Epitalon
Epitalon (epithalon) is a synthetic four-amino-acid peptide, Ala-Glu-Asp-Gly, studied mainly in cell and animal experiments for effects related to aging.
US regulatory status
Not approved for human use in the US
Epitalon is not approved by the FDA for any use; in April 2026 the FDA moved it off its Category 2 safety-risk list after the nomination was withdrawn. In July 2026 an FDA advisory committee voted, against FDA staff advice, to recommend adding it to the 503A bulks list; that vote is not binding, and as of October 16, 2026 the FDA had not published a proposed or final rule. The FDA found no approved epitalon product in the EU, the UK, Canada or Australia.
At a glance
- Also known as
- Epithalon, Epitalone, AEDG peptide, Ala-Glu-Asp-Gly
- Supplied as
- Freeze-dried powder, mixed before use
- Research
- Limited human evidence
- US status
- US status: Not approvedchecked
What the research shows
Evidence grade
Limited human evidence
Some studies in people, but they are small, short, early-phase or uncontrolled.
Cell studies report that epitalon can switch on telomerase and lengthen telomeres in human cell lines. Human data are limited and mostly describe effects on melatonin or its breakdown products. The FDA evaluated epitalon for insomnia, the use it was nominated for, found no studies in people with insomnia, and concluded “there is a lack of evidence to support the effectiveness” for that use. Mouse studies reporting fewer spontaneous tumors used one fixed dose, female mice only and short exposure, so the FDA says they “do not adequately inform” its cancer risk. A 2026 review groups epitalon under telomere biology and says non-approved peptides “lack long-term safety data and systematic validation,” and a ClinicalTrials.gov search on October 16, 2026 found no registered trial.
How we grade evidence
Strong human evidence
Consistent results from large randomized controlled trials in people.
Limited human evidence · this page
Some studies in people, but they are small, short, early-phase or uncontrolled.
Mixed evidence
Studies in people disagree, or strong evidence for one use sits beside weak evidence for another.
Animal or lab studies only
Studied in cells or animals, not properly in people. Animal results may not apply to humans.
The grade describes how much research exists and in whom. It is not a judgment that a compound works or is safe.
Side effects and safety
The FDA concluded “there are no clinical data to support the safety” of epitalon in humans. Its review raises a cancer concern: because epitalon activates telomerase and lengthens telomeres, and “longer telomeres are generally associated with increased risk for cancer,” it “has the potential to be carcinogenic” from a mechanistic standpoint. The FDA also warns injected compounded epitalon may cause immune reactions due to aggregation and peptide-related impurities. Its searches found no reports in FAERS (through December 8, 2025) or its food and supplement complaint system (through December 5, 2025), but no reports is not evidence of safety. Products sold online are unregulated, so their identity, purity and sterility are not verified.
Vial math
Pre-filled calculators turn your vial, water and prescribed dose into syringe units.
Pre-filled for your vial size
- Epitalon 10 mgReconstitution calculator
- Epitalon 50 mgReconstitution calculator
- Any vial sizePeptide reconstitution calculator
This is arithmetic, not medical advice. Confirm with your prescriber or pharmacist.
Questions people ask
What is epitalon (epithalon)?
Epitalon, also spelled epithalon, is a lab-made peptide of four amino acids: alanine, glutamic acid, aspartic acid and glycine (AEDG). It is not the same as epithalamin: the FDA treats them as different substances, because epithalamin is a mix of peptides extracted from the pineal gland, while epitalon is a single peptide designed from epithalamin’s amino-acid content. It is also different from pinealon, a three-amino-acid peptide (Glu-Asp-Arg) from the same research group.
Sources
- U.S. Food and Drug Administration, 2026: FDA Briefing Document for Epitalon-Related Bulk Drug Substances (PCAC, July 23-24, 2026) (opens in a new tab)
- Biochemistry (Mosc), 2011: Penetration of short fluorescence-labeled peptides into the nucleus in HeLa cells and in vitro specific interaction of the peptides with deoxyribooligonucleotides and DNA (opens in a new tab)
Is epitalon FDA-approved?
No. Epitalon is not approved for any use in the US, and the FDA found no approved epitalon product in Canada, Australia, the UK or the European Union. On July 24, 2026 the FDA’s Pharmacy Compounding Advisory Committee reviewed it for insomnia and voted, against FDA staff advice, to recommend adding it to the list of substances pharmacies may compound. That vote is not binding: the FDA would still need to propose and finalize a rule, and as of October 16, 2026 it had not published one.
