$ cat dose-ranges.txt

WHAT THIS PAGE DOCUMENTS

This page documents dose ranges that appear in the published peer-reviewed and regulatory record for sermorelin. It does not recommend a dose. It is a structured summary of what was studied — by whom, at what dose, in what population, by what route, for how long — with citations.

Sermorelin previously held FDA approval for two specific indications with labeled dose ranges. The product is no longer marketed as a finished FDA-approved drug ^[1][2]. Compounded preparations available through 503A pharmacies are not reviewed by FDA for safety, efficacy, or quality before patient use ^[16]. What you are reading is the historical and research-context record, not a protocol.

WHAT THIS PAGE IS

This page documents the dose ranges that appear in the published peer-reviewed and regulatory record for sermorelin. It does not recommend a dose. It does not describe a current treatment protocol. It is a structured summary of what was studied, by whom, at what dose, in what population, by what route, for how long — with citations.

Sermorelin previously held FDA approval for two specific indications (pediatric GH-deficiency diagnosis and treatment) with labeled dose ranges. The product is no longer marketed as a finished FDA-approved drug. Compounded preparations available through 503A pharmacies and 503B outsourcing facilities are not reviewed by FDA for safety, efficacy, or quality before patient use ^[16].

FDA-APPROVED PEDIATRIC TREATMENT DOSE

30 μg/kg subcutaneously, nightly at bedtime — the dosing schedule used to support FDA approval of the 0.5 mg and 1.0 mg therapeutic formulations under NDA 20-443 (1997) for the treatment of idiopathic growth hormone deficiency in children ^[1][3]. Sustained increases in height velocity were documented through 12-36 months of treatment in extension cohorts ^[3].

FDA-APPROVED PEDIATRIC DIAGNOSTIC DOSE

1 μg/kg as a single intravenous bolus, with serum GH sampling at baseline and at 15, 30, 45, and 60 minutes post-injection — the provocative diagnostic protocol that supported FDA approval of the 0.05 mg diagnostic ampule under NDA 19-863 (1990) ^[1][4]. The test assesses pituitary somatotroph reserve; subnormal responses to additional non-GHRH stimuli are required to confirm hypothalamic versus pituitary etiology because hypothalamic GHRH-deficient patients may still respond to exogenous GHRH ^[4].

ADULT GHD COMBINED DIAGNOSTIC DOSE

1 μg/kg intravenous sermorelin combined with 0.5 g/kg intravenous L-arginine infused over 30 minutes — the GHRH-arginine stimulation test, validated for adult GH-deficiency diagnosis with accuracy at least comparable to the insulin tolerance test ^[11]. Used in clinical endocrinology as a single-occasion diagnostic procedure, not a chronic treatment. The 2008 US sermorelin withdrawal reduced availability of this test and shifted clinical practice toward glucagon stimulation and macimorelin ^[11].

AGING-POPULATION PHARMACODYNAMIC DOSES

Khorram et al. 1997 — 10 μg/kg subcutaneously nightly for 16 weeks in healthy adults aged 55-71. The regimen produced significant increases in skin thickness in both sexes and a +1.26 kg increase in lean body mass in men, with improved insulin sensitivity and self-reported gains in well-being and libido in men ^[6].

Vittone et al. 1997 — 2 mg fixed-dose subcutaneously nightly for 6 weeks in healthy elderly men aged 64-76. IGF-1 elevation was evident by 2 weeks and sustained through 12 weeks; lean body mass increased significantly in the longer-treated subgroup. The regimen was well tolerated ^[7].

PEDIATRIC IDIOPATHIC SHORT STATURE DOSE

Kirk et al. 1994 — 20 μg/kg subcutaneously twice daily for 12 months in prepubertal children with idiopathic short stature not classified as GH-insufficient. Height velocity increased throughout the treatment period and returned to pretreatment values after cessation, confirming GHRH-axis dependence ^[5]. This was a research study, not an FDA-approved indication.

PHARMACOKINETIC NUMBERS

Plasma half-life ~11-12 minutes after both subcutaneous and intravenous administration ^[10]. Peak plasma concentration 5-20 minutes after a 2 mg subcutaneous dose ^[10]. Less than 5% of an administered dose remains detectable in plasma at 60 minutes ^[10]. Adult clearance 2.4-2.8 L/min ^[10]. Downstream GH pulse persists for 2-4 hours after a single dose ^[10].

Class comparison: sermorelin t1/2 ~12 min; tesamorelin t1/2 ~26 min after SC dosing; CJC-1295 DAC several days due to albumin bioconjugation ^[19].

STABILITY AND HANDLING

Lyophilized sermorelin acetate is stable when stored refrigerated (2-8°C) and protected from light. Reconstituted aqueous solution should be refrigerated and used promptly. The C-terminal amide and unprotected backbone make sermorelin sensitive to proteolytic and oxidative degradation. Repeated freeze-thaw cycles or warm-temperature exposure degrade biological activity. The (1-29) fragment is more chemically stable than full-length GHRH (1-44) but is far shorter-acting than the modified GRF(1-29) backbone used in CJC-1295.

STDERR

Compounded preparations are not FDA-reviewed for safety, efficacy, or quality before patient use ^[16]. The off-label use of sermorelin for anti-aging, body-recomposition, sleep, and 'longevity' purposes in healthy adults is not supported by adequately powered randomized controlled trials in those populations. Sermorelin is prohibited at all times by WADA Section S2 — any athlete subject to WADA testing using sermorelin without a granted Therapeutic Use Exemption commits an Anti-Doping Rule Violation ^[13].