adults without growth hormone deficiency.
- Whether today's compounded sermorelin products are chemically or pharmacologically equivalent to the discontinued approved drug (Geref).
- Whether current marketed uses -- weight loss, sleep, libido, general anti-aging -- have any human trial support.
- How commonly antibody formation would blunt effect with modern, longer-term use.
Important limitations
- The pivotal trials are decades old (1986-1993), predating ClinicalTrials.gov and modern trial-reporting standards.
- All efficacy trials were conducted exclusively in children with a confirmed hormone deficiency, not in healthy adults.
- Sample sizes were small to moderate (8-60 participants per trial).
- The intranasal delivery route tested was itself judged unsuitable and was not pursued further.
- None of this evidence applies to unsupervised or online-purchased sermorelin, which is a different, unapproved product.
Regulatory status
Sermorelin was formerly approved by the FDA for growth hormone deficiency in children, marketed as Geref, but that approved product was discontinued from the U.S. market by its manufacturer for business reasons rather than a safety or efficacy finding. Sermorelin is not currently an FDA-approved product in any form; versions sold today, including through compounding pharmacies, have not independently gone through FDA review.
Primary research sources
- Wilton P, et al. Pharmacokinetics of growth hormone-releasing hormone(1-29)-NH2 and stimulation of growth hormone secretion in healthy subjects
- Acta Paediatr Suppl 1993;388:10-5. PMID: 8329825
- Neyzi O, et al. Growth response to growth hormone-releasing hormone(1-29)-NH2 compared with growth hormone
- Acta Paediatr Suppl 1993;388:16-21. PMID: 8329826
- Chen RG, et al. A comparative study of growth hormone and GH-releasing hormone(1-29)-NH2 for stimulation of growth in children with GH deficiency
- Acta Paediatr Suppl 1993;388:32-5. PMID: 8329830
- Hümmelink R, et al. Intranasal administration of growth hormone-releasing hormone(1-29)-NH2 in children with growth hormone deficiency
- Acta Paediatr Suppl 1993;388:23-6. PMID: 8329828
- Ranke MB. Clinical experience with GRF
- Acta Paediatr Scand Suppl 1986;325:100-6. PMID: 2884799
Full evidence entry (complete data, registry records, dosing evidence)
At a glance
- Also known as
- GRF(1-29)-NH2, GHRH(1-29), Geref (discontinued U.S. brand)
- Class
- Synthetic growth-hormone-releasing hormone (GHRH) fragment
- Derived from
- The first 29 amino acids of natural human growth-hormone-releasing hormone (GHRH) — the shortest fragment found to retain the hormone's full biological activity
- Registered human trials
- Predates the ClinicalTrials.gov registry (launched 2000); modern registry searches for \"sermorelin\" return only trials of unrelated, newer GHRH analogs such as tesamorelin
- …with published results
- Multiple randomized trials from the late 1980s and 1990s were published directly in medical journals
- Largest human trial
- 60 children with confirmed growth hormone deficiency, randomized to compare two sermorelin doses directly against growth hormone injections over six months (published 1993)
- Studied for
- growth hormone deficiency in children (the historic FDA-approved indication), diagnostic testing of growth hormone reserve
- Dosing evidence
- Prescribed by a clinicianUnder its now-discontinued FDA-approved brand (Geref), sermorelin had regulator-approved labeled dosing for diagnosing and treating growth hormone deficiency in children; no such approved product is currently marketed in the United States, and today's compounded versions have not themselves gone through that review.
- Regulatory status
- Formerly approved by the FDA for growth hormone deficiency, marketed under the brand name Geref. The approved product was later discontinued from the U.S. market, a business decision by its manufacturer rather than a safety or efficacy finding. Sermorelin is not currently an FDA-approved product; versions sold today, including through compounding pharmacies, are not the approved drug and have not independently gone through FDA review.
What it is
Sermorelin is a synthetic copy of the first 29 amino acids of human growth-hormone-releasing hormone (GHRH) — the natural signal the hypothalamus sends to the pituitary gland to release growth hormone. Researchers found, decades ago, that this shorter fragment retains essentially the full biological activity of the complete natural hormone.
Sermorelin holds a different regulatory history than every other compound in this library: it was, at one point, an FDA-approved prescription drug, marketed in the United States under the brand name Geref. That approved product was later discontinued from the U.S. market — a business decision by its manufacturer, not a finding that it was unsafe or ineffective. Sermorelin is not currently FDA-approved, and products sold today under this name — often compounded for adult "anti-aging" use — are not the approved drug and have not themselves been reviewed by the FDA.
