# Sermorelin Legal — Primary sources and references

> Full citation list with DOIs, PubMed identifiers, Federal Register references, and direct links: peer-reviewed clinical literature, FDA prescribing information, FDA guidance, the 2013 Federal Register withdrawal determination, the 2025 WADA Prohibited List, and the Controlled Substances Act schedule lookup.

The complete reference list, sortable and filterable. Peer-reviewed clinical papers, FDA documents, Federal Register notices, WADA materials, and the Controlled Substances Act.

## How to read this list

Each reference is numbered to match the inline citations across the site. The table below carries the citation, the source type, the year, and a direct link to the primary document. Citations for FDA materials link to Drugs@FDA or the Federal Register; WADA materials link directly to the WADA document repository; peer-reviewed literature links to PubMed, PMC, or the publishing journal. Outbound links here are to legitimate primary-source repositories only — there are no affiliate links, no vendor links, and no other commercial outbound links anywhere on this site.

## Categories represented in this list

The full reference list collects four categories of primary source. First, peer-reviewed clinical literature — the foundational 1990s pharmacokinetic and clinical-efficacy papers (Wilton 1993, Prakash and Goa 1999, Khorram et al. 1997, Vittone et al. 1997), the mechanism-of-action and review literature (Walker 2006, Ishida et al. 2020), the contemporary 2024 Schally lab review, and the preclinical receptor-expression literature (Recinella et al. 2017, Kanashiro-Takeuchi et al. 2015). Second, FDA documents — the original sermorelin prescribing information archived in Drugs@FDA, the tesamorelin medical review for direct regulatory comparison, and the current 2024 FDA guidance on Section 503A compounding bulk substances. Third, Federal Register notices — most importantly the March 2013 determination at 78 FR 14296 that the 2008 commercial withdrawal was not for reasons of safety or effectiveness. Fourth, regulatory documents from the DEA (the Controlled Substances Act statutory text and the published schedules under 21 CFR 1308) and from WADA (the 2025 Prohibited List and the technical document on Growth Hormone Releasing Factors). One regulatory-bulletin secondary source documents the September 2024 FDA action removing other peptides from Category 2 of the 503A interim bulks list — included because it situates sermorelin's regulatory zone in active context.

## Reference list

The full reference list is rendered below in a sortable, searchable table. Sort by year to read the record chronologically; filter by source type to isolate FDA documents, WADA materials, or peer-reviewed studies; filter by jurisdiction to isolate the regulatory record from the scientific record. The complete bibliographic data, DOIs, and PubMed identifiers are listed in the `references_index` section of this page's machine-readable companion.

## References

[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. https://pubmed.ncbi.nlm.nih.gov/8329825/
[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. https://pubmed.ncbi.nlm.nih.gov/18031173/
[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. https://pubmed.ncbi.nlm.nih.gov/18031173/
[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. https://pubmed.ncbi.nlm.nih.gov/9141548/
[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. https://pubmed.ncbi.nlm.nih.gov/9005976/
[6] U.S. Food and Drug Administration. Sermorelin Acetate FDA Prescribing Information (archived). Drugs@FDA, ApplNo 020443. 1997. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020443
[7] Walker RF. Sermorelin: A better approach to management of adult-onset growth hormone insufficiency? Clinical Interventions in Aging. 2006;1(4):307-308. https://pmc.ncbi.nlm.nih.gov/articles/PMC2699646/
[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. https://pmc.ncbi.nlm.nih.gov/articles/PMC12137413/
[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. https://pmc.ncbi.nlm.nih.gov/articles/PMC4496393/
[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. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6033336/
[11] Prakash A, Goa KL. Sermorelin pediatric tolerability and adverse-event profile summary. BioDrugs. 1999;12(2):139-157. https://pubmed.ncbi.nlm.nih.gov/18031173/
[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. https://onlinelibrary.wiley.com/doi/full/10.1002/rco2.9
[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. https://www.federalregister.gov/documents/2013/03/04/2013-04827/determination-that-geref-sermorelin-acetate-injection-05-milligrams-basevial-and-10-milligrams
[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. https://www.fda.gov/media/174456/download
[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. https://www.wada-ama.org/sites/default/files/2024-09/2025list_en_final_clean_12_september_2024.pdf
[16] World Anti-Doping Agency. Growth Hormone Releasing Factors (GHRFs) — Technical Document. 2023. https://www.wada-ama.org/sites/default/files/growth_hormone_releasing_factors_2.0_1.pdf
[17] U.S. Drug Enforcement Administration. Controlled Substances Act — Schedules of Controlled Substances. 21 U.S.C. § 812; 21 CFR 1308. https://www.dea.gov/drug-information/csa
[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. https://pubmed.ncbi.nlm.nih.gov/15249570/
[19] U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Tesamorelin FDA Medical Review, Application Number 22-505. 2010. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022505Orig1s000MedR.pdf
[20] Frier Levitt / Lexology regulatory analysis. FDA Removes Certain Peptide Bulk Drug Substances from Category 2 of Interim 503A Bulks List and Sets Dates for PCAC Review. 2024. (Citing FDA Federal Register notices on AOD-9604, CJC-1295, ipamorelin, thymosin alpha-1, and Selank.) https://www.lexology.com/library/detail.aspx?g=2e55b76a-3173-4e04-beda-bf021202f18d
[21] U.S. Drug Enforcement Administration. Special restrictions on recombinant human growth hormone distribution outside FDA-approved indications. 21 U.S.C. § 333(e). https://www.dea.gov/drug-information/csa
[22] European Medicines Agency. Centrally authorized medicinal products — search of sermorelin (no centrally authorized product). EMA Public Register. https://www.ema.europa.eu/en/medicines
[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. https://pubmed.ncbi.nlm.nih.gov/18981489/
[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. https://pubmed.ncbi.nlm.nih.gov/39537825/
[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. https://pubmed.ncbi.nlm.nih.gov/22869065/
[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. https://pubmed.ncbi.nlm.nih.gov/1379256/
[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. https://pubmed.ncbi.nlm.nih.gov/8772599/

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An independent reading of the regulatory and scientific record — not legal advice, not medical guidance.