# Sermorelin Dosage Research Context — What the Studies and Historical Label Recorded > A research-context summary of sermorelin doses as documented in pediatric pivotal trials, adult investigational studies, the historical NDA 020443 label, and current 503A/503B compounding practice. Not a dosing guide. A research-context reading of pediatric pivotal doses, adult investigational regimens, intravenous diagnostic use, pharmacokinetic constraints, and the compounding practice that succeeded the branded formulation. ## A note before the dosage record This page describes doses as they appear in published studies and in the historical NDA 020443 label. It is a research-context record, not a dosing guide. No dose on this page is presented as a recommendation for any person. The pediatric label called for 30 micrograms per kilogram injected subcutaneously once nightly at bedtime. The two main adult investigational studies used 10 and 14 micrograms per kilogram nightly — roughly 0.5 mg to 1 mg per evening dose in a typical adult. All of these schedules were timed to the body's natural early-slow-wave-sleep growth-hormone burst, because sermorelin's 12-minute plasma half-life means it must be timed to the window it is trying to reinforce. ## What the historical label and pivotal trials recorded The FDA-approved pediatric therapeutic regimen, as labeled in the historical NDA 020443 product, was 30 mcg/kg subcutaneous once daily, administered at bedtime to coincide with the natural early-slow-wave-sleep GH pulse [3]. This is the regimen used in the pivotal multicenter International Study Group trial that enrolled 110 prepubertal GH-deficient children and reported sustained increases in height velocity over 36 months of treatment [15]. The Kirk trial published in Clinical Endocrinology in 1994 used a different regimen — 20 mcg/kg subcutaneous twice daily over 12 months in 17 children with idiopathic short stature — and reported a mean height-velocity rise from 4.8 to 7.2 cm per year [2]. The twice-daily program was investigational and did not become the labeled schedule. The original 1990 FDA-approved diagnostic indication for sermorelin used a single 1 mcg/kg intravenous bolus as a provocative GH-stimulation test for hypothalamic-pituitary GHD; the test was characterized as relatively specific, with fewer false positives than alternative provocative agents available at the time [4]. ## What the adult investigational studies recorded Two adult anti-aging investigational regimens recur in the literature. The Khorram trial published in 1997 used 10 mcg/kg subcutaneous nightly over 16 weeks in adults aged 55 to 71 [6]. The Vitiello NIH-funded program used 14 mcg/kg subcutaneous nightly, approximately equivalent to a 1 mg evening dose, over six months in healthy older men and women [8]. Both schedules were timed to the bedtime GH burst. The doses cited above are study-documented doses in identified research populations. They are not recommendations. The sermorelin adult investigational record is small relative to the pediatric record, and long-term safety data in healthy adults remain limited [14]. ## Pharmacokinetic constraints on dosing The 11-to-12-minute plasma half-life and approximately 6 percent subcutaneous bioavailability are the pharmacokinetic facts that shape every sermorelin dosing schedule [5]. Less than 5 percent of administered drug remains circulating one hour after injection. The biological signal — the induced GH pulse and the downstream hepatic IGF-1 response — outlasts the parent peptide by hours and days respectively, but the parent peptide itself does not accumulate. The consequence has been once-nightly administration timed to the natural early-slow-wave-sleep GH burst across essentially every study of sermorelin in adults. Twice-daily dosing has appeared in pediatric short-stature investigational protocols [2] but did not carry into the labeled pediatric regimen, which adopted the once-nightly schedule [15]. Tesamorelin, the related stabilized analog with an approximately 26-minute half-life, is the structural alternative when more sustained GHRHR engagement is required, and it is dosed at 1 to 2 mg subcutaneous daily in its own clinical record [7][16]. ## Handling, reconstitution, and the compounding pathway Sermorelin acetate ships as a lyophilized powder, with historical labeled presentations at 0.5 mg and 1.0 mg base per vial for therapeutic use and 0.05 mg base per ampoule for diagnostic use [3]. Contemporary 503A compounded preparations are supplied lyophilized at 0.5 to 10 mg per vial and reconstituted at the point of dispensing [17]. The handling protocol is reasonably specific. Reconstitution uses bacteriostatic water for injection (sterile water containing 0.9 percent benzyl alcohol as a preservative), introduced down the side of the vial wall with gentle swirling to dissolve the peptide; vigorous shaking denatures the chain. The reconstituted solution is stored at 2 to 8 degrees Celsius, protected from light and from elevated temperature, with a beyond-use date consistent with USP <797> peptide compounding guidance [17]. Legal access to sermorelin in the United States runs through patient-specific compounding under section 503A of the Federal Food, Drug, and Cosmetic Act, and through FDA-registered outsourcing facilities under section 503B, because the active ingredient is a component of a previously-approved drug product (the historical NDA 020443) [13]. The FDA's January 7, 2025 final interim guidance discontinued the forward-looking Category 1/2/3 nomination process for newly nominated bulks but explicitly preserved the previously-approved-active pathway under which sermorelin sits. FDA inspection findings across the compounding sector have included occasional sub-labeled potency and sterility variability, which is why state-licensed pharmacy selection has become a material part of the contemporary compounded-sermorelin discussion. --- An editorial reading of the published pharmacology and regulatory record — not a clinic, not a pharmacy, not a dosing guide.