What is Epitalon?
Tetrapeptide AEDG (Ala-Glu-Asp-Gly) developed by Khavinson (1980s) based on bovine pineal gland extract (Epithalamin).[1]
Pineal tetrapeptide · research peptide
Epitalon (AEDG / Epithalon)
Studied for: telomerase activation, telomere length, pineal-gland function, longevity biomarkers (Khavinson program; preclinical + limited translational)
Epitalon is a synthetic tetrapeptide — Ala-Glu-Asp-Gly (AEDG) — developed by Russian researcher Vladimir Khavinson in the 1980s based on the amino-acid composition of Epithalamin, a bovine pineal-gland extract. Published peer-reviewed work from the Khavinson program centers on telomerase activation, telomere elongation, and binding to a specific ATTTG DNA sequence present in the TERT promoter. It is not FDA-approved and was included in the April 15, 2026 FDA 503A Category 2 removal.
- Class
- Pineal-derived tetrapeptide (peptide bioregulator)
- Sequence
- Ala-Glu-Asp-Gly (AEDG, 4 AA)[1]
- Developer
- Vladimir Khavinson, St. Petersburg Institute of Bioregulation and Gerontology (1980s)[1]
- Parent preparation
- Epithalamin (bovine pineal extract)
- Published mechanism
- Telomerase activation · ATTTG DNA-sequence binding (TERT promoter)[2]
- Plasma half-life
- Minutes (tetrapeptide class — not precisely summarized)
- FDA status
- Not approved · April 15 2026 503A Cat. 2 removal · PCAC 23 Jul 2026[3]
Educational reference only. The Epitalon peer-reviewed record is dominated by Russian-language research by Vladimir Khavinson and colleagues. Western replication has been more limited. This page summarizes the published findings without endorsing claims about longevity or aging outcomes. It does not recommend doses, protocols, or acquisition channels.
What Epitalon is
Epitalon — also spelled Epithalon or Epithalone — is a synthetic tetrapeptide consisting of four amino acids in a specific order: alanine, glutamic acid, aspartic acid, and glycine (AEDG). It was developed in the 1980s by Russian scientist Vladimir Khavinson at what is now the St. Petersburg Institute of Bioregulation and Gerontology, as part of a broader program on "peptide bioregulators" derived from animal organ extracts. Epitalon specifically is based on the amino-acid composition of Epithalamin, an extract of the bovine pineal gland.[1]
Mechanism
The published peer-reviewed mechanism centers on two linked observations:[2]
- Telomerase activation. In human somatic cell lines, Epitalon treatment has been reported to increase telomerase activity and induce telomere elongation. The 2003 paper by Khavinson et al. in Neuro Endocrinology Letters and a 2025 follow-up paper on telomerase upregulation via ALT-pathway activity are the most cited references.
- ATTTG DNA binding. Epitalon has been reported to bind a specific ATTTG DNA sequence through hydrophobic interactions and hydrogen bonds. The Khavinson group correlates this binding with Epitalon's biological activity because the ATTTG motif is present multiple times in the promoter region of the telomerase reverse transcriptase (TERT) gene.
A 2025 peer-reviewed overview titled "Epitalon — highly bioactive pineal tetrapeptide with promising properties" notes that despite the documented telomerase and DNA-binding findings, the complete mechanism remains incompletely characterized.[1]
The Khavinson research program
Vladimir Khavinson's team has published more than 100 papers on Epitalon over four decades. Research areas span:[1]
- Animal longevity and lifespan-extension studies
- Telomere / telomerase biology in cell lines and tissue models
- Pineal-gland function and age-related melatonin decline
- Aging-biomarker readouts in human cohorts
- Retinal disease and visual function in elderly patients
A substantial portion of this literature is published in Russian-language journals, with selective English-language publication. Independent Western replication at scale has been limited — a point that reviewers routinely note when citing the work.
Pharmacokinetics
- Plasma half-life. Tetrapeptides of this class have short plasma half-lives in the range of minutes. A precise, peer-reviewed human half-life value for Epitalon specifically is not prominently summarized in the translational literature.
- Focus of the research program. The Khavinson program has focused on downstream biomarker effects — telomere length, immune indices, circadian and melatonin-axis indices — measured days to months after treatment cycles, rather than on detailed plasma pharmacokinetic characterization.
