Sermorelin: evidence, results, and legal status

Summary

Sermorelin is the first 29 amino acids of human growth hormone releasing hormone (GHRH), the brain hormone that tells the pituitary to release growth hormone. It raises growth hormone and IGF-1 (a growth factor that growth hormone raises) in humans, and it was FDA approved as Geref for diagnosing GH deficiency (1990) and treating GH deficiency of unknown cause in children (1997) before the sponsor withdrew both NDAs, its approved drug applications, in 2009 for reasons FDA later confirmed were not safety or effectiveness. In adults the best trial is a 19 person, 16 week study showing higher IGF-1, thicker skin, and a small gain in lean mass in men only; there is no current FDA approved product and compounded (pharmacy-made) sermorelin sold by telehealth clinics for anti-aging or fat loss rests on that limited evidence.

What is Sermorelin?

Sermorelin is a synthetic 29 amino acid N-terminal fragment of human growth hormone releasing hormone (GHRH 1-29), the shortest fragment with full GHRH receptor activity. It is also known as Sermorelin acetate, GHRH(1-29)-NH2, GRF 1-29, Geref, Growth hormone releasing hormone 1-29.

How does it work?

Sermorelin binds the GHRH receptor on pituitary somatotrophs and stimulates synthesis and pulsatile release of growth hormone, which in turn raises hepatic IGF-1. Because it works upstream of the pituitary, the response is limited by somatostatin tone and by the pituitary's own capacity, so it cannot push GH to the levels seen with injected recombinant GH. Its plasma half life is minutes, which is why it is given by nightly or twice daily subcutaneous injection.

Key facts
Cluster	Metabolic and growth hormone axis
Routes	Subcutaneous injection, usually at bedtime (approved and trial use); Intravenous bolus (former diagnostic use); Intranasal (research only, lower bioavailability); Oral tablets and troches sold by some compounders have no published pharmacokinetic data
Conditions studied	Growth hormone deficiency and GH secretagogue use
Record	v3, draft, verified Sep 23, 2026

Sermorelin before and after: what trials measured

Human RCT evidenceGrade assigned per the methodology.

Human data are real but small and mostly from the 1980s and 1990s. Dose response studies in healthy men established that intravenous, subcutaneous, and intranasal GHRH(1-29) release GH acutely. A 12 month open study in 18 short children raised height velocity from 4.8 to 7.2 cm per year. A single blind, placebo controlled, 5 month trial in 19 adults aged 55 to 71 raised nocturnal GH and IGF-1 and increased skin thickness in both sexes, with lean mass, insulin sensitivity, and well being gains in men only; sleep quality did not change. No trial has tested sermorelin for fat loss, athletic performance, or longevity in adults, and the pediatric approval rested on growth velocity, not long term outcomes.

Indexed studies by evidence grade
Evidence type	Indexed studies	Participants (human)
Human randomized trials	2	19
Human observational studies	5	48
Animal studies	0	n/a
All indexed studies	7	67

Human evidence

Vance 1986: dose response in normal men showed GH release after intravenous, subcutaneous, and intranasal [Nle27]GHRH(1-29). Kirk 1994: 18 prepubertal children with idiopathic short stature given 20 ug/kg subcutaneously twice daily for 12 months; mean height velocity rose from 4.8 to 7.2 cm per year (p = 0.001) with catch down growth after stopping. Khorram 1997: 10 women and 9 men aged 55 to 71 self injected placebo nightly for 4 weeks then 10 ug/kg [Nle27]GHRH(1-29) nightly for 16 weeks; 12 hour nocturnal GH and IGF-1 rose significantly, skin thickness increased in both sexes, lean body mass and insulin sensitivity improved in men only, sleep quality was unchanged, and the only adverse effect was transient hyperlipidemia. Regulatory reviews summarize the pediatric trials that supported the 1997 Geref approval.

Animal evidence

Preclinical work in rats and other species established that GHRH(1-29) is the minimal fragment with full GH releasing activity and that its effect depends on an intact pituitary. Animal data are mainly mechanistic and supported the human pharmacology rather than any independent claim.

