Sermorelin

Summary

Sermorelin acetate is a GHRH analog used diagnostically to assess GH secretory capacity of the pituitary gland and therapeutically (historically) for treatment of idiopathic GH deficiency in children. It stimulates endogenous GH release rather than directly replacing GH, preserving physiological feedback mechanisms. The branded product Geref was withdrawn from the US market in 2002 for commercial reasons; compounded sermorelin remains in use.

Mechanism of Action

Sermorelin is a synthetic analog of endogenous GHRH (comprising the first 29 amino acids of GHRH 1-44). It binds to GHRH receptors on somatotroph cells in the anterior pituitary, stimulating the synthesis and pulsatile secretion of endogenous growth hormone (GH) in a physiologically regulated manner.

Routes of Administration

Goals & Uses

• Muscle mass and recoveryPerformance / Body CompositionLow
• Reduction of adiposityMetabolicLow
• Adult GH deficiency / body composition improvementOff Label / Anti AgingModerate
• Treatment of pediatric idiopathic GH deficiencyTherapeuticHigh
• Improved sleep qualityOff Label / WellnessLow
• Diagnosis of growth hormone deficiencyDiagnosticHigh

Contraindications

• Hypothyroidism (untreated)EndocrineModerate
• ObesityMetabolicLow
• Active intracranial neoplasmOncologicHigh
• PregnancyPopulationModeratePotential fetal risk or insufficient safety data
• Known hypersensitivity to sermorelin or componentsAllergy / ImmunologicHigh

Adverse Effects

• Hypersensitivity / anaphylaxisImmunologicalRare
• Injection site reactionsLocalCommon
• HeadacheNeurologicUncommonPain in the head or upper neck
• FlushingVascularCommonWarmth and redness of the skin
• Elevated IGF-1 / GH excessEndocrine / MetabolicUncommon
• NauseaGastrointestinalUncommonFeeling of sickness or urge to vomit

Drug Interactions

• GlucocorticoidsModerate
• Thyroid hormonesLow
• Somatostatin analogs (e.g., octreotide)High
• Exogenous GH (somatropin)Moderate
• Insulin / antidiabetic agentsModerate

Population Constraints

• Patients with prior or active malignancyOncologyRelative
• Pediatric patients under 2 yearsAgeRelative
• Patients with diabetes mellitusMetabolicRelative
• Elderly patientsAgeRelative
• Pregnant womenReproductiveRelative

Regulatory Status

• European UnionUnknownNo currently marketed authorized product identified in the EU; availability through compounding pharmacies or research settings.
• United StatesApprovedApproved: Diagnostic evaluation of GH secretory capacity (pituitary stimulation test), Treatment of idiopathic GH deficiency in children (Geref; brand withdrawn 2002)Geref (Serono) voluntarily withdrawn from US market in 2002 for commercial reasons. Compounded sermorelin used off-label in adults. FDA-approved NDA remains on record.
• United KingdomUnknownNo currently authorized product identified by MHRA; off-label or specials manufacturing basis if used.

FDA-approved (Geref, Serono) for diagnostic use and pediatric GH deficiency; brand withdrawn in 2002 for non-safety commercial reasons. Compounded formulations widely used off-label in adults for anti-aging, body composition, and GH deficiency. Not currently approved for adult indications in the US.

Evidence & Sources

No sources recorded yet.