What is Sermorelin used for?

What it is being studied for

• Children with growth-hormone deficiency: in a 60-child randomized trial, height velocity was 9.2–9.3 cm/yr on sermorelin versus 14.6 cm/yr on growth hormone, which produced significantly better growth (human randomized trial) [1].
• Dose comparison in 43 children: the high dose matched growth hormone on height velocity, the low dose lagged, and height for bone age rose only with growth hormone (human randomized trial) [2].
• Once-daily bedtime injections in 110 children: height velocity rose from 4.1 cm/yr to 8.0 at 6 months and 7.2 at 12 months, with no control group (human observational study) [3].
• Short children without growth-hormone deficiency: in 18 children, height velocity rose from 4.8 to 7.2 cm/yr over 12 months and fell back after stopping (human observational study) [4].
• Healthy older men: 11 men aged 64–76 given nightly injections for 6 weeks had more night-time growth-hormone release, but IGF-1, body composition and blood lipids did not change (small uncontrolled human observational study) [5]. No placebo-controlled adult trial of body composition, strength or “anti-aging” outcomes was found.
• Men on testosterone: a chart review of 14 men also taking GHRP-6 and GHRP-2 with sermorelin reported IGF-1 rising from 159.5 to 239.0 ng/mL; the effect cannot be assigned to sermorelin alone (human observational study) [6].
• Nasal spray: a pharmacokinetic study gave intranasal sermorelin to 30 healthy men and measured bioavailability of only 3–5% (human pharmacokinetic study) [7]. Two brain experiments used intranasal “GHRH” without naming the fragment — about 12% fewer word pairs recalled in 12 men [8], and more REM and deep sleep in 23 men [9] (human placebo-controlled crossover studies). Neither was a sermorelin treatment trial.
• Regulatory status: both US applications for Geref (NDA 019863, 1990; NDA 020443, 1997) are listed as discontinued, and the FDA record carries a determination that the discontinuation was not for safety or effectiveness reasons [10].

How it works

1. It is the active front section of the natural growth-hormone-releasing hormone; laboratory substitution studies mapped which of its 29 building blocks are needed for its growth-hormone-releasing strength [11].
2. It triggers growth-hormone release from rat pituitary cells in a dish and in live rats (laboratory and animal studies) [12].
3. In people, nightly injections increased night-time growth-hormone release without changing IGF-1 over 6 weeks [5].
4. During continuous infusion under the skin, growth hormone kept coming in natural pulses and the pituitary still responded to an extra large dose [13].
5. What sets it apart: it is the plain, unmodified 1–29 fragment. CJC-1295 was built from the same fragment as a long-lasting version that binds the blood protein albumin, and that work used plain hGRF(1-29) as its comparator [12]. Unlike growth hormone itself, it works through the pituitary’s own release, and in the pediatric trial growth hormone produced faster growth [1].

Adverse events reported

• No serious side effects in the 60-child trial; 3 children on sermorelin reported mild injection-site irritation, and 39 of 40 developed antibodies to it, nearly gone 9 months after stopping [1].
• Antibodies developed in 14 of 18 children in an earlier study, with no evident effect on growth [14].
• The 110-child study reported no adverse changes in blood chemistry or hormones and no change in fasting glucose [3].
• Fasting glucose and insulin rose during treatment in the short-stature study [4].
• The older-men study reported no significant adverse effects over 6 weeks [5].
• These statements come from the study abstracts; the full safety sections were not read.

Forms

Human studies used under-the-skin injection once or twice daily [3][14], continuous under-the-skin infusion [1][13] and intravenous doses as a stimulation test [14][4]. Intranasal data are limited to one pharmacokinetic study, which measured 3–5% bioavailability [7], and two brain experiments with intranasal “GHRH” of unstated fragment [8][9]. No oral studies were found.

Which peptides have actually been studied or approved as a nasal spray, compound by compound. Which peptides come as a nasal spray?.