Sermorelin
Evidence: B/C — Meaningful Human EvidenceGH Axis / Body Composition
Key facts
- Research areaGH Axis / Body Composition
- Research statusdiscontinued
- Study records148 human
- Last updated2026-07-12
Evidence Snapshot
Regulatory Context
Historical U.S. products contained sermorelin acetate. Geref Diagnostic (NDA 19-863; approved December 28, 1990) was used to evaluate pituitary growth-hormone secretory capacity. Geref Pediatric (NDA 20-443; approved September 26, 1997) was indicated for idiopathic growth-hormone deficiency in children with growth failure. FDA withdrew approval of both NDAs effective June 18, 2009 after sponsor discontinuation and later determined that the products were not withdrawn for reasons of safety or effectiveness. No FDA-approved sermorelin product is currently marketed in the United States.
In Plain English
A quick, research-focused overview. It does not replace, and cannot outrank, the detailed evidence below.
What is it?
A synthetic 29-amino-acid GHRH fragment that stimulates the pituitary GHRH receptor and promotes endogenous growth-hormone release.
Why are researchers interested in it?
Historically evaluated as a diagnostic stimulus for growth-hormone deficiency, as a pediatric therapy for growth failure associated with GH deficiency, and in small studies of age-related changes in the GH axis.
What is it being studied for?
- Pediatric growth hormone deficiency (historical GEREF approval)Human Studies & Clinical Data
- Diagnostic testing for GH secretory capacityHuman Studies & Clinical Data
- Adult growth-hormone axis stimulation (age-related)Human Studies & Clinical Data
What does the evidence look like?
The strongest evidence is historical human pharmacology, pediatric clinical data, and former FDA-approved uses. Adult wellness claims are supported mainly by small or indirect studies rather than modern outcome trials.
Biggest things to know
The former products are discontinued, current compounded products are not FDA-approved, and historical findings should not be generalized to unstudied adult wellness uses.
What don't we know yet?
Sermorelin's only FDA-approved products (GEREF Diagnostic and GEREF Pediatric) were discontinued and their approvals formally withdrawn in 2009 — FDA later confirmed this was not for safety or effectiveness reasons, but no sermorelin product is currently FDA-approved or marketed in the United States. Modern compounded sermorelin preparations are not the same regulated products as the historical GEREF formulations, and equivalence has not been independently established. Evidence for anti-aging, recovery, or body-composition benefits in healthy adults remains limited; the strongest human data come from historical pediatric growth-hormone-deficiency studies, which do not automatically generalize to adult wellness use.
Research status
Reviewed August 25, 2026
Research Takeaway
Sermorelin is growth hormone-releasing hormone 1-29 amide, GHRH(1-29)-NH2/GRF(1-29)-NH2; sermorelin acetate is its acetate-salt drug-substance form.
See all 12 evidence claims →Quick Summary
Sermorelin is the amidated 1–29 fragment of human growth hormone–releasing hormone. Historical human studies and former U.S. approvals support its ability to stimulate pituitary growth-hormone release and, in selected pediatric growth-hormone-deficiency populations, promote growth. Evidence for modern adult wellness, anti-aging, recovery, or body-composition uses remains limited and should not be inferred from the former pediatric and diagnostic indications.
Mechanism & Research Overview
Sermorelin is the amidated 1–29 fragment of human growth hormone–releasing hormone and acts as an agonist at growth hormone–releasing hormone receptors on anterior-pituitary somatotrophs. The human GHRH receptor is a secretin-family G-protein-coupled receptor; receptor activation increases intracellular cAMP and stimulates secretion of endogenous growth hormone. Sermorelin therefore acts upstream of growth hormone itself and should not be described as recombinant growth hormone or as a direct growth-hormone-receptor agonist.
Read more about the mechanism
Its plasma exposure is brief, but the downstream growth-hormone response lasts longer than the peptide remains in circulation. Official Geref product information reported an intravenous plasma half-life of 6–7 minutes, a peak growth-hormone response at about 30 minutes, and a response lasting approximately 2–3 hours. In a randomized study of 30 healthy men, intravenous GHRH(1–29)-NH2 was rapidly eliminated while growth hormone remained elevated for about 3 hours; intranasal bioavailability was only 3–5%, demonstrating that administration route materially changes systemic exposure.
