FreePeptideCalc

Sermorelin Dosage and Reconstitution Calculator

Once FDA-approved as Geref, withdrawn in 2009. No label survives on FDA's systems, which means no reconstitution volume for it has a primary source.

Written by , who builds and maintains this site and is not a clinician. Every figure links to its primary source.

Not approved

Approval withdrawn in 2009; no current FDA product

Sermorelin acetate was approved as GEREF (NDA 020443, 0.5 mg and 1.0 mg vials) and GEREF Diagnostic (NDA 019863). EMD Serono requested withdrawal in December 2008 and the FDA withdrew approval effective 18 June 2009. The FDA determined in 2013 that the withdrawal was not for reasons of safety or effectiveness. Sermorelin sold today is compounded or grey-market, not an approved product.

No approved human dose exists for this compound in any country. The figures below are the doses used in named published studies, reproduced for reference only. Doses given to rats or mice do not convert to a human dose. The FDA has stated that labelling a product “research use only” or “not for human consumption” does not change its legal status when the seller's own marketing shows it is intended for people.

Calculator inputs

Set up your vial

Enter the label, dilution and dose. The result updates as you type.

Syringe volume
Syringe volume
Sermorelin in the vial
Sermorelin in the vial
Approved Geref vials were 0.5 and 1 mg; compounded vials are larger
Bacteriostatic water to add
Bacteriostatic water to add
Dose per injection
Dose per injection
No approved human dose exists for this compound. The dose shown is only a calculator input, not a recommendation or starting point.
More optionsReverse calculation, schedule and cost

Enter the bacteriostatic water you added and get the volume to draw.

Draw to
8units(0.08 mL)
8 units01020304050Drag the plunger, or focus it and use the arrow keys
Draw to 8 units on a 50-unit U-100 syringe.
Concentration
2500 mcg/mL
Water added
2 mL
Doses in vial
25
How the concentration is calculated

This divides the peptide by the water you add. The powder occupies a little volume of its own, which is negligible on a typical vial but not on one with a heavy bulking agent. When a product label states a concentration, use the label’s number.

Key facts

Half-life
Not published. No accessible human pharmacokinetic study reports one, so any specific figure quoted elsewhere has no primary source behind it.
Also sold as
Geref, GRF(1-29)

Published doses

None. No study has published a dose for Sermorelin that can be responsibly reproduced. That is a finding, not an omission — every dose figure you see for it elsewhere online comes from community convention rather than a source.

How good is the evidence?

This one deserves an unusual warning. Drugs@FDA states plainly that the label for NDA 020443 “is not available on this site”, and the hosted pre-1996 approval package for the diagnostic product contains the approval letter and chemistry review but no labelling. That means the diluent, the reconstitution volume, the resulting concentration, the dose and the post-reconstitution storage are all unavailable from any primary source. Every sermorelin reconstitution figure circulating online traces back to compounding pharmacies rather than to an FDA label. We publish the vial strengths, which are documented, and nothing else — because nothing else can be sourced.

Why a withdrawn approval leaves less behind than you would expect

Sermorelin was approved. That fact is often used to imply that approved dosing information exists somewhere and merely needs finding. It does not. Drugs@FDA states plainly that the label for NDA 020443 is not available on its site, and the hosted pre-1996 approval package for the diagnostic product contains the approval letter and the chemistry review but no labelling.

The consequence is unusually complete: the diluent, the reconstitution volume, the resulting concentration, the dose and the post-reconstitution storage window are all unavailable from any primary source. Not disputed, not superseded — unavailable. Every sermorelin reconstitution figure in circulation traces back to a compounding pharmacy or a vendor rather than to an FDA label, and this page reproduces none of them.

Withdrawn, but not for safety

EMD Serono requested withdrawal in December 2008 and the FDA withdrew the approval effective 18 June 2009. In 2013 the FDA determined that the withdrawal was not for reasons of safety or effectiveness — a specific finding with a specific legal function, since it is the determination that allows generic applications to reference a withdrawn product.

It does not mean the product remains available, and it does not confer any status on compounded sermorelin sold today. What it means is that the reason the label vanished was commercial. The label vanished nonetheless, and with it every citable number.

Common questions

Sources

Every number on this page comes from one of the documents below. Where no reliable source exists, the page says so instead of filling the gap.

  1. RegulatorFDA / Federal Register· 2009-05-19
    Withdrawal of approval of GEREF (sermorelin acetate), NDA 020443 and NDA 019863 — 74 FR 23407
  2. RegulatorFDA· 2026-05-14
    Bulk Drug Substances Nominated for Use in Compounding Under Section 503A
  3. RegulatorFDA / CDER· 2026-09
    Drugs@FDA — application and approval records for semaglutide (NDA 209637, 213051, 215256, 218316) and tirzepatide (NDA 215866, 217806)
  4. ReferenceFDA / CDER
    Drugs@FDA: FDA-Approved Drugs — searchable database of approved applications and products