Key studies

Indexed studies of Sermorelin
Study	Design and population	Outcome	Grade
Endocrine and metabolic effects of long-term administration of [Nle27]growth hormone-releasing hormone-(1-29)-NH2 in age-advanced men and women1997 PMID 9141536	Single blind, randomized, placebo controlled trial, 4 weeks placebo then 16 weeks active, nightly subcutaneous injectionn = 19 Healthy men and women aged 55 to 71	Increased 12 hour nocturnal GH, IGF-1, and IGFBP-3; increased skin thickness in both sexes; increased lean mass, insulin sensitivity, well being, and libido in men only; sleep unchanged; transient hyperlipidemia	Evidence: Human RCT evidence
Treatment with GHRH(1-29)NH2 in children with idiopathic short stature induces a sustained increase in growth velocity1994 PMID 7955460	Open label, single arm, 12 month treatment study with pre and post treatment comparisonn = 18 Prepubertal children aged 4 to 11 with idiopathic short stature (not GH deficient)	Mean height velocity rose from 4.8 to 7.2 cm per year (p = 0.001) on 20 ug/kg twice daily; catch down growth after stopping; fasting glucose and insulin rose	Evidence: Human observational evidence
The effect of intravenous, subcutaneous, and intranasal GH-RH analog, [Nle27]GHRH(1-29)-NH2, on growth hormone secretion in normal men: dose-response relationships1986 PMID 3096623	Dose response pharmacology study in healthy volunteersHealthy adult men	GH release after intravenous, subcutaneous, and intranasal dosing with dose dependent responses; intranasal route least potent	Evidence: Human observational evidence
Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency1999 PMID 18031173	Drug evaluation reviewChildren with idiopathic GH deficiency in the registration trials	Summarizes growth velocity gains with 30 ug/kg daily and the tolerability profile (injection site reactions, flushing, headache) that supported the 1997 approval	Evidence: Human RCT evidence
Sermorelin: a better approach to management of adult-onset growth hormone insufficiency?2006 PMID 18046908	Narrative review and opinionAdults with age related decline in GH secretion	Argues that GHRH analog therapy preserves feedback regulation compared with recombinant GH; presents no new trial data	Evidence: Human observational evidence
Growth hormone (GH)-releasing hormone-(1-29) twice daily reverses the decreased GH and insulin-like growth factor-I levels in old men1992 PMID 1379256	Randomized crossover of two dose levels, 14 days each, with a young male comparison groupn = 19 Healthy old men (n = 10) compared with healthy young men (n = 9)	At the higher dose, 24 hour GH and IGF-1 in old men rose to levels not different from young men; no change in fasting glucose or blood pressure	Evidence: Human observational evidence
Effects of single nightly injections of growth hormone-releasing hormone (GHRH 1-29) in healthy elderly men1997 PMID 9005976	Uncontrolled before and after study, 6 weeksn = 11 Healthy non-obese men aged 64 to 76 with low baseline IGF-1	Nocturnal GH rose without a change in IGF-1; 2 of 6 strength measures and one endurance test improved; no change in DEXA muscle or fat, weight, glucose, or lipids	Evidence: Human observational evidence

Conditions studied

Conditions with evidence for Sermorelin
Condition	Grade	Note
Growth hormone deficiency and GH secretagogue use	Evidence: Human RCT evidence	Formerly FDA approved (Geref) for pediatric GH deficiency; product withdrawn for commercial reasons; compounded widely.

Is Sermorelin legal in the United States?

Regulatory status unknownWADA prohibited

FDA and compounding status

There is no currently approved sermorelin product in the United States. Geref (sermorelin acetate) was approved as a diagnostic on December 28, 1990 (NDA 19-863) and for treatment of idiopathic growth hormone deficiency in children on September 26, 1997 (NDA 20-443); the sponsor discontinued both in 2008 and FDA withdrew the approvals effective June 18, 2009. In March 2013 FDA determined in the Federal Register that Geref was not withdrawn for reasons of safety or effectiveness, which allows generic applications. Sermorelin was not placed on the 503A Category 2 list in 2023 and is not on the 503A bulks list; many 503A pharmacies compound it on the basis of the former approval, and whether that satisfies the component of an approved drug condition depends on how a state board and the pharmacy read it. Compounded sermorelin for adult anti-aging, fat loss, or sleep is an unapproved use with no supporting trial.

WADA status

WADA prohibited. Athletes subject to anti-doping testing should treat this as prohibited at all times unless the current prohibited list says otherwise.

