Scientifically reviewed by Dr Stephan Hansberg
Epitalon peptide: structure, research and legal status (2026)
Epitalon (Epithalon) is a synthetic tetrapeptide, Ala-Glu-Asp-Gly, developed in Russia in the late 1980s. Its identity data, origin, the cell and animal work on telomerase and the pineal gland, the July 2026 FDA advisory review and its status with the MHRA, TGA and WADA.
Key takeaways
- •Epitalon is a synthetic tetrapeptide, Ala-Glu-Asp-Gly (AEDG), with a molar mass of 390.35 g/mol.
- •It was first synthesised in the late 1980s by Vladimir Khavinson's group in St Petersburg, as a putative active component of a bovine pineal extract called epithalamin.
- •Best-known studies examine telomerase activity in human fetal fibroblast cultures and pineal function in rats and monkeys; most of the literature comes from one research group.
- •No studies are registered on ClinicalTrials.gov. FDA staff proposed not adding epitalon to the 503A bulks list in July 2026; the advisory committee recommended it, and rulemaking was pending in October 2026.
- •It is not named on the WADA 2026 List or in Australia's Poisons Standard, but neither absence means it is approved anywhere. Celyfe does not sell epitalon.
What is epitalon?
Epitalon, also spelled Epithalon, is a synthetic peptide of just four amino acids: alanine, glutamic acid, aspartic acid and glycine (Ala-Glu-Asp-Gly, or AEDG). It was developed in Russia as a defined, synthetic stand-in for epithalamin, a peptide extract of bovine pineal gland, and it is studied mainly in research on cellular ageing, telomerase and pineal gland function.
Nearly all published work is in cell cultures and animal models, much of it from a single research group and a large share in Russian-language journals. It is not an approved medicine in the US, UK or Australia.
Identity at a glance
Identifiers checked against PubChem and the FDA's July 2026 briefing document.
| Property | Epitalon |
|---|---|
| Aliases | Epithalon, Epithalone, AEDG peptide, Ala-Glu-Asp-Gly |
| Sequence (4 aa) | H-Ala-Glu-Asp-Gly-OH |
| Molecular formula | C14H22N4O9 |
| Molar mass | 390.35 g/mol (free base) |
| CAS number | 307297-39-8 |
| PubChem CID | 219042 |
| FDA UNII | O65P17785G |
| Melting point (FDA briefing) | 198.0 to 202.0 C |
| Salt forms reviewed by FDA | Epitalon (free base) and epitalon acetate |
Origin and discovery
According to the FDA's 2026 briefing document, epitalon was first synthesised in the late 1980s by researchers under Professor Vladimir Khavinson in St Petersburg, and may be identified as the putative active component of epithalamin, a bovine pineal gland extract. The idea behind it was to replace a variable tissue extract with a short, defined sequence that can be made by peptide synthesis and characterised precisely.
Khavinson's group went on to publish a long series of papers on short regulatory peptides, and epitalon remains the most cited of them. Readers should be aware that independent replication outside that group is limited.
What has been studied, by model
Representative studies are below. Cell and animal findings describe experimental observations and do not establish effects in people.
| Research area | Model | Example study (year, PMID) |
|---|---|---|
| Pineal secretion under stress | Animal (rat) | Sibarov et al., Neuro Endocrinol Lett (2002), PMID 12500171 |
| Telomerase activity and telomere length | Human fetal fibroblast culture | Khavinson et al., Bull Exp Biol Med (2003), PMID 12937682 |
| Age-related pineal function | Animal (monkey) | Goncharova et al., Adv Gerontol (2003), PMID 14743609 |
| Cell division limit | Human cell culture | Khavinson et al., Bull Exp Biol Med (2004), PMID 15455129 |
| Daily melatonin rhythm | Animal (monkey) and small human study, Russian-language | Korkushko et al., Adv Gerontol (2007), PMID 17969590 |
| Overview of published work | Review | Araj et al., Int J Mol Sci (2025), PMID 40141333 |
Human trial status
A search of ClinicalTrials.gov for epitalon and epithalon in October 2026 returned no registered studies. The small human studies that exist were published in Russian journals and were not designed or registered to the standard of modern randomised trials, so they are not a basis for conclusions about effects in people.
