Sermorelin: Safety Profile & Research Summary
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Clinical Studies
🏛️ Sermorelin is the classic GHRH fragment — formerly FDA-registered, with a robust tolerability record spanning pediatric, geriatric, and diagnostic applications. Its pulsatile GH release and somatostatin regulation provide a unique tolerability profile.
| Study | Type | n= | Indication | Key Result | Outcome |
|---|---|---|---|---|---|
| Khorram 1997 (Metabolic) | RCT | 19 | Healthy Elderly | +107% nocturnal GH (men), +1.26 kg lean mass | ✅ Positive |
| Khorram 1997 (Immune) | RCT | 19 | Healthy Elderly | +30% B cells, +50% T-cell responsiveness | ✅ Positive |
| Vittone 1997 | Prospective | 11 | Elderly Men | 2x 12h GH release, improved muscle strength | ✅ Positive |
| Corpas 1992 | Dose-ranging | 19 | Young vs Elderly | High-dose restored IGF-1 to young adult levels | ✅ Positive |
| Sigalos 2017 | Retrospective | 14 | Hypogonadal Men | Significant IGF-1 increase at 90, 180, 270 days | ✅ Positive |
| Thorner 1996 (Geref ISG) | Multicenter OL | 110 | Pediatric GHD | 8.0 cm/yr (from 4.1), 74% good response | ✅ Positive |
| Diagnostic | Standard | — | Pituitary Function | 1 µg/kg IV; fewer false positives | ✅ Standard |
| Veldhuis 2008 | Physiology | 22 | GH Burst Waveform | GHRH+GHRP-2 → 54x GH mass vs saline | ✅ Positive |
Reported Tolerability Profile
Sermorelin has a well-established tolerability record from FDA-registered experimental investigation. [4]
- Common: Injection site reactions (~16%), transient facial flushing, headache, nausea, dizziness
- Immunogenicity: Up to 70% develop anti-GRF antibodies with chronic use — typically non-neutralizing, do not affect efficacy
- Rare: Dysphagia, hyperactivity, somnolence, urticaria, chest tightness
- Reproductive: Pregnancy Category C — minor fetal variations in rats/rabbits at 3–6x human dose
- Contraindications: Active malignancy, untreated hypothyroidism, hypersensitivity, pregnancy
- Key Regulatory Note: FDA confirmed Geref was NOT withdrawn for tolerability or efficacy reasons [4]
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References
- Chang Y, Huang R, Zhai Y, et al. A potentially effective compound for study subjects with recurrent glioma: sermorelin. Ann Transl Med, 9(5), 406, 2021.
- Prakash A, Goa KL. Sermorelin: a review of its use in the diagnosis and investigation of children with idiopathic growth hormone deficiency. BioDrugs, 12(2), 139-157, 1999.
- Walker RF. Sermorelin: a better approach to management of adult-onset growth hormone insufficiency? Clin Interv Aging, 1(4), 307-308, 2006.
- Food and Drug Administration. Determination That GEREF (Sermorelin Acetate) Injection Was Not Withdrawn From Sale for Reasons of tolerability or Effectiveness. Fed Register, 78(42), 14095-14096, 2013.
- Sinha DK, Balasubramanian A, Tatem AJ, et al. Beyond the androgen receptor: the role of growth hormone secretagogues in the modern management of body composition in hypogonadal males. Transl Androl Urol, 9(Suppl 2), S149-S159, 2020.
- Grossman AB, Savage MO, Lytras N, Besser GM. Responses to analogues of growth hormone releasing hormone in normals and in GH-deficient children and young adults. Clin Endocrinol (Oxf), 21(3), 321-330, 1984.
- Corpas E, Harman SM, Piñeyro MA, et al. Growth hormone (GH)-releasing hormone-(1-29) twice daily reverses the decreased GH and insulinlike growth factor-I levels in old men. J Clin Endocrinol Metab, 75(2), 530-535, 1992.
- Heiman ML, Nekola MV, Murphy WA, Lance VA, Coy DH. An extremely sensitive in vitro model for elucidating structure-activity relationships of growth hormone-releasing factor analogs. Endocrinology, 116(1), 410-415, 1985.
- Gelander L, Lindstedt G, Selstam G, et al. Effects of acute IV injection of two growth hormone-releasing hormones on serum GH and other pituitary hormones in short children. Horm Res, 31(5-6), 213-220, 1989.
- Khorram O, Laughlin GA, Yen SS. Endocrine and metabolic effects of long-term administration of [Nle27]GHRH-(1-29)-NH2 in age-advanced men and women. J Clin Endocrinol Metab, 82(5), 1472-1479, 1997.
- 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. J Clin Endocrinol Metab, 82(11), 3590-3596, 1997.
- Vittone J, Blackman MR, Busby-Whitehead J, et al. Effects of single nightly injections of GHRH 1-29 in healthy elderly men. Metabolism, 46(1), 89-96, 1997.
- Vitiello MV, Schwartz RS, Moe KE, Mazzoni G, Merriam GR. Treating age-related changes in somatotrophic hormones, sleep, and cognition. Dialogues Clin Neurosci, 3(3), 229-236, 2001.
- Sigalos JT, Pastuszak AW, Allison A, et al. Growth Hormone Secretagogue research application in Hypogonadal Men Raises Serum IGF-1 Levels. Am J Mens Health, 11(6), 1752-1757, 2017.
- Schally AV, Wang H, He J, et al. Agonists of growth hormone-releasing hormone (GHRH) inhibit human experimental cancers in vivo by down-regulating receptors for GHRH. PNAS, 115(47), 12028-12033, 2018.
- Jaszberenyi M, Rick FG, Popovics P, et al. Potentiation of cytotoxic chemotherapy by growth hormone-releasing hormone agonists. PNAS, 111(2), 781-786, 2014.
- Soule SG, King JA, Millar RP. Incorporation of D-Ala2 in GHRH-(1-29)-NH2 increases half-life and decreases metabolic clearance in normal men. J Clin Endocrinol Metab, 79(4), 1208-1211, 1994.
- Merriam GR, Buchner DM, Prinz PN, Schwartz RS, Vitiello MV. Potential applications of GH secretagogs in the evaluation and investigation of the age-related decline in GH secretion. Endocrine, 7(1), 49-52, 1997.
- Walker RF, Yang SW, Bercu BB. Robust Growth Hormone (GH) secretion in aged female rats co-administered GH-releasing hexapeptide (GHRP-6) and GH-releasing hormone (GHRH). Life Sci, 49(20), 1499-1504, 1991.
- Rafferty B, Coy DH, Poole S. Pharmacokinetic evaluation of superactive analogues of growth hormone-releasing factor (1-29)-amide. Peptides, 9(1), 207-209, 1988.
Related Research Questions
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