Unknown in humans. In mice, long-term low doses showed no toxic effect, but FDA notes immunogenicity risk and no identified safety information for proposed routes.

Monograph in Regulatory peptides

Epitalon

The tetrapeptide Ala-Glu-Asp-Gly, modeled on a bovine pineal extract and promoted as an anti-aging peptide. Its best evidence is in cell lines and mice.

Also called Epithalon · Epithalone · AEDG peptide · Ala-Glu-Asp-Gly

Best evidence: Limited / early human data

Human data are limited to an uncontrolled clinical report; the substantive evidence is cellular and murine.

Not FDA-approved · FDA compounding nomination withdrawn

Residue Editorial Team · updated Oct 19, 2026

What is Epitalon?

Epitalon (also spelled epithalon) is the synthetic tetrapeptide Ala-Glu-Asp-Gly, designed from the amino-acid composition of epithalamin, a bovine pineal-gland extract11PubMedOverview of Epitalon-Highly Bioactive Pineal Tetrapeptide with Promising Properties. Araj SK et al. Int J Mol Sci. 2025.. In human cell lines it lengthened telomeres by up-regulating telomerase22PubMedEpitalon increases telomere length in human cell lines through telomerase upregulation or ALT activity. Al-Dulaimi S et al. Biogerontology. 2025., and in HER-2/neu transgenic mice it extended average lifespan by 13.5%33PubMedEpithalon decelerates aging and suppresses development of breast adenocarcinomas in transgenic her-2/neu mice. Anisimov VN et al. Bull Exp Biol Med. 2002.. Human evidence is limited to uncontrolled reports, and it is not FDA-approved44FDACertain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. U.S. FDA, content current as of 04/22/2026..

PubMed records: 12112 reviews
Trial publications: 10 tagged RCT
Registered studies: 00 active · 0 phase 3
Molecular weight: 390.35g/mol · PubChem
Evidence grade: CLimited / early human data

Key findings

Epitalon was synthesized based on the amino-acid composition of epithalamin, a bovine pineal extract1.
In normal human epithelial and fibroblast cells, it produced dose-dependent telomere lengthening via hTERT and telomerase up-regulation; in breast-cancer cell lines, lengthening occurred through ALT activation2.
In female HER-2/neu transgenic mice, 1 mg five times weekly extended mean lifespan by 13.5% and maximum by 13.9%, and reduced breast adenocarcinomas3.
A 2002 report claimed a positive clinical effect in 90% of patients with degenerative retinal lesions, without a described control group55PubMedPineal-regulating tetrapeptide epitalon improves eye retina condition in retinitis pigmentosa. Khavinson V et al. Neuro Endocrinol Lett. 2002..
ClinicalTrials.gov lists no registered study66TrialClinicalTrials.gov registry search: epitalon OR epithalon. 0 registered studies at fetch.; FDA lacks sufficient information to know whether it would cause harm in humans4.

Written by Residue Editorial Team

Reviewed by Residue Editorial Team · source-by-source check, Oct 19, 2026

First published October 19, 2026

Last updated October 19, 2026

Registry data October 19, 2026 · How we grade · Markdown + sources

What is Epitalon, chemically?

**Identifiers** retrieved from PubChem.
PubChem CID	219042 “Epitalon”
Formula	C14H22N4O9
Molecular weight	390.35 g/mol
CAS (as listed)	307297-39-8, 64082-79-7
FDA UNII	O65P17785G
InChIKey	HGHOBRRUMWJWCU-FXQIFTODSA-N
Length	4 residues
Mechanism	Proposed: telomerase induction, melatonin and gene-expression effects (mechanism uncertain)

Hydrophobic
Acidic (−)
Gly / Pro / Cys

Figure 1. Residue sequence of Epitalon (4 positions) as recorded in PubChem CID 219042 — H-Ala-Glu-Asp-Gly-OH.

What is epitalon?

Epitalon is the tetrapeptide Ala-Glu-Asp-Gly (AEDG), designed from the amino-acid composition of epithalamin, an extract of bovine pineal gland, before AEDG itself was found in pineal polypeptide preparations1. Figure 1 shows its four residues from PubChem77PubChemPubChem compound record: Epitalon. C14H22N4O9 · MW 390.35 g/mol..

How is Epitalon thought to work?

A 2025 review lists reported effects on melatonin synthesis, interleukin-2 mRNA, thymocyte mitogenic activity and enzymes including telomerase, while concluding that it remains uncertain whether these are its sole mechanisms. The same review notes that physico-chemical and structural studies of the peptide are quite limited1.

The best-quantified mechanism is telomere maintenance. In normal epithelial and fibroblast cells, epitalon extended telomere length in a dose-dependent manner through up-regulation of hTERT mRNA and telomerase activity. In the breast-cancer lines 21NT and BT474, telomeres also lengthened, but through Alternative Lengthening of Telomeres (ALT) — an ALT effect the authors found to be specific to the cancer cells2.

What have studies found?

Mice. In female HER-2/neu transgenic mice given 1 mg subcutaneously five times a week from the second month of life, mean and maximum lifespan rose 13.5% and 13.9%; breast adenocarcinomas, lung metastases and multiple tumors were reduced3. In one-year-old female C3H/He mice, 0.1 µg five times weekly for 6.5 months reduced the number with malignant tumors, and no metastases were found versus 3 of 9 tumor-bearing controls88PubMedEffect of the synthetic pineal peptide epitalon on spontaneous carcinogenesis in female C3H/He mice. Kossoy G et al. In Vivo. 2006..