Rapid clearance is consistent with enzymatic degradation of GHRH-family peptides in plasma, principally by dipeptidyl peptidase IV cleavage near the amino terminus and, to a lesser extent, by trypsin-like enzymes. The magnitude of growth-hormone release also depends on functioning pituitary somatotrophs and physiologic context. Somatostatin tone, obesity, hyperglycemia, elevated circulating free fatty acids, untreated hypothyroidism, and drugs that alter pituitary growth-hormone secretion can blunt or otherwise change the response. An acute rise in growth hormone does not by itself establish sustained IGF-1 elevation or clinical benefits for fat loss, muscle gain, sleep, recovery, longevity, or anti-aging.
Mechanism pathway
Relationship-support labels describe the type and directness of the research available, not proof of safety or effectiveness. Indirectly supported, inferred and uncertain relationships are not equivalent to directly supported ones.
- CompoundSermorelin
- Directly supported (Directly supported relationship)Biological targetGHRH receptorReceptor
- Supported indirectly (Indirectly supported relationship)Signal / mechanism stepcAMP generationSecretin-family GPCR activation increases intracellular cAMP in somatotrophs.
- Leads toPathwayGrowth Hormone / IGF Axis
- Contributes to
- Biological processEndogenous growth hormone secretion
Relationship support in this pathway
- Directly supported
- Supported indirectly
Thin grey links (“Leads to”, “Contributes to”) show structure only and carry no support rating.
Relationship details
- Sermorelin → GHRH receptor — Directly supportedAgonist at pituitary GHRH receptors on somatotrophs.
- cAMP generation — Supported indirectlySources: study-sermorelin-prakash-goa-1999-review
- Endogenous growth hormone secretion — contributes to the pathway (structural link, no support rating)Sources: study-sermorelin-prakash-goa-1999-review
A biological process is not the same as a proven health or treatment outcome.
Relevant tissue/system context: Anterior pituitary
Evidence Claims
Individual scientific statements drawn from the sources cited below, each shown with the specific evidence boundary that statement does not establish.
Supported
Sermorelin is growth hormone-releasing hormone 1-29 amide, GHRH(1-29)-NH2/GRF(1-29)-NH2; sermorelin acetate is its acetate-salt drug-substance form.
Sources: Growth hormone-releasing hormone(1-29)-NH2 for stimulation of growth in children with GH deficiency; Growth response to growth hormone-releasing hormone(1-29)-NH2 compared with growth hormone; Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency
Supported
GEREF (sermorelin acetate) historically had FDA-approved diagnostic and pediatric growth-hormone-deficiency products, including a 1997 treatment approval for children with growth failure due to growth hormone deficiency.
Sources: Determination That GEREF (Sermorelin Acetate) Injection Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness; FDA Orphan Drug Designations and Approvals — Sermorelin acetate / Geref
Supported
FDA later determined that the discontinued GEREF products were not withdrawn from sale for reasons of safety or effectiveness.
Supported
A historical multicenter study reported accelerated growth during one year of once-daily GHRH(1-29)-NH2 therapy in children with growth hormone deficiency.
Supported
Evidence for anti-aging, recovery, and body-composition benefits in healthy adults remains limited.
Supported
Modern compounded sermorelin preparations should not be represented as the historical FDA-approved GEREF products unless product-specific approval and equivalence are independently established.
Sources: Determination That GEREF (Sermorelin Acetate) Injection Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness; FDA Orphan Drug Designations and Approvals — Sermorelin acetate / Geref
Supported
FDA withdrew approval of the GEREF NDAs effective June 18, 2009 after the sponsor discontinued the products and requested withdrawal.
Supported
Historical pediatric clinical studies show that GHRH(1-29)-NH2 can stimulate growth in children with hypothalamic growth hormone deficiency or idiopathic short stature; these are historical pediatric endocrine findings and do not establish equivalence for current compounded adult-wellness products.
Sources: Growth hormone-releasing hormone(1-29)-NH2 for stimulation of growth in children with GH deficiency; Growth response to growth hormone-releasing hormone(1-29)-NH2 compared with growth hormone; 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; Treatment with GHRH(1-29)NH2 in children with idiopathic short stature induces a sustained increase in growth velocity
Supported
In a randomized pediatric comparison, higher-dose GHRH(1-29)-NH2 increased height velocity, while recombinant growth hormone remained superior on at least one bone-age-adjusted height outcome.
