Sermorelin Side Effects: Incidence Rates Across Clinical Trials

What trial data exist?

Three studies are described here, and their designs differ too much to pool.

The largest was a 1-year, open-label, multicenter study of 110 previously untreated prepubertal children with growth hormone deficiency (86 evaluable), given 30 micrograms/kg subcutaneously at bedtime, with clinical chemistry checked every 3 to 6 months [1]. In older men, one randomized study gave 10 men (mean age 68) 0.5 mg and 1 mg twice daily for 14 days each in random order, compared with 9 young men [2]; another gave 11 men aged 64 to 76 with low baseline IGF-I 2 mg nightly for 6 weeks [3].

Which side effects are reported?

A review of sermorelin in children reports that single intravenous doses and repeated once-daily subcutaneous doses were well tolerated, and that transient facial flushing and pain at the injection site were the most commonly reported adverse events; the review's abstract gives no percentages [6]. The pediatric study described its safety findings in aggregate rather than as event counts [1].

What the 1-year pediatric study recorded

No adverse changes were noted in general biochemical or hormonal analyses, fasting glucose did not change, IGF-I was not excessively generated, and sermorelin was well tolerated overall [1]. Mean 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% of children were good responders at 6 months [1]. The study was open-label, with no placebo group [1].

What the two adult studies measured

In the 10 older men, 24-hour growth hormone and IGF-I rose at 1 mg twice daily to levels not significantly different from the young men [2]. In the 11 men treated for 6 weeks, nocturnal growth hormone rose, while IGF-I, IGFBP-3 and growth hormone binding protein did not change, and glucose, insulin and growth hormone responses to an oral glucose tolerance test did not change [3].

Is there a current label to check for side-effect rates?

No. Geref was the only FDA-approved sermorelin: a 0.05 mg/ampule diagnostic product (approved December 28, 1990) and 0.5 mg and 1 mg vials for treating idiopathic growth hormone deficiency in children with growth failure (approved September 26, 1997) [4]. The maker discontinued both in 2008, and FDA withdrew the approvals effective June 18, 2009; in March 2013 FDA determined Geref was not withdrawn for reasons of safety or effectiveness [4]. The pediatric study used 30 micrograms/kg once daily at bedtime [1]. With the approvals withdrawn, there is no current FDA-approved sermorelin dose [4]. Sermorelin sold in the US today is compounded, not FDA-approved [5].