Sermorelin
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.
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(sermorelin acetate) for the diagnosis and treatment of growth hormone deficiency; the product was discontinued and withdrawn from the US market around 2008 for commercial reasons, not because of safety or efficacy concerns.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
Related Clinical Trials
- A Window-of-Opportunity Trial of Giredestrant +/- Triptorelin vs. Anastrozole + Triptorelin in Premenopausal Patients With ER-positive/HER2-negative Early Breast CancerPhase 2 · Completed
- Study of Intranasal Octreotide (DP1038) in Healthy Adult VolunteersPhase 1 · Completed
- Dehydroepiandrosterone Versus Growth Hormone in Women Undergoing ICSI With Expected Poor Ovarian ResponsePhase 3 · Unknown
- Estradiol-Receptor Blockade in Older Men and WomenPhase 1 · Completed
- Observational Longitudinal Study in Children Affected by Idiopathic Growth Hormone Deficiency (GHD)N/A · Completed
- Three Month Treatment of Growth Hormone Releasing Hormone (GHRH) in the ElderlyPhase 2 · Terminated
- VRS-317 in Adult Subjects With Growth Hormone DeficiencyPhase 1 · Completed
- Six Month Treatment of Growth Hormone Releasing Hormone (GHRH) in the ElderlyPhase 2 · Terminated