$ man sermorelin — a terminal-style reading room for the GHRH(1-29) record, from the 1990 NDA to the 2025 503A interim policy.
onlinesermorelin

REFERENCES

$ cat references.bib

Nineteen sources. FDA Federal Register documents, the foundational pediatric and adult clinical trials, the GHRH+GHRP synergy work, the WADA Prohibited List, and the 2024-2025 regulatory updates.

Primary regulatory sources

References [1], [2], [16], [17] are FDA Federal Register and FDA Pharmacy Compounding Advisory Committee primary documents. Reference [13] is the WADA Prohibited List. These are the authoritative sources for current US regulatory status and global anti-doping status. See the full numbered list below.

Foundational pediatric and adult clinical trials

References [3], [4], [5], [7], [8] are the published clinical trials that supported FDA approval and the parallel pediatric studies in idiopathic short stature. Reference [6] is the Khorram aging study. Reference [11] is the GHRH-arginine adult diagnostic combination.

Mechanism and class pharmacology

References [9], [10], [12], [14], [15], [19] cover mechanism, pharmacokinetics, the GHRH+GHRP synergy, slow-wave sleep regulation, the tesamorelin cognitive trial as class-level comparator, and the head-to-head half-life comparison across the GHRH agonist class.

Analytical chemistry and anti-doping

Reference [18] is the 2024 nano-LC Orbitrap mass-spectrometric method paper validated to WADA technical-document specifications for sermorelin and related GHRH analogs in athlete urine.

  1. U.S. Food and Drug Administration. Determination That GEREF (Sermorelin Acetate) Injection, 0.5 Milligrams Base/Vial and 1.0 Milligrams Base/Vial, and GEREF (Sermorelin Acetate) Injection, 0.05 Milligrams Base/Amp, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness. Federal Register, Vol. 78, No. 42. 2013. ↗
  2. U.S. Food and Drug Administration. Determination That GEREF (Sermorelin Acetate) Injection Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness. Federal Register. 2013. ↗
  3. 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. ↗
  4. Prakash A, Goa KL. Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency (diagnostic-test review section). BioDrugs. 1999;12(2):139-157. ↗
  5. Kirk JM, Trainer PJ, Majrowski WH, Murphy J, Savage MO, Besser GM. Treatment with GHRH(1-29)NH2 in children with idiopathic short stature induces a sustained increase in growth velocity. Clinical Endocrinology. 1994;41(4):487-493. ↗
  6. 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. ↗
  7. Vittone J, Blackman MR, Busby-Whitehead J, Tsiao C, Stewart KJ, Tobin J, Stevens T, Bellantoni MF, Rogers MA, Baumann G, Roth J, Harman SM, Spencer RG. Effects of single nightly injections of growth hormone-releasing hormone (GHRH 1-29) in healthy elderly men. Metabolism: Clinical and Experimental. 1997;46(1):89-96. ↗
  8. Smith PJ, Brook CGD, Rivier J, Vale W, Thorner MO. Continuous subcutaneous GHRH(1-29)NH2 promotes growth hormone secretion and growth in children with growth hormone deficiency. Clinical Endocrinology. 1986;25(1):35-44. ↗
  9. Bowers CY, Reynolds GA, Durham D, Barrera CM, Pezzoli SS, Thorner MO. Combined administration of GHRH and GHRP-6 acts in synergy on growth hormone (GH) release in humans. Journal of Clinical Endocrinology and Metabolism. 1990;70(4):975-982. ↗
  10. Prakash A, Goa KL. Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency (pharmacokinetics section). BioDrugs. 1999;12(2):139-157. ↗
  11. Aimaretti G, Baffoni C, DiVito L, Bellone S, Grottoli S, Maccario M, Arvat E, Camanni F, Ghigo E. Growth hormone-releasing hormone combined with arginine or growth hormone secretagogues for the diagnosis of growth hormone deficiency in adults. European Journal of Endocrinology. 2001;145(4):369-376. ↗
  12. Prakash A, Goa KL. Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency (safety profile section). BioDrugs. 1999;12(2):139-157. ↗
  13. World Anti-Doping Agency. World Anti-Doping Code International Standard — The 2025 Prohibited List. ↗
  14. 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. ↗
  15. Steiger A, Guldner J, Hemmeter U, et al. Growth hormone-releasing hormone (GHRH) and sleep regulation. Psychoneuroendocrinology. 1992;17(2-3):125-137. ↗
  16. U.S. Food and Drug Administration. Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry. Federal Register. 2025. ↗
  17. U.S. Food and Drug Administration. October 29, 2024 Meeting of the Pharmacy Compounding Advisory Committee — Briefing Materials. FDA Briefing Materials. 2024. ↗
  18. Thomas A, Walpurgis K, Tretzel L, Brinkkotter P, Fussholler G, Gorgens C, Geyer H, Thevis M. Chromatographic-mass spectrometric analysis of peptidic analytes (2-10 kDa) in doping control urine samples. Journal of Mass Spectrometry. 2024. ↗
  19. 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. ↗
  20. 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):677-679. ↗
  21. 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. ↗
  22. 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):1189-1196. ↗
  23. Corpas E, Harman SM, Pineyro MA, Roberson R, Blackman MR. Growth hormone (GH)-releasing hormone-(1-29) twice daily reverses the decreased GH and insulin-like growth factor-I levels in old men. Journal of Clinical Endocrinology and Metabolism. 1992;75(2):530-535. ↗
  24. A comparative study of growth hormone (GH) and GH-releasing hormone(1-29)-NH2 for the treatment of children with idiopathic GH deficiency. Acta Paediatrica Supplement. 1993. ↗
  25. 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(5):3590-3596. ↗
  26. Maa M, et al. Polyethylene glycol-conjugated growth hormone-releasing hormone is long acting and stimulates GH release with preservation of pulsatility. European Journal of Endocrinology. 2005;153(1):15-22. ↗
  27. Balber T, et al. Long-term therapy with a single daily subcutaneous dose of growth hormone releasing factor in children with growth hormone deficiency. Journal of Pediatric Endocrinology and Metabolism. 1994;7(4):303-313. ↗
  28. Hindmarsh P, et al. Effects of acute intravenous injection of two growth hormone-releasing hormones on pituitary hormone secretion in short children. Hormone Research. 1989;31(1-2):33-38. ↗
  29. Smith PJ, et al. Growth hormone (GH) profiles in response to continuous subcutaneous infusion of GH-releasing hormone in children with GH deficiency. Acta Paediatrica Supplement. 1993. ↗
  30. Pedersen L, et al. A new era of doping? Use of peptide and peptide-analog drugs in recreational and competitive athletes. Journal of Sports Medicine and Physical Fitness. 2026. ↗
  31. Dhurat R, et al. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Conditions: A Systematic Review. Sports Medicine. 2026. ↗
  32. Thomas A, et al. Advances in the detection of growth hormone releasing hormone synthetic analogs. Drug Testing and Analysis. 2021. ↗
  33. 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. ↗
  34. Popovic V, et al. Clinical review: Is lack of recombinant growth hormone (GH)-releasing hormone in the United States a setback or a blessing in disguise? Journal of Clinical Endocrinology and Metabolism. 2009;94(8):2756-2761. ↗
  35. U.S. Food and Drug Administration. Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry. 2025. ↗