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Sermorelin held two US approvals, both withdrawn effective June 18, 2009.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
The only doses ever approved — and what they were for
| Dose | Route | Frequency | Approved for |
|---|---|---|---|
0.5 mg and 1.0 mg base per vial (product strengths) Withdrawn FDA label | Injection | Per the withdrawn GEREF labeling | NDA 20-443, approved September 26, 1997 — treatment of idiopathic growth hormone deficiency in children with growth failure |
0.05 mg base per ampoule (product strength) Withdrawn FDA label | Injection | Single diagnostic administration | NDA 19-863, approved December 28, 1990 — evaluating the ability of the somatotroph of the pituitary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.
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.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.