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Sermorelin Dosage: What the Approved Product and Trials Actually Used

A single diagnostic dose, a nightly pediatric regimen, and two small studies in older men. That is the whole documented record for sermorelin dosing.

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By Craig PalmerPublished

Sermorelin has a documented dose for exactly two uses, both from its time as an approved drug called GEREF: a one-time diagnostic test of the pituitary, and nightly treatment of growth hormone deficiency in children. Everything written about adult dosing since then rests on a handful of small studies, and this page reports those doses as what the studies used, not as a recommendation.

Sermorelin is the first 29 amino acids of growth-hormone-releasing hormone [1], which acts on the pituitary to release growth hormone in pulses. Its side effects are covered in sermorelin side effects, and what a peptide is, and why most are injected, in what are peptides.

What the approved product was supplied as

FDA’s 2013 notice lists the approved GEREF presentations: 0.5 mg and 1.0 mg vials for treating idiopathic growth hormone deficiency in children with growth failure, and a 0.05 mg ampule for testing whether the pituitary can secrete growth hormone [2]. Both were discontinued in 2008, and the notice records FDA’s finding that neither was withdrawn for reasons of safety or effectiveness.

The diagnostic dose

The 1999 review describes the test as a single intravenous dose of 1 microgram per kilogram of body weight [1]. The growth hormone response that follows is fast and fairly specific, which is what made it useful for diagnosis, though the review notes a normal response cannot rule out a deficiency that starts in the hypothalamus rather than the pituitary.

The treatment dose in children

For treatment, the review describes once-daily injections under the skin of 30 micrograms per kilogram, given at bedtime, as effective in some prepubertal children with idiopathic growth hormone deficiency [1]. The review also reports that the same total given as a continuous infusion or in three divided doses produced smaller gains than once-daily somatropin.

The largest trial of that regimen treated 110 previously untreated prepubertal children for up to a year [3]. Among the 86 eligible for the efficacy analysis, mean height velocity rose from 4.1 cm a year at baseline to 8.0 cm at 6 months and 7.2 cm at 12 months, and 74% were judged good responders at 6 months. The study was open-label, with no placebo group.

What adult studies used

In a 1992 study, 10 healthy older men injected both 0.5 mg and 1 mg under the skin twice a day, in random order, each for 14 days [4]. Growth hormone and IGF-1 rose significantly only on the higher dose, which brought them back to the levels measured in young men.

In a 1997 study, 11 men aged 64 to 76 injected 2 mg once each night for 6 weeks [5]. Nighttime growth hormone release rose, but IGF-1 did not, and body composition did not change. The authors concluded that a single nightly dose was less effective than multiple daily doses, so even the timing of an adult dose is an open question in this record.

What these doses do not tell you

None of these studies tested sleep, recovery or aging as outcomes. Only the 1997 study measured muscle strength, in 11 men, and none of the adult studies ran longer than six weeks. How sermorelin compares with a growth hormone peptide that works through a different receptor is in sermorelin vs ipamorelin, and the sleep studies of this hormone family are in peptides for sleep. A prescriber sets any actual dose.

Frequently asked questions

What was the approved sermorelin dose?
For growth hormone deficiency in children, the 1999 review describes 30 micrograms per kilogram under the skin once daily at bedtime. For the diagnostic test, a single intravenous dose of 1 microgram per kilogram.
Is there an approved adult dose of sermorelin?
Not in the sources read here. The approved uses were a pediatric treatment and a diagnostic test. Two small studies in older men used 0.5 mg to 2 mg injections.
Is sermorelin taken at night?
The pediatric regimen was given at bedtime. A 1997 study of once-nightly 2 mg in older men concluded that a single nightly dose was less effective than multiple daily doses.
What strengths was GEREF supplied in?
FDA's 2013 notice lists 0.5 mg and 1.0 mg vials for treatment and a 0.05 mg ampule for diagnostic testing.

Sources

5 cited
  1. 1Prakash A, Goa KL (1999). Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency BioDrugs. PMID 18031173
  2. 2U.S. Food and Drug Administration (2013). 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. Source
  3. 3Thorner M, Rochiccioli P, Colle M, et al. (1996). 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 Journal of Clinical Endocrinology and Metabolism. PMID 8772599
  4. 4Corpas E, Harman SM, Piñeyro MA, et al. (1992). 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 and Metabolism. PMID 1379256
  5. 5Vittone J, Blackman MR, Busby-Whitehead J, et al. (1997). Effects of single nightly injections of growth hormone-releasing hormone (GHRH 1-29) in healthy elderly men Metabolism. PMID 9005976

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