Sermorelin Meds

BOARD J·05 · CITATION NET

References

Every citation referenced from the mechanism, research, dosage, and FAQ pages — with DOI, PMID, and direct links to PubMed, PMC, and the source repositories.

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Reading note

Citations are numbered 1 through 18 and used consistently across every page on this site. Where a single source supports a claim on multiple pages — for example, the historic FDA prescribing information [6][10] or the 2013 Federal Register determination [18] — the same numeric anchor is used throughout. External links open to PubMed, PubMed Central, the publishing journal, or the FDA / Federal Register source repository.

Pediatric efficacy

[1] Thorner M, Rochiccioli P, Colle M, Lanes R, Grunt J, Galazka A, Landy H, Eengrand P, Shah S; International Multicenter GHRH Study Group. 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 & Metabolism. 1996;81(3):1189-1196. DOI: 10.1210/jcem.81.3.8772599. PMID: 8772599. https://pubmed.ncbi.nlm.nih.gov/8772599/

[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. DOI: 10.2165/00063030-199912020-00007. PMID: 18031173. https://pubmed.ncbi.nlm.nih.gov/18031173/

[5] Wit JM, Kamp GA, Rikken B. Treatment with GHRH(1-29)NH2 in children with idiopathic short stature induces a sustained increase in growth velocity. Journal of Clinical Endocrinology & Metabolism. 1994;79(5):1349-1356. DOI: 10.1210/jcem.79.5.7962328. PMID: 7955460. https://pubmed.ncbi.nlm.nih.gov/7955460/

Adult aging-axis and somatopause

[3] Corpas E, Harman SM, Piñeyro 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 & Metabolism. 1992;75(2):530-535. DOI: 10.1210/jcem.75.2.1379256. PMID: 1379256. https://pubmed.ncbi.nlm.nih.gov/1379256/

[4] Khorram O, Laughlin GA, Yen SSC. 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. DOI: 10.1210/jcem.82.5.3943. PMID: 9141537. https://academic.oup.com/jcem/article-abstract/82/5/1472/2823341

[11] Walker RF. Sermorelin: a better approach to management of adult-onset growth hormone insufficiency? Clinical Interventions in Aging. 2006;1(4):307-308. DOI: 10.2147/ciia.2006.1.4.307. PMID: 18046908. https://pubmed.ncbi.nlm.nih.gov/18046908/

[15] Fernández-Garza LE, Guillen-Silva F, Sotelo-Ibarra MA, Domínguez-Mendoza AE, Barrera-Barrera SA, Barrera-Saldaña HA. Growth hormone and aging: a clinical review. Frontiers in Aging. 2025;6:1549453. DOI: 10.3389/fragi.2025.1549453. PMID: 40260058. https://pmc.ncbi.nlm.nih.gov/articles/PMC12009952/

Cognitive trials

[7] 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. DOI: 10.1001/archneurol.2012.1970. PMID: 22869065. https://pmc.ncbi.nlm.nih.gov/articles/PMC3764914/

[8] Friedman SD, Baker LD, Borson S, Jensen JE, Barsness SM, Craft S, Merriam GR, Otto RK, Novotny EJ, Vitiello MV. Growth hormone-releasing hormone effects on brain γ-aminobutyric acid levels in mild cognitive impairment and healthy aging. JAMA Neurology. 2013;70(7):883-890. DOI: 10.1001/jamaneurol.2013.1425. PMID: 23689947. https://jamanetwork.com/journals/jamaneurology/fullarticle/1696089

[9] Vitiello MV, Moe KE, Merriam GR, Mazzoni G, Buchner DH, Schwartz RS. Growth hormone-releasing hormone improves the cognition of healthy older adults. Neurobiology of Aging. 2006;27(2):318-323. DOI: 10.1016/j.neurobiolaging.2005.01.010. PMID: 16399218. https://www.sciencedirect.com/science/article/abs/pii/S0197458005000631

[17] Winston CN, Goetzl EJ, Baker LD, Vitiello MV, Rissman RA. Growth hormone-releasing hormone modulation of neuronal exosome biomarkers in mild cognitive impairment. Journal of Alzheimer's Disease. 2018;66(3):971-981. DOI: 10.3233/JAD-180302. PMID: 30372680. https://journals.sagepub.com/doi/10.3233/JAD-180302

Mechanism and receptor signaling

[12] Cui T, Jimenez JJ, Block NL, Badiavas EV, Rodriguez-Menocal L, Vila Granda A, Cai R, Sha W, Zarandi M, Perez R, Schally AV. Agonistic analogs of growth hormone-releasing hormone (GHRH) promote wound healing by stimulating the proliferation and survival of human dermal fibroblasts through ERK and AKT pathways. Oncotarget. 2016;7(33):52661-52672. DOI: 10.18632/oncotarget.11024. PMID: 27623072. https://pmc.ncbi.nlm.nih.gov/articles/PMC5288139/

[13] Halmos G, Szabo Z, Dobos N, Juhasz E, Schally AV. Growth hormone-releasing hormone receptor (GHRH-R) and its signaling. Reviews in Endocrine and Metabolic Disorders. 2025;26(3):343-352. DOI: 10.1007/s11154-025-09952-x. PMID: 39934495. https://pmc.ncbi.nlm.nih.gov/articles/PMC12137518/

