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
- Khavinson VK, Malinin VV. (2005). Peptides and Ageing (review of Khavinson group peptide bioregulators, including Epitalon). *Neuroendocrinology Letters*
- 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*
- 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)