Humans. A 2002 paper reported that in Campbell rats epitalon preserved retinal structure and function, and that in patients with degenerative retinal lesions it produced "a positive clinical effect in 90% of the cases"5. The abstract gives no control group, patient numbers or outcome measures. ClinicalTrials.gov lists no registered epitalon study6.

Is Epitalon FDA-approved?

**Table 1. Regulatory status of Epitalon in the United States** — from Drugs@FDA (openFDA) and FDA’s bulk-substance compounding categories, as fetched.
Record	Status	Source
FDA approval	No approved application Drugs@FDA returned no application for “Epitalon”.	openFDA
Compounding: nominated, then withdrawn Epitalon	Withdrawn nomination FDA still lists its safety concerns: “Compounded drugs containing epitalon may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities. FDA has not identified safety-related information regarding epitalon for the proposed route of administration. Therefore, the agency lacks sufficient information to know whether the drug would cause harm if administered to humans.”	4

FDA lists epitalon among withdrawn compounding nominations, noting possible immunogenicity from aggregation and peptide-related impurities, and that it has not identified safety-related information for the proposed route — so it lacks sufficient information to know whether the drug would cause harm in humans4.

What is still unknown?

Controlled human studies of any outcome, published with full methods.
The cancer-cell telomere finding needs reconciling with anti-tumor claims from mouse studies2,3.

What effects has Epitalon shown, by body system?

Each row is graded separately using the Residue evidence scale: a compound can carry an A for one use and a D for another.

**Table 2.** Research-observed effects of Epitalon by body system, with the strongest evidence available for each.
System	What was observed	Grade
Telomeres (cells)	Telomere extension via telomerase in normal cells, via ALT in cancer cell lines2.	D
Lifespan and tumors (mice)	Longer lifespan and fewer breast tumors in HER-2/neu mice3; fewer malignant tumors and no metastases in C3H/He mice8.	D
Retina	Uncontrolled report of benefit in retinitis pigmentosa patients; rat retinal function preserved5.	C

How much research is there on Epitalon?

Figure 2. PubMed records per publication year matching (epitalon[tiab] OR epithalon[tiab] OR epithalone[tiab]) — 121 in total; peak 19 in 2002. The 2026 bar is year-to-date (hatched). Volume of literature is not evidence of efficacy. Run this query on PubMed.

No studies listing Epitalon as an intervention were returned by ClinicalTrials.gov at the last fetch.

Figure 3. 0 studies on ClinicalTrials.gov match the registry search epitalon OR epithalon. Multi-phase studies are counted at their highest phase.

Compare and continue

MOTS-cMitochondria-targeted peptides
SelankRegulatory peptides
GHK-CuTissue-repair & anti-inflammatory peptides

Questions readers ask

Is epitalon the same as epithalon?

Yes — the same tetrapeptide, Ala-Glu-Asp-Gly, also spelled epithalone1.

Does epitalon lengthen telomeres?

In cell lines, yes: a 2025 study found dose-dependent telomere lengthening in normal cells via telomerase, and in cancer cells via the ALT pathway2. That study used cultured cells, not people.

Does epitalon extend lifespan?

In one transgenic mouse strain prone to breast cancer, mean lifespan rose 13.5%3. There are no human lifespan data.

Is epitalon FDA-approved?

No. FDA lists epitalon among withdrawn compounding nominations and says it lacks sufficient information to know whether it would cause harm in humans4.

Is epitalon safe?

Unknown in humans. In mice, long-term low doses showed no toxic effect8, but FDA notes immunogenicity risk and no identified safety information for proposed routes4.

References

Every source below was retrieved from its official API or page and cached on the data-edition date. Numbers match the margin notes.

1 PubMed Araj SK, Brzezik J, Mądra-Gackowska K, et al. Overview of Epitalon-Highly Bioactive Pineal Tetrapeptide with Promising Properties. Int J Mol Sci 2025. PMID 40141333; doi:10.3390/ijms26062691.
2 PubMed Al-Dulaimi S, Thomas R, Matta S, et al. Epitalon increases telomere length in human cell lines through telomerase upregulation or ALT activity. Biogerontology 2025. PMID 40908429; doi:10.1007/s10522-025-10315-x.
3 PubMed Anisimov VN, Khavinson VKh, Alimova IN, et al. Epithalon decelerates aging and suppresses development of breast adenocarcinomas in transgenic her-2/neu mice. Bull Exp Biol Med 2002. PMID 12459848; doi:10.1023/a:1021104819170.
4 FDA Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. U.S. FDA, content current as of 04/22/2026.
5 PubMed Khavinson V, Razumovsky M, Trofimova S, et al. Pineal-regulating tetrapeptide epitalon improves eye retina condition in retinitis pigmentosa. Neuro Endocrinol Lett 2002. PMID 12195242.
6 ClinicalTrials.gov ClinicalTrials.gov registry search: epitalon OR epithalon. 0 registered studies at fetch.
7 PubChem PubChem compound record: Epitalon. C14H22N4O9 · MW 390.35 g/mol.
8 PubMed Kossoy G, Anisimov VN, Ben-Hur H, et al. Effect of the synthetic pineal peptide epitalon on spontaneous carcinogenesis in female C3H/He mice. In Vivo 2006. PMID 16634527.