Sermorelin Super-Responder Profile: Who Gets the Best Results and Why

At a glance

  • Regulatory status / Not FDA-approved today; Geref approvals were withdrawn in 2009 [3]
  • Largest response dataset / 110 children with growth hormone deficiency, 86 evaluable, 1 year [1]
  • Good responders / 74% at 6 months after 30 micrograms/kg nightly [1]
  • Growth result / Height velocity 4.1 cm/yr at baseline, 8.0 at 6 months, 7.2 at 12 months [1]
  • Age finding / At 1 mg twice daily, older men's GH and IGF-I were not significantly different from young men's [2]
  • Sport status / Prohibited at all times by WADA [5]

Does sermorelin have a proven super-responder profile?

No. Sermorelin is a 29-amino-acid analogue of growth hormone-releasing hormone, the shortest synthetic peptide with the full biological activity of GHRH, and it makes the pituitary release the body's own growth hormone rather than supplying growth hormone itself [6]. The closest thing to response data is one large pediatric growth trial and one small hormone study in older men, both described below.

What the largest trial showed

The Geref International Study Group trial (Thorner et al., 1996) was an open-label, multicenter, 1-year study of 110 previously untreated prepubertal children with growth hormone deficiency, 86 evaluable, given 30 micrograms/kg subcutaneously at bedtime [1]. Mean height velocity rose from 4.1 cm/yr to 8.0 cm/yr at 6 months and 7.2 cm/yr at 12 months, and 74% were good responders at 6 months [1]. Fasting glucose did not change, IGF-I was not excessively raised, and the treatment was well tolerated overall [1].

The older-men study

A 1992 study enrolled 10 healthy older men (mean age 68) and 9 younger men (mean age 26) [2]. The older men received 0.5 mg and 1 mg in random order, each twice daily for 14 days, with a 14-day period without treatment between doses [2]. At baseline, the older men had lower IGF-I and a shorter mean peak duration of spontaneous GH release than the young men [2]. At 1 mg twice daily, 24-hour GH, area under peaks, peak amplitude and IGF-I all rose significantly versus the older men's baseline, and none differed significantly from the young men afterward [2]. This was a short physiology study, not a clinical-benefit trial [2].

Dose

No sermorelin product is FDA-approved today, so there is no current approved dose [3]. The doses used in the studies above were 30 micrograms/kg nightly in children [1] and 0.5 mg or 1 mg twice daily for 14 days in older men [2]. These are study doses, not recommended doses.

Regulatory status and sport

Geref was approved in 1990 as a diagnostic test of pituitary GH reserve and in 1997 for pediatric GH deficiency [3]. The manufacturer discontinued it in 2008 and FDA withdrew both approvals effective June 18, 2009, later determining it had not been withdrawn for safety or effectiveness [3]. It was never approved for adults, anti-aging, weight loss or athletic performance [3]. Sermorelin sold today is compounded, and compounded drugs are not FDA-approved [8]. HealthRX.com offers sermorelin by prescription. WADA's 2026 Prohibited List names sermorelin in S2.2.4, prohibited at all times [5], and so does the 2027 List [9].

Frequently asked questions

Who responds best to sermorelin?
No responder profile has been established. In the one large trial, 74% of children with growth hormone deficiency were good responders at 6 months on 30 micrograms/kg nightly [1].
Did older men respond differently?
In a 14-day study, 10 older men at 1 mg twice daily reached GH and IGF-I levels not significantly different from those of 9 young men [2]. It was a short physiology study, not a responder analysis.
Is sermorelin FDA approved today?
No. Geref was discontinued in 2008 and both approvals were withdrawn effective June 18, 2009 [3]. Sermorelin sold today is compounded and not FDA-reviewed [8].

References

  1. 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. 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
  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. J Clin Endocrinol Metab. 1992;75(2):530-5. Growth hormone (GH)-releasing hormone-(1-29) twice daily reverses the decreased GH and insulin-like growth factor-I levels in old men
  3. Federal Register :: Request Access. Federal Register :: Request Access
  4. Veldhuis JD, Iranmanesh A, Ho KK, Waters MJ, Johnson ML, Lizarralde G. Dual defects in pulsatile growth hormone secretion and clearance subserve the hyposomatotropism of obesity in man. J Clin Endocrinol Metab. 1991;72(1):51-9. Dual defects in pulsatile growth hormone secretion and clearance subserve the hyposomatotropism of obesity in man
  5. World Anti-Doping Agency. World Anti-Doping Agency
  6. 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. Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency
  7. Van Cauter E, Leproult R, Plat L. Age-related changes in slow wave sleep and REM sleep and relationship with growth hormone and cortisol levels in healthy men. JAMA. 2000;284(7):861-8. Age-related changes in slow wave sleep and REM sleep and relationship with growth hormone and cortisol levels in healthy men
  8. Official web page. Official web page
  9. World Anti-Doping Agency. World Anti-Doping Agency
Evidence overview for Sermorelin Super-Responder Profile: Who Gets the Best Results and Why