Regulatory timeline

Sep 21, 2026WADA
WADA publishes the 2027 Prohibited List
WADA published the 2027 Prohibited List on September 21, 2026, and it takes effect January 1, 2027. The S2 peptide hormone and growth factor classes are unchanged. BPC-157 is still named under S0, and MOTS-c is still named under S4.4 as an activator of AMP-activated protein kinase. WADA added a note that many peptides without approval for human use fall under S0 or another section, and that a peptide not named on the list may still be prohibited. GLP-1 receptor agonists such as semaglutide and tirzepatide are still not on the list.
Source: WADA 2027 Prohibited List
Jan 1, 2026WADA
WADA 2026 Prohibited List takes effect
The 2026 WADA Prohibited List took effect on January 1, 2026 and continues to prohibit the S2 peptide hormone and growth factor classes (GHRH analogs, growth hormone secretagogues, GH fragments, IGF-1 and analogs, MGF, thymosin beta-4 and derivatives, hCG and GnRH-class releasing factors in males), myostatin inhibitors, insulin and the AMPK activator MOTS-c under S4, desmopressin under S5, and BPC-157 under S0. GLP-1 receptor agonists such as semaglutide and tirzepatide are not on the list.
Source: WADA Prohibited List
Jan 1, 2025WADA
WADA 2025 Prohibited List keeps peptide hormones and growth factors banned at all times
The 2025 WADA Prohibited List took effect on January 1, 2025. Section S2 (peptide hormones, growth factors, related substances and mimetics) covers GHRH analogs such as CJC-1295, sermorelin, and tesamorelin, growth hormone secretagogues such as ipamorelin, GHRP-2, GHRP-6, hexarelin, and ibutamoren (MK-677), growth hormone fragments such as AOD-9604, growth factors including IGF-1 and its analogs, MGF, and thymosin beta-4 (TB-500), and chorionic gonadotropin and releasing factors such as gonadorelin and kisspeptin (prohibited in males). Myostatin inhibitors such as ACE-031 fall under S4, insulin under S4 metabolic modulators, desmopressin under S5, and BPC-157 remains an S0 non-approved substance.
Source: WADA Prohibited List

Full tracker for Sermorelin or the category-wide tracker.

What published studies of Sermorelin used

Ranges below are reported from published studies and labeling only. PeptideAgent does not recommend doses or protocols.

Geref label (pediatric idiopathic GH deficiency): 30 ug/kg subcutaneously once daily at bedtime. Geref diagnostic: 1 ug/kg as a single intravenous dose. Khorram 1997 adult trial: 10 ug/kg subcutaneously nightly for 16 weeks. Kirk 1994: 20 ug/kg subcutaneously twice daily for 12 months in children. No dose has been established for adult anti-aging, body composition, or sleep use.

Routes reported

Routes of administration reported for Sermorelin
#	Route
1	Subcutaneous injection, usually at bedtime (approved and trial use)
2	Intravenous bolus (former diagnostic use)
3	Intranasal (research only, lower bioavailability)
4	Oral tablets and troches sold by some compounders have no published pharmacokinetic data

Sermorelin side effects

Side effects

Side effects reported for Sermorelin
#	Reported side effect
1	Injection site pain, redness, or swelling (most common in the pediatric trials)
2	Facial flushing, headache, and dizziness after injection
3	Transient hyperlipidemia in the adult trial, which resolved by study end
4	Rising fasting glucose and insulin during treatment in children
5	Antibody formation to sermorelin was reported in the pediatric program without apparent loss of effect
6	Theoretical GH related effects (fluid retention, joint pain, carpal tunnel, reduced insulin sensitivity) at higher exposures

Interactions

Interactions reported for Sermorelin
#	Interaction
1	Glucocorticoids, particularly at supraphysiologic doses, blunt the GH response to GHRH
2	Somatostatin analogs (octreotide, lanreotide) directly oppose GH release
3	Insulin and diabetes medications: GH raises glucose and may change requirements
4	Levothyroxine: untreated hypothyroidism reduces the GH response; thyroid status should be normal before use
5	Cyclooxygenase inhibitors and antimuscarinic drugs can alter GH release in provocative testing

Contraindications

Contraindications for Sermorelin
#	Contraindication
1	Hypersensitivity to sermorelin or the formulation
2	Active malignancy (GH and IGF-1 are growth promoting; no human safety data)
3	Pregnancy and breastfeeding (no data)
4	Untreated hypothyroidism (blunts response)
5	Competitive athletes subject to WADA testing (prohibited under S2)

How do people access Sermorelin legally?

