Sermorelin

What it is. What the evidence says.

A lab-made copy of the first 29 building blocks of GHRH, the brain hormone that tells the pituitary gland to release growth hormone.

Moderate EvidenceUnapproved

Predominant research setting. Clinical confidence is claim-specific.

Updated Scientific review pending
Sequence diagram and chemical structure information for Sermorelin.
Sermorelin Chemical Structure & Sequence · Inside Peptides Scientific Library
Compound
Sermorelin
Human effectiveness
Increased growth rate in children with GH deficiency in 1990s trials, but less than GH in a randomized comparison. Studies in older adults are small and short; they show hormone changes, not proven anti-aging benefit.
Regulatory status
Unapproved Compound
START HERE · PLAIN LANGUAGE

Sermorelin: the basics

What is it?

A lab-made copy of the first 29 building blocks of GHRH, the brain hormone that tells the pituitary gland to release growth hormone.

Research paper 1 ↗Research paper 2 ↗Research paper 3 ↗

What do people claim it helps with?

Clinics and websites promote it for anti-aging, muscle, fat loss, sleep and recovery. Those uses were never approved and have not been proven in good trials.

What has research actually shown?

In the 1990s it helped some children with growth hormone deficiency grow faster, though less than growth hormone itself. In small studies of older men it raised hormone levels for a short time.

Research paper 1 ↗Research paper 2 ↗Research paper 3 ↗

Has this been demonstrated in people?

Human studies exist, mostly from the 1990s: pediatric trials without long follow-up and a few small, short studies in older adults. No large modern trials test the adult uses people promote.

Research paper 1 ↗Research paper 2 ↗Research paper 3 ↗

What side effects, risks and unknowns should I understand?

In children, flushing of the face and pain where it was injected were the most common reported effects. Long-term effects of raising growth hormone in healthy adults are not known.

Research paper 1 ↗Research paper 2 ↗

Is it an approved medicine?

Not currently. FDA approved it as Geref in 1990 and 1997, but the maker stopped selling it in 2008. FDA says that was not for safety or effectiveness reasons. Today no FDA-approved sermorelin product is sold in the U.S.

FDA safety information 1 ↗FDA safety information 2 ↗FDA briefing 3 ↗

Approval here means U.S. FDA approval and applies to a particular product, formulation and use. This is a starting overview, not a complete side-effect list. Sources checked 10 October 2026; independent scientific review pending.

How is it used or studied?

Was an injectable prescription product (Geref). Any sermorelin offered today is compounded or sold as a research chemical, not an FDA-approved product.

Different routes and formulations can have different effects. A study of one product does not validate every product with the same peptide name.

A common misunderstanding

Past FDA approval for children with growth hormone deficiency does not mean it was ever approved or proven for adult anti-aging or bodybuilding use.

What should I ask a clinician?
  • What diagnosis or goal are we trying to address, and what established options are available?
  • Was the expected benefit shown in people like me, using this exact product?
  • How could my medicines, health conditions or pregnancy plans affect the risks?
  • What monitoring is needed, and what would tell us the treatment is helping or should be stopped?
What do the research words mean?
Peptide
A short chain of amino acids, the building blocks of proteins.
Preclinical
Research in cells, tissues or animals before dependable treatment evidence in people.
Controlled trial
A study comparing a treatment with another treatment or a placebo to help separate its effects from other explanations.
Biomarker
A measurement, such as a hormone level. A change does not necessarily mean someone feels better or lives longer.
THE AVAILABLE RESEARCH

Sermorelin Evidence & Clinical Profile

Human Clinical Evidence

Human Study Limits

Sermorelin has been investigated in clinical contexts. Patient outcomes must be evaluated against study size, design, and control cohorts.

Preclinical & Pharmacological Data

Laboratory & In Vivo Assays

Cellular and animal disease models examine receptor binding affinities and signaling cascades, which require human confirmation.

IDENTITY & STRUCTURE

What is Sermorelin?

Sermorelin Acetate (formerly Geref) is Sermorelin is the first 29 amino acids of human growth hormone-releasing hormone (GHRH). FDA approved it as Geref for a pituitary diagnostic test (1990) and for growth failure in children with idiopathic GH deficiency (1997). The manufacturer discontinued both products in 2008, and FDA later found the withdrawal was not for safety or effectiveness reasons. No FDA-approved sermorelin product is marketed in the U.S. today. Aliases include: Geref, GHRH(1-29)NH2, GRF(1-29)NH2, Groliberin.

Chemical sequence and molecular parameters of Sermorelin
Primary sequence schematic · Inside Peptides Molecular Database
Chemical reference
Sequence (one-letter)
YADAIFTNSYRKVLGQLSARKLLQDIMSR-NH2
Molecular formula
C149H246N44O42S
Molecular weight
3357.9 g/mol
CAS Number
86168-78-7
UNII Code
89243S03TE
PubChem CID
16132413

Identifiers checked against PubChem and FDA's Global Substance Registration System on 13 October 2026. FDA substance record ↗ · PubChem record ↗ See all names and codes in the peptide name index.

