Epitalon · Dose evidence · updated 8 October 2026
Epitalon dosage: what studies actually used
The short answer
Epitalon is not part of any FDA-approved drug, and FDA’s 2026 review found no clinical data to support its safety in people, so no dose is established3. Every published study that gave it to people came from Vladimir Khavinson’s research network in Russia, and as of 7 October 2026 we found no independent human trial, published or registered123. Those studies used short courses: 0.5 mg a day as a spray under the tongue for 20 days, 5 µg per eye a day by injection around the eyeball for 10 days, and 10 µg a day into muscle for 10 days; none tested injections under the skin, the route proposed to FDA345.
Not dosing advice. This page reports doses that studies and approved labels used, with their sources. It does not recommend a dose, and we do not give mixing, injection or unit-conversion instructions. Gray-market vials often do not contain what their label says. How we report doses.
Every dose studied in people
| Study | Who | People | Dose and route | What happened |
|---|---|---|---|---|
| Khavinson 2002, controlled trial in Saint Petersburg | People aged 18 to 72 with retinitis pigmentosa, an inherited disease that slowly destroys the retina; a comparison group got standard drugs | 162 | 5.0 µg per eye a day Injection around the eyeball (parabulbar) · 10 days in a row |
The abstract reports ‘a positive clinical effect in 90% of the cases’6. A 2025 review adds that visual acuity rose by 0.15 to 0.20 on average, the edges of the visual field widened in every treated patient and none reported side effects; neither source describes randomization or blinding46. |
| Ivko 2020, randomized, placebo-controlled trial | Healthy women aged 40 to 50, mostly night-shift workers, with low levels of a urine melatonin marker; 20 got epitalon and 20 a saltwater spray | 40 | 0.5 mg a day, given as 3 sprays twice a day Spray under the tongue · 20 days |
The marker, 6-sulfatoxymelatonin, rose 1.7-fold on epitalon to the level of a 35-woman reference group and did not change on placebo, and readings of the Clock, Cry2 and Csnk1e genes in blood cells shifted37. FDA noted that the paper did not specify blinding, did not measure sleep and did not report safety data3. |
| Khavinson patent 2004, example 9; no comparison group, not peer reviewed | Adults aged 34 to 69 with high blood pressure, ischemic heart disease, chronic gastritis or type 2 diabetes, and weak antioxidant defenses in the blood | 14 | 10 µg once a day Injection into muscle · 10 days |
The patent reports a significant rise in superoxide dismutase, an antioxidant enzyme, and a fall in products of fat oxidation in the blood5. |
| Khavinson patent 2004, example 10; no comparison group, not peer reviewed | Adults aged 39 to 63 with aspirin-induced asthma who stayed on their usual asthma drugs, including inhaled and oral steroids | 11 | 10 µg once a day, in the morning Injection into muscle · 10 days |
Most patients’ symptoms eased by the end of treatment, and a urine melatonin marker rose by day and by night, but standard lung-function tests right after treatment showed no essential change5. |
Studies, animals and users: kept apart
Doses below are what studies used or what a label says. They are not advice, and gray-market products may not contain what their label says.
In human studies
All published human dosing comes from Khavinson’s network. Under the tongue: 0.5 mg a day as a spray for 20 days, in the one placebo-controlled trial37. Around the eyeball: 5 µg per eye a day for 10 days, in retinitis pigmentosa4. Into muscle: 10 µg a day for 10 days, in two small uncontrolled case series; the patent proposes 0.01 to 100 µg/kg a day for 10 to 40 days5. FDA found no human study of injections under the skin, the route proposed to FDA and common online, at any dose3.
In animal studies
As reported. Mice: 0.1 µg or 1 µg per mouse by injection under the skin on 5 days in a row each month91011. Dosing started at 2 to 6 months of age and went on for life or until the study ended; FDA estimated the doses at about 3 to 4 and 30 to 40 µg/kg a day391011. Rhesus monkeys: 2 µg/kg a day by injection into muscle for 10 days312. Rats, in the developer’s patent (not peer reviewed): 1 µg/kg to 3 mg/kg a day into muscle for 90 days, and 1 µg/kg to 1 mg/kg a day for 6 months, with no reported harm5. Mice: single doses of up to 5 mg/kg into muscle caused no acute toxic reactions, the patent says5. Fruit flies: added to the food of developing larvae13. These are animal doses, not human doses.