Sources: Growth response to growth hormone-releasing hormone(1-29)-NH2 compared with growth hormone
Supported
GHRH(1-29) administration increased GH and IGF-1 levels in older men in a human endocrine-physiology study.
Supported
Sermorelin must not be conflated with CJC-1295, CJC-1295 with DAC, CJC-1295 without DAC, marketplace 'Modified GRF(1-29)', tesamorelin, or full-length native GHRH.
Sources: Growth hormone-releasing hormone(1-29)-NH2 for stimulation of growth in children with GH deficiency; Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency
Supported
A human pharmacokinetic/pharmacodynamic study in healthy adult men compared intravenous and intranasal GHRH(1-29)-NH2 administration and reported route-dependent growth-hormone response.
Does not establish
Evidence boundary: This is administration-route pharmacokinetic and endocrine-response evidence in healthy adults, not evidence of therapeutic anti-aging or body-composition efficacy.
Safety & Evidence Limitations
Considerations reported in the sources cited on this page — not a complete list of every possible risk, and not medical advice.
Safety Consideration
Historical FDA review and clinical literature reported transient injection-site pain, redness or swelling, facial flushing, headache, nausea, vomiting, altered taste, chest tightness and related short-lived reactions.Safety Consideration
Historical pediatric exposure was associated with anti-sermorelin antibodies in some patients; FDA reviewers reported that these were not clearly linked to generalized allergic reactions or reduced efficacy, but immunogenicity remains relevant for peptide products.Safety Consideration
Current compounded preparations do not undergo FDA premarket review for safety, effectiveness, or manufacturing quality.Safety Consideration
Small studies showed endocrine and body-composition changes, but do not establish broad anti-aging, recovery, sleep, or longevity benefits in healthy adults.Safety Consideration
Sustained or excessive activation of the GH/IGF-1 axis may be clinically relevant for glucose metabolism, edema-related symptoms, sleep apnea, proliferative disorders, or other conditions; long-term safety for contemporary compounded use is not established.
Research Areas Being Studied
Human research includes GH-stimulation testing, pediatric growth-hormone deficiency, and small studies of age-related GH-axis changes. Those settings do not establish effectiveness for modern adult wellness uses.
Findings Reported in Studies
Educational summary only — reported in cited studies, not a claim of proven benefit.
Show findings from 8 human studies
- Endocrine and metabolic effects of long-term administration of [Nle27]growth hormone-releasing hormone-(1-29)-NH2 in age-advanced men and women (1997):
- 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):
- Treatment with GHRH(1-29)NH2 in children with idiopathic short stature induces a sustained increase in growth velocity (1994):
- Growth hormone-releasing hormone(1-29)-NH2 for stimulation of growth in children with GH deficiency (1993):
- Growth response to growth hormone-releasing hormone(1-29)-NH2 compared with growth hormone (1993):
- Pharmacokinetics of growth hormone-releasing hormone(1-29)-NH2 and stimulation of growth hormone secretion in healthy subjects after intravenous or intranasal administration (1993):
- Growth hormone-releasing hormone-(1-29) twice daily reverses the decreased GH and insulin-like growth factor-I levels in old men (1992):
- The effect of intravenous, subcutaneous, and intranasal GH-RH analog, [Nle27]GHRH(1-29)-NH2, on growth hormone secretion in normal men: dose-response relationships (1986):
Study Tables by Evidence Type
14 study records
Human Studies & Clinical Data(8)
Endocrine and metabolic effects of long-term administration of [Nle27]growth hormone-releasing hormone-(1-29)-NH2 in age-advanced men and women
1997PMID 9141536
- Population / Model
- 19 adults (10 women, 9 men), ages 55-71, placebo-controlled
- Dose / Duration / Finding
Activated the somatotropic axis in both sexes; men gained lean mass (+1.26kg) and improved insulin sensitivity, libido, and well-being; women showed minimal metabolic gains beyond increased skin thickness. Only adverse effect was transient elevated cholesterol.