What the studies actually found
Unlike most compounds in this library, sermorelin (studied under research names like GRF(1-29) or GHRH(1-29)) has a real body of controlled human trial evidence, dating mostly to the late 1980s and 1990s, in children being treated for growth hormone deficiency — the condition it was approved to treat.
Randomized trials directly compared sermorelin injections to growth hormone injections in children with confirmed growth hormone deficiency. The consistent finding: sermorelin did increase growth hormone secretion and height velocity compared with no treatment, but growth hormone itself worked better. In one 60-child trial, average height velocity was distinctly higher in the group given growth hormone directly than in either sermorelin dose group.
A recurring problem showed up across several of these trials: the immune system frequently produced antibodies against sermorelin after weeks to months of use, and the growth-hormone-releasing effect faded as antibody levels rose. In one small intranasal study, nearly all of the children developed these antibodies within six weeks, and the treatment's effectiveness declined sharply as that happened.
An intranasal delivery form was tested specifically to avoid injections, but it turned out to be poorly absorbed through the nose, required much larger doses than injection to produce a similar effect, and still triggered antibody formation and local nasal irritation. The intranasal approach was judged unsuitable in the form tested.
What exists in humans
Because sermorelin's key trials were run in the 1980s and 1990s, before ClinicalTrials.gov existed (the registry launched in 2000), there is no clean registry count the way there is for newer compounds — a modern registry search for "sermorelin" mostly returns trials of unrelated, newer GHRH analog drugs rather than sermorelin itself. Sermorelin's real evidence base instead lives directly in the published medical literature: multiple randomized, controlled trials in children with confirmed growth hormone deficiency, the population the drug was approved to treat, alongside pharmacokinetic studies in healthy adults.
That evidence base does not extend to the reasons sermorelin is most heavily marketed today — weight loss, sleep, libido, and general anti-aging in healthy adults. No trial of that kind was found this session.
What doses have been studied in humans
Randomized pediatric trials compared different injected daily doses of sermorelin against growth hormone injections, over six-month treatment periods, measuring height velocity and growth hormone/IGF-1 levels directly — real efficacy-level dosing evidence, but only in children with a confirmed hormone deficiency, given under medical supervision as part of an approved product that is no longer on the market.
An intranasal version was also dose-tested in children, but required substantially higher doses than the injected form to achieve a similar effect, with efficacy declining over time — a route that was ultimately not pursued.
None of this dosing evidence applies to sermorelin as sold today through compounding pharmacies or online vendors for adult use — that is a different, unapproved product, and no controlled human trial has established a dose for that population or purpose.
What remains unknown
- Whether sermorelin has any measurable benefit in healthy adults without growth hormone deficiency — this population was not studied in the trials found here
- Whether today's compounded versions are chemically and pharmacologically equivalent to the discontinued approved product
- How commonly antibody formation blunts its effect with long-term modern use
- Whether current marketed uses (weight loss, sleep, libido) have any trial support at all
- What quality and purity controls apply to a compounded or online product versus the discontinued approved drug
Registry and study records
- Pharmacokinetics of GHRH(1-29)-NH2 and stimulation of growth hormone secretion in healthy subjects
- PubMed · DOI: 10.1111/j.1651-2227.1993.tb12827.x — randomized trial, healthy adult men
- Growth response to GHRH(1-29)-NH2 compared with growth hormone
- PubMed · DOI: 10.1111/j.1651-2227.1993.tb12828.x — randomized trial, n=43 children with growth hormone deficiency
- A comparative study of growth hormone and GH-releasing hormone(1-29)-NH2 for stimulation of growth in children with GH deficiency
- PubMed · DOI: 10.1111/j.1651-2227.1993.tb12834.x — randomized trial, n=60 children with growth hormone deficiency
- Intranasal administration of GHRH(1-29)-NH2 in children with growth hormone deficiency
- PubMed · DOI: 10.1111/j.1651-2227.1993.tb12830.x — pilot trial, n=8 children; documents antibody formation and declining efficacy
- Clinical experience with GRF
- PubMed · DOI: 10.1111/j.1651-2227.1986.tb10375.x — early review of GRF(1-29) diagnostic and therapeutic use in children
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Evidence last reviewed: September 2026. Peptide Proof reports what studies found. We do not give medical advice, dosing guidance, or treatment recommendations.