Sermorelin
/ Synthetic GHRH(1-29)-NH2 — minimum bioactive fragment of endogenous GHRHALIAS · GRF 1-29 · Geref (discontinued)
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Previously FDA-approved as Geref (1990); commercially discontinued 2008.
Synthetic GHRH(1-29)-NH2 — the minimum bioactive fragment of endogenous 44-amino-acid growth hormone-releasing hormone. Full agonist at pituitary GHRH receptors. Short half-life of approximately 11-12 minutes produces pulsatile GH release that preserves negative feedback via somatostatin. Mechanistically distinct from ghrelin mimetics such as ipamorelin and MK-677, which act at GHS-R1a.
Pediatric growth-hormone-deficiency data supported the original Geref approval (Thorner 1996). Adult off-label aging / body-composition studies exist but are small and not primary-endpoint RCTs.
Factual reporting of what cited studies used — not a recommendation.
- Thorner 1996 pediatric GHD trial — Pediatric humans with growth hormone deficiency — 30 mcg/kg Subcutaneous nightlyREFThorner 1996 (Sermorelin)
Labeled adverse events include injection-site reaction (most common), flushing, headache, dysphagia, and dizziness. Rare hypersensitivity. No malignancy signal in approved labeling.
Regulatory status
- FDA status:
- Previously approved, discontinued
- Compounding:
- Compounding eligibility ambiguous
Because the original Geref product was FDA-approved before commercial discontinuation (not safety or efficacy), compounding is on softer ground than for peptides that were never approved. However, sermorelin acetate was placed in Category 2 of FDA’s 503A bulk substance evaluation in 2023 pending further review.