Regulatory status in 2026
Epitalon was reviewed by the FDA's Pharmacy Compounding Advisory Committee on 24 July 2026. FDA staff proposed that neither epitalon free base nor epitalon acetate be added to the 503A bulks list. Reported coverage says the committee recommended adding it by a narrow margin; the FDA had not completed rulemaking as of October 2026.
| Authority | Status (checked October 2026) |
|---|---|
| US FDA | Not an approved drug. PCAC recommended adding it to the 503A bulks list against the FDA staff proposal; rulemaking pending. |
| UK MHRA | No UK marketing authorisation. Medicines law applies if it is supplied for human use. |
| AU TGA | Not named in the Poisons Standard (October 2026 instrument). General rules for unapproved therapeutic goods still apply. |
| WADA 2026 | Not named. The S0 class covers pharmacological substances with no current governmental approval for human therapeutic use; athletes should check with their anti-doping organisation. |
Stability and handling notes
Epitalon is small and highly polar, carrying three acidic side chains. Its Asp-Gly pair is the sequence motif most prone to aspartimide formation and isomerisation to isoaspartate in peptide chemistry, so isomeric impurities are a known risk for this sequence, and they share the same mass. That is why HPLC purity, not only mass spectrometry, matters for a tetrapeptide like this.
The FDA briefing listed both a free base and an acetate salt as commercially available forms. A certificate should say which form was tested.
Open questions
The main gaps are independent replication of the telomerase and pineal findings, a defined molecular target, and any registered, controlled human research. How a four-residue peptide would act on gene expression, as some of the literature proposes, has not been established outside the originating group.
Where Celyfe fits
Celyfe does not sell epitalon, and no Celyfe pen contains it. If you are evaluating any epitalon source, the most useful document is its batch certificate of analysis: check that it names the form (free base or acetate), the identity method and the purity method. Our COA library at /coa shows what a complete certificate looks like, using Celyfe's published NAD+ (batch A26085) and WOLVERINE (batch C26071) certificates from Analiza Bialek.
Sources
Primary and official sources checked October 2026:
- PubChem: Epitalon, CID 219042 (pubchem.ncbi.nlm.nih.gov)
- FDA: Briefing document for epitalon-related bulk drug substances, Pharmacy Compounding Advisory Committee, 23-24 July 2026 (fda.gov)
- Sibarov DA et al. Epitalon influences pineal secretion in stress-exposed rats in the daytime. Neuro Endocrinol Lett, 2002. PMID 12500171
- Khavinson VKh et al. Epithalon peptide and telomerase activity in human fetal fibroblast culture. Bull Exp Biol Med, 2003. PMID 12937682
- Goncharova ND et al. Peptide correction of age-related pineal disturbances in monkeys. Adv Gerontol, 2003. PMID 14743609
- Khavinson VKh et al. Peptide and the division limit in human somatic cells. Bull Exp Biol Med, 2004. PMID 15455129
- Korkushko OV et al. Pineal gland peptides and the daily melatonin rhythm in old monkeys and elderly people (in Russian). Adv Gerontol, 2007. PMID 17969590
- Araj SK et al. Overview of Epitalon, a pineal tetrapeptide. Int J Mol Sci, 2025. PMID 40141333
- ClinicalTrials.gov search for epitalon and epithalon, October 2026 (no registered studies)
- AJMC: FDA panel backs 6 peptides for compounding, 31 July 2026
- Therapeutic Goods (Poisons Standard, October 2026) Instrument 2026, F2026L01327 (legislation.gov.au)
- WADA: Prohibited List 2026, in force 1 January 2026 (wada-ama.org)
Research use only
Celyfe supplies research peptides for laboratory and research use only. Nothing on this page is guidance on use in humans or animals.
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