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Sermorelin Side Effects: Withdrawal and Discontinuation Syndrome Explained

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At a glance

  • What it is / 29-amino-acid GHRH analogue that triggers pituitary growth hormone release [1]
  • FDA status / Geref discontinued 2008; approvals withdrawn June 2009; none approved today [2]
  • Approved uses were / Pediatric growth hormone deficiency and a pituitary diagnostic test [2]
  • Withdrawal syndrome / Not reported in the sermorelin trials and reviews on this page [1][3][4][5]
  • Effect of one dose / Growth hormone raised for about 3 hours after an intravenous dose in a study of 30 healthy men [5]
  • 1-year pediatric data / No adverse hormone or chemistry changes; fasting glucose unchanged [3]

Does sermorelin cause withdrawal symptoms?

No withdrawal syndrome is described in the sermorelin studies on this page. They report what happened during treatment, so they cannot predict symptoms after stopping [3][4]. No taper schedule or post-treatment symptom timeline is reported in them [3][4].

What sermorelin does, and how long a dose lasts

Sermorelin is a 29-amino-acid analogue of human growth hormone-releasing hormone, the shortest synthetic peptide with the full biological activity of GHRH [1]. It acts on the pituitary's GHRH receptor to trigger release of the body's own growth hormone; it is not growth hormone [1].

In 30 healthy men aged 19 to 43, intravenous GHRH(1-29) was rapidly eliminated, yet growth hormone stayed elevated for about 3 hours [5]. In the same study, growth hormone secretion was not suppressed overnight after three intranasal doses in a day [5]. These findings describe short-term hormone responses to a single day of dosing [5].

What the 1-year pediatric trial recorded

Thorner et al. gave 110 previously untreated prepubertal children with growth hormone deficiency 30 micrograms per kg subcutaneously at bedtime for up to 1 year; 86 were evaluable for efficacy [3]. Height velocity rose from 4.1 cm/yr at baseline to 8.0 cm/yr at 6 months and 7.2 cm/yr at 12 months, and 74 percent had a good response at 6 months [3]. No adverse changes in general biochemical or hormonal analyses were reported, fasting glucose did not change, IGF-I was not excessively raised, and the peptide was well tolerated overall [3].

The adult study in older men

Corpas et al. gave 10 healthy older men (mean age 68) GHRH(1-29) at 0.5 mg and 1 mg subcutaneously twice daily for 14 days each, in random order with a 14-day no-treatment gap, and compared them with 9 young men (mean age 26) [4]. At the 1 mg dose, 24-hour growth hormone and IGF-I rose to levels not significantly different from the young men [4]. It is a short physiology study, not a trial of symptoms or clinical benefit [4].

The regulatory backdrop

Geref, the only approved sermorelin brand, was discontinued by its manufacturer in 2008, and FDA withdrew both applications effective June 18, 2009; in March 2013 FDA determined it was not withdrawn for reasons of safety or effectiveness [2]. Its approved uses were pediatric growth hormone deficiency and a diagnostic test of pituitary growth hormone reserve, not adult anti-aging or weight loss [2]. Sermorelin sold in the United States now is compounded, and FDA does not review compounded drugs for safety, effectiveness or quality before they are marketed [6].

Frequently asked questions

Does sermorelin cause withdrawal symptoms when you stop?
No withdrawal syndrome is described in the sermorelin studies on this page. They report effects during treatment, so they do not show what happens after stopping [3][4].
Do you need to taper off sermorelin?
No taper schedule or post-treatment symptom timeline is reported in the sermorelin studies on this page [3][4]. Sermorelin prompts the pituitary to release the body's own growth hormone rather than supplying growth hormone itself [1], and growth hormone stayed elevated for about 3 hours after an intravenous dose in a study of 30 healthy men [5].
How long does a sermorelin dose last?
In 30 healthy men, intravenous GHRH(1-29) was rapidly eliminated but growth hormone stayed elevated for about 3 hours [5]. In the same study, growth hormone secretion was not suppressed during the night after three intranasal doses in one day [5].
Is sermorelin FDA-approved?
Not today. Geref was approved for pediatric growth hormone deficiency and a pituitary diagnostic test, was discontinued in 2008, and its approvals were withdrawn in 2009; FDA later determined it was not removed for safety or effectiveness reasons [2].
What was reported during treatment?
In the 1-year pediatric study of 110 children, there were no adverse changes in biochemical or hormonal tests, fasting glucose was unchanged, IGF-I was not excessively raised, and the drug was well tolerated [3].

References

  1. 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
  2. Federal Register :: Request Access. Federal Register :: Request Access
  3. 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
  4. 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
  5. 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. Pharmacokinetics of growth hormone-releasing hormone(1-29)-NH2 and stimulation of growth hormone secretion in healthy subjects after intravenous or intranasal administration
  6. Official web page. Official web page
  7. MedWatch: The FDA Safety Information and Adverse Event Reporting Program | FDA. MedWatch: The FDA Safety Information and Adverse Event Reporting Program | FDA
Evidence overview for Sermorelin Side Effects: Withdrawal and Discontinuation Syndrome Explained