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Sermorelin for Adults 65 and Older: School, Activity, and Daily-Life Considerations

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At a glance

  • Drug / sermorelin acetate, a 29-amino-acid GHRH analogue; not growth hormone itself [3]
  • FDA status / Geref discontinued in 2008, approvals withdrawn 2009; nothing approved today [2]
  • Older-adult data / a randomized study, 10 men, mean age 68, 14 days of treatment [1]
  • Outcomes measured / 24-hour growth hormone and IGF-I blood levels [1]
  • Sport status / WADA category S2.2.4, prohibited at all times [4]
  • Current approved dose / none; sermorelin sold today is compounded and not FDA-approved [2][5]

What is the evidence in adults 65 and older?

A randomized study by Corpas and colleagues, published in the Journal of Clinical Endocrinology and Metabolism in 1992, is the older-adult study cited here [1]. Ten healthy men with a mean age of 68 and nine young men with a mean age of 26 had baseline IGF-I measurements and 24-hour growth hormone profiles. The older men took GHRH(1-29) 0.5 mg and 1 mg subcutaneously twice daily for 14 days each, in random order. Only the 1 mg dose raised 24-hour growth hormone and IGF-I significantly above baseline, and after it those measures were no longer significantly different between the age groups [1].

A separate 1-year open-label, multicenter study in children is the main safety data for the daily injection. It enrolled 110 previously untreated children with growth hormone deficiency (86 evaluable for efficacy) and found no adverse changes in general biochemical or hormonal tests and no change in fasting glucose [6]. That study was in children, not older adults. A pharmacokinetic study in healthy men aged 19 to 43 also measured hormone responses rather than exercise or daily-life outcomes [7].

Exercise and daily life: what was measured

The 1992 study recorded hormone levels only. It did not measure exercise capacity, falls or memory [1].

What is documented is how the drug works: sermorelin acts on the pituitary's GHRH receptor to prompt the body to release its own growth hormone, and the effect is short-lived. After an intravenous dose in healthy men aged 19 to 43, the peptide was rapidly eliminated while growth hormone stayed raised for about 3 hours [3][7].

Regulatory status, and why there is no standard dose

Sermorelin acetate was approved as Geref, for a pituitary diagnostic test of growth hormone reserve and for pediatric growth hormone deficiency [2]. The manufacturer discontinued it in 2008 and asked FDA to withdraw the applications; FDA withdrew the approvals effective June 18, 2009 [2]. In March 2013, FDA determined that Geref was not withdrawn from sale for reasons of safety or effectiveness [2][8].

Geref was never approved for adults, anti-aging, weight loss or athletic performance [2]. Sermorelin sold in the US today is compounded, and compounded drugs are not FDA-approved: FDA does not review their safety, effectiveness or quality before they are marketed [5].

There is no current FDA-approved sermorelin dose because Geref's approvals were withdrawn and no sermorelin product is FDA-approved today [2][5]. For context only, the pediatric study used 30 micrograms/kg once daily at bedtime and the older-men study used 0.5 mg or 1 mg twice daily for 14 days; neither is a recommended dose for an adult today [6][1].

Sport status

WADA's 2026 Prohibited List names sermorelin in S2.2.4 (growth hormone releasing factors: GHRH and its analogues), prohibited at all times, in and out of competition, as a non-Specified Substance [4]. The 2027 List, in force January 1, 2027, also names it [9].

Frequently asked questions

Is sermorelin FDA-approved for adults over 65?
No. Geref was approved for pediatric growth hormone deficiency and a pituitary diagnostic test, never for adults [2]. The maker discontinued it in 2008 and FDA withdrew the approvals in 2009, so sermorelin sold today is compounded and not FDA-approved [2][5].
Can sermorelin improve exercise capacity or daily function in older adults?
That has not been shown. One older-adult study recorded 24-hour growth hormone and IGF-I levels over 14 days of treatment, not exercise capacity, falls or memory [1].
What dose of sermorelin is used in people 65 and older?
There is no current FDA-approved dose because no sermorelin product is approved [2][5]. For reference only, the pediatric study used 30 micrograms/kg once daily at bedtime and the older-men study used 0.5 mg or 1 mg twice daily for 14 days; neither is a recommended adult dose [6][1].
Was Geref withdrawn because it was unsafe?
No. The maker discontinued it and asked FDA to withdraw the applications, and in March 2013 FDA determined that Geref was not withdrawn from sale for reasons of safety or effectiveness [2][8].
Is sermorelin allowed in sport?
No. WADA's 2026 Prohibited List names sermorelin in S2.2.4, prohibited at all times, in and out of competition [4].

References

Show all 9 referencesHide references
  1. 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. J Clin Endocrinol Metab. 1992;75(2):530-5.
  2. Federal Register :: Request Access.
  3. 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):139-57.
  4. World Anti-Doping Agency.
  5. Official web page.
  6. Thorner M, Rochiccioli P, Colle M, Lanes R, Grunt J, Galazka A, et al. Once daily subcutaneous growth hormone-releasing hormone therapy accelerates growth in growth hormone-deficient children during the first year of therapy. Geref International Study Group. J Clin Endocrinol Metab. 1996;81(3):1189-96.
  7. 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 Paediatr Suppl. 1993;388:10-5.
  8. U.S. Food and Drug Administration.
  9. World Anti-Doping Agency.
Evidence overview for Sermorelin for Adults 65 and Older: School, Activity, and Daily-Life Considerations