Epitalon

What it is

Epitalon is a synthetic tetrapeptide made of alanine, glutamic acid, aspartic acid and glycine, usually written AEDG [1]. It was designed in Russia from the amino-acid composition of epithalamin, a pineal gland extract from cattle first described in 1973, and the same tetrapeptide was later detected in a physiological pineal extract in 2017 [1]. Most of the research comes from one group, led by V. Khavinson at the St Petersburg Institute of Bioregulation and Gerontology, and spans roughly 25 years of laboratory, animal and small clinical work [1]. The names Epithalon and Epithalone refer to the same molecule [1]. It is not an approved drug in the United States [11].

How it works

The most-cited mechanism is telomerase activation: in human somatic cell cultures epitalon induces expression of the telomerase catalytic subunit hTERT, raises enzyme activity and lengthens telomeres enough for cells to divide past the usual limit [5]. A second line concerns the pineal gland, where epitalon is reported to raise night-time melatonin and shift expression of circadian genes [5]. Laboratory work also describes antioxidant, antimutagenic and immune-modulating effects, and changes in gene expression and protein synthesis during neurogenesis in cell models [1][4]. The review literature is candid that it remains uncertain whether these are the only mechanisms, and that physico-chemical and structural study of the peptide is still thin [1].

What the evidence shows

The human evidence is small, mostly old, and almost entirely from one research group, and it was not run to modern trial standards [1][5]. The largest report is an open study in 162 people with retinitis pigmentosa, aged 18 to 72, given epitalon by injection around the eye for ten consecutive days; the authors describe improved visual acuity, wider visual fields and smaller scotomas against a conventionally treated control group [1][2]. A separate study in 75 women used sublingual epitalon for 20 days and reported a 1.6-fold rise in urinary 6-sulfatoxymelatonin against placebo, with changes in Clock, Cry2 and Csnk1e expression [1]. Older work reports restored night melatonin release in elderly people with pineal insufficiency [3].

Regulatory status

Not an FDA-approved drug. On Jul 23–24 2026 the FDA Pharmacy Compounding Advisory Committee voted to recommend adding it to the 503A bulk drug substances list; FDA has not finalized that listing (as of Sep 24 2026). [6] The epitalon vote, held on 24 July 2026, was 7 in favour and 5 against with one abstention, for a proposed use in insomnia [8]. FDA staff had proposed the opposite, saying no publication showed efficacy in insomnia and citing immunogenicity risk and peptide-related impurities [7][8]. In April 2026 FDA removed epitalon from Category 2 after the nomination was withdrawn, which did not place it on the bulks list [10]. Listing requires rulemaking and is not FDA approval [9].

Half-life and what it means for a level curve

No human pharmacokinetic study of epitalon has been published that reports an elimination half-life, and the most recent review states plainly that short peptides like this one are typically unstable and degrade rapidly in the body [1]. STACK has no reference half-life for this compound because no human value has been published; you can enter your own estimate. The published human studies used ten-day and twenty-day courses with outcome measurements rather than pharmacokinetic sampling, so there is nothing to derive a curve from [1]. If you enter an estimate, the chart rises at each logged dose and decays between doses, approaching about 97% of steady state after roughly five half-lives on a regular schedule. STACK’s curve is an estimate from this published half-life, not a blood level.

Reported side effects

No FDA-approved label exists, so there is no regulated list of adverse reactions [11]. The retinitis pigmentosa report states that none of the epitalon-treated patients reported side effects, but it was an open study rather than a blinded safety trial, so it is weak evidence about harm [1]. The 2025 review is explicit that information on critical safety questions is missing, and that short- and long-term toxicity, genotoxic activity, carcinogenic potential and drug interactions all need study before this peptide could be considered as an active ingredient [1]. At the July 2026 meeting, committee members voting no cited poor characterisation, potential carcinogenicity risk and a significant lack of safety data [8].

Storage and handling

Epitalon has no FDA-approved label, so the compounding pharmacy’s label governs storage, beyond-use date and handling [11]. Drugs compounded under section 503A are exempt from current good manufacturing practice requirements and are overseen mainly by state boards of pharmacy, so the printed label and the pharmacist’s written instructions stand in for a package insert [11]. FDA warns that poor compounding practice can lead to contamination or to a preparation containing too much or too little active ingredient [11]. Reviewers note that peptides of this size are typically unstable, which is one reason the beyond-use date on your own label matters [1]. STACK’s reconstitution calculator does the mixing arithmetic.

What STACK tracks for it

STACK logs each dose as your prescriber wrote it, with date, time and route, so sublingual and injected use both fit the same record. The estimated-level chart stays off unless you enter your own half-life, because no human value has been published [1]. You can record the schedule your prescriber gave you and mark doses against it, and track sleep, side effects and any other measure your prescriber is watching alongside the doses. Vial or container inventory is tracked with reconstitution details. Everything exports as a plain summary for your next appointment. STACK shows what you logged; it does not prescribe and does not suggest amounts.

The reference half-life in STACK

STACK ships Epitalon without a default half-life: No published human value; short peptides degrade rapidly. You enter your own estimate before a curve is drawn.

Estimate only. Modelled from the published half-life you selected and the doses you logged — not a measured blood level. Do not use it to make medication decisions.

Free tools for Epitalon

Read next

Sources

Every URL below was fetched and checked on 2026-09-24. Bracketed numbers in the text link here.

1. ReviewOverview of Epitalon - Highly Bioactive Pineal Tetrapeptide with Promising Properties
2. TrialPineal-regulating tetrapeptide epitalon improves eye retina condition in retinitis pigmentosa
3. TrialNormalizing effect of the pineal gland peptides on the daily melatonin rhythm in old monkeys and elderly people
4. OtherAEDG Peptide (Epitalon) Stimulates Gene Expression and Protein Synthesis during Neurogenesis: Possible Epigenetic Mechanism
5. ReviewTherapeutic peptides in gerontology: mechanisms and applications for healthy aging
6. FDAJuly 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee
7. FDAFDA Briefing Document, Pharmacy Compounding Advisory Committee, July 23-24 2026
8. OtherFDA advisory committee backs two more peptides, rejects one for compounding list
9. OtherBulk List Bound: PCAC Backs Majority of Peptides in Two-Day Public Meeting
10. OtherFDA Announces Removal of 12 Peptides from Category 2 and Schedules PCAC Meetings
11. FDACompounding and the FDA: Questions and Answers