Epitalon

What is Epitalon and what has it been studied for?

FDA's compounding briefing describes epitalon (also called epithalon) as "a synthetic tetrapeptide (L-Alanine-L-Glutamate-L-Aspartate-L-Glycine)," developed from epithalamin, a pineal-gland extract from the work of "Professor Vladimir Khavinson from the Saint Petersburg University, Russia" [1]. A 2025 study in cultured cells found epitalon produced "dose-dependent telomere length extension" through upregulation of the telomerase gene hTERT, tested in breast-cancer cell lines and normal epithelial and fibroblast cells [2]. A 2002 review by Khavinson reports that epithalamin "increases melatonin production by the pineal gland of rats" and extended lifespan in rats, mice and fruit flies [3].

Does Epitalon work, and is it FDA-approved?

FDA reviewed a 2021 placebo-controlled study of 75 night-shift working women aged 40-50; 40 with low urinary 6-SMT, a melatonin metabolite, took a sublingual epitalon spray or placebo for 20 days, and 6-SMT rose 1.7-fold, but the study did not evaluate sleep outcomes [1]. FDA concluded there is "a lack of evidence to support the effectiveness" of epitalon for insomnia and "no clinical data to support the safety" of epitalon in humans [1]. On July 24, 2026, a compounding advisory panel recommended adding epitalon to the list; that recommendation is not a binding decision, and formal rulemaking is still required before any change takes effect [4].