Sermorelin study doses

The former diagnostic and pediatric labels

The archived FDA prescribing information and the clinical review describe two historical uses. The diagnostic test used a single intravenous bolus of 1 microgram per kilogram. The pediatric treatment used 30 micrograms per kilogram, administered subcutaneously at bedtime once daily, in prepubertal children with idiopathic growth hormone deficiency.

Those are former clinical regimens for named indications. The sponsor’s commercial withdrawal in 2008, followed by withdrawal of approval effective June 18, 2009. That ended the marketed-product context described by those labels. FDA’s 2013 determination explains the withdrawal history. No FDA-approved finished sermorelin product is currently marketed in the United States.

A historical label carries an indication along with the amount. I’m unwilling to discard it. This page provides no personal dosing or administration advice.

Adult study protocols

In Wilton and colleagues’ 1993 pharmacokinetic experiment, healthy adults received intravenous GHRH(1-29)-NH2 at doses from 0.25 to 2 micrograms per kilogram. Significant growth hormone release occurred at the lower end; maximal release occurred at 1–2 micrograms per kilogram. The study also examined intranasal administration, with bioavailability of 3–5%.

The 1992 Corpas experiment used 0.5 mg and 1 mg subcutaneously twice daily for 14 days in healthy older men. It was a short endocrine study, testing whether the reduced growth hormone and IGF-1 levels associated with age could be raised. Its protocol supplies no established adult anti-aging regimen.

My interest in comparing protocols lies in the question each investigator asked: an acute hormone response, a diagnostic distinction or a course of childhood growth. Copying the quantity while discarding that question loses the reason it was measured.

Half-life and absorption

The archived pharmacokinetic information reports a terminal half-life of 11–12 minutes after intravenous or subcutaneous administration. In healthy adults given a 2 mg subcutaneous dose, mean absolute bioavailability was approximately 6 percent, peak plasma concentrations occurred within 5–20 minutes, and clearance was 2.4–2.8 L/min.

Growth hormone remained elevated for approximately three hours in the Wilton experiment, despite the peptide’s rapid elimination. The pituitary response therefore outlasts the circulating signal. These measurements describe the behavior of the studied preparation and route; they cannot establish the contents or absorption of an unrelated formulation.

Present-day compounded preparations

Patient-specific compounded sermorelin comes under Section 503A’s ingredient, prescription and pharmacy requirements, together with applicable state rules. FDA has not approved the resulting compounded product. Its formulation and handling instructions come from the dispensing pharmacy.

The literature describes degradation in solution and a short circulating life, but a general account cannot replace instructions for a particular preparation. I regard a universal amount, storage interval or schedule as guesswork given these scattered adult protocols. Those decisions require the prescriber and pharmacist responsible for the individual case.