Sermorelin
GHRH(1-29) analogue; formerly marketed in the US as GEREF; discontinued by the manufacturer in 2008; FDA determined it was not withdrawn for safety or effectiveness reasons.
60-Second Scientific Briefing
Sermorelin is the first 29 amino acids of growth hormone-releasing hormone (GHRH), the active part that tells the pituitary to release growth hormone. It was marketed in the US as GEREF and used in children with growth hormone deficiency and in diagnostic testing; the manufacturer discontinued it in 2008, and the FDA later determined that it was not withdrawn for safety or effectiveness reasons. No sermorelin product is currently marketed in the US, and it is prohibited in sport.
What is Sermorelin?
Pharmacological Classification & Molecular IdentitySermorelin is a synthetic peptide corresponding to the first 29 amino acids of human growth hormone-releasing hormone (GHRH 1-29), the shortest fully active fragment. [1] Federal Register (U.S. Food and Drug Administration), 2013 ↗
Verified Chemical & Regulatory Registry Identifiers
Mechanism of Action & Receptor Targets
Biological Pathway and Target BindingReceptor Selectivity: Activates GHRH receptors on the pituitary, stimulating the release of the body's own growth hormone, which remains under normal feedback control. Response depends on a functioning pituitary. [1] Endocrine, 2001 ↗
Regulatory & FDA Approval Status
Legal and Regulatory ClassificationsFormerly FDA-approved as GEREF (sermorelin acetate) injection. The manufacturer notified the FDA in December 2008 that GEREF was being discontinued, and the FDA determined (Federal Register, 2013) that it was not withdrawn from sale for reasons of safety or effectiveness. No sermorelin product is currently marketed in the US. It is prohibited at all times by WADA (S2.2.4). [1] World Anti-Doping Agency, 2024 ↗ [2] Federal Register (U.S. Food and Drug Administration), 2013 ↗
Sermorelin is not approved for commercial sale, prescription therapy, or compounded medication distribution. It exists strictly within authorized scientific and clinical research frameworks.
Human Evidence & Clinical Trials
Clinical Study Readouts and Evidence SynthesesSermorelin (GEREF) was used in children with idiopathic growth hormone deficiency and in diagnostic testing. In a follow-up study (Endocrine 2001), 27 children who withdrew from a GEREF trial, mostly because of inadequate growth velocity (25 of 27), responded well when switched to recombinant growth hormone for an average of 51 months. No recent controlled trials support current uses such as anti-ageing. [1] Endocrine, 2001 ↗
Clinical Evidence
Sermorelin (GEREF) was used in children with idiopathic growth hormone deficiency and in diagnostic testing. In a follow-up study (Endocrine 2001), 27 children who withdrew from a GEREF trial, mostly because of inadequate growth velocity (25 of 27), responded well when switched to recombinant growth hormone for an average of 51 months. No recent controlled trials support current uses such as anti-ageing.
Safety Profile & Clinical Limitations
Documented Adverse Events and Known UncertaintiesIn the paediatric GEREF experience, injection-site reactions were among the reasons for stopping (1 of 27 children in the follow-up study). The FDA determined that the product was not withdrawn for safety reasons. [1] Endocrine, 2001 ↗
Some children did not achieve or maintain adequate growth on sermorelin. Benefit and safety for non-approved uses (for example anti-ageing or body composition) are not established, and the quality of non-pharmaceutical products is unknown. [1] Endocrine, 2001 ↗
Dose Approval Status
Commercial Dosing Status and Policy DirectivesNo sermorelin product is currently approved or marketed in the US, so there is no current approved dose. No dose is approved or established. Amounts used in the published human studies are part of each study's design and are described in the linked papers; they are not a recommendation. [1] Federal Register (U.S. Food and Drug Administration), 2013 ↗
Under Egypt Peptides medical governance policies, no personal dosages, titration intervals, cycles, stacking recommendations, or self-injection instructions may be provided for unapproved investigational compounds. Clinical study protocols represent controlled experimental research parameters exclusively.
What is Known vs. What is Unknown
Evidence Comparison and Clinical Evidence Boundaries✓ Confirmed Scientific Evidence
- Sermorelin is a synthetic peptide corresponding to the first 29 amino acids of human growth hormone-releasing hormone (GHRH 1-29), the shortest fully active fragment.
