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Therapeutics

Epitalon (Epithalon)

Epitalon (Ala-Glu-Asp-Gly) is a synthetic tetrapeptide developed in the 1980s–90s by Vladimir Khavinson's group at the St Petersburg Institute of Bioregulation and Gerontology, and proposed as a telomerase activator and pineal-gland modulator. The clinical literature is dominated by small, mostly unblinded studies from a single research network with serious methodological concerns (limited randomization, soft endpoints, no independent Western replication). Epitalon is not approved as a medicinal product by the FDA or EMA. The FDA placed it on the 503A Category 2 bulk-substance list in 2023, then removed it on 22 April 2026 alongside eleven other peptides whose nominators withdrew, with a formal PCAC consultation scheduled for 24 July 2026. It is sold internationally as a research peptide; longevity or telomerase claims are not supported by adequately powered, independently replicated trials.

Sources

  1. Khavinson VK, Malinin VV. (2005). Peptides and Ageing (review of Khavinson group peptide bioregulators, including Epitalon). *Neuroendocrinology Letters*
  2. Khavinson VK, Bondarev IE, Butyugov AA. (2003). Epithalon peptide induces telomerase activity and telomere elongation in human somatic cells. *Bulletin of Experimental Biology and Medicine*
  3. U.S. Food and Drug Administration. (2023). Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks (503A Category 2; includes Epitalon)