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What Is Epitalon? The Khavinson Tetrapeptide and FDA's 2026 Vote

Epitalon is a synthetic four-amino-acid peptide modeled on a pineal gland extract studied by Vladimir Khavinson's group in Russia. Here's what the research covers, how FDA's compounding advisers voted in July 2026, what's happened since, and how to check a COA.

Epitalon is a synthetic tetrapeptide, Ala-Glu-Asp-Gly, designed from a bovine pineal gland extract studied by Vladimir Khavinson's group in St. Petersburg; it isn't an approved drug in the US. In July 2026 an FDA advisory committee voted 7-4 to recommend letting pharmacies compound it, but that vote is non-binding and hasn't changed its status. Most Epitalon research is in cells and animals.

Notice: Research peptides are sold for in-vitro laboratory research only. They are not FDA-approved, not for human or animal consumption, and this page is not medical advice. It contains no dosing or use guidance.

What Epitalon is

Epitalon (also spelled Epithalon, or written AEDG) is four amino acids: alanine, glutamic acid, aspartic acid and glycine, joined in that order.

According to a 2025 review in the International Journal of Molecular Sciences, it was synthesized based on the amino acid composition of Epithalamin, an extract of bovine pineal gland. The review credits V.K. Khavinson and V.N. Anisimov with leading the work on the extract's activity. Epitalon belongs to the family of short "bioregulator" peptides from that group, alongside pinealon, which is a different, three-residue peptide (see best pinealon vendors for the contrast).

What the research covers

The 2025 review (Araj, Brzezik, Mądra-Gackowska and Szeleszczuk) is the most complete recent summary. It sorts the evidence like this:

Evidence typeExamples cited in the review
In vitroRat pinealocytes, HeLa cells, human fibroblasts, stem cells, neuroblastoma and immune cell lines; effects on telomerase, antioxidant enzymes and melatonin-related signaling
In silicoDocking and molecular dynamics models of interactions with DNA and histones
AnimalFruit flies, mice, rats (the most common model), rhesus monkeys and rabbits
HumanA trial in 162 patients with retinitis pigmentosa, a study of 75 women measuring melatonin and circadian gene markers, and ex vivo work on donor lymphocytes

Much of the literature comes from the same research network, and independent replication is limited. The review itself is cautious on three points:

  • Mechanism: "its mechanism of action remains unclear."
  • Characterization: "the number of physico-chemical and structural works on this peptide are very limited."
  • Safety: it calls for short- and long-term toxicity, genotoxicity and carcinogenicity studies before approval as a new active ingredient.

None of this establishes an effect on aging or any disease in people.

The July 2026 FDA advisory vote

Epitalon became a regulatory story in 2026 because of pharmacy compounding, not because of any drug approval.

DateEventSource
Apr 22, 2026FDA's Category 2 page lists Epitalon among nominations "withdrawn by the nominators," noting FDA "has not identified safety-related information regarding epitalon for the proposed route of administration"FDA
Jul 24, 2026The Pharmacy Compounding Advisory Committee reviews "Epitalon (free base)/ Epitalon acetate" for insomnia, the nominated useFDA meeting page
Jul 24, 2026The committee votes 7 yes, 4 no, 1 abstaining to recommend Epitalon for the 503A bulks list; FDA staff had recommended against inclusionMcDermott Will & Schulte
Aug 18, 2026Law firm analysis notes the votes "did not amend the 503A Bulks List"; FDA would need a proposed rule, comments and a final ruleBuchanan Ingersoll & Rooney
Oct 14, 2026FDA submits an "Interim Access Policy for Compounding Using Certain Peptides" to the White House Office of Information and Regulatory Affairs; text and covered peptides not publicBuchanan Ingersoll & Rooney, Oct 16, 2026

Epitalon was one of six peptides the committee recommended over the two days, along with BPC-157, KPV, TB-500, MOTs-C and Semax; emideltide (DSIP) wasn't recommended.

