Sermorelin has a dosing history in two halves that never meet. The first half is an approved product, Geref, with a weight-based paediatric regimen recorded in the trial that supported it, withdrawn from sale in 2008 for commercial reasons and with no label served anywhere today. The second half is a compounding convention, hundreds of micrograms at bedtime, cited on clinic and pharmacy pages and connected to the first half by nothing. This page reports both halves with their sources and dates, shows the arithmetic distance between them, and then works the units for the research-vial sizes sold.
Sermorelin is GHRH(1-29), the first 29 residues of human growth-hormone-releasing hormone, developed by Serono. Medibact's Sermorelin guide covers the molecule and its evidence; this page stays with figures. The dosage hub lists every compound's page.
What the sources state
| Source | Kind | Figure | Date read |
|---|---|---|---|
| Drugs@FDA, NDA 020443 (Geref 0.5 mg and 1 mg vials, approved 1997-09-26, EMD Serono) and NDA 019863 (Geref 0.05 mg ampule, approved 1990-12-28) | Approved product record | Both products discontinued; no label document attached | 2026-09-18 |
| Federal Register, 2013-03-04 (document 2013-04827) | Regulator determination | Products "were not withdrawn from sale for reasons of safety or effectiveness" | 2026-09-18 |
| DailyMed SPL searches, "sermorelin" and "Geref" | Label search | Zero records each; no label served | 2026-09-18 |
| Thorner et al., JCEM 1996 (PMID 8772599) | Trial publication | 30 mcg/kg GHRH(1-29) subcutaneously once daily at bedtime; 110 children; up to one year; height velocity 4.1 to 8.0 cm/year at six months | 2026-09-18 |
| NCT00324064 (Children's Mercy Hospital; 90 participants) | Trial protocol | "GHRH (Geref) 1 mcg/kg" intravenous push, stimulation test | 2026-09-18 |
| ClinicalTrials.gov search, "sermorelin" | Registry | 42 records, most for tesamorelin or GHRH(1-44); none using the clinic figures | 2026-09-18 |
| Clinic, pharmacy and vendor pages | Commonly cited | 200 to 500 mcg once daily at bedtime; 200 to 300 mcg at the start, 100 mcg increments, 500 to 600 mcg as a ceiling | 2026-09-18 |
The first six rows describe one drug in one population at one weight-based dose, plus a diagnostic test. The last row describes a different practice altogether, and it is the only row a search for "sermorelin dosage" is likely to find first.
The historic label
Geref existed in two forms. The therapeutic product (NDA 020443) came as 0.5 mg and 1 mg vials of sermorelin acetate for daily subcutaneous injection in children with growth-hormone deficiency; the diagnostic product (NDA 019863) was a 0.05 mg ampule given intravenously at 1 mcg/kg to provoke a growth-hormone response for testing. EMD Serono withdrew both from sale in 2008. The FDA's 2013 determination that the withdrawal was not for safety or effectiveness is what allowed the compound to remain available through other routes.
The label document itself is not on DailyMed, which began in 2005 and holds only labels submitted electronically, and Drugs@FDA attaches no label to the application. The regimen is therefore reported here from the pivotal publication rather than from the label: 30 mcg/kg once daily at bedtime, the dose at which a 25 kg child receives 750 mcg from a 1 mg vial.
Units per amount at each research-vial size
Research-market sermorelin is supplied in 5 mg and 10 mg vials. The table takes each at 1, 2 and 3 mL of water, states the concentration, and converts the circulating clinic figures, plus the 1 mg vial size of the historic product, into U-100 syringe units (100 units = 1 mL).
| Vial | Water added | Concentration | 200 mcg | 300 mcg | 500 mcg | 1 mg |
|---|---|---|---|---|---|---|
| 5 mg | 1 mL | 5 mg/mL | 4 | 6 | 10 | 20 |
| 5 mg | 2 mL | 2.5 mg/mL | 8 | 12 | 20 | 40 |
| 5 mg | 3 mL | 1.67 mg/mL | 12 | 18 | 30 | 60 |
| 10 mg | 1 mL | 10 mg/mL | 2 | 3 | 5 | 10 |
| 10 mg | 2 mL | 5 mg/mL | 4 | 6 | 10 | 20 |
| 10 mg | 3 mL | 3.33 mg/mL | 6 | 9 | 15 | 30 |
Every cell fits one syringe, because the circulating figures are microgram figures. The practical question the table answers is readability: 2 or 3 units at 10 mg/mL is a fraction of a millimetre on a 1 mL syringe, while the same amounts at 2.5 mg/mL are 8 and 12 units. A 5 mg vial at 2.5 mg/mL holds twenty-five 200 mcg amounts. The sermorelin calculator works any combination entered, and the sermorelin reconstitution page covers the water volumes per vial size.
The arithmetic gap between the label and the clinic
The two halves of the record can be put on one scale. The trial regimen was 30 mcg/kg once daily. At 25 kg that is 750 mcg; at 40 kg, 1.2 mg; scaled to a 70 kg adult it would be 2.1 mg, which no clinic page cites and no research vial at the concentrations above would deliver in fewer than 42 units at 5 mg/mL. The clinic figures of 200 to 500 mcg are a fixed amount between a tenth and a quarter of that extrapolation. Nothing in the registry connects the two: a ClinicalTrials.gov search for sermorelin on 2026-09-18 returned 42 records, the great majority for tesamorelin or full-length GHRH(1-44), and the only ones naming Geref used the 1 mcg/kg diagnostic bolus. The gap is reported here as a finding about where the figures come from, not as an argument for either.
What the figures omit
The historic regimen came with a population, growth-hormone-deficient children, a weight-based dose, a daily bedtime timing tied to the physiology of growth-hormone release, and monitoring under an endocrinologist. The diagnostic figure came with an intravenous route and a single administration. The clinic figures come with the practice of the clinic citing them and nothing that can be opened. A research vial carries none of these, and the arithmetic above moves the microgram figures into units without their conditions.
Related pages
Tesamorelin dosage reports the other GHRH analogue on this site, the one whose labels are current and state a daily dose. The tesamorelin and ipamorelin stack article covers the combination most often searched beside sermorelin, and the blend calculator works two-vial arithmetic. The general mixing procedure is documented on medibact.com's how to reconstitute peptides page.
The insulin syringe units how-to explains the U-100 and U-40 scales and how a microgram figure becomes a syringe reading.
What this page does not do
This page reports what Drugs@FDA, the Federal Register, DailyMed, one pivotal trial, the registry and the public web state about sermorelin dosing, each with its source and date, and converts the circulating microgram figures into syringe units for two vial sizes. It does not recommend an amount, a timing or an increment, and it does not present either the historic paediatric regimen or the clinic convention as a figure to follow. The comparison between them is arithmetic about their origins, nothing more.
Sources and dates
Opened 2026-09-18: Drugs@FDA through the openFDA endpoint for the brand name Geref (NDA 020443 and NDA 019863) and the Drugs@FDA overview for NDA 020443; the Federal Register document 2013-04827 through its API; the DailyMed SPL searches for sermorelin and for Geref (zero records each); PMID 8772599 (Thorner et al., JCEM 1996); NCT00324064 and the ClinicalTrials.gov search for sermorelin (42 records); and a read of clinic, pharmacy and vendor pages for the figures in circulation. Corrections go to the contact page.