# Sermorelin Pediatric Growth Hormone Deficiency: What the Trials Reviewed > Sermorelin pediatric growth hormone deficiency trials reviewed: once-daily subcutaneous GHRH(1-29) raised first-year height velocity from ~4.1 to ~7-8 cm/year, and a former US approval, withdrawn in 2008. The childhood-growth chapter that earned a former US approval — the height-velocity data, the long-term safety record, and the regulatory history, read straight. ## The short version This page covers sermorelin pediatric growth hormone deficiency research — the studies in children who were short because their bodies made too little growth hormone. The headline result: a daily bedtime injection of GHRH(1-29) sped up growth, lifting first-year height velocity from about 4.1 cm a year toward 7-8 cm a year [1]. This is the work that made sermorelin an approved children's medicine in the US. It was later pulled from the US market in 2008 for business reasons — not because it was unsafe or didn't work — and is now made by compounding pharmacies. The details and the regulatory history follow. ## The height-velocity result The central finding in **sermorelin pediatric growth hormone deficiency** research is acceleration of linear growth. In a multicenter trial of prepubertal GH-deficient children, once-daily subcutaneous GHRH(1-29) raised first-year height velocity from about 4.1 cm/year to roughly 7-8 cm/year, and did so without excessive IGF-1 generation [1] — the growth response came on while the feedback loop appeared to hold. Height velocity — how many centimeters a child grows in a year — is the standard yardstick in this field precisely because it is sensitive and quick to read: you do not have to wait for final adult height to see whether a treatment is doing anything. Going from roughly 4.1 to 7-8 cm/year is close to a doubling of the growth rate, and the qualifier "without excessive IGF-1 generation" is doing real work in that sentence. It signals that the acceleration was driven by the body's own feedback-regulated GH release rather than by flooding the system, which is the mechanistic distinction this whole site turns on [1]. A head-to-head comparison sharpened the picture. In 43 prepubertal children with hypothalamic-origin GH deficiency randomized to low-dose GHRH(1-29)NH2 (30 mcg/kg/day), high-dose (60 mcg/kg/day), or growth hormone for six months, height velocity was lowest in the low-dose GHRH group but comparable between the high-dose GHRH and growth-hormone groups [10]. One distinction stood out: an increase in height SDS for bone age — a measure of how a child's height compares to peers, corrected for skeletal maturity — occurred only in the growth-hormone-treated group [10]. The reading is careful: high-dose GHRH(1-29) matched growth hormone on raw growth rate over six months, but the two approaches were not identical on every measure, and that nuance is exactly the kind of detail a literature review should surface rather than smooth over. ## The long-term pediatric safety record The longest pediatric cohort ran 12-24 months. Prepubertal GH-deficient children treated with a single daily subcutaneous 30 mcg/kg dose developed GHRH antibodies in several responders, but those antibodies did not appear to interfere with growth, and no side effects or changes in glucose and lipid levels were noted during therapy [7]. The continuous-infusion literature flagged a different pattern worth knowing. In six children given GHRH(1-29)NH2 by continuous subcutaneous infusion for six months, an early increase in integrated GH was followed by a consistent decline by 3-6 months, with one child showing complete suppression of GH secretion [9]. Investigators studied whether this reflected GHRH antibodies, somatostatin changes, or desensitization of pituitary GHRH receptors [9]. The lesson the field drew is that pulse-aligned, intermittent stimulation preserves responsiveness in a way that continuous exposure may not — which is why the efficacy work used once-daily bedtime dosing rather than an infusion. ## Why sermorelin left the US market Sermorelin was an FDA-approved prescription drug for the evaluation and treatment of growth hormone deficiency and short stature in children (under NDA 020443), and it was withdrawn from the US market in 2008 for commercial reasons — not because of safety or efficacy problems. The approval history is frequently misstated in popular summaries, which variously claim sermorelin was "never approved" or was "pulled for safety," so it is worth stating precisely: it was approved, it remained safe and effective on its label, and it was then commercially discontinued. The distinction is not pedantic. A drug withdrawn because it failed or harmed people carries a very different signal than one withdrawn because a manufacturer decided the product was no longer commercially worthwhile, and sermorelin is squarely the latter. After the branded product left the market, the molecule did not disappear; it is now prepared by compounding pharmacies for individual patients. Its compounding status is also specific. Sermorelin is treated as a long-standing Category 1 bulk drug substance under FDA's interim Section 503A policy (final guidance issued January 2025), and FDA has stated it does not intend to take enforcement action against Category 1 compounding while its review continues. That situation is distinct from other GH-axis peptides that were taken up by the Pharmacy Compounding Advisory Committee, and the two should not be conflated. This is a research digest, not legal or regulatory advice; the framing here simply states the documented history and status. ## Acute endocrine effects in children Beyond growth, the acute pediatric studies characterized the immediate hormonal response. In 20 short prepubertal children, an acute intravenous 1 mcg/kg injection of GHRH 1-29 produced a GH rise comparable to native GHRH 1-40, but also induced small short-term increases in serum prolactin, luteinizing hormone, and follicle-stimulating hormone [8]. These off-target rises were minor and transient — a reminder that even a near-selective GHRH stimulus touches neighboring pituitary outputs briefly. They are reported here as study observations, not as predicted effects in any individual. --- A reviewer's reading desk for the Sermorelin record — the GHRH(1-29) pediatric height-velocity, half-life, and adult GH/IGF-1 figures loaded into one window and read straight from the published literature; no clinic behind the screen and nothing here sourced, dispensed, or sold.