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Synthetic pineal tetrapeptide bioregulator (Ala-Glu-Asp-Gly / AEDG); studied as a telomerase-related peptide

Epithalon

Investigationalaka Epitalon, Epithalone, AEDG peptide, Ala-Glu-Asp-Gly, Epithalamin analog

Epithalon was created at the St. Petersburg Institute of Bioregulation and Gerontology by the Khavinson group and has been investigated for effects on telomerase, melatonin/circadian rhythm and aging, mainly in cell cultures, rodents and small cohorts. Rigorous, independently replicated human trials are lacking, and it remains an unapproved research compound worldwide.

Mechanism

In cell culture, epithalon has been reported to induce expression of the telomerase catalytic subunit (hTERT) and to elongate telomeres in telomerase-negative human fetal fibroblasts (Khavinson et al., 2003), with a 2025 independent cell-line study describing telomere lengthening via telomerase upregulation and/or alternative lengthening of telomeres (ALT). Proposed additional actions include modulation of pineal melatonin secretion and gene expression. These mechanisms derive largely from in-vitro and preclinical work and remain incompletely verified in humans.

Regulatory Status by Region

  • United States (FDA)Not FDA-approved for any indication. Historically placed on the FDA 503A 'Category 2' bulk drug substances list (substances with significant safety concerns) restricting pharmacy compounding; subject of ongoing FDA compounding review in 2026.
  • Australia (TGA)Not approved by the TGA and not entered on the Australian Register of Therapeutic Goods (ARTG); no registered therapeutic product.
  • European Union (EMA)No EMA marketing authorisation; not an approved medicine in the EU.
  • WADANot listed by name on the Prohibited List, but unapproved peptides of this type are generally captured by the S0 'Non-Approved Substances' category (any pharmacological substance with no current approval by a governmental health authority for human therapeutic use), which is prohibited at all times. Athletes should treat it as prohibited.

Key Studies

  • Epithalon Peptide Induces Telomerase Activity and Telomere Elongation in Human Somatic Cells (Khavinson VK, Bondarev IE, Butyugov AA. Bull Exp Biol Med. 2003;135(6):590-592.)
  • Epitalon increases telomere length in human cell lines through telomerase upregulation or ALT activity (Scientific Reports (2025), PMC12411320.)
  • Overview of Epitalon - Highly Bioactive Pineal Tetrapeptide with Promising Properties (review) (PMC11943447.)