Dosage evidence

Sermorelin Dosage: The Only Doses Ever FDA-Approved

Sermorelin held two US approvals, both withdrawn effective June 18, 2009. Neither was ever for adult body composition, sleep, or anti-aging use — one was for growth failure in children, the other for pituitary function testing.

Where Sermorelin stands with the FDA

No current US approval

The only doses ever approved — and what they were for

DoseRouteFrequencyApproved for
0.5 mg and 1.0 mg base per vial (product strengths)
Withdrawn FDA label
InjectionPer the withdrawn GEREF labelingNDA 20-443, approved September 26, 1997 — treatment of idiopathic growth hormone deficiency in children with growth failure
0.05 mg base per ampoule (product strength)
Withdrawn FDA label
InjectionSingle diagnostic administrationNDA 19-863, approved December 28, 1990 — evaluating the ability of the somatotroph of the pituitary gland to secrete growth hormone

The strengths above are the marketed product strengths recorded in the Federal Register determination, not a dosing regimen for adults. No current US label exists, so there is no labeled adult dose to cite.

Read the “Approved for” column before anything else. A labeled dose belongs to the population it was studied in. It is not a general-purpose number, and it is not automatically the right dose for a different indication.

Convert your prescribed dose to syringe units

If a clinician has prescribed Sermorelin for you, the number that matters next is how far to draw the syringe — and that depends on how much bacteriostatic water went into the vial, not on the peptide itself. Note the unit change: the doses above are written in milligrams, and the calculator takes micrograms. Multiply by 1,000 — a 1.4 mg dose is 1,400 mcg.

What this does — and what it does not

This converts a dose your prescriber has already given you into a volume and a number of units on a U-100 insulin syringe. It does not suggest a dose, and it does not tell you whether a peptide is appropriate for you. Most research peptides have no FDA-approved dosing, so there is no “standard” number for us to fill in. Doses here are in micrograms (mcg) — confusing mcg with mg is a 1,000-fold error and the single most common way people get this wrong.

Enter the dose your prescriber gave you, in micrograms, to see the volume and syringe units.

Your 5 mg vial in 2 mL of bacteriostatic water is —.

Keep reading

References

  1. 1.US Food and Drug Administration. Determination That GEREF (Sermorelin Acetate) Injection Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness (Docket No. FDA-2012-P-1071). Federal Register, 78 FR 14095. 2013. https://www.federalregister.gov/documents/2013/03/04/2013-04827/determination-that-geref-sermorelin-acetate-injection-05-milligrams-basevial-and-10-milligrams

This page reports what regulators and published sources say about Sermorelin. It is not medical advice, not a recommendation to use Sermorelin, and not a dosing instruction. Every source above was opened and read on the date recorded in our data; regulatory status changes, so check the primary source before relying on it.