HUMAN RESEARCH

Clinical Trials & Human Cohorts

Human research can examine tolerability, symptoms or patient outcomes. The design and comparator determine what each result can establish.

Multicenter open-label study1996

Once daily subcutaneous GHRH therapy accelerates growth in GH-deficient children during the first year of therapy [1]

n = 110110 previously untreated prepubertal children with GH deficiency; 86 eligible for efficacy analysis

What was reported

Average height velocity roughly doubled over the first 6 months and stayed raised at 12 months, without excess bone-age advance or adverse laboratory changes.

What limits the conclusion

No control group and only one year of follow-up; final adult height was not reported. The study was run by the Geref International Study Group.

Read primary source ↗ (external website)
Randomized three-arm comparison1993

Growth response to growth hormone-releasing hormone(1-29)-NH2 compared with growth hormone [2]

n = 4343 prepubertal children with GH deficiency of hypothalamic origin

What was reported

Most children grew faster on GHRH(1-29). Growth with the lower GHRH regimen was the slowest, and only the GH-treated group improved height relative to bone age.

What limits the conclusion

Small, six-month study. It suggests sermorelin is not superior to growth hormone itself.

Read primary source ↗ (external website)
Randomized crossover of two regimens1992

GH-releasing hormone-(1-29) twice daily reverses the decreased GH and IGF-I levels in old men [3]

n = 1910 older men treated; 9 young men as a reference group

What was reported

Over 14 days, the higher regimen raised 24-hour GH and IGF-I in older men to levels similar to young men. Glucose and blood pressure did not change.

What limits the conclusion

Hormone levels only, over two weeks. No body-composition, strength or clinical outcomes were tested.

Read primary source ↗ (external website)
Uncontrolled before-after study1997

Effects of single nightly injections of GHRH (GHRH 1-29) in healthy elderly men [4]

n = 1111 healthy men aged 64 to 76 with low IGF-I

What was reported

Night-time GH release rose, but IGF-I did not. Two of six strength measures improved; body composition did not change.

What limits the conclusion

No placebo group, 11 participants and multiple outcomes tested. The authors judged this regimen less effective than repeated daily dosing.

Read primary source ↗ (external website)
MECHANISMS OF ACTION

How the compound may work

Mechanisms describe how Sermorelin may affect biological processes. Laboratory findings and patient outcomes answer different questions.

01
Human pharmacology

Pituitary GHRH receptor agonism

Sermorelin binds the GHRH receptor on pituitary somatotroph cells and triggers growth hormone release. Because it works through the pituitary, GH output is still limited by somatostatin and IGF-I feedback. [5]

02
Clinical diagnostic testing

Diagnostic use of the GH response

A brief GH rise after intravenous sermorelin shows that the pituitary can secrete GH. A normal response cannot rule out deficiency caused by the hypothalamus, so it was used alongside other tests. [5]

RESEARCH AREAS

Areas Being Studied

These research topics reflect active areas of scientific exploration, distinct from unverified commercial marketing claims.

Clinical trials (1990s)

Pediatric GH deficiency

Growth velocity in prepubertal children with idiopathic GH deficiency; the basis of the 1997 approval. [1]

Diagnostic studies

Adult GH deficiency testing

GHRH (as Geref) combined with arginine as a provocative test for adult GH deficiency. [11]

Small human studies

Age-related GH decline

Short-term hormone and strength measures in older men; clinical anti-aging benefit is unproven. [3]

AT A GLANCE

Compare the study designs.

Overview of Key Sermorelin Studies: clinical and preclinical records
Study Design / sample Outcome type Key limitation
Pediatric GH deficiency · 1996 [1] Multicenter open-label study
n = 110
Clinical endpoint evaluation No control group and only one year of follow-up; final adult height was not reported. The study was run by the Geref International Study Group.
GHRH vs GH in children · 1993 [2] Randomized three-arm comparison
n = 43
Clinical endpoint evaluation Small, six-month study. It suggests sermorelin is not superior to growth hormone itself.
Older men, 2 weeks · 1992 [3] Randomized crossover of two regimens
n = 19
Clinical endpoint evaluation Hormone levels only, over two weeks. No body-composition, strength or clinical outcomes were tested.
Older men, 6 weeks · 1997 [4] Uncontrolled before-after study
n = 11
Clinical endpoint evaluation No placebo group, 11 participants and multiple outcomes tested. The authors judged this regimen less effective than repeated daily dosing.
FDA & SAFETY

Regulatory Status & Clinical Safety

Regulatory Classification

Geref approvals (NDA 019863 and NDA 020443) were withdrawn at the sponsor's request after 2008 discontinuation; FDA determined in 2013 that this was not for safety or effectiveness reasons. Sermorelin acetate is in FDA's 503B category 1 (under evaluation). WADA S2 prohibited substance.

