1992
This landmark study showed that twice-daily GHRH (the brain signal that triggers growth hormone; sermorelin is a copy of it) injections in older men completely restored their GH (growth hormone) and IGF-1 (a growth hormone helper made in the liver) levels to match those of young men. After just 14 days, the age-related hormone decline was reversed, suggesting that the pituitary gland can still respond; it just needs the right signal.
Corpas E, Harman SM, Pineyro MA, Roberson R, Blackman MR
1997
Tested [Nle27]GHRH-(1-29)-NH2, a norleucine analog (a close chemical variant), not sermorelin itself: 10 mcg/kg nightly for 16 weeks in 9 men and 10 women aged 55-71. GH, IGF-1 and skin thickness rose in both sexes. Lean mass, insulin sensitivity (how well cells respond to insulin), well-being and libido improved in men only. Fat, bone density and sleep quality did not change. The only side effect was transient hyperlipidemia (a short-lived rise in blood fats).
Khorram O, Laughlin GA, Yen SS
1997
Six weeks of nightly sermorelin increased night-time GH release and improved some measures of muscle strength in healthy elderly men. The study suggested that once-daily dosing helps, but twice-daily dosing may be more effective for maximizing benefits.
Vittone J, Blackman MR, Busby-Whitehead J, et al.
1999
This study proved that aging causes reduced GHRH (the brain signal that triggers growth hormone) output from the hypothalamus (the brain area that controls the pituitary), not just a tired pituitary. The pituitary still responds well to GHRH stimulation in elderly people, which is why sermorelin works: it provides the signal the aging hypothalamus no longer sends strongly enough.
Russell-Aulet M, Jaffe CA, Demott-Friberg R, Barkan AL
2017
Men taking sermorelin combined with GHRPs (growth hormone-releasing peptides) three times daily showed significant increases in IGF-1 levels (from 160 to 239 ng/mL on average). The study confirmed that growth hormone secretagogues (drugs that trigger GH release) are effective for raising IGF-1 in adults seeking to improve body composition (the balance of fat and muscle).
Sigalos JT, Pastuszak AW, Allison A, Khera M
1999
Sermorelin is the shortest synthetic fragment of growth hormone-releasing hormone that keeps full biological activity. A single 1 mcg/kg dose through a vein is a rapid, relatively specific provocative test (a test that triggers a response) for growth hormone deficiency. Once-daily 30 mcg/kg injected under the skin at bedtime raised height velocity (growth speed) over 12 months in some prepubertal children with idiopathic deficiency (growth hormone deficiency with no known cause). Single doses through a vein and repeated once-daily doses under the skin were well tolerated. Transient facial flushing and pain at the injection site were the most commonly reported side effects.
Prakash A, Goa KL
2013
FDA's regulatory record for sermorelin. GEREF injection 0.5 and 1.0 mg base/vial is NDA 20-443 (an NDA is a New Drug Application, the FDA's approval file), held by EMD Serono and first approved on September 26, 1997, to treat children who fail to grow because of growth hormone deficiency with no known cause. GEREF injection 0.05 mg base/amp is NDA 19-863, first approved December 28, 1990, as a test of how well the pituitary's growth hormone-making cells (somatotrophs) can release growth hormone. EMD Serono notified FDA in letters dated July 11 and December 2, 2008 that the products were being discontinued and requested withdrawal of the applications. Approval of both NDAs was withdrawn effective June 18, 2009. FDA determined that neither product was withdrawn from sale for reasons of safety or effectiveness.
US Food and Drug Administration
2018
Review of clinical studies of growth hormone secretagogues (drugs that trigger GH release) in humans. Secretagogues cause GH to be released in pulses and remain subject to negative feedback (the body's braking system), which can prevent GH levels higher than needed for treatment and their harmful effects. In contrast, exogenous GH (GH given from outside the body) has drawbacks believed to be due in part to damaged feedback control. Across the available studies, secretagogues improved growth velocity (growth speed) in children, stimulated appetite, improved lean mass in wasting states and in obese individuals, increased fat-free mass and improved sleep, and were well tolerated, with some concern for increases in blood glucose from decreased insulin sensitivity. The authors note that few long-term, rigorously controlled studies exist.
Sigalos JT, Pastuszak AW
1991
Twenty-one healthy men aged 21-71 of near-normal body weight were sampled every 10 minutes for 24 hours and analysed by deconvolution (a math method that works out how much hormone was released). At a normal body mass index (BMI), each decade of increasing age lowered the GH production rate by 14% and the GH half-life by 6%. Age and BMI together accounted for more than 60% of the variability in 24-hour GH production rates.
Iranmanesh A, Lizarralde G, Veldhuis JD