Sources
- U.S. Food and Drug Administration, 2026: FDA Briefing Document for Epitalon-Related Bulk Drug Substances (PCAC, July 23-24, 2026) (opens in a new tab)
- U.S. Food and Drug Administration, 2026: July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee (opens in a new tab)
- ABC News, 2026: FDA advisers narrowly vote to add 6 peptides to a drug compounding list. What's next? (opens in a new tab)
- Federal Register (U.S. Food and Drug Administration), 2026: Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List (opens in a new tab)
Does epitalon lengthen telomeres?
In lab studies of human cell lines, epitalon increased telomerase activity and telomere length. That has not been shown to translate into health benefits in people. The FDA reads the same finding as a warning sign: longer telomeres are generally linked to higher cancer risk, so it says epitalon “has the potential to be carcinogenic” from a mechanistic standpoint, and the mouse tumor studies are too limited to settle the question.
Sources
- Bull Exp Biol Med, 2003: Epithalon peptide induces telomerase activity and telomere elongation in human somatic cells (opens in a new tab)
- Biogerontology, 2025: Epitalon increases telomere length in human cell lines through telomerase upregulation or ALT activity (opens in a new tab)
- U.S. Food and Drug Administration, 2026: FDA Briefing Document for Epitalon-Related Bulk Drug Substances (PCAC, July 23-24, 2026) (opens in a new tab)
Does epitalon help with sleep?
There is no good evidence that it does. Insomnia was the use the FDA evaluated in 2026. Its review found that the human data describe effects on melatonin or melatonin breakdown products, but no studies in people with insomnia, particularly with injection under the skin, and it concluded there is “a lack of evidence to support the effectiveness” of epitalon for insomnia.
Is epitalon safe?
Its safety in people has not been established. The FDA found “no clinical data to support the safety” of epitalon in humans, flagged a possible cancer risk from its effect on telomeres, and noted a risk of immune reactions from aggregation and impurities when injected. FDA searches found no adverse-event reports, which reflects how little it has been studied and monitored, not proof that it is safe. Products sold online are not FDA-approved, so their contents are not verified.
Sources
- U.S. Food and Drug Administration, 2026: FDA Briefing Document for Epitalon-Related Bulk Drug Substances (PCAC, July 23-24, 2026) (opens in a new tab)
- U.S. Food and Drug Administration, 2026: Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (opens in a new tab)
Can I use the reconstitution calculator for epitalon?
Yes, the calculator is plain arithmetic for any powder vial. There are ready-made pages for a 10 mg vial and a 50 mg vial; enter the amount of water and the dose your prescriber gave you. The FDA’s 2026 review cites reports that epitalon free base has limited water solubility and says it “may not be possible” to make a 3 mg/mL injection with water as the solvent, so ask a pharmacist about any powder that does not fully dissolve. Epitalon is not FDA-approved, and no dose for it has been established.
Sources
- Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety RisksU.S. Food and Drug Administration, 2026 · Accessed Oct 15, 2026 (opens in a new tab)
- July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory CommitteeU.S. Food and Drug Administration, 2026 · Accessed Oct 15, 2026 (opens in a new tab)
- FDA Briefing Document for Epitalon-Related Bulk Drug Substances (PCAC, July 23-24, 2026)U.S. Food and Drug Administration, 2026 · Accessed Oct 15, 2026 (opens in a new tab)
- FDA advisers narrowly vote to add 6 peptides to a drug compounding list. What’s next?ABC News, 2026 · Accessed Oct 15, 2026 (opens in a new tab)
- Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances ListFederal Register (U.S. Food and Drug Administration), 2026 · Accessed Oct 16, 2026 (opens in a new tab)
- Epithalon peptide induces telomerase activity and telomere elongation in human somatic cellsBull Exp Biol Med, 2003 · Accessed Oct 15, 2026 (opens in a new tab)
- Epitalon increases telomere length in human cell lines through telomerase upregulation or ALT activityBiogerontology, 2025 · Accessed Oct 15, 2026 (opens in a new tab)
- Therapeutic peptides in gerontology: mechanisms and applications for healthy agingFront Aging, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
- ClinicalTrials.gov intervention searches for selank, semax, dihexa, pinealon and epitalonClinicalTrials.gov, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
- Penetration of short fluorescence-labeled peptides into the nucleus in HeLa cells and in vitro specific interaction of the peptides with deoxyribooligonucleotides and DNABiochemistry (Mosc), 2011 · Accessed Oct 16, 2026 (opens in a new tab)
Related compounds
Guides
Every medical and regulatory statement on this page links to a checkable source, listed above. Peptinote does arithmetic and education, not medical advice, and never sells or links to sellers of peptides.