- Targets & Selectivity: Activates GHRH receptors on the pituitary, stimulating the release of the body's own growth hormone, which remains under normal feedback control. Response depends on a functioning pituitary.
- Sermorelin (GEREF) was used in children with idiopathic growth hormone deficiency and in diagnostic testing. In a follow-up study (Endocrine 2001), 27 children who withdrew from a GEREF trial, mostly because of inadequate growth velocity (25 of 27), responded well when switched to recombinant growth hormone for an average of 51 months. No recent controlled trials support current uses such as anti-ageing.
- Safety considerations: In the paediatric GEREF experience, injection-site reactions were among the reasons for stopping (1 of 27 children in the follow-up study). The FDA determined that the product was not withdrawn for safety reasons.
? Unknown / Under Ongoing Investigation
- Some children did not achieve or maintain adequate growth on sermorelin. Benefit and safety for non-approved uses (for example anti-ageing or body composition) are not established, and the quality of non-pharmaceutical products is unknown.
Verified Questions & Answers
10 Verified scientific answers with permanent anchor keysSermorelin is the active first 29 amino acids of growth hormone-releasing hormone (GHRH). It was marketed in the US as GEREF until 2008.
- Determination that GEREF (sermorelin acetate) injection was not withdrawn from sale for reasons of safety or effectiveness (Federal Register (U.S. Food and Drug Administration), 2013-03-04)
- Outcome of growth hormone therapy in children with growth hormone deficiency showing an inadequate response to growth hormone-releasing hormone (GEREF) (Endocrine, 2001-06-01)
It activates GHRH receptors on the pituitary so that the body releases its own growth hormone under normal feedback control; it needs a working pituitary.
Not currently. It was FDA-approved as GEREF, discontinued by the manufacturer in 2008, and the FDA determined it was not withdrawn for safety or effectiveness reasons. No sermorelin product is marketed in the US today.
- The Prohibited List (World Anti-Doping Agency, 2024-01-01)
- Determination that GEREF (sermorelin acetate) injection was not withdrawn from sale for reasons of safety or effectiveness (Federal Register (U.S. Food and Drug Administration), 2013-03-04)
It was used in children with growth hormone deficiency and in diagnostic tests. In a follow-up of 27 children who left a GEREF trial (mostly for inadequate growth), switching to growth hormone worked well. No recent controlled trials support uses such as anti-ageing.
In the paediatric experience, injection-site reactions were one reason for stopping. The FDA determined the product was not withdrawn for safety reasons.
Some children did not grow adequately on sermorelin. Benefit and safety for anti-ageing or body-composition uses are not established, and non-pharmaceutical products are of unknown quality.
No sermorelin product is currently approved or marketed in the US, so there is no current approved dose.
- Determination that GEREF (sermorelin acetate) injection was not withdrawn from sale for reasons of safety or effectiveness (Federal Register (U.S. Food and Drug Administration), 2013-03-04)
No current US label exists, so there are no current official storage instructions.
Yes. Sermorelin is prohibited at all times under section S2.2.4 (growth hormone secretagogues and releasing factors) of the 2026 WADA Prohibited List.
- WADA Prohibited List (World Anti-Doping Agency)
Egypt Peptides publishes reviewed scientific reference monographs for documentation and research. The site does not give individual medical advice, preparation or injection instructions, combination protocols or off-label use instructions. Decisions about any medicine belong to the treating physician.
- Determination that GEREF (sermorelin acetate) injection was not withdrawn from sale for reasons of safety or effectiveness (Federal Register (U.S. Food and Drug Administration), 2013-03-04)
Authoritative Sources & Literature Registry
Regulatory dossiers, clinical trial registries, and published studiesThe Prohibited List ↗
https://www.wada-ama.org/en/prohibited-list
Determination that GEREF (sermorelin acetate) injection was not withdrawn from sale for reasons of safety or effectiveness ↗
https://public-inspection.federalregister.gov/2013-04827.pdf
Outcome of growth hormone therapy in children with growth hormone deficiency showing an inadequate response to growth hormone-releasing hormone (GEREF) ↗
https://pubmed.ncbi.nlm.nih.gov/11572326/