Typical cost: About 105 to 180 USD per month for compounded sermorelin through licensed telehealth programs, including the consultation and medication. Research chemical listings are not lawful for human use. Prices checked 2026-09-22 on published provider and pharmacy price pages.

Verified access options

Step 1
Prescription from a licensed provider filled by a state licensed 503A compounding pharmacy, commonly through telehealth clinics.
Step 2
No FDA approved product is currently marketed (Geref was withdrawn in 2009).
Step 3
Products labeled research use only are not lawful for human use and are not verified for purity.

Access paths are verified against public regulatory records and prescriber licensing. We never list unlicensed vendors.

Compare Sermorelin

What's actually offered, and what that means for you

Licensed compounding pharmacies, clinics, and telehealth prescribers openly offer many unapproved peptides, and prescribers write prescriptions for them. Sermorelin has no currently approved product. Pharmacies compound it on the basis of an approval that was withdrawn in 2009, and whether that is lawful depends on how a state board and the pharmacy read federal law. [6] [7]

Enforcement is uneven. FDA mostly acts through warning letters to compounders and online sellers, Category 2 safety listings, and import alerts that let it detain shipments, rather than stopping every pharmacy. State pharmacy boards oversee pharmacies day to day, and their rules differ. [13] [14] [15] [16] [17]

What changes for you

No FDA review of the product: FDA does not check a compounded drug's safety, effectiveness, or quality before it is sold. [17]
Identity, purity, sterility, and dose accuracy can vary from batch to batch. [15]
Insurance rarely covers it, so you usually pay cash.
For tested athletes, sermorelin is prohibited at all times on the WADA list, whatever the source. [8]

What to check

Before you accept a compounded product, check for:

A 503A pharmacy licensed in your state (your state board of pharmacy publishes license lookups). [17]
A real evaluation by a licensed prescriber, not just an online form.
A certificate of analysis for the specific batch.

Blends that contain Sermorelin

Sermorelin is sold in a premixed blend under the name below. No blend has been tested as a combination, and a mix is only as lawful as its least lawful ingredient.

Sermorelin and ipamorelin: with Ipamorelin. No lawful path.

All peptide blends

Frequently asked questions

Is sermorelin FDA approved or legal?

It was. Geref (sermorelin acetate) was FDA approved in 1990 as a diagnostic and in 1997 to treat GH deficiency in children, but the manufacturer discontinued it and FDA withdrew the approvals in 2009. FDA later confirmed the withdrawal was not for safety or effectiveness. Today there is no approved product; sermorelin is prescribed and compounded (custom-made) by 503A pharmacies, which compound for individual patients, and it was not placed on FDA's 2023 Category 2 list of compounding ingredients with significant safety risks. Possessing it is not a crime, but research chemical versions are not lawful for human use. [6] [7]

Does sermorelin work?

It reliably raises the body's own growth hormone and IGF-1; several small human studies show that. Evidence for the results people want is thin. The only placebo controlled adult trial had 19 people aged 55 to 71 treated nightly for 16 weeks: skin thickness increased in both sexes, and men (not women) gained lean body mass and insulin sensitivity. Body weight, blood pressure, and bone density did not change and sleep quality was unaffected. That is evidence of a hormonal effect with modest, sex dependent physical changes, not proof of anti-aging or meaningful muscle gain. [1] [3] [11]

Sermorelin before and after: what did trials actually measure?

Hormones and body composition, not appearance. In 10 healthy older men, two weeks of twice daily injections at the higher of two doses raised 24 hour GH and IGF-1 to levels seen in young men. In 19 adults aged 55 to 71, 16 weeks of nightly injections raised IGF-1 within 2 weeks, thickened skin, and added lean mass in men only, with no change in weight or bone density. In 11 older men, 6 weeks of nightly injections improved 2 of 6 strength measures without changing muscle or fat on DEXA, in a study with no placebo group. Before and after photos and testimonials are not trial data. [1] [11] [12]

Sermorelin reviews: what does the evidence say?

Published reviews describe sermorelin as an effective growth hormone stimulant that was approved for children with growth hormone deficiency. A 2006 review proposed it for adult-onset growth hormone insufficiency, but the adult trials behind that idea enrolled 20 or fewer people each and ran 2 to 16 weeks. None tested anti-aging, fat loss, or sleep as a primary outcome in a large controlled trial. Clinic testimonials and online ratings are not controlled evidence. [1] [4] [5] [12]

What are the side effects of sermorelin?

