Overview

Epitalon is a tiny four-amino-acid peptide made in the lab, modeled on an extract from the pineal gland. It is popular in anti-aging circles because cell studies suggested it can switch on telomerase, the enzyme that protects chromosome ends. Good human evidence is lacking, though an FDA advisory panel voted in 2026 to recommend allowing compounding for insomnia.

How it works

Proposed. Cell studies from the developing group report that epitalon activates telomerase and lengthens telomeres in human somatic cells, and that it may act on gene expression (an 'epigenetic' effect) in neural cells. Effects on melatonin and circadian rhythm have also been proposed. These findings come mostly from one research group and have not been independently confirmed in rigorous human trials.

What research shows

Cell study: epithalon induced telomerase activity and telomere elongation in human somatic cells (2003) ⁶.
Cell study: the peptide helped human somatic cells pass their normal division limit (2004) ⁷.
Cell study: AEDG stimulated gene expression and protein synthesis during neurogenesis, proposed as an epigenetic mechanism (2020) ⁸.
Small Russian human studies of epitalon/epithalamin in older adults have been reported, but they were not verified from primary sources in this review.
FDA's July 2026 briefing found insufficient evidence of effectiveness for insomnia and raised cancer-risk concerns; the advisory committee voted 7–4 in favor anyway ³⁴.

Doses studied in people

No verified dose from a published controlled human trial; doses circulating online are not trial-derived.

Read this first: these are the amounts given to participants in published studies or written on official prescribing labels, reported for reference. They are not recommendations. Trial doses were chosen for specific patients under medical supervision, and a dose that is safe in one person can be harmful in another.

Weekly protocol

How the schedule looks week by week. Each chart says where it comes from: a prescribing label, a clinical trial, or a protocol commonly reported online.

Commonly reported course

Commonly reported, not studied

One week

D1D2D3D4D5D6D7

Once daily, in the evening or at bedtime · Subcutaneous injection

Syringe units (U-100)

Vial Water added

Dose by week

5 mgwk 1–3

Supplies for one course (estimate)

Counts only. This site does not sell or link to supplies.

Course: 20 consecutive days, repeated every 4–6 months (about 2 courses a year)
Note: An alternative is 10 mg daily for 10 days (same 100 mg total), matching the Khavinson protocol, which was given by intramuscular injection in observational reports.
Source: PeptideDosages.com: Epitalon (10 mg vial) dosage protocol
Also: Peptide Protocol Wiki: Epitalon dosing protocols

Reference only, not a recommendation. Charts marked "commonly reported" describe what public sources say people use. They have not been tested in trials, and their safety and effect are unknown. Label and trial schedules were set for specific patients under medical supervision. Use the calculator only to understand the arithmetic.

Vial math

Many research vials hold 5 or 10 mg of powder. This table shows how much ends up in each mark on a U-100 insulin syringe for common amounts of added liquid. It is arithmetic only, not a dose.

Vial	Liquid added	Concentration	Per unit (0.01 mL)
5 mg	1 mL	5 mg/mL	50 mcg	Open in calculator
5 mg	2 mL	2.5 mg/mL	25 mcg	Open in calculator
5 mg	3 mL	1.67 mg/mL	16.7 mcg	Open in calculator
10 mg	1 mL	10 mg/mL	100 mcg	Open in calculator
10 mg	2 mL	5 mg/mL	50 mcg	Open in calculator
10 mg	3 mL	3.33 mg/mL	33.3 mcg	Open in calculator

More sizes: all vial sizes · How this works: Syringes and units · Reconstitution guide.

Safety

Theoretical cancer risk: turning on telomerase is a hallmark of many cancers, and FDA's 2026 briefing raised cancer-risk concerns ⁴.
Long-term human safety is unknown.
Unregulated 'research' products may vary in purity and content.

Report side effects of any drug or product to the FDA through MedWatch. For a possible poisoning in the US, call Poison Control at 1-800-222-1222.

Legal status

FDA: Not FDA-approved.
Compounding: Removed from 503A Category 2 in April 2026 (nomination withdrawn); PCAC voted 7–4 on July 24, 2026 to recommend adding it to the 503A bulks list (insomnia). Non-binding; FDA rulemaking still required, and no Category 1 placement or enforcement-discretion statement was reported as of Aug–Sept 2026 ¹²³⁵. Update: on October 28, 2026 HHS issued an interim enforcement discretion policy covering Epitalon: HHS does not intend to take action against 503A pharmacies, federal facilities or physicians that compound it under set conditions (patient-specific prescription, FDA-registered ingredient source with a certificate of analysis, single ingredient, adverse-event reporting), limited to injection under the skin or into muscle, in intermittent courses. This is not FDA approval, is non-binding, and applies only until a final rule on the 503A bulks list ¹¹¹².
Sports (WADA): Not named. Likely captured by S0 (non-approved substances, prohibited at all times) if it has no current government approval for human therapeutic use anywhere — confirm with your anti-doping organization. ¹⁰
Other: Sold as a 'research chemical' internationally; not an approved medicine in the US or EU.

Rules change often. See Legal status of peptides for how these categories work.

History

Developed in Russia by Vladimir Khavinson's group (St. Petersburg Institute of Bioregulation and Gerontology) as a synthetic version of the pineal extract epithalamin. In the US it was on FDA's Category 2 compounding safety list until its nomination was withdrawn (removed April 2026). On July 24, 2026 the FDA Pharmacy Compounding Advisory Committee voted 7–4 (1 abstention) to recommend adding it to the 503A bulks list for insomnia.

Common questions

Is Epitalon FDA-approved or legal to compound?

No. It is not FDA-approved. An FDA advisory committee voted 7 to 4 in July 2026 to recommend allowing compounding for insomnia, but the vote is non-binding and FDA rulemaking is still required ²⁵. Update: on October 28, 2026 HHS issued an interim, non-binding policy saying it does not intend to take action against licensed pharmacies, federal facilities or physicians that compound Epitalon under set conditions, including a patient-specific prescription. This is not FDA approval, and it applies only until a final rule on the 503A bulks list ¹¹¹².

Does Epitalon lengthen telomeres?

Cell studies from 2003 and 2004 reported that it switched on telomerase and helped human cells divide past their normal limit ⁶⁷. These results come mostly from one research group and have not been confirmed in rigorous human trials.

Does Epitalon help with insomnia?

FDA's July 2026 briefing found insufficient evidence that it works for insomnia, though the advisory committee voted in favor anyway ³⁴.

What doses were studied in people?

No dose from a published controlled human trial has been verified. Doses seen online are not from trials.

Is Epitalon safe?

Turning on telomerase is a hallmark of many cancers, and FDA's 2026 briefing raised cancer-risk concerns ⁴. Long-term human safety is unknown.

Is Epitalon banned in sport?

It is not named on WADA's list, but it is likely covered by the S0 'prohibited at all times' rule if no government anywhere has approved it for human use ¹⁰.

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