Show full finding- Study/Trial Dosing:
- 10 mcg/kg subcutaneous nightly
- Duration:
- 16 weeks (after a 4-week placebo run-in)
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
1996PMID 8772599 · DOI 10.1210/jcem.81.3.8772599
- Population / Model
- Children with growth-hormone deficiency
- Dose / Duration / Finding
The trial reported accelerated growth during the first year in children with GH deficiency.
- Study/Trial Dosing:
- Study / Trial Dosing: once-daily subcutaneous GHRH therapy as specified in the original trial; retain the exact numeric regimen only after source-level extraction is confirmed.
- Duration:
- 1 year
Safety note
Use the original publication and historical FDA labeling for detailed adverse-event interpretation.
Treatment with GHRH(1-29)NH2 in children with idiopathic short stature induces a sustained increase in growth velocity
1994PMID 7955460
- Population / Model
- Children with idiopathic short stature
- Dose / Duration / Finding
Sermorelin (GHRH(1-29)-NH2) treatment produced a sustained increase in growth velocity in children with idiopathic short stature.
Safety note
Historical pediatric idiopathic-short-stature population; distinct from modern adult wellness/anti-aging use and must not be generalized to it.
Growth hormone-releasing hormone(1-29)-NH2 for stimulation of growth in children with GH deficiency
1993PMID 8329830 · DOI 10.1111/j.1651-2227.1993.tb12834.x
- Population / Model
- Dose / Duration / Finding
In children with hypothalamic growth hormone deficiency, GHRH(1-29)-NH2 treatment stimulated growth, providing direct historical human therapeutic evidence.
Growth response to growth hormone-releasing hormone(1-29)-NH2 compared with growth hormone
1993PMID 8329826 · DOI 10.1111/j.1651-2227.1993.tb12828.x
- Population / Model
- Dose / Duration / Finding
In prepubertal children with hypothalamic GHD, higher-dose GHRH(1-29)-NH2 increased height velocity comparably to GH on some measures, although GH was superior on at least one bone-age-adjusted height measure.
Pharmacokinetics of growth hormone-releasing hormone(1-29)-NH2 and stimulation of growth hormone secretion in healthy subjects after intravenous or intranasal administration
1993PMID 8329825
- Population / Model
- Healthy subjects
- Dose / Duration / Finding
Characterized pharmacokinetics of GHRH(1-29)-NH2 and GH-secretion response after intravenous versus intranasal administration in healthy subjects.
Safety note
Route-of-administration pharmacokinetic study in healthy subjects; does not establish therapeutic efficacy for any indication.
Growth hormone-releasing hormone-(1-29) twice daily reverses the decreased GH and insulin-like growth factor-I levels in old men
1992PMID 1379256 · DOI 10.1210/jcem.75.2.1379256
- Population / Model
- Dose / Duration / Finding
Repeated GHRH(1-29) administration increased GH and IGF-1 levels in older men, demonstrating endocrine activity but not establishing anti-aging, body-composition, or longevity efficacy.
The effect of intravenous, subcutaneous, and intranasal GH-RH analog, [Nle27]GHRH(1-29)-NH2, on growth hormone secretion in normal men: dose-response relationships
1986PMID 3096623 · DOI 10.1038/clpt.1986.237
- Population / Model
- Normal adult men
- Dose / Duration / Finding
The 29-amino-acid analog stimulated GH release by all three routes, with the strongest response after intravenous administration and weaker exposure-response by subcutaneous and intranasal routes.
- Study/Trial Dosing:
- Multiple intravenous, subcutaneous, and intranasal dose levels were evaluated; the source reported dose-response relationships rather than a therapeutic recommendation.
- Duration:
- Acute pharmacodynamic sampling after single administrations
Safety note
The abstract reported no adverse effect in this small acute study; this does not establish long-term safety.
Animal / Cell / Preclinical Data
No Animal / Cell / Preclinical Data Listed Yet
This section will be updated as sources are added.
Regulatory Documents & Official Trial Registries(4)
2026 World Anti-Doping Agency Prohibited List
2026- Population / Model
- Anti-doping regulatory standard
- Dose / Duration / Finding
WADA lists growth-hormone-releasing factors and secretagogues, including CJC-1295, sermorelin, GHRP-2, GHRP-6, and examorelin/hexarelin, as prohibited in sport.