[16] 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. DOI: 10.1002/rco2.9. https://onlinelibrary.wiley.com/doi/full/10.1002/rco2.9

Pharmacokinetics, safety, and historic labeling

[6] Sermorelin acetate injection — historic FDA-approved prescribing information (NDA 020443). Pharmacokinetics, indications, and dosing labeling. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020443

[10] Sermorelin acetate injection — historic FDA-approved prescribing information (NDA 020443). Adverse-event summary and safety record from the pediatric registration trial dataset. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020443

Regulatory and clinical practice context

[14] Caputo M, Mele C, Ferrero A, Leone I, Daffara T, Marzullo P, Prodam F, Aimaretti G. A 2024 update on growth hormone deficiency syndrome in adults: from guidelines to real life. Journal of Clinical Medicine. 2024;13(20):6079. DOI: 10.3390/jcm13206079. PMID: 39458029. https://www.mdpi.com/2077-0383/13/20/6079

[18] U.S. Food and Drug Administration. Determination That Sermorelin Acetate Injection (the formerly approved finished product), 0.5 mg/vial, 1.0 mg/vial, and 0.05 mg/amp, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness. Federal Register. 2013;78 FR 14114. https://www.federalregister.gov/documents/2013/03/04/2013-04827/determination-that-geref-sermorelin-acetate-injection-05-milligrams-basevial-and-10-milligrams

  1. Thorner M, Rochiccioli P, Colle M, Lanes R, Grunt J, Galazka A, Landy H, Eengrand P, Shah S; International Multicenter GHRH Study Group. 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 & Metabolism. 1996;81(3):1189-1196. ↗
  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. Corpas E, Harman SM, Piñeyro 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 & Metabolism. 1992;75(2):530-535. ↗
  4. Khorram O, Laughlin GA, Yen SSC. 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. Wit JM, Kamp GA, Rikken B. Treatment with GHRH(1-29)NH2 in children with idiopathic short stature induces a sustained increase in growth velocity. Journal of Clinical Endocrinology & Metabolism. 1994;79(5):1349-1356. ↗
  6. Sermorelin acetate injection — historic FDA-approved prescribing information (NDA 020443). Pharmacokinetics, indications, and dosing labeling. ↗
  7. 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. ↗
  8. Friedman SD, Baker LD, Borson S, Jensen JE, Barsness SM, Craft S, Merriam GR, Otto RK, Novotny EJ, Vitiello MV. Growth hormone-releasing hormone effects on brain γ-aminobutyric acid levels in mild cognitive impairment and healthy aging. JAMA Neurology. 2013;70(7):883-890. ↗
  9. Vitiello MV, Moe KE, Merriam GR, Mazzoni G, Buchner DH, Schwartz RS. Growth hormone-releasing hormone improves the cognition of healthy older adults. Neurobiology of Aging. 2006;27(2):318-323. ↗
  10. Sermorelin acetate injection — historic FDA-approved prescribing information (NDA 020443). Adverse-event summary and safety record from the pediatric registration trial dataset. ↗
  11. Walker RF. Sermorelin: a better approach to management of adult-onset growth hormone insufficiency? Clinical Interventions in Aging. 2006;1(4):307-308. ↗
  12. Cui T, Jimenez JJ, Block NL, Badiavas EV, Rodriguez-Menocal L, Vila Granda A, Cai R, Sha W, Zarandi M, Perez R, Schally AV. Agonistic analogs of growth hormone-releasing hormone (GHRH) promote wound healing by stimulating the proliferation and survival of human dermal fibroblasts through ERK and AKT pathways. Oncotarget. 2016;7(33):52661-52672. ↗
  13. Halmos G, Szabo Z, Dobos N, Juhasz E, Schally AV. Growth hormone-releasing hormone receptor (GHRH-R) and its signaling. Reviews in Endocrine and Metabolic Disorders. 2025;26(3):343-352. ↗
  14. Caputo M, Mele C, Ferrero A, Leone I, Daffara T, Marzullo P, Prodam F, Aimaretti G. A 2024 update on growth hormone deficiency syndrome in adults: from guidelines to real life. Journal of Clinical Medicine. 2024;13(20):6079. ↗
  15. Fernández-Garza LE, Guillen-Silva F, Sotelo-Ibarra MA, Domínguez-Mendoza AE, Barrera-Barrera SA, Barrera-Saldaña HA. Growth hormone and aging: a clinical review. Frontiers in Aging. 2025;6:1549453. ↗
  16. 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. ↗
  17. Winston CN, Goetzl EJ, Baker LD, Vitiello MV, Rissman RA. Growth hormone-releasing hormone modulation of neuronal exosome biomarkers in mild cognitive impairment. Journal of Alzheimer's Disease. 2018;66(3):971-981. ↗
  18. U.S. Food and Drug Administration. Determination That Sermorelin Acetate Injection (the formerly approved finished product), 0.5 mg/vial, 1.0 mg/vial, and 0.05 mg/amp, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness. Federal Register. 2013;78 FR 14114. ↗
  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):677-679. ↗
  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 release in elderly subjects. European Journal of Endocrinology. 2005;153(3):353-361. ↗
  22. Esposito S, et al. Advances in the detection of growth hormone releasing hormone synthetic analogs. Drug Testing and Analysis. 2021;14(3):448-460. ↗