# Sermorelin dose context — diagnostic, pediatric, and adult research protocols

> The published dose values for sermorelin: 1 microg/kg IV for diagnostic stimulation, 30 microg/kg/day SC for the historical pediatric label, and the adult research protocols. Research context only.

Diagnostic, pediatric, and adult research-context dose values — annotated to the study that used them. Not a protocol, not a recommendation.

## Read this first

This page collects the dose figures that appear in the published sermorelin record: what was given, to whom, by which route, and in which study. It is a research archive, not guidance. Nothing on this page is a recommendation for human use; no titration instructions appear here. Sermorelin is not an FDA-approved drug product on the US market today, and the dose values reproduced below come from the registration-era label and the peer-reviewed trial record, anchored to a named study in every case. Three figures cover most of the literature: a diagnostic IV bolus, a pediatric subcutaneous bedtime protocol, and two adult research-context subcutaneous doses from 1997 and 2012 [1][3][4][16]. The kinetics behind the nightly timing are explained in a dedicated section.

## How to read this page

Each dose below is paired with the study, indication, and route the published record used. Nothing here is a recommendation. Sermorelin is not an FDA-approved drug product on the US market today, and the dose values reproduced here are reported as documented in the registration-era label and the peer-reviewed trial record. The body of this notebook is research summary and historical context; it is not clinical guidance.

## Diagnostic stimulation dose

In the historical diagnostic formulation, a single 1 microg/kg intravenous bolus produced a rapid, specific GH response in pituitary stimulation testing — peaking within minutes and showing fewer false positives than several other historical provocative tests for growth hormone deficiency diagnosis [2]. This was the dose value attached to the 1990 diagnostic NDA (19-863) and to the modern review literature on GHRH-arginine testing where GHRH is available [13].

Clinical reviews of adult GH-deficiency diagnostics note that the disappearance of FDA-approved GHRH in the United States created a diagnostic gap, with arginine-stimulation and glucagon testing now used in its place; the same reviews reaffirm sermorelin's historical specificity and tolerability in the stimulation-test record [13].

## Historical pediatric therapeutic dose

The 1997 pediatric NDA (020443) attached a once-daily subcutaneous dose of 30 microg/kg at bedtime in prepubertal children with idiopathic growth hormone deficiency [1][5]. The published pediatric data support sustained increases in height velocity over 12 months at this dose, with effects maintained over 36 months in subsets [1]. The Ishida 2020 review reproduces this dose value — 30 microg/kg/day subcutaneously for six months in GH-deficient children — as the standard registration-era pediatric protocol [16].

This pediatric dose value is the strongest human dose-finding the sermorelin record carries. It was the basis for the 1997 approval and remains the most cited dose in the modern secretagogue literature [1][5][16].

## Adult research-context dose values

The adult literature reports two specific dose values, both subcutaneous and both nightly. Vittone and colleagues used 1 mg subcutaneously nightly in healthy elderly men aged 64 to 76 and observed increased nocturnal GH pulse amplitude and 24-hour integrated GH, with IGF-1 rising into the young-adult range [3]. Khorram and colleagues used 10 microg/kg subcutaneously nightly at 21:00 in men and women aged 55 to 71 for 16 weeks, with sustained nocturnal GH release and a significant IGF-1 elevation maintained across the full treatment period [4]. The Baker 2012 cognition trial used 1 mg of GHRH subcutaneously nightly for 20 weeks in older adults [16].

The modern compounded research dose range reported in the literature for adult research models typically falls between 100 and 500 microg subcutaneously nightly, with timing 30 to 45 minutes before sleep — anchoring the dose to the body's own nocturnal GH window [16].

## Half-life and dosing rhythm

Sermorelin's pharmacokinetics shape the dosing schedules above. Plasma half-life is approximately 11 to 12 minutes after either IV or subcutaneous administration; peak plasma concentration after SC arrives in 5 to 20 minutes; mean absolute SC bioavailability is approximately 6% [8]. The clearance pathways are DPP-4 and neutral endopeptidase [8].

The parent peptide clears fast, but the downstream effects do not. A single nightly pulse drives a 1- to 2-hour GH peak, and the resulting IGF-1 elevation persists for days after dosing ends [8]. This is the kinetic basis for the once-nightly intermittent pattern: a fast pulse aligned with the body's own slow-wave-sleep GH window, followed by a longer IGF-1 tail [8][9].

## Why intermittent, not continuous

Across the literature, continuous GHRH infusion produces tachyphylaxis (loss of response) while intermittent dosing preserves pulsatile, sleep-entrained GH secretion over weeks to months [9]. This is the empirical reason every published protocol — pediatric, elderly-adult, cognition-trial — is intermittent rather than continuous. The dosing rhythm is not stylistic; it is the pattern the receptor biology requires.

## Routes documented in the published record

Three routes appear in the published literature. Intravenous dosing is the diagnostic route — used in the 1990 diagnostic stimulation protocol at 1 microg/kg [2][13]. Subcutaneous dosing is the therapeutic and modern research route — used in every pediatric trial and every adult research protocol [1][3][4][16]. Intranasal dosing appears in early-phase research with limited bioavailability and is not the route used in any of the major trials. The IV and SC dose values are not interchangeable: the diagnostic test relies on a rapid plasma peak, while the therapeutic and research protocols rely on a slower SC absorption that aligns the GH pulse with sleep onset.

## Stability notes from the research record

Lyophilized sermorelin acetate is stable when refrigerated; reconstituted solutions in the research literature are typically used within 14 to 28 days when refrigerated. Susceptibility to DPP-4 and neutral endopeptidase cleavage in plasma is the same reason the parent peptide's plasma residence is short [8]. None of this constitutes preparation guidance — it is the storage profile reported in the secretagogue review literature and is included here only because readers consistently ask why sermorelin's plasma half-life is so much shorter than its downstream IGF-1 signal.

## Where these dose values came from

The 1 microg/kg IV diagnostic value traces to the historical diagnostic NDA (19-863, 1990) and to the modern review literature on GHRH stimulation testing where GHRH is available [2][13]. The 30 microg/kg/day SC pediatric value traces to the pediatric therapeutic NDA (020443, 1997) and is replicated in the Prakash & Goa 1999 review and the Ishida 2020 review [1][5][16]. The 1 mg SC nightly adult value appears in Vittone 1997 and Baker 2012; the 10 microg/kg SC nightly value appears in Khorram 1997 [3][4][16]. Every dose number in this notebook is anchored to a named trial or NDA — there are no synthesized, averaged, or otherwise reconstructed dose values.

## A note on dose values from compounding pharmacies

Compounded sermorelin formulations dispensed by state-licensed Section 503A pharmacies follow individual prescriptions, and dose values prescribed under that framework can differ from the historical pediatric label, which was indication-specific to idiopathic GHD in prepubertal children at 30 microg/kg/day SC [1][5][12]. The modern compounded research dose range reported in the secretagogue review literature for adult research models falls within 100 to 500 microg SC nightly, with timing 30 to 45 minutes before sleep to align the GH pulse with the nocturnal slow-wave-sleep window [9][16]. This notebook reports the values that appear in the published record; it does not synthesize them into a recommendation.

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An annotated reading of the published research — not a clinic, not a pharmacy, not advice.
