Epitalon (epithalon) peptide

Summary

Epitalon is a four amino acid synthetic peptide developed in St. Petersburg as a defined version of Epithalamin, an extract of the pineal gland (a small hormone gland in the brain). In cultured human cells it activates telomerase, the enzyme that rebuilds telomeres (the protective caps on chromosome ends), and lengthens telomeres, and in mice it modestly extended life span and reduced spontaneous tumors, but the only human data are small, non-randomized reports (no chance assignment to a comparison group) from the group that invented it. FDA removed it from the 503A Category 2 list (compounding ingredients flagged for significant safety risks) in April 2026 and its advisory committee recommended it for the 503A bulks list (ingredients pharmacies may use to compound drugs for individual patients) in July 2026, but no final rule has been published.

What is Epitalon?

Epitalon is a synthetic tetrapeptide (Ala-Glu-Asp-Gly) modeled on the bovine pineal extract Epithalamin. It is also known as Epithalon, Epithalone, Ala-Glu-Asp-Gly, AEDG peptide, Epithalamin (pineal extract it was derived from), Epitalon peptide, Epithalon peptide, Epitalone.

How does it work?

In human fibroblast and other cell lines, epitalon induces expression of the telomerase catalytic subunit (hTERT), increases telomerase activity, and lengthens telomeres; a 2025 study found telomere elongation through telomerase upregulation or the alternative lengthening pathway depending on the cell line. The developers also propose that it binds DNA and regulates gene expression epigenetically and that it normalizes melatonin rhythms through the pineal gland. These mechanisms are documented in cell culture and rodents and have not been confirmed in humans.

Epitalon benefits: what the evidence shows

Cell culture studies show telomerase activation and telomere elongation in human somatic cells. In female SHR mice given epitalon monthly for life, mean life span of the last 10% of survivors increased and spontaneous tumor incidence fell, while overall mean life span did not change significantly. Human data consist of open, non-randomized reports from the developer's institute in elderly patients, mostly using the pineal extract Epithalamin rather than the synthetic peptide, with reported reductions in mortality and cardiovascular events over 6 to 12 years. No independent randomized human trial has been published, so the grade is animal-only. The human observational reports are non-randomized institutional series, mostly of the pineal extract rather than the synthetic peptide; they are listed but do not raise the grade.

Human evidence

No independent randomized controlled trial identified. Khavinson and Morozov (2003) reported that elderly patients treated with pineal peptide preparations (Epithalamin, with Thymalin) in open, non-randomized follow up over 6 to 12 years had lower mortality and fewer cardiovascular and respiratory events than untreated controls; this work comes from the developing institute and used the extract rather than synthetic epitalon in most arms. Cell studies used human fibroblasts and other human cell lines, not people.

Animal evidence

Anisimov et al. (2003) gave female Swiss-derived SHR mice epitalon 0.1 ug subcutaneously five times a week, monthly courses, from age 3 months until death: the peptide slowed some aging biomarkers, increased the life span of the longest lived 10% of mice, and reduced spontaneous tumor incidence, but did not significantly change mean life span. Rat studies from the same group report protective effects against light-induced pineal aging and retinal changes.

Key studies

Conditions studied

Is Epitalon legal in the United States?

FDA and compounding status

Epitalon was placed on the FDA 503A Category 2 list (substances with significant safety risks) in 2023 and removed from it on April 15, 2026. On July 23 to 24, 2026 the Pharmacy Compounding Advisory Committee recommended adding epitalon to the 503A bulks list. As of the last verification date FDA has not published a final rule, so compounding pharmacies and state boards vary in whether they will fill it. It is not an FDA approved drug and is not eligible for 503B outsourcing.

WADA status

WADA prohibited. Athletes subject to anti-doping testing should treat this as prohibited at all times unless the current prohibited list says otherwise.

Regulatory timeline

1. Jul 23, 2026PCAC

   PCAC recommends six peptides for the 503A bulks list

   At its July 23 to 24, 2026 meeting, FDA's Pharmacy Compounding Advisory Committee voted to recommend that BPC-157, KPV, TB-500, MOTS-c, semax, and epitalon be added to the 503A bulk drug substances list. A committee recommendation is advisory; FDA must still issue a rule before the substances are formally listed.

   Regulatory: Under FDA reviewSource: Pharmacy Compounding Advisory Committee
2. Apr 15, 2026FDA

   FDA lists BPC-157 and 16 other peptides as withdrawn from 503A Category 2

   FDA's Category 2 page, revised in April 2026 and current as of April 22, 2026, moved BPC-157, AOD-9604, CJC-1295, dihexa, DSIP, epitalon, injectable GHK-Cu, ipamorelin, KPV, LL-37, melanotan II, MOTS-c, PEG-MGF, selank, semax, thymosin alpha-1, and thymosin beta-4 fragment (TB-500) to a list of bulk drug substances nominated but withdrawn by their nominators. A withdrawn substance is no longer in 503A Category 2, but withdrawal is not an approval and does not place a substance on the 503A bulks list; a 503A pharmacy still needs a listing before it may compound it. Ipamorelin acetate remains in 503B Category 2. Seven of the withdrawn peptides (BPC-157, KPV, TB-500, MOTS-c, semax, epitalon, and DSIP) were taken to the Pharmacy Compounding Advisory Committee in July 2026.