Half-life and how it is taken
- Half-life
- Not known3FDA found no data on how epitalon is absorbed or cleared in people3. The only distribution data FDA found come from one study of fluorescent-labeled epitalon in pregnant rabbits, and FDA said the signal may not have been epitalon itself3. A 2025 review notes that short peptides like epitalon usually break down quickly in the body4.
- Routes
- Injection under the skin (the route proposed to FDA and the usual gray-market route; no human data found)
- Spray under the tongue (the one placebo-controlled human trial, 0.5 mg a day for 20 days)
- Injection into muscle (two small uncontrolled case series in the developer’s patent; Russian monkey and rat studies)
- Injection around the eyeball (one Russian trial in retinitis pigmentosa)
- Capsules and oral sprays (sold online and by clinics; no human data found)
Why every human dose comes from one Russian network
FDA’s 2026 review says most pharmacological studies of epitalon ‘have been conducted and published by Dr. Khavinson’s research group in Russia’3. Its literature search found only three studies in which people were given epitalon: two of a spray under the tongue in night-shift workers and one of injections around the eyeball3.
Both journal reports in the table list the Saint Petersburg Institute of Bioregulation and Gerontology, where Khavinson worked, among the authors’ affiliations67. The two series of injections into muscle appear in Khavinson’s US patent rather than a peer-reviewed paper, and neither had a comparison group5. A 2026 review of peptides in gerontology noted that epitalon lacks independent Western validation14.
Has anyone outside that network tested a dose in people?
We found no such study. On 7 October 2026 we searched PubMed for epitalon under six names and found 168 records; every report in which people were given epitalon came from Khavinson’s group or its co-authors1. ClinicalTrials.gov, the US trial registry, listed no epitalon study when searched on 5 and 7 October 2026215.
The studies we found from outside the former Soviet Union, without Khavinson or his colleague Vladimir Anisimov, used only cells in the lab: human cell lines in a 2025 UK study, and mouse and cow egg cells161718. Amounts added to a lab dish are not human doses.
Human reports that give no dose
Two more reports from the network say people were given epitalon but give no dose we could use319:
- Korkushko 2007, with Khavinson among the authors: epitalon and epithalamin raised night-time melatonin in older people with weak pineal function and had no side effects, the abstract says19. FDA noted that the abstract gives no route, dose, length of treatment or number of people3.
- Khavinson, Linkova and Ivko 2021: FDA counts this report on clock genes in night-shift workers given epitalon under the tongue as one of its three human studies, but gives no separate dose or group size for it3.
Questions people ask
How much epitalon should I take?
No dose is established: FDA found no clinical data to support epitalon’s safety in people and a lack of evidence that it works for insomnia3. The few human studies used 0.5 mg a day under the tongue for 20 days, or 5 µg per eye or 10 µg a day by injection for 10 days345. Epitalon is not an FDA-approved drug, and US pharmacies may not compound it32122.
What dose of epitalon is used for sleep?
None has been tested: FDA’s search found no published study of epitalon’s effectiveness in people with insomnia3. The one placebo-controlled trial, 0.5 mg a day under the tongue for 20 days, measured a urine melatonin marker, not sleep3.
How long can you take epitalon?
We found no published human study with a stated schedule that gave epitalon for more than 20 days345. FDA found no clinical data on its safety in people and noted that continuous long-term exposure could cause cancer by switching on telomerase, the enzyme that rebuilds the ends of chromosomes3.
