What epitalon is
Epitalon, also spelled epithalon, is a peptide of four amino acids: alanine, glutamic acid, aspartic acid and glycine. FDA's review gives the formula of the free base as C14H22N4O9 and its molecular weight as 390.35 g/mol.
FDA treats it as a different substance from epithalamin, which is an extract of the pineal gland. Epitalon is a synthetic peptide modeled on that extract.
Where it stands with the FDA
Epitalon isn't approved by the FDA, and the agency says it isn't a component of any FDA-approved drug. It was nominated for compounding, the nominations were withdrawn, and FDA reviewed it on its own initiative.
The review evaluated one use, insomnia, and concluded that the criteria weigh against putting epitalon on the list of substances pharmacies may compound with.
FDA took the question to its Pharmacy Compounding Advisory Committee on July 24, 2026. Its meeting page had no minutes posted as of October 2026, so this page doesn't report a vote.
The strength in the record
The products described in the nominations were injections under the skin at 3,000 mcg/mL and at 10 mg/mL.
| Strength in the record | Water for a 10 mg vial | One unit holds | 10 units hold |
|---|---|---|---|
| 3,000 mcg/mL | 3.333 mL | 30 mcg | 300 mcg |
| 10,000 mcg/mL | 1 mL | 100 mcg | 1 mg |
Add that much water to a 10 mg vial and it comes to that strength. Any other amount of water works too. It only changes how many units the same dose takes up.
Storing epitalon
FDA's review says the free base is expected to be stable stored below -20°C, and repeats a report that the lyophilized powder is stable at room temperature for three weeks. Both describe the dry powder, not a mixed vial.
There's no approved label for epitalon, so nothing official says how long a mixed vial keeps.
Epitalon dosage calculator questions
How do I turn a epitalon dose into syringe units?
Divide the dose by the concentration to get millilitres, then multiply by 100. A 10 mg vial mixed with 1 mL is 10 mg/mL, so one unit on an insulin syringe holds 100 mcg and ten units hold 1 mg.
How much bacteriostatic water goes in a 10 mg vial of epitalon?
There's no single right amount. The water only sets the concentration, and the amount of epitalon in the vial stays the same. With 10 mg, 1 mL makes 10 mg/mL, 2 mL makes 5 mg/mL and 3 mL makes 3.333 mg/mL. Choose the amount that puts your dose somewhere between about 10 and 40 units, where it's easiest to read.
Is epitalon approved by the FDA?
No. FDA says epitalon isn't a component of any FDA-approved drug. It reviewed epitalon for use in compounded drugs and concluded the criteria weigh against it, then took it to an advisory committee on July 24, 2026.
Does this page tell me how much epitalon to take?
No. There's no FDA-approved epitalon product, so there's no approved dose to point to. The dose box starts empty for that reason, and the chart only converts.
Is epitalon the same as epithalon or epithalamin?
Epitalon and epithalon are two spellings of the same four amino acid peptide. Epithalamin is different. FDA's review describes it as an extract of the pineal gland, and epitalon as a synthetic peptide modeled on it.
More peptide calculators by name
The same instrument, set up one peptide at a time. For any other vial, use the peptide reconstitution calculator.