Safety Realities & Impurities

Safety depends on the molecule, formulation, route and evidence. A laboratory purity measurement alone cannot establish safety for human use.

REGISTRY CHECK

Clinical Trials Registry Records

Official registry records from ClinicalTrials.gov. Study registration does not imply government endorsement or guaranteed efficacy.

Not applicableCompleted

Sexually Dimorphic Effects of GHRH in Adult Growth Hormone Testing [12]

Planned enrollment
90 (patients)
Posted results
Pending in registry
Sponsor
Children's Mercy Hospital Kansas City
Last updated
2010
NCT00324064 · Open registry ↗ (external website)
COMPETITIVE SPORT

WADA & Anti-Doping Regulations

Prohibited (S2)

WADA Section S2: Prohibited Substance

The World Anti-Doping Agency (WADA) classifies Sermorelin under Section S2 of the Prohibited List. Prohibited at all times (in- and out-of-competition). Last verified: October 2026.

SELECTED MILESTONES

Research Timeline

  1. 1990

    Diagnostic approval

    FDA approves Geref (NDA 019863) to test whether the pituitary can secrete GH. [6]

  2. 1997

    Treatment approval

    FDA approves Geref (NDA 020443) for growth failure in children with idiopathic GH deficiency. [7]

  3. 2008

    Discontinued

    EMD Serono tells FDA both Geref products are being discontinued. FDA withdraws the approvals effective June 2009. [8]

  4. 2013

    FDA determination

    FDA concludes Geref was not withdrawn from sale for reasons of safety or effectiveness. [8]

  5. 2026

    Current status

    No approved U.S. product. Sermorelin acetate is listed in FDA's 503B bulk-substance category 1 (under evaluation). [9]

  6. 2026

    Banned in sport

    WADA's 2026 Prohibited List names sermorelin among GHRH analogues in class S2, banned at all times. [10]

OPEN QUESTIONS

What Researchers Still Don't Know

Long-term safety profiles

Multi-year observational data in broader heterogeneous cohorts remains uncharacterized.

Optimal dose-response thresholds

Comparative trials optimizing minimal effective exposure versus adverse event rates.

Formulation bioavailability

Differences between oral, subcutaneous, and modified peptide delivery vehicles.

TRACEABLE SOURCES

References

Primary sources verified against PubMed / NLM and regulatory databases.

  1. Multicenter open-label trial

    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. ↗ (external website)

    Thorner M et al. · J Clin Endocrinol Metab · 1996
  2. Randomized comparative trial

    Growth response to growth hormone-releasing hormone(1-29)-NH2 compared with growth hormone. ↗ (external website)

    Neyzi O et al. · Acta Paediatr Suppl · 1993
  3. Randomized crossover study

    Growth hormone (GH)-releasing hormone-(1-29) twice daily reverses the decreased GH and insulin-like growth factor-I levels in old men. ↗ (external website)

    Corpas E et al. · J Clin Endocrinol Metab · 1992
  4. Uncontrolled pilot study

    Effects of single nightly injections of growth hormone-releasing hormone (GHRH 1-29) in healthy elderly men. ↗ (external website)

    Vittone J et al. · Metabolism · 1997
  5. Drug review

    Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency. ↗ (external website)

    Prakash A et al. · BioDrugs · 1999
  6. FDA Drugs@FDA record

    Drugs@FDA: GEREF (sermorelin acetate) injection, NDA 019863 (diagnostic product, discontinued) ↗ (external website)

    U.S. FDA · 1990
  7. FDA Drugs@FDA record

    Drugs@FDA: GEREF (sermorelin acetate) injection, NDA 020443 (treatment product, discontinued) ↗ (external website)

    U.S. FDA · 1997
  8. Federal Register notice

    Determination that GEREF (sermorelin acetate) injection products were not withdrawn from sale for reasons of safety or effectiveness ↗ (external website)

    U.S. FDA · 2013
  9. FDA compounding list

    Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the FD&C Act (categories, updated March 21, 2025) ↗ (external website)

    U.S. FDA · 2025
  10. Anti-doping rule

    World Anti-Doping Code International Standard: Prohibited List 2026 ↗ (external website)

    World Anti-Doping Agency · 2026
  11. Registry Record

    Diagnosing Adult Growth Hormone Deficiency ↗ (external website)

    ClinicalTrials.gov · 2017
  12. Registry Record

    Sexually Dimorphic Effects of GHRH in Adult Growth Hormone Testing ↗ (external website)

    ClinicalTrials.gov · 2010