Three points are easy to miss:

  1. FDA's meeting page says "Advisory committees make non-binding recommendations to the FDA."
  2. Even a final rule would cover licensed pharmacy compounding under a prescription, not online "research use only" sales.
  3. As of October 21, 2026, we found no published FDA decision adding Epitalon to the 503A list, and the interim policy's terms weren't public.

We track updates in peptide regulatory news and explain the framework in FDA peptide regulation in 2026.

Other agencies

  • FDA enforcement: FDA's 2020 warning letter to Tailor Made Compounding listed Epitalon among bulk substances that weren't eligible for compounding at the time.
  • WADA: the 2026 Prohibited List doesn't name Epitalon (WADA; 2026 list text). Its S0 section covers "any pharmacological substance which is not addressed by any of the subsequent sections" and has no current approval for human therapeutic use.
  • DEA: not on DEA's controlled substances list dated August 27, 2026.

More: are peptides legal?

Research-grade vials: what the market looks like

As of October 21, 2026, 73 vendors in our Epitalon price index had it in stock, at a median of $3.50 per mg, one of the lower medians in our index. The cheapest in-stock listings per mg are all 50 mg vials:

VendorListingPrice$/mgReview
Maximum PeptidesEpithalon 50mg$55.00$1.10Review
True Research LabsEpitalon 50mg$59.00$1.18Review
Go Alpha LabsEpitalon 50mg$59.49$1.19Review

Prices are as listed on vendors' sites on October 21, 2026 and change often. We compare documentation and labs in best Epitalon vendors, and current discounts are on the Epitalon coupon code page.

How to check an Epitalon COA

  1. Confirm it's Epitalon, not pinealon. Epitalon is a four-residue peptide; the mass-spec result should match Ala-Glu-Asp-Gly, not the three-residue Glu-Asp-Arg.
  2. Check measured content. Large 50 mg vials make fill errors matter more. See peptide purity vs net content.
  3. Match the lot number on the certificate to the vial, and look for a recent test date.
  4. Know what you're buying. Oral "bioregulator" capsules and lyophilized research vials are different products.
  5. Verify the lab. Use our COA guide and COA checklist.

Bottom line

Epitalon is a small synthetic peptide with a long research history, most of it from one group and most of it preclinical. The July 2026 FDA advisory vote was a step toward possible pharmacy compounding, not an approval, and as of October 21, 2026 FDA hadn't acted on it. Research-labeled Epitalon remains an unapproved chemical.

Sources are linked inline and were checked October 21, 2026.

FAQ

Frequently asked questions

What is Epitalon?

Epitalon (also spelled Epithalon, or AEDG) is a synthetic tetrapeptide with the sequence Ala-Glu-Asp-Gly. It was designed from the amino acid composition of Epithalamin, a bovine pineal gland extract studied by V. Khavinson and V. Anisimov's group.

Is Epitalon FDA approved?

No. As of October 21, 2026, Epitalon isn't an approved drug. FDA's Pharmacy Compounding Advisory Committee voted 7-4 with one abstention on July 24, 2026 to recommend it for the 503A bulks list, but that vote is non-binding and FDA hasn't added it.

What happened after the July 2026 FDA vote on Epitalon?

FDA hasn't amended the 503A bulks list. On October 14, 2026, FDA submitted an 'Interim Access Policy for Compounding Using Certain Peptides' for White House review; as of October 21, 2026 its text and covered peptides weren't public.

Is there human research on Epitalon?

A little. A 2025 review cites a trial in 162 patients with retinitis pigmentosa and a study in 75 women, mostly from the developer's group. Most of the research is in cells and animals, and the review says key safety studies are still missing.

Is Epitalon the same as pinealon?

No. Epitalon is a tetrapeptide (Ala-Glu-Asp-Gly); pinealon is a tripeptide (Glu-Asp-Arg). Both come from the same research group, but they're different molecules.

Is Epitalon banned by WADA?

WADA's 2026 Prohibited List doesn't name Epitalon. Its S0 section covers pharmacological substances with no current approval for human therapeutic use, but WADA hasn't ruled on Epitalon by name.

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