In trials the common effects were injection site pain or redness, facial flushing, headache, and dizziness. The adult trial reported transient hyperlipidemia that resolved, and the pediatric study saw rises in fasting glucose and insulin during treatment. Because sermorelin raises GH and IGF-1, the theoretical concerns of GH therapy (fluid retention, joint pain, insulin resistance, growth of existing tumors) apply, though no long term adult safety study exists. [1] [2]

Is sermorelin an injection or a pill?

The approved product, Geref, was an injection, and the adult trials used injections under the skin, usually at bedtime. A 1986 study found intranasal sermorelin raised growth hormone only weakly, releasing about a fifth as much as an intravenous dose even when far more was given. Some compounders sell troches, tablets, or nasal sprays; no published trial shows those forms produce the effects seen with injections. [1] [3] [4]

How much does sermorelin cost?

Compounded sermorelin through licensed telehealth programs costs about 105 to 180 USD per month including the prescriber consultation, depending on plan length. There is no branded product and no insurance coverage for adult off-label use. Prices were checked on 2026-09-22 and change often. [7] [9] [10]

Is sermorelin banned by WADA?

Yes. Sermorelin is named explicitly in section S2 of the WADA Prohibited List (growth hormone releasing hormone and its analogues, alongside CJC-1295 and tesamorelin) and is prohibited at all times, in and out of competition. Tested athletes should not use it. [8]

Sermorelin vs ipamorelin vs CJC-1295: what is the difference?

Sermorelin and CJC-1295 are both GHRH analogs that act on the GHRH receptor; sermorelin lasts minutes, CJC-1295 with DAC lasts about a week. Ipamorelin is a ghrelin receptor agonist that releases GH through a different receptor and is often stacked with a GHRH analog. Sermorelin is the only one that was ever FDA approved and the only one currently compounded by licensed pharmacies without a Category 2 history; ipamorelin and CJC-1295 were placed in Category 2 in 2023 and later listed as withdrawn nominations. [5] [7]

Does sermorelin help you sleep?

Not according to the trial data. In the 16 week adult study, sleep quality measured by questionnaire did not change in either sex, even though nocturnal GH rose. Claims that sermorelin improves deep sleep are extrapolated from GH physiology, not from a sermorelin sleep trial. [1]

Decisions about starting, stopping, or combining any treatment belong with a licensed clinician who knows your history.

From the blog

Sermorelin vs HGH: mechanism, evidence, and legal status
Sermorelin signals the pituitary to release growth hormone; HGH (somatropin) is the hormone itself. Only somatropin is FDA approved today, and anti-aging use of either is off-label.
Tesamorelin vs sermorelin vs ipamorelin: evidence and legality
Tesamorelin, sermorelin, and ipamorelin compared in one table: mechanism, FDA approval, compounding status, human evidence, and WADA status, with links to each pairwise comparison.
CJC-1295 side effects: what the human studies reported
CJC-1295 side effects in small human studies included injection site reactions, headache, flushing, diarrhea, and a faster heart rate. It has no FDA approval and no lawful compounding path.
Does tesamorelin build muscle? What the trials show
Tesamorelin raised lean body mass about 1.2 kg in HIV trials and slightly increased trunk muscle area, but no trial tested strength or muscle growth, and it is prohibited in sport.
Peptides for muscle growth, ranked by human evidence
MK-677, sermorelin, tesamorelin, CJC-1295, IGF-1 LR3, and more ranked by human evidence. None is approved for muscle growth, and all ten are banned in tested sport.
What is peptide therapy? What clinics sell, what is legal, and what works
Peptide therapy means three different things: FDA-approved drugs, compounded prescriptions, and research-only products. Here is how to tell them apart, what the evidence shows, and what it costs.

Sources

Numbered citations above point to these primary sources. PubMed entries link to the indexed abstract.

Cite this page

Free to cite and quote with a link. Data is licensed CC BY 4.0 with attribution to PeptideAgent.

APA style: PeptideAgent. (2026, September 23). Sermorelin: evidence, legality, and access. https://peptideagent.ai/peptides/sermorelin
HTML link: <a href="https://peptideagent.ai/peptides/sermorelin">Sermorelin: evidence, legality, and access</a>, PeptideAgent, updated September 23, 2026.

Sermorelin

At a glance