Somatropin (HGH)
FDA-approved recombinant human growth hormone — the direct hormone replacement, with multiple clinical indications, prescription-only status, and specific federal criminal provisions against off-label distribution.
The 191-amino-acid recombinant form of human growth hormone, produced in E. coli (Genotropin, Humatrope) or mouse-cell expression systems, used to replace deficient GH across pediatric and adult indications and — unlike most drugs — subject to federal criminal penalties for off-label distribution under 21 U.S.C. §333(e).
Mechanism of action
Binds dimerized GH receptors on target tissues, triggering JAK2/STAT5 signaling. Direct effects include lipolysis (adipocyte), gluconeogenesis and insulin antagonism (hepatic), and anabolic effects on muscle, bone, and cartilage. Indirect effects are mediated by hepatic IGF-1 production, which drives most of the somatic growth effects. Exogenous administration suppresses endogenous pulsatile secretion via negative feedback on hypothalamic somatostatin and GHRH neurons.
Primary uses
- Pediatric and adult GH deficiency
- Turner syndrome
- Prader-Willi syndrome
- Chronic kidney disease in children
- HIV-associated wasting (Serostim)
- Short bowel syndrome (Zorbtive)
- Idiopathic short stature
- SHOX deficiency
- Noonan syndrome
- Off-label: anti-aging, bodybuilding (illegal under federal HGH distribution law)
Typical dosing
Pediatric GHD: 0.16–0.3 mg/kg/week divided daily. Adult GHD: 0.15–0.3 mg/day titrated to IGF-1 target. Bodybuilding "anti-aging" community use (2–4 IU/day ≈ 0.66–1.33 mg/day) is illegal under federal law and carries meaningful long-term safety concerns including insulin resistance, carpal tunnel syndrome, and accelerated growth of occult neoplasms.
Regulatory status
FDA-approved for: pediatric GH deficiency, adult GH deficiency, Turner syndrome, chronic renal insufficiency in children, Prader-Willi syndrome, idiopathic short stature, small-for-gestational-age children, SHOX deficiency, Noonan syndrome, short bowel syndrome (Zorbtive, daily high-dose), HIV-associated wasting (Serostim). Brand names include Humatrope (Lilly), Genotropin (Pfizer), Norditropin (Novo Nordisk), Omnitrope (Sandoz), Saizen (Merck), Zomacton (Ferring), Serostim (EMD Serono), Skytrofa (Ascendis, weekly), Ngenla (Pfizer, weekly).
References
- [fda-pi] Humatrope (somatropin) Prescribing Information. Eli Lilly.
- [fda-pi] Genotropin (somatropin) Prescribing Information. Pfizer.
- [fda-pi] Norditropin (somatropin) Prescribing Information. Novo Nordisk.
- [fda-pi] Skytrofa (lonapegsomatropin) Prescribing Information. Ascendis Pharma.
- [review] Molitch ME, et al. "Evaluation and Treatment of Adult Growth Hormone Deficiency: An Endocrine Society Clinical Practice Guideline." J Clin Endocrinol Metab, 2011;96:1587-1609.
- [fda-pi] 21 U.S.C. §333(e). Federal HGH distribution law: specific criminal penalties for off-label distribution.
Related peptides
This entry is for educational purposes only and does not constitute medical advice. Dosing information reflects published regulatory or research data and is not a recommendation. Many compounds described here are not approved for human use in the United States. Consult a licensed medical professional before considering any peptide therapy.