Synthetic analogue of growth hormone-releasing hormone comprising its first 29 amino acids (GHRH 1-29); formerly FDA-approved (Geref), later withdrawn from the US market
Sermorelin
Unclearaka GRF 1-29, Geref, GHRH(1-29)
Sermorelin is a GHRH(1-29) analogue with a documented history as an approved medicine (Geref) used for diagnosis of growth hormone secretory capacity and treatment of growth hormone deficiency. The manufacturer discontinued and withdrew Geref from the US market around 2008 for commercial reasons; no FDA-approved sermorelin product is currently marketed, and it is now supplied primarily via compounding pharmacies, often promoted off-label for anti-aging and growth-hormone-related uses without support from large modern trials.
Compare
Mechanism
In plain terms, sermorelin prompts the pituitary gland to release growth hormone. Technically, it is a synthetic peptide corresponding to GHRH(1-29), the shortest sequence of GHRH that retains full biological activity; it binds the GHRH receptor on anterior-pituitary somatotrophs, stimulating synthesis and pulsatile release of endogenous growth hormone, which secondarily raises IGF-1. Because it acts upstream on the pituitary, its effect depends on a functioning pituitary gland.
Regulatory Status by Region
- United States (FDA)Previously approved as Geref (sermorelin acetate) for the diagnosis and treatment of growth hormone deficiency; the product was discontinued and withdrawn from the US market around 2008 for commercial reasons, not because of safety or efficacy concerns. No FDA-approved sermorelin product is currently marketed; it is available in the US only through pharmacy compounding.
- Australia (TGA)Not registered on the Australian Register of Therapeutic Goods (ARTG); no approved sermorelin product. Supply for human therapeutic use would be prescription-only or via compounding.
- European Union (EMA)No current EMA marketing authorisation; not an approved medicine in the European Union.
- WADAProhibited at all times under Section S2 (Peptide Hormones, Growth Factors, Related Substances and Mimetics); growth-hormone-releasing factors, including GHRH and its analogues such as sermorelin, are prohibited.
Key Studies
- Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency (Prakash and Goa) (opens in a new tab) (BioDrugs 1999;12(2):139-157; DOI 10.2165/00063030-199912020-00007; PMID 18031173)
Related Clinical Trials
- A Study Investigating the Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of Teverelix DP, a Gonadotropin-releasing Hormone (GnRH) Antagonist, in Patients With Advanced Prostate CancerPhase 2 · Not Yet Recruiting
- A Short-term Preoperative, Evaluating Activity and Safety of Elacestrant Monotherapy as Compared to Elacestrant + Ovarian Function Suppression (LHRH Agonist) in Premenopausal Patients With Stage I-II ER+/HER2- Breast CancerPhase 2 · Recruiting
- Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIVPhase 2 · Recruiting
- A Window-of-Opportunity Trial of Giredestrant +/- Triptorelin vs. Anastrozole + Triptorelin in Premenopausal Patients With ER-positive/HER2-negative Early Breast CancerPhase 2 · Completed
- GnRHa + Letrozole in Obese Progestin-insensitive Endometrial Atypical Hyperplasia PatientsPhase 2/Phase 3 · Active Not Recruiting
- GnRHa + Letrozole in Obese Progestin-insensitive Endometrial Cancer PatientsPhase 2/Phase 3 · Recruiting
- Androgen Deprivation, With or Without pTVG-AR, and With or Without T-Cell Checkpoint Blockade, in Patients With Newly Diagnosed, High-Risk Prostate CancerPhase 1/Phase 2 · Active Not Recruiting
- Pharmacokinetics and Pharmacogenomics of Ribociclib in Race-based CohortsPhase 4 · Terminated
Common Questions
- What is Sermorelin?
- Sermorelin is a synthetic peptide corresponding to the first 29 amino acids of growth hormone-releasing hormone (GHRH), the shortest fully active fragment. It was previously FDA-approved as Geref (for assessing pituitary growth hormone function and for growth hormone deficiency) but was withdrawn from the US market around 2008 for commercial reasons, not for safety or efficacy concerns; today it is supplied mainly through pharmacy compounding. It is prohibited in sport by WADA as a growth-hormone-releasing factor.
- Is Sermorelin approved for medical use?
- Sermorelin does not have a settled approval status and is not an approved medicine for general clinical use. United States (FDA): Previously approved as Geref (sermorelin acetate) for the diagnosis and treatment of growth hormone deficiency; the product was discontinued and withdrawn from the US market around 2008 for commercial reasons, not because of safety or efficacy concerns. No FDA-approved sermorelin product is currently marketed; it is available in the US only through pharmacy compounding. European Union (EMA): No current EMA marketing authorisation; not an approved medicine in the European Union. Australia (TGA): Not registered on the Australian Register of Therapeutic Goods (ARTG); no approved sermorelin product. Supply for human therapeutic use would be prescription-only or via compounding.
- How does Sermorelin work?
- In plain terms, sermorelin prompts the pituitary gland to release growth hormone. Technically, it is a synthetic peptide corresponding to GHRH(1-29), the shortest sequence of GHRH that retains full biological activity; it binds the GHRH receptor on anterior-pituitary somatotrophs, stimulating synthesis and pulsatile release of endogenous growth hormone, which secondarily raises IGF-1.
- Is Sermorelin legal in Australia?
- Sermorelin in Australia (TGA): Not registered on the Australian Register of Therapeutic Goods (ARTG); no approved sermorelin product. Supply for human therapeutic use would be prescription-only or via compounding.
- Is Sermorelin banned in sport?
- Sermorelin under the World Anti-Doping Agency (WADA) code: Prohibited at all times under Section S2 (Peptide Hormones, Growth Factors, Related Substances and Mimetics); growth-hormone-releasing factors, including GHRH and its analogues such as sermorelin, are prohibited.