Safety note
Anti-doping status is not a clinical safety or efficacy determination.
Determination That GEREF (Sermorelin Acetate) Injection Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
2013- Population / Model
- FDA regulatory determination
- Dose / Duration / Finding
Geref was approved as a diagnostic agent (NDA 019863, ~1990) and later a pediatric GHD therapeutic (NDA 020443, 1997); the manufacturer voluntarily discontinued it in 2008 for commercial/supply reasons, and the FDA formally withdrew marketing approval effective June 18, 2009. FDA's later determination confirmed the withdrawal was not for safety or effectiveness reasons.
Show full finding
Safety note
This determination does not mean the products remain approved and marketed, and it does not establish safety for modern compounded adult-wellness use.
FDA EGRIFTA (NDA 022505) Medical Review — Historical Discussion of Geref Diagnostic and Pediatric Use (Not a Geref NDA Approval File)
2010- Population / Model
- FDA review of historical regulatory and safety information
- Dose / Duration / Finding
FDA reviewers summarized former diagnostic and pediatric indications, discontinuation, common transient reactions, and anti-Geref antibody observations.
- Study/Trial Dosing:
- Study / Trial Dosing: historical approved contexts included a single diagnostic intravenous dose and a daily pediatric subcutaneous regimen; retain exact numeric values only in the source record, not as general-use guidance.
Safety note
Historical safety findings were indication-, population-, dose-, and route-specific and cannot be extrapolated to contemporary compounded adult use.
FDA Orphan Drug Designations and Approvals — Sermorelin acetate / Geref
1997- Population / Model
- Dose / Duration / Finding
FDA records Geref (sermorelin acetate) as approved on September 26, 1997 for the designated pediatric growth-hormone-deficiency context.
Review Articles / Secondary Sources(2)
Sermorelin: a better approach to management of adult-onset growth hormone insufficiency?
2006PMID 18046908 · DOI 10.2147/ciia.2006.1.4.307
- Population / Model
- Editorial/perspective piece on adult-onset GH insufficiency management
- Dose / Duration / Finding
Perspective piece discussing sermorelin's potential role in adult-onset GH insufficiency; editorial format with no underlying data table independently extracted.
Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency
1999PMID 18031173 · DOI 10.2165/00063030-199912020-00007
- Population / Model
- Review of pediatric GHD diagnostic and therapeutic use
- Dose / Duration / Finding
Sustained height-velocity increase in GH-deficient children, though inferior to direct somatropin therapy; well tolerated, main adverse effects were facial flushing and injection-site pain. Also reviewed diagnostic use, noting fewer false positives than other provocative GH tests.
Show full finding- Study/Trial Dosing:
- 30 mcg/kg subcutaneous nightly at bedtime (therapeutic use reviewed)
- Duration:
- 12 months (therapeutic use reviewed)
Anecdotal Reported Patterns — Not Medical Advice
Anecdotal Reported Patterns — Not Medical Advice
Reported dosing patterns are included for educational context only. They are self-reported, unverified, not medical advice, and not instructions for human use. Community-submitted patterns are not yet available in this Phase 1 prototype; this section is a placeholder reserved for moderated, aggregated community data.
Lab Markers to Discuss With a Clinician
Educational topics only — not self-monitoring instructions.
FAQ
Disclaimer
Educational research summary only. This page does not provide medical advice, treatment guidance, product-quality assurance, or instructions for human use.
Educational use only. This content is provided for informational and research-summary purposes only. It is not medical advice, not a treatment recommendation, not a dosing guide, and not a substitute for care from a licensed medical professional. Nothing here is intended to diagnose, treat, cure, prevent, or mitigate disease. Reported dosing patterns, when shown elsewhere on the site, must be labeled either as Study / Trial Dosing or Anecdotal Reported Patterns — Not Medical Advice. Community reports are self-reported, unverified, and not scientific proof.
Community-reported experiences, once enabled, must be displayed only as moderated, anonymized, or aggregated data. They are anecdotal, self-reported, unverified, and should never be presented as proof of safety, efficacy, or expected results.
Content status: Published. Last updated 2026-07-12.
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