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Sermorelin Legal

A withdrawal finding, read at its proper size.

References

Regulatory documents and research papers, including the older records that still shape the conversation.

Regulatory documents

The March 2013 Federal Register notice supplies the reason-for-withdrawal finding. The archived FDA application record belongs alongside it when considering the former product, its indications and its label. FDA’s Section 503A guidance addresses compounding, a different regulatory decision from approval of a finished medicine.

DEA’s Controlled Substances Act material and the 2025 WADA Prohibited List answer their own legal questions. The date and institution matter as much as the peptide name.

Clinical trials and reviews

The 1996 pediatric trial, 1993 pharmacokinetic experiment and 1992 study in older men are useful starting points for three quite different outcomes: growth, an acute hormone response and a short adult endocrine intervention.

The 2012 cognition trial used tesamorelin. Blackman’s editorial questions the case for using secretagogues against aging, while the 2025 GHRH review takes a broader view of the class. The skeptical assessment remains useful beside the attractive experimental findings.

  1. Wilton P, Chardet Y, Danielson K, Widlund L, Gunnarsson R. Pharmacokinetics of growth hormone-releasing hormone(1-29)-NH2 and stimulation of growth hormone secretion in healthy subjects after intravenous or intranasal administration. Acta Paediatrica Supplement. 1993. ↗
  2. 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. ↗
  3. Prakash A, Goa KL. Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency — diagnostic provocative testing summary. BioDrugs. 1999;12(2):139-157. ↗
  4. Khorram O, Laughlin GA, Yen SS. Effects of [Nle27]growth hormone-releasing hormone (1-29)-NH2 administration on the growth hormone-insulin-like growth factor I axis in normal aging men and women. Journal of Clinical Endocrinology and Metabolism. 1997;82(5):1472-1479. ↗
  5. 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. ↗
  6. U.S. Food and Drug Administration. Sermorelin Acetate FDA Prescribing Information (archived). Drugs@FDA, ApplNo 020443. 1997. ↗
  7. Walker RF. Sermorelin: A better approach to management of adult-onset growth hormone insufficiency? Clinical Interventions in Aging. 2006;1(4):307-308. ↗
  8. Schally AV, Cai R, Zhang X, Sha W, Wangpaichitr M. The development of growth hormone-releasing hormone analogs: Therapeutic advances in cancer, regenerative medicine, and metabolic disorders. Reviews in Endocrine and Metabolic Disorders. 2024. ↗
  9. Kanashiro-Takeuchi RM, Schulman IH, Hare JM. New therapeutic approach to heart failure due to myocardial infarction based on targeting growth hormone-releasing hormone receptor. Oncotarget. 2015;6(12):9728-9739. ↗
  10. Recinella L, Chiavaroli A, Orlando G, et al. Growth hormone-releasing hormone (GHRH) and its agonists inhibit hepatic and tumoral secretion of IGF-1. Oncotarget. 2017. ↗
  11. Prakash A, Goa KL. Sermorelin pediatric tolerability and adverse-event profile summary. BioDrugs. 1999;12(2):139-157. ↗
  12. 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. ↗
  13. U.S. Food and Drug Administration. Determination That Sermorelin Acetate Injection, 0.5 Milligrams Base/Vial and 1.0 Milligrams Base/Vial, and 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, 14296 (March 4, 2013). Notice 2013-04827. ↗
  14. 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 (Revised). 2024. ↗
  15. World Anti-Doping Agency. The World Anti-Doping Code International Standard — Prohibited List 2025 (effective 1 January 2025). Section S2.2.4 — Growth Hormone Releasing Factors. ↗
  16. World Anti-Doping Agency. Growth Hormone Releasing Factors (GHRFs) — Technical Document. 2023. ↗
  17. U.S. Drug Enforcement Administration. Controlled Substances Act — Schedules of Controlled Substances. 21 U.S.C. § 812; 21 CFR 1308. ↗
  18. Falutz J, Allas S, Blot K, et al. Effects of tesamorelin on visceral fat and liver fat in HIV-infected patients with abdominal fat accumulation: a randomized clinical trial. JAMA. 2014. ↗
  19. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Tesamorelin FDA Medical Review, Application Number 22-505. 2010. ↗
  20. Frier Levitt / Lexology regulatory analysis. Peptide compounding and PCAC review (secondary analysis; FDA's page current as of April 22, 2026 documents withdrawn 503A nominations for CJC-1295 and ipamorelin acetate with the safety assessments intact, and a continuing Category 2 entry for ipamorelin acetate under 503B for outsourcing facilities). 2024. (Citing FDA Federal Register notices on AOD-9604, CJC-1295, ipamorelin, thymosin alpha-1, and Selank.) ↗
  21. U.S. Drug Enforcement Administration. Special restrictions on recombinant human growth hormone distribution outside FDA-approved indications. 21 U.S.C. § 333(e). ↗
  22. European Medicines Agency. Centrally authorized medicinal products — search of sermorelin (no centrally authorized product). EMA Public Register. ↗
  23. 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. ↗
  24. 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. ↗
  25. 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. ↗
  26. 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. ↗
  27. 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. ↗