Epithalon

Overview

Regulates pineal gland and melatonin production for better sleep cycles.

Reported benefits

Improved sleep quality, circadian rhythm regulation, anti-aging

Protocols & dosing

Typical dosage: 5-10 mg (cycle protocol).

Detailed dosing protocols have not yet been catalogued.

FDA & legal status

Epithalon is not currently FDA-approved for any indication. Effective April 22, 2026, the FDA removed Epithalon from Category 2 of its Section 503A bulk drug substances list after the original nominators withdrew their nominations. This removal lifts the prior “significant safety risk” designation but does not place Epithalon on the 503A Bulks List. Compounding pharmacies may prepare it with a valid physician prescription and pharmaceutical-grade API from an FDA-registered manufacturer. The FDA’s Pharmacy Compounding Advisory Committee (PCAC) is scheduled to review this substance at its July 23–24, 2026 public meeting. Removed from FDA Category 2 effective April 22, 2026. Selected for PCAC review Day 2 — July 24, 2026. PCAC agenda: DSIP (Emideltide), Semax, Epitalon. NOT currently on 503A Bulks List — requires physician Rx. Source: FDA Advisory Committee Calendar / Lengea Law, May 2026.

Vendor information

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Side effects & safety

Reported side effects: Minimal side effects during cycles

References

No external sources have been catalogued for this article yet.