Go deeper
Sources
- 1PubMed search: epitalon, epithalon, epithalone, epitalone, AEDG and Ala-Glu-Asp-Gly in titles and abstracts (168 records) National Library of Medicine (PubMed), accessed 7 Oct 2026. pubmed.ncbi.nlm.nih.gov
- 2ClinicalTrials.gov search: epitalon, epithalon, epithalone, epitalone, AEDG or Ala-Glu-Asp-Gly (0 studies) ClinicalTrials.gov, accessed 7 Oct 2026. clinicaltrials.gov
- 3July 23-24, 2026, Meeting of the Pharmacy Compounding Advisory Committee – FDA Briefing Document for Epitalon-Related Bulk Drug Substances (Epitalon (free base) and Epitalon acetate); FDA evaluation dated 12 May 2026 U.S. Food and Drug Administration, Jul 2026. fda.gov
- 4Overview of Epitalon-Highly Bioactive Pineal Tetrapeptide with Promising Properties International Journal of Molecular Sciences, 17 Mar 2025. pubmed.ncbi.nlm.nih.gov
- 5US 6,727,227 B1: Tetrapeptide revealing geroprotective effect, pharmacological substance on its basis, and the method of its application (inventor Vladimir K. Khavinson) Google Patents (U.S. Patent and Trademark Office record), 27 Apr 2004. patents.google.com
- 6Pineal-regulating tetrapeptide epitalon improves eye retina condition in retinitis pigmentosa Neuroendocrinology Letters, Aug 2002. pubmed.ncbi.nlm.nih.gov
- 7AEDG peptide regulates human circadian rhythms genes expression during pineal gland accelerated aging (in Russian; English version: Advances in Gerontology 2021;11(1):53-58) Uspekhi Gerontologii (Advances in Gerontology), 2020. pubmed.ncbi.nlm.nih.gov
- 8Epitalon: How It Works, Mechanism & Evidence (2026) The Peptide Catalog, 18 Apr 2026. thepeptidecatalog.com
- 9Effect of synthetic thymic and pineal peptides on biomarkers of ageing, survival and spontaneous tumour incidence in female CBA mice Mechanisms of Ageing and Development, Jan 2001. pubmed.ncbi.nlm.nih.gov
- 10Effect of Epitalon on biomarkers of aging, life span and spontaneous tumor incidence in female Swiss-derived SHR mice Biogerontology, 2003. pubmed.ncbi.nlm.nih.gov
- 11Inhibitory effect of the peptide epitalon on the development of spontaneous mammary tumors in HER-2/neu transgenic mice International Journal of Cancer, 1 Sep 2002. pubmed.ncbi.nlm.nih.gov
- 12Regulatory effect of Epithalon on production of melatonin and cortisol in old monkeys Bulletin of Experimental Biology and Medicine, Apr 2001. pubmed.ncbi.nlm.nih.gov
- 13Effect of epitalon on the lifespan increase in Drosophila melanogaster Mechanisms of Ageing and Development, 1 Dec 2000. pubmed.ncbi.nlm.nih.gov
- 14Therapeutic peptides in gerontology: mechanisms and applications for healthy aging Frontiers in Aging, 2026. pubmed.ncbi.nlm.nih.gov
- 15ClinicalTrials.gov search for ‘epitalon’, ‘epithalon’ or ‘AEDG’ (no registered studies) ClinicalTrials.gov, accessed 5 Oct 2026. clinicaltrials.gov
- 16Epitalon increases telomere length in human cell lines through telomerase upregulation or ALT activity Biogerontology, 4 Sep 2025. pubmed.ncbi.nlm.nih.gov
- 17Epitalon protects against post-ovulatory aging-related damage of mouse oocytes in vitro Aging (Albany NY), 12 Apr 2022. pubmed.ncbi.nlm.nih.gov
- 18Epitalon-activated telomerase enhance bovine oocyte maturation rate and post-thawed embryo development Life Sciences, 1 Feb 2025. pubmed.ncbi.nlm.nih.gov
- 19Normalizing effect of the pineal gland peptides on the daily melatonin rhythm in old monkeys and elderly people (in Russian) Uspekhi Gerontologii (Advances in Gerontology), 2007. pubmed.ncbi.nlm.nih.gov
- 20Peptides of pineal gland and thymus prolong human life Neuroendocrinology Letters, 2003. pubmed.ncbi.nlm.nih.gov
- 21Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (categories list) U.S. Food and Drug Administration, 14 May 2026. fda.gov
- 22Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks U.S. Food and Drug Administration, 22 Apr 2026. fda.gov
Not medical advice. Talk to a licensed clinician before using any drug. Report an error.