Epitalon dosage: what published studies used
Published protocols, not a recommendation. Published protocols vary; a licensed provider sets your dose; never self-dose.
The one human injection study of synthetic Epitalon we could trace gave 0.01 mg a day by intramuscular injection for 10 days. There are no dose-ranging studies. Epitalon is not FDA-approved, and REMEVi does not currently offer it. Published protocols vary; a licensed provider sets your dose; never self-dose.
Epitalon is not FDA-approved. Since HHS’s October 2026 interim policy, a state-licensed 503A pharmacy may compound it on a patient-specific prescription under listed conditions.
REMEVi does not currently offer Epitalon.
Published Epitalon injection protocols
HHS’s interim policy lists Epitalon for injection in intermittent courses, so this table covers injected protocols from human studies of the synthetic peptide. Each row names its source.
| Study | Who was studied | Route | Amount and frequency | Course |
|---|---|---|---|---|
| Korkushko et al., 2007, as summarized by Jain et al., 2026 | Older adults with reduced melatonin output (15 received Epitalon) | Intramuscular injection | 0.01 mg once a day | 10 days (0.1 mg per course) |
Other human studies of synthetic Epitalon used routes the policy does not list: a 20-day course under the tongue in middle-aged women, and injections beside the eye in a retinitis pigmentosa study. Those are outside the policy’s route, so their amounts are not listed here.
Animal studies dose by body weight in rodents. Those amounts are not converted to human doses here: animal-to-human conversion is not a dose a person should use.
Published protocols vary; a licensed provider sets your dose; never self-dose. This page lists what studies used. It is not dosing advice.
Why published Epitalon dosage charts differ
- Epithalamin vs Epitalon: older long-term studies used Epithalamin, a pineal extract, in much larger milligram amounts. Those numbers are often copied into Epitalon charts, but they describe a different substance.
- Online charts commonly list milligram-scale daily amounts for 10 to 20 days. We could not trace those figures to a published human study of synthetic Epitalon.
- Route: studies used intramuscular injection, under-the-tongue and eye-adjacent routes, and amounts do not carry across routes.
- Salt form and vial strength: the policy names epitalon acetate; labels state milligrams per vial, and the amount drawn depends on how the vial is prepared.
- No dose-ranging data: the 2026 review found pharmacokinetic, dose-ranging and long-term safety data inadequate, so no chart rests on dose-finding trials.
Reconstitution and injection basics
Compounded injectables can arrive as a liquid or as a freeze-dried powder that has to be mixed before use. If a pharmacy dispenses Epitalon on your prescription, the label and your provider tell you the diluent, the volume, how to store it and how long it keeps.
- Use a new sterile syringe for each injection. Under the policy, the one device that may be packaged with the drug is an FDA 510(k)-cleared syringe.
- Do not add another peptide to the vial: a covered product has a single active ingredient.
- Do not use a vial that looks cloudy, has particles or is past the pharmacy’s beyond-use date.
- A vial sold for research use is not prepared for human use, and the policy does not cover it.
How much Epitalon per day do studies use?
In the one human injection study of synthetic Epitalon we could trace, older adults received 0.01 mg a day by intramuscular injection for 10 days. A separate under-the-tongue study used a larger daily amount for 20 days. No study has compared doses. Published protocols vary; a licensed provider sets your dose; never self-dose.
Sources
- Jain et al., Int J Mol Sci 2026 — Epitalon and Epithalamin: a narrative review of mechanistic, preclinical, and clinical evidence (read November 2, 2026)
- HHS — Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances, 91 FR 68526 (Federal Register, October 30, 2026) (read November 2, 2026)
- Nutritional Outlook 2026 — HHS peptide compounding policy: supplement industry implications (read November 2, 2026)
- Foley & Lardner, National Law Review 2026 — Peptides: HHS announces limited enforcement discretion for compounding six peptides (read November 2, 2026)
Medically reviewed by Linda West-Conforti, RN · CA RN #389453 ·