// ARCHIVE :: DOSE_RECORD
What the literature reports — not what anyone should do.
Every dose on this page is sourced to a published study or to the original FDA-archived prescribing information. None of this is a recommendation. There is no FDA-approved finished sermorelin product currently on the U.S. market, and this site does not provide medical or dosing advice.
// SHORT_VERSION :: DOSES_IN_THE_RECORD
Every dose figure on this page comes from a primary source — a published study, the FDA-archived prescribing information, or the pharmacokinetic record. None of it is a personal recommendation, and no dose is given as one. The original FDA labeling specified two regimens: a single intravenous bolus for diagnosis and a once-daily subcutaneous dose for treating growth-hormone-deficient children. Both were withdrawn when the product left the market in 2008. The adult aging-axis studies used smaller subcutaneous doses at bedtime, aligned with the body's natural nocturnal GH secretion pattern. Compounded research-use preparations appear in the literature at a range of doses that this site describes, not recommends. The pharmacokinetics — an eleven-minute half-life, six-percent subcutaneous bioavailability — constrain what any dosing discussion has to contend with.
What the original FDA labeling specified
Two FDA-labeled dosing regimens are anchored in the original prescribing information for the discontinued sermorelin product [6][13]. The diagnostic regimen, approved in 1990, was a single 1 microgram per kilogram intravenous bolus used to provoke GH release for the differential diagnosis of pediatric growth hormone deficiency [3][11]. The treatment regimen, approved in 1997, was 30 micrograms per kilogram administered subcutaneously at bedtime, once daily, in prepubertal children with idiopathic GH deficiency [2][6].
Both regimens were withdrawn administratively when the sponsor exited the U.S. market in 2008 [13]. There is currently no FDA-approved finished sermorelin product on the U.S. market, which means the original labeled regimens describe historical clinical practice under those NDAs rather than current FDA-recommended use [13][14].
Doses that appear in the published clinical literature
The Wilton et al. (1993) pharmacokinetic study administered intravenous doses ranging from 0.25 to 2 micrograms per kilogram in healthy adult volunteers, with the lower end of the range eliciting significant GH release and the upper end producing maximal response [1]. The same study tested intranasal administration at approximately 50 micrograms per kilogram, producing 3–5 percent bioavailability [1].
The Khorram, Laughlin and Yen (1997) aging-axis study administered 10 micrograms per kilogram nightly subcutaneously over 16 weeks in nineteen healthy adults aged 55–71 [4]. The Vittone et al. (1997) study used nightly subcutaneous GHRH(1-29) over three months in healthy elderly men, with the published report describing the regimen as a 'single nightly injection' without the more specific microgram-per-kilogram value reported by Khorram [5].
The Prakash and Goa (1999) review aggregates the pediatric labeled regimen at 30 micrograms per kilogram subcutaneously at bedtime and the diagnostic regimen at 1 microgram per kilogram intravenously [2][3].
Doses in compounded research-use contexts
Outside the labeled regimens, compounded sermorelin preparations have appeared in adult research-use contexts at doses commonly labeled in the 100 to 500 microgram range per administration, far smaller in absolute terms than the pediatric weight-based dose but in the same general pulse-eliciting range when normalized to body weight in adults. These appear in the literature as research-context observations rather than as FDA-recommended regimens. The substance, source, sterility, and potency of compounded preparations depend on the individual 503A pharmacy's compliance with USP <797> and, where applicable, USP <800> standards — and are not reviewed by FDA for safety, efficacy, or quality as finished products [14].
Any such regimen described in the literature is described as it was administered in the cited research context — typically subcutaneously, typically at bedtime to align with native nocturnal GH secretion, and typically reconstituted from a lyophilized preparation that requires refrigeration before reconstitution and rapid use after. None of these descriptive features constitute clinical guidance. The route, formulation, and timing decisions in any specific therapeutic context belong to the prescriber and pharmacist, not to an editorial summary of the published record.
Storage and handling notes from the published record
Lyophilized sermorelin is stable under refrigeration for the periods specified in the original FDA-archived labeling [6]. Reconstituted solutions degrade rapidly at room temperature; the active peptide is susceptible to dipeptidyl peptidase-IV (DPP-IV) cleavage in plasma, and the same DPP-IV vulnerability that drives the short circulating half-life is present in any in-solution preparation [6]. Compounded preparations from licensed 503A pharmacies are dispensed with handling instructions appropriate to the specific formulation; those instructions come from the dispensing pharmacy and supersede any general literature description.
Pharmacokinetic constraints any dosing discussion has to contend with
Sermorelin's terminal plasma half-life is 11–12 minutes after either intravenous or subcutaneous administration [6]. Mean clearance is 2.4–2.8 L/min [6]. Mean absolute bioavailability after a 2 mg subcutaneous dose in healthy adults is approximately 6 percent [6]. Peak plasma concentrations occur within 5–20 minutes [6]. Despite the rapid elimination, the GH pulse that sermorelin triggers persists for approximately three hours, because the pulse is a one-time pituitary release event rather than a steady-state circulation of sermorelin itself [1][6].
The short half-life is the reason most published regimens administer sermorelin at bedtime — aligning the iatrogenic pulse with the body's natural nocturnal GH secretion pattern rather than fighting daytime somatostatin tone. The same short half-life is also the reason later GHRH analogs were engineered for DPP-IV resistance: tesamorelin's trans-3-hexenoic acid modification extends the effective half-life and permits once-daily dosing for an adult indication (HIV-associated lipodystrophy) that sermorelin's pharmacology does not naturally support [18][19].
What no published source supports
There is no FDA-recommended sermorelin dose for adult anti-aging use. The 1997 Khorram and Vittone studies, often cited in adult-use discussions, are small (n=19 and a comparable healthy-elderly cohort) and have not been replicated in adequately powered modern randomized trials [4][5]. The labeled pediatric dose was studied and approved specifically for prepubertal children with idiopathic GH deficiency, not for adult body-composition or aging-axis indications [2][13]. Any specific dose for any specific person sits outside what published evidence supports — and outside what this site discusses.