Sermorelin
Sermorelin is a synthetic growth hormone–releasing hormone (GHRH 1-29) analog that stimulates the pituitary to release endogenous growth hormone. It was historically approved for pediatric growth hormone deficiency and for diagnostic testing of GH secretion, but it is no longer marketed as an FDA-approved product. Human studies showed it could increase growth velocity in some children with GH deficiency, especially during the first year of therapy.
Overview
Sermorelin acetate is a shortened synthetic analog of natural GHRH. FDA review materials describe it as having been approved in the early 1990s as a single IV diagnostic agent for adult GH deficiency evaluation and later as a daily subcutaneous treatment for short stature associated with pediatric GH deficiency. It is best understood as a pituitary stimulant, not as direct recombinant growth hormone replacement.
What it is
Sermorelin is a 29-amino-acid peptide analog of growth hormone–releasing hormone. It works upstream of growth hormone by stimulating pituitary somatotrophs rather than supplying GH directly.
Mechanism (high level)
Sermorelin binds the GHRH receptor on pituitary somatotroph cells and promotes pulsatile release of endogenous growth hormone. Because it depends on an intact and responsive pituitary, its effect may be less robust in patients with more severe pituitary dysfunction. Clinical literature and reviews note it can produce a more physiologic GH pattern than exogenous GH, but its pediatric growth effects were generally less dramatic than direct GH therapy.
Quick facts
- Dosage
- Historically, FDA review materials report 30 mcg/kg/day subcutaneously for pediatric treatment use and 1 mcg/kg as a single IV injection for diagnostic use. There is no current FDA-approved marketed sermorelin dosing standard because the approved products were withdrawn from sale.
- Route
- treatment use Intravenous injection for historic diagnostic use
- Cycle
- No modern approved “cycle” exists. Historic pediatric treatment studies evaluated sermorelin over months to a year or longer, with the clearest growth acceleration reported during the first year of daily subcutaneous therapy.
- Storage
- Follow manufacturer or compounding-pharmacy instructions exactly Protect from heat and light Do not use beyond labeled storage limits Because there is no currently marketed FDA-approved sermorelin product, storage depends on the specific dispensed formulation.
Research indications
- Idiopathic growth hormone deficiency research
- Pediatric growth failure research
- Pituitary GH reserve testing research
- Hypothalamic-pituitary axis research
- Adult GH deficiency diagnostic research
- Endogenous GH stimulation research
Research protocols (education)
30 mcg/kg/day subcutaneous dosing in historic pediatric treatment use 1 mcg/kg single IV injection in historic diagnostic use First-year pediatric growth studies showed increased growth velocity Better responses were often seen in milder GH insufficiency than in severe deficiency
Interactions
Often avoided with
- Use outside medical supervision
- Use for bodybuilding or anti-aging claims without evidence-based indication
- Use with caution in active malignancy risk states involving GH/IGF-1 pathways
- Pregnancy unless specifically clinician supervised
- Breastfeeding unless specifically clinician supervised
- Use with caution in patients with glucose intolerance or endocrine instability
Often combined with
- Sleep hygiene
Clinician-supervised endocrine evaluation Historic GH deficiency diagnostic context Clinician-supervised research or compounding discussion Monitoring of IGF-1, growth response, and tolerability when clinically indicated
Side effects & safety
- Injection-site pain
- Injection-site redness
- Injection-site swelling
- Facial flushing
- Headache
- Nausea
- Vomiting
- Dizziness
- Somnolence
- Urticaria
- Antibody formation reported historically.
Regulatory notes
- Previously FDA approved as Geref Diagnostic and Geref Pediatric
- No longer marketed as an FDA-approved product
- FDA determined withdrawal was not for reasons of safety or effectiveness
- Historic approved uses included pediatric treatment and adult GH diagnostic testing
- Current use should not be confused with an actively marketed approved drug
FAQ
What is sermorelin?
Sermorelin is a synthetic GHRH analog that stimulates the pituitary gland to release endogenous growth hormone.
Is sermorelin FDA approved?
It was previously FDA approved as Geref Diagnostic and Geref Pediatric, but those products were later withdrawn from the market and are no longer marketed. FDA determined they were not withdrawn for safety or effectiveness reasons.
What was sermorelin used for?
Historically it was used to evaluate pituitary GH secretion and to treat idiopathic growth hormone deficiency in children with growth failure.
How is sermorelin different from growth hormone?
Sermorelin stimulates the body to release its own GH from the pituitary, while recombinant GH directly replaces the hormone itself.
Does sermorelin still have a current marketed approved product?
No. FDA review materials state the Geref products were withdrawn and are no longer marketed.
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Educational content only. This material is not medical advice. Verify legality, sourcing, and dosing with a qualified professional.