Chapter V · Apparatus

References

the apparatus.

Twenty-one primary studies, regulatory documents, and review articles. Each entry carries the canonical identifier (PMID, DOI, NDA, Federal Register volume) and a direct link to the source.

Art Nouveau ornamental frieze of twenty floral citation markers in alternating sage, rose, gold, and plum, framed by gold whiplash borders
FIG. VI — Ornamental frieze marking the apparatus.

How the apparatus is organized

The references are numbered in the order they are first cited across the compendium and grouped only by Roman-numeral entry. Each citation gives author group, full title, journal or document of record, year, volume and pages where applicable, DOI, PubMed identifier where available, and the canonical source URL. Outbound links lead only to PubMed, PubMed Central, FDA databases, the Federal Register, journal publishers, and the World Anti-Doping Agency.

Primary studies and registration documents

The pediatric registration trial (Thorner 1996, citation 1), the adult somatopause trials (Corpas 1992 citation 2, Khorram 1997 citation 3), the cognitive trials (Baker 2012 citation 4, Friedman 2013 citation 5, Vitiello 2006 citation 16, Winston 2018 citation 17), the pharmacokinetics record from the historic Geref label (citation 6), the adverse-event summary from the Geref monograph (citation 8), the obesity / HOMA-IR stimulation-test study (citation 7), the BioDrugs pediatric review (citation 19), the idiopathic-short-stature study (citation 21), and the Walker mechanistic-aging review (citation 20).

Review literature 2024-2025

The Dulce 2025 cardiovascular review (citation 9), the Steenblock 2024 diabetes review (citation 10), the Schally 2024 consolidation (citation 11), and the Caputo 2024 adult-GHD practice update (citation 12) collectively reframe the GHRH receptor as a broader endocrine and regenerative target than the historical pituitary GH-release framing implied.

Related-class and regulatory documents

The tesamorelin NEJM HIV-lipodystrophy trial (Falutz 2007 citation 15), the GH-secretagogue review (Ishida 2020 citation 14), the GHRH-agonist wound-healing study (Cui 2016 citation 13), and the Federal Register determination of March 4, 2013 (78 FR 14114, citation 18) that codifies sermorelin's compounding-pathway legal predicate.

The Twenty-One Entries

  1. Thorner M, Rochiccioli P, Colle M, Lanes R, Grunt J, Galazka A, Landy H, Pescovitz O, Heinrich JJ, Reiter EO, et al. (Geref International 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. PMID 8772599 · DOI 10.1210/jcem.81.3.8772599 · Source
  2. 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. PMID 1379256 · DOI 10.1210/jcem.75.2.1379256 · Source
  3. 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. PMID 9141537 · DOI 10.1210/jcem.82.5.3943 · Source
  4. 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. PMID 22869065 · DOI 10.1001/archneurol.2012.1970 · Source
  5. 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 gamma-aminobutyric acid levels in mild cognitive impairment and healthy aging. JAMA Neurology. 2013;70(7):883-890. PMID 23689947 · DOI 10.1001/jamaneurol.2013.1425 · Source
  6. Serono Laboratories. GEREF (sermorelin acetate) injection — FDA-approved prescribing information. FDA Drug Label / NDA 020443. 1997. Source
  7. Cordido F, Garcia-Buela J, Sangiao-Alvarellos S, Martinez T, Vidal O. The decreased growth hormone response to growth hormone releasing hormone in obesity is associated to cardiometabolic risk factors. Mediators of Inflammation. 2010;2010:434562. PMID 20150954 · DOI 10.1155/2010/434562 · Source
  8. Serono Laboratories. Sermorelin acetate prescribing information / drug monograph. FDA-approved label, summarized in RxList monograph. 1997. Source
  9. Dulce RA, Hatzistergos KE, Kanashiro-Takeuchi RM, Takeuchi LM, Balkan W, Hare JM. Growth hormone-releasing hormone signaling and manifestations within the cardiovascular system. Reviews in Endocrine and Metabolic Disorders. 2025. PMID 39883351 · DOI 10.1007/s11154-024-09939-0 · Source
  10. Steenblock C, Bornstein SR. GHRH in diabetes and metabolism. Reviews in Endocrine and Metabolic Disorders. 2024. PMID 39560873 · DOI 10.1007/s11154-024-09930-9 · Source
  11. 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. PMID 39592529 · DOI 10.1007/s11154-024-09929-2 · Source
  12. 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. PMID 39458029 · DOI 10.3390/jcm13206079 · Source
  13. 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. PMID 27623072 · DOI 10.18632/oncotarget.11024 · Source
  14. 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 · Source
  15. Falutz J, Allas S, Blot K, Potvin D, Kotler D, Somero M, Berger D, Brown S, Richmond G, Fessel J, Turner R, Grinspoon S. Metabolic effects of a growth hormone-releasing factor in patients with HIV. New England Journal of Medicine. 2007;357(23):2359-2370. PMID 18057338 · DOI 10.1056/NEJMoa072375 · Source
  16. 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. PMID 16399218 · DOI 10.1016/j.neurobiolaging.2005.01.010 · Source
  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. PMID 30372680 · DOI 10.3233/JAD-180302 · Source
  18. 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. 2013;78 FR 14114. Source
  19. 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. PMID 18031173 · DOI 10.2165/00063030-199912020-00007 · Source
  20. Walker RF. Sermorelin: a better approach to management of adult-onset growth hormone insufficiency? Clinical Interventions in Aging. 2006;1(4):307-308. PMID 18046908 · DOI 10.2147/ciia.2006.1.4.307 · Source
  21. 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. PMID 7962328 · DOI 10.1210/jcem.79.5.7962328 · Source