● TIER 3 — Information onlyGRADE CBioregulators
Epitalon
Synthetic tetrapeptide. Research verification: Yes (TGA pending). Origin: Russia (Khavinson, St. Petersburg Institute of Bioregulation & Gerontology). Citations verified: yes. 2 human study record(s) in the FitClinicMD studies database.
GOALS · Longevity · Sleep
FDA status
Not approved.
Compounding (503A/503B)
Removed from 503A Category 2 on ~Apr 22 2026 after nominations were withdrawn; PCAC voted Jul 23-24 2026 to recommend 503A bulks-list inclusion, but no rulemaking yet, so not lawfully compoundable and not in Category 1. FDA list:
DEA
Not controlled.
WADA (sport)
Not listed on 2026 Prohibited List (no matching section found)
Mechanism
Claimed telomerase activation. (East) Epithalamin = bovine pineal peptide extract; Epitalon = synthetic tetrapeptide Ala-Glu-Asp-Gly. In telomerase-negative human fetal fibroblasts, Epitalon induced telomerase catalytic-subunit expression and telomere elongation (in vitro only) 3.
Human evidence · 2
Korkushko OV, Khavinson VKh, et al. Geroprotective effect of epithalamine... Bull Exp Biol Med 2006;142(3):356-9.
Khavinson VKh, Morozov VG. Peptides of pineal gland and thymus prolong human life. Neuro Endocrinol Lett 2003.
Reference only. This page summarizes publicly available regulatory and research information about Epitalon. It is not a prescription, an endorsement, or an offer to dispense, and regulatory status can change. Clinicians should verify current status before prescribing or compounding.
Related compounds
● TIER 3GRADE C
Khavinson short peptides (Cytogens/'peptide bioregulators': Pinealon EDR, Vilon KE, Livagen, etc.)
Hypothesis that di-/tripeptides enter cells and bind histones/DNA to alter gene expression.
● TIER 3GRADE B
Thymalin (Тималин)
Polypeptide complex extracted from bovine thymus; immunomodulator (T-cell function).