- Metabolism. Peptidase-mediated, as is typical for unmodified short peptides.
Regulatory status
- FDA approval: None in the United States.
- Russia: Peptide bioregulators from the Khavinson program have been used in research and some clinical contexts within Russia. This is not the same as FDA approval for the U.S. market.
- April 15, 2026 503A update. Epitalon was listed for removal from Category 2 as one of twelve peptide bulk drug substances affected by the update.[3]
- PCAC review. Scheduled for July 23, 2026, for Epitalon-related bulk drug substances. Removal from Category 2 does not itself permit compounding; PCAC review and 503A bulks-list inclusion are required.
Storage and handling
- Lyophilized powder. Store sealed per supplier instructions — typically refrigerated at 2–8 °C or frozen at −20 °C.
- After reconstitution. Refrigerate at 2–8 °C. Bacteriostatic water (0.9% benzyl alcohol) for multi-draw use; sterile water for single-draw.
- Handling. Swirl to mix. Avoid freeze–thaw. Discard cloudy or discolored solutions.
Reconstitution math
Math only — no dose recommendation. Concentration after reconstitution determines how many insulin-syringe units equal a given mcg amount.
Example 1 · 10 mg vial + 2 mL bac water
concentration = 10 mg / 2 mL = 5 mg/mL = 5000 mcg/mL
1 unit = 0.01 mL = 50 mcg
→ 500 mcg = 10 units
→ 1 mg = 20 units
→ 5 mg = 100 units (full syringe)
1 unit = 0.01 mL = 50 mcg
→ 500 mcg = 10 units
→ 1 mg = 20 units
→ 5 mg = 100 units (full syringe)
Example 2 · 10 mg vial + 1 mL bac water
concentration = 10 mg / 1 mL = 10 mg/mL = 10,000 mcg/mL
1 unit = 0.01 mL = 100 mcg = 0.1 mg
→ 500 mcg = 5 units
→ 1 mg = 10 units
→ 10 mg = 100 units (full syringe)
1 unit = 0.01 mL = 100 mcg = 0.1 mg
→ 500 mcg = 5 units
→ 1 mg = 10 units
→ 10 mg = 100 units (full syringe)
Example 3 · 20 mg vial + 2 mL bac water
concentration = 20 mg / 2 mL = 10 mg/mL = 10,000 mcg/mL
1 unit = 0.01 mL = 100 mcg = 0.1 mg
→ 500 mcg = 5 units
→ 1 mg = 10 units
→ 10 mg = 100 units (full syringe)
1 unit = 0.01 mL = 100 mcg = 0.1 mg
→ 500 mcg = 5 units
→ 1 mg = 10 units
→ 10 mg = 100 units (full syringe)
Frequently asked questions
How does it work?
Published mechanism: telomerase activation + telomere elongation; ATTTG DNA-sequence binding in TERT promoter region. Exact mechanism remains incompletely characterized.[2]
What's the half-life?
Minutes (tetrapeptide class). A precise peer-reviewed human half-life is not prominently summarized.
How do I reconstitute a 10 mg vial?
Typical: 10 mg + 2 mL bac water = 5 mg/mL → 1 unit = 50 mcg; 1 mg = 20 units. Using 1 mL doubles concentration.
Is it FDA-approved?
No. April 15, 2026 503A Category 2 removal. PCAC review scheduled July 23, 2026.[3]
Who is Khavinson?
Russian scientist Vladimir Khavinson, St. Petersburg Institute of Bioregulation and Gerontology. Developed Epitalon in 1980s. 100+ papers published across four decades.[1]
Primary references
- Marozik P, et al. Overview of Epitalon — highly bioactive pineal tetrapeptide with promising properties. Int J Mol Sci, 2025 (PMC11943447). PMC11943447 · MDPI
- Khavinson VK, Bondarev IE, Butyugov AA. Epithalon peptide induces telomerase activity and telomere elongation in human somatic cells. Bull Exp Biol Med, 2003 (PubMed 12937682). PubMed 12937682
- U.S. Food and Drug Administration. 503A Categories Update for April 2026 — Epitalon listed for Category 2 removal; PCAC consultation scheduled July 23, 2026. fda.gov/media/94155
- Epitalon increases telomere length in human cell lines through telomerase upregulation or ALT activity (2025 peer-reviewed follow-up, PMC12411320). PMC12411320
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