   Regulatory: Removed from Category 2 (Apr 2026)Source: FDA: Certain bulk drug substances for use in compounding may present significant safety risks (503A and 503B Category 2 lists and withdrawn nominations, content current as of April 22, 2026)
3. Sep 2023FDA

   FDA places a batch of nominated peptides in 503A Category 2

   In September 2023 FDA updated its 503A bulk drug substances category lists to place a group of nominated peptides in Category 2, which means FDA identified significant safety risks and the substances may not be used in 503A compounding while the evaluation continues. Kisspeptin-10 and ibutamoren (MK-677) were added on September 29, 2023 and remain in Category 2 on the FDA page current as of April 22, 2026. BPC-157, CJC-1295, ipamorelin, AOD-9604, dihexa, DSIP, epitalon, KPV, MOTS-c, selank, semax, melanotan II, LL-37, thymosin alpha-1, and thymosin beta-4 fragment (TB-500) were also placed in Category 2 under the 503A interim policy; that same page now lists them as nominated but withdrawn (see the April 2026 event). Hexarelin, PNC-27, and 5-amino-1MQ have never appeared on the FDA category lists.

   Regulatory: Not eligible for compoundingSource: FDA: Certain bulk drug substances for use in compounding may present significant safety risks (503A and 503B Category 2 lists and withdrawn nominations, content current as of April 22, 2026)

Full tracker for Epitalon or the category-wide tracker.

What published studies of Epitalon used

Ranges below are reported from published studies and labeling only. PeptideAgent does not recommend doses or protocols.

Not established in human literature. Mouse life span studies used 0.1 ug per mouse subcutaneously in monthly 5 day courses. Human reports from the developer's institute describe 10 mg intramuscular courses of the related extract Epithalamin, not a dose finding study of epitalon. No human pharmacokinetic or dose ranging study has been published.

Routes reported

Epitalon side effects

Side effects

Interactions

Contraindications

How do people access Epitalon legally?

Typical cost: No lawful compounded price: Epitalon is not on the 503A bulks list, and PCAC's July 2026 recommendation is advisory until FDA publishes a final rule. Advertised clinic prices are not a comparable price. Products sold as research chemicals are not lawful for human use and are not verified for identity or purity.

• Epitalon cost by channel
• Rules by state
• Verified provider directory

Compare Epitalon

• Epitalon vs MOTS-c
• Epitalon vs thymalin
• Pinealon vs epitalon

What's actually offered, and what that means for you

Licensed compounding pharmacies, clinics, and telehealth prescribers openly offer many unapproved peptides, and prescribers write prescriptions for them. That does not make epitalon lawful. FDA's advisory committee recommended epitalon for the 503A bulks list in July 2026, but FDA has not published a final rule, so a pharmacy has no federal basis to compound it yet. [5] [6]

Enforcement is uneven. FDA mostly acts through warning letters to compounders and online sellers, Category 2 safety listings, and import alerts that let it detain shipments, rather than stopping every pharmacy. State pharmacy boards oversee pharmacies day to day, and their rules differ. [9] [10] [11] [12] [13]

What changes for you

• No FDA review of the product: FDA does not check a compounded drug's safety, effectiveness, or quality before it is sold. [13]
• Identity, purity, sterility, and dose accuracy can vary from batch to batch. [11]
• Insurance rarely covers it, so you usually pay cash.
• For tested athletes, epitalon is prohibited at all times on the WADA list, whatever the source. [7]

What to check

These checks lower some risks, but they do not make an unlawfully compounded product lawful or safe. Check for:

• A 503A pharmacy licensed in your state (your state board of pharmacy publishes license lookups). [13]
• A real evaluation by a licensed prescriber, not just an online form.
• A certificate of analysis for the specific batch.

Frequently asked questions

Decisions about starting, stopping, or combining any treatment belong with a licensed clinician who knows your history.

From the blog

• Epitalon human studies: what the small cohorts actually measured

  Most epitalon human data come from one research group and used the pineal extract Epithalamin, not synthetic epitalon. What each study measured, plus the melatonin, telomerase, and cancer questions.

• PCAC recommended six peptides. What changes and what does not

  FDA's compounding advisory committee backed BPC-157, KPV, TB-500, MOTS-c, semax, and epitalon for the 503A bulks list and rejected DSIP. Here is what the vote does and does not do.

Sources

Numbered citations above point to these primary sources. PubMed entries link to the indexed abstract.