Legit Sermorelin

§ 04 · the binder

References, in full

Every citation used across this site, with DOIs and PubMed / PMC / Federal Register links.

Back to the researchOpen the FAQ

How this list was built

The references below are drawn from the research file that anchors this notebook: a small set of peer-reviewed trials and reviews on sermorelin (1990s registration-era through 2021), the 2013 FDA Federal Register determination, and the 2024-2025 FDA Pharmacy Compounding Advisory Committee briefing record. Where a primary source has a DOI or a PubMed ID, both are included. The Federal Register notice and FDA materials link directly to fda.gov and federalregister.gov.

Reading order, if you want to do this yourself

If you want to read the primary literature in roughly the order this notebook was assembled, start with the Prakash & Goa 1999 review for the registration-era clinical record [1], then the Vittone 1997 and Khorram 1997 trials for the elderly-adult work [3][4], the Yuen 2009 clinical review for the post-withdrawal diagnostic context [13], the 2012 Baker cognition trial [16], the 2020 Ishida secretagogue review for mechanism and pharmacokinetics consolidation [8], and the 2013 FDA Federal Register notice plus the 2024 PCAC briefing for the regulatory thread [6][17]. The 2025 Frier Levitt analysis is useful as a legal-regulatory summary of where compounded peptides sit in the current rulemaking cycle [19].

Primary literature, regulatory record, and reviews

See the numbered list below. Each entry corresponds to the inline citation markers [N] used throughout the notebook. tippy_js attaches a soft popover to each [N] inline in the body pages so the full citation is one hover away — this page is the canonical, linkable binder.

  1. Prakash A, Goa KL. Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency. BioDrugs. 1999;12(2):139-157. ↗
  2. Prakash A, Goa KL. Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency (diagnostic stimulation testing section). BioDrugs. 1999;12(2):139-157. ↗
  3. Vittone J, Blackman MR, Busby-Whitehead J, et al. Effects of single nightly injections of growth hormone-releasing hormone (GHRH 1-29) in healthy elderly men. Metabolism. 1997;46(1):89-96. ↗
  4. Khorram O, Laughlin GA, Yen SS. Endocrine and metabolic effects of long-term administration of [Nle27]growth hormone-releasing hormone-(1-29)-NH2 in age-advanced men and women. Journal of Clinical Endocrinology & Metabolism. 1997;82(5):1472-1479. ↗
  5. U.S. Food and Drug Administration. Determination That Sermorelin Acetate Injection (NDA 19-863 and NDA 020443) Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness. Federal Register. 2013;78(42):14299-14300. ↗
  6. U.S. Food and Drug Administration. Determination That Sermorelin Acetate Injection, 0.5 mg Base/Vial and 1.0 mg Base/Vial (NDA 020443), and Sermorelin Acetate Injection, 0.05 mg Base/Amp (NDA 19-863), Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness. Federal Register. 2013. FR Doc. 2013-04827. ↗
  7. Prakash A, Goa KL. Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency (specificity and off-target endocrine section). BioDrugs. 1999;12(2):139-157. ↗
  8. Ishida J, Saitoh M, Ebner N, Springer J, Anker SD, von Haehling S. Growth hormone secretagogues: history, mechanism of action, and clinical development. JCSM Rapid Communications. 2020;3(1):25-37. ↗
  9. Ishida J, Saitoh M, Ebner N, Springer J, Anker SD, von Haehling S. Growth hormone secretagogues: history, mechanism of action, and clinical development (intermittent dosing and tachyphylaxis section). JCSM Rapid Communications. 2020;3(1):25-37. ↗
  10. Chang Y, et al. A potentially effective drug for patients with recurrent glioma: sermorelin. Annals of Translational Medicine. 2021;9(6):406. ↗
  11. Prakash A, Goa KL. Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency (tolerability and injection-site reactions section). BioDrugs. 1999;12(2):139-157. ↗
  12. U.S. Food and Drug Administration. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act. FDA Guidance. 2023. ↗
  13. Yuen KC. Clinical review: Is lack of recombinant growth hormone (GH)-releasing hormone in the United States a setback or time to consider glucagon testing for adult GH deficiency? Journal of Clinical Endocrinology & Metabolism. 2009;94(8):2702-2707. ↗
  14. Khorram O, Yeung M, Vu L, Yen SS. Effects of [norleucine27]growth hormone-releasing hormone (GHRH) (1-29)-NH2 administration on the immune system of aging men and women. Journal of Clinical Endocrinology & Metabolism. 1997;82(11):3590-3596. ↗
  15. Baker LD, Barsness SM, Borson S, Merriam GR, Friedman SD, Craft S, Vitiello MV. Effects of growth hormone-releasing hormone on cognitive function in adults with mild cognitive impairment and healthy older adults: results of a controlled trial. Archives of Neurology. 2012;69(11):1420-1429. ↗
  16. U.S. Food and Drug Administration. FDA Briefing Document — Pharmacy Compounding Advisory Committee (PCAC) Meeting on Peptide Bulk Drug Substances. 2024. ↗
  17. U.S. Food and Drug Administration; PCAC. FDA to Reconsider Popular Peptides for Inclusion on 503A Bulks List. Federal Register notice / FDA advisory committee calendar. 2025. ↗
  18. Frier Levitt. Regulatory Status of Peptide Compounding in 2025. Frier Levitt White Paper. 2025. ↗
  19. Blackman MR. Use of growth hormone secretagogues to prevent or treat the effects of aging: not yet ready for prime time. Annals of Internal Medicine. 2008;149(9):677-9. ↗
  20. Granata R, Leone S, Zhang X, Gesmundo I, Steenblock C, Cai R, Sha W, Ghigo E, Hare JM, Bornstein SR, Schally AV. Growth hormone-releasing hormone and its analogues in health and disease. Nature Reviews Endocrinology. 2025;21(3):180-195. ↗
  21. Munafo A, Nguyen TX, Papasouliotis O, et al. Polyethylene glycol-conjugated growth hormone-releasing hormone is long acting and stimulates GH in healthy young and elderly subjects. European Journal of Endocrinology. 2005;153:249-56. ↗
  22. Chen RG, Shen YN, Yei J, et al. A comparative study of growth hormone (GH) and GH-releasing hormone(1-29)-NH2 for stimulation of growth in children with GH deficiency. Acta Paediatrica Supplement. 1993;388:32-5. ↗
  23. Khorram O, Laughlin GA, Yen SS. Endocrine and metabolic effects of long-term administration of [Nle27]growth hormone-releasing hormone-(1-29)-NH2 in age-advanced men and women. Journal of Clinical Endocrinology and Metabolism. 1997;82:1472-9. ↗
  24. Tauber MT, Pienkowski C, Pigeon P, et al. Growth hormone (GH) profiles in response to continuous subcutaneous infusion of GH-releasing hormone(1-29)-NH2 in children with GH deficiency. Acta Paediatrica Supplement. 1993;388:28-30. ↗
  25. Thorner M, Rochiccioli P, Colle M, Lanes R, Grunt J, Galazka A, Landy H, Eengrand P, Shah S. Once daily subcutaneous growth hormone-releasing hormone therapy accelerates growth in growth hormone-deficient children during the first year of therapy. Journal of Clinical Endocrinology and Metabolism. 1996;81(3):1189-96. ↗