# Sermorelin references — primary literature, FDA Federal Register, and PCAC briefings

> Full citation list for the sermorelin notebook: PubMed-indexed reviews and trials, the FDA's 2013 Federal Register determination, and the 2024-2025 PCAC briefing record.

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

## 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.

## References

[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. https://pubmed.ncbi.nlm.nih.gov/18031173/
[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. https://pubmed.ncbi.nlm.nih.gov/18031173/
[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. https://pubmed.ncbi.nlm.nih.gov/9005976/
[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. https://pubmed.ncbi.nlm.nih.gov/9141538/
[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. https://www.federalregister.gov/documents/2013/03/04/2013-04827/determination-that-geref-sermorelin-acetate-injection-05-milligrams-basevial-and-10-milligrams
[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. https://www.federalregister.gov/documents/2013/03/04/2013-04827/determination-that-geref-sermorelin-acetate-injection-05-milligrams-basevial-and-10-milligrams
[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. https://pubmed.ncbi.nlm.nih.gov/18031173/
[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. https://onlinelibrary.wiley.com/doi/full/10.1002/rco2.9
[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. https://onlinelibrary.wiley.com/doi/full/10.1002/rco2.9
[10] Chang Y, et al. A potentially effective drug for patients with recurrent glioma: sermorelin. Annals of Translational Medicine. 2021;9(6):406. https://pubmed.ncbi.nlm.nih.gov/33842627/
[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. https://pubmed.ncbi.nlm.nih.gov/18031173/
[12] U.S. Food and Drug Administration. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act. FDA Guidance. 2023. https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act
[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. https://pubmed.ncbi.nlm.nih.gov/19509104/
[15] 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. https://pubmed.ncbi.nlm.nih.gov/9360512/
[16] 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://jamanetwork.com/journals/jamaneurology/article-abstract/1357113
[17] U.S. Food and Drug Administration. FDA Briefing Document — Pharmacy Compounding Advisory Committee (PCAC) Meeting on Peptide Bulk Drug Substances. 2024. https://www.fda.gov/media/182088/download
[18] 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. https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026
[19] Frier Levitt. Regulatory Status of Peptide Compounding in 2025. Frier Levitt White Paper. 2025. https://www.frierlevitt.com/articles/regulatory-status-of-peptide-compounding-in-2025/
[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):677-9. https://pubmed.ncbi.nlm.nih.gov/18981489/
[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. https://pubmed.ncbi.nlm.nih.gov/39537825/
[22] 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. https://pubmed.ncbi.nlm.nih.gov/16061831/
[23] 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. https://pubmed.ncbi.nlm.nih.gov/8329830/
[24] 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. https://pubmed.ncbi.nlm.nih.gov/9141536/
[25] 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. https://pubmed.ncbi.nlm.nih.gov/8329829/
[26] 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. https://pubmed.ncbi.nlm.nih.gov/8772599/

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An annotated reading of the published research — not a clinic, not a pharmacy, not advice.