Epitalon: what the studies show, status and safety
Summary
Epitalon is a synthetic chain of four amino acids, worked out in St Petersburg from a cattle pineal gland extract. Only three published reports exist in which a person received it. The one randomised study ran 20 days and measured neither sleep nor safety. In July 2026 the FDA proposed keeping it off the pharmacy compounding list.
Key findings at a glance
- Three published reports, in total, of a person receiving Epitalon. The FDA searched PubMed, Embase, Cochrane and the trials registry. It found two studies of a spray in night-shift workers, and one injection behind the eye in retinal disease [1].
- Zero registered trials. Queries to the ClinicalTrials.gov interface on 7 September 2026 returned nothing for epitalon, epithalon, epithalamin or AEDG [2].
- The one randomised study ran for 20 days in 20 women. They used a spray under the tongue. A urine marker of melatonin rose 1.7-fold. Sleep was never measured and no safety data were recorded [1], [3].
- The FDA proposed a no. On 24 July 2026 the agency asked its advisory committee to keep both Epitalon free base and Epitalon acetate off the 503A compounding list. Both nominations had already been withdrawn [1], [4].
- Telomere lengthening is real in a dish, and only there. Brunel University London reproduced the 2003 finding of the inventors in 2025. In two breast cancer cell lines, the telomeres grew by a different route entirely [5], [6].
- The famous survival studies are about a different substance. The work in 266 older people, and the 12-year and 15-year follow-ups, used epithalamin, the cattle extract. The FDA set aside seven submitted articles for exactly this reason [1], [7].
- Banned in sport around the clock. Category S0 covers substances no health authority has approved, which is why Epitalon is caught without being named [8].
What it is
Epitalon is a fully synthetic tetrapeptide, meaning a chain of just four amino acid building blocks: alanine, glutamic acid, aspartic acid and glycine [9]. It is not a hormone, it has no known receptor of its own, and it is licensed as a medicine nowhere. On the market it circulates as a research chemical.
Vladimir Khavinson and colleagues at the St Petersburg Institute of Bioregulation and Gerontology derived the sequence from epithalamin, an extract of cattle pineal glands [1]. The molecule was built on the bench rather than isolated from tissue.
Only in 2017, long after the synthesis, did the same group report finding the sequence in the pineal peptide mixture. No one else has confirmed that [10].
Epitalon, Epithalon and Epithalone are three spellings of the same substance, all listed under one PubChem entry [9]. That inconsistency is not harmless. It is one of the two reasons the FDA classes the substance as poorly characterised, alongside missing quality data for an injectable form [1].
Quick facts
| Field | Value | Ref |
|---|---|---|
| Class | Synthetic tetrapeptide, sold as a research chemical | [1], [9] |
| Sequence | H-Ala-Glu-Asp-Gly-OH, four amino acids, all in the natural L-form | [1], [9] |
| Formula and mass | C14H22N4O9, 390.35 g/mol for the free base | [9] |
| CAS registry number | 307297-39-8 free base; 307297-40-1 for the acetate | [1] |
| PubChem CID | 219042 | [9] |
| UNII | O65P17785G | [9] |
| Wikidata | Q27285389 | [11] |
| Melting point | 198.0 to 202.0 degrees Celsius | [1] |
| How long it lasts in the body | No published value in any species | [1] |
| Status | Approved nowhere; in no pharmacopoeia; no registered trial | [1], [2] |
| Where it came from | St Petersburg Institute of Bioregulation and Gerontology | [1], [12] |
How it works
No mechanism has been established in a living person, so everything below is written as a proposal rather than a finding.
- Switching telomerase on. Telomeres are the caps on the ends of chromosomes that shorten each time a cell divides. Epitalon may raise the level of telomerase, the enzyme that rebuilds them, and so lengthen the caps [5], [6].
- Nudging the pineal gland. The substance may lift night-time melatonin and settle the daily rhythm in older animals. An independent laboratory in Paris perfused isolated rat pineal glands and found no effect at all [13], [14].
- Binding to DNA directly. The inventors propose that the peptide docks onto stretches of the double helix and switches genes on. No structure of such a complex has ever been solved, and no one outside the group has confirmed it [15].
- Getting into the cell. Transport through amino acid and peptide carriers has been modelled on a computer, with fluorescent peptide seen gathering in cell nuclei. No transport experiment has been run [16].
- Mopping up free radicals. Two papers from the same laboratory contradict each other. One describes antioxidant properties; the other states plainly that the peptide has no direct antioxidant activity [17].
The FDA puts the position bluntly. It writes that the mechanisms by which Epitalon regulates melatonin in the living body remain unknown [1].
There are also no measurements of how the body absorbs, distributes or clears it, in any species. A short chain of ordinary amino acids is, in addition, easy prey for the enzymes that chop peptides up.
What the studies found
Almost the whole record comes from cell cultures, flies, mice, rats and monkeys. The human part is three publications, and only one of them was randomised.
Counts as of 7 September 2026. Sources [1], [2].
Telomeres and telomerase
Cell culture In 2003 the inventors added the peptide to human foetal lung fibroblasts for four days. They reported telomerase activity and longer telomeres in cells that had neither before [6]. A follow-up described the treated cells dividing 44 times instead of 34 [18]. Both are very short notes without replicate counts or statistics.
Cell culture The important check came in 2025 from Brunel University London, with no involvement of the original group. Four rising concentrations over four days lengthened telomeres in normal human breast cells and fibroblasts, in step with the concentration, through telomerase [5]. That confirms the 2003 result.
Cell culture The same paper carries a finding that rarely gets quoted. In the two breast cancer lines, 21NT and BT474, the telomeres grew through a separate route called alternative lengthening. That route is a hallmark of cancer cells.
Cell culture The authors name their main limitation themselves: flat cell cultures only, no animals [5]. A correction was later published, because the wrong figures had been printed [5].
The human record
Randomised, small The single randomised, placebo-controlled study enrolled 75 healthy women aged 40 to 50, mostly night-shift workers [3]. The 35 with normal excretion of a melatonin breakdown product served as an untreated reference; the 40 with low excretion were split into two arms of 20. The spray went under the tongue, twice a day for 20 days.
Randomised, small In the treated arm the urine marker rose 1.7-fold, and stayed flat under salt water [3]. The authors also reported clock genes shifting in blood cells. They noted a positive change in mood and general condition in 83 per cent of the treated group, against 25 per cent on placebo. How that was assessed is not described.
Randomised, small The FDA lists the weaknesses in detail. Blinding is never specified, the arms hold 20 people each, and the study runs 20 days. The reference ranges are missing, no sleep endpoint was measured, and no safety data were reported [1].
Randomised, small The route was under the tongue, not the injection the market sells. A second paper from the same group, in a journal PubMed does not index, appears to report the same women again [19].
Uncontrolled The third report, from 2002, injected the peptide behind the eye in people with retinal degeneration. It claimed a positive clinical effect in 90 per cent of cases [20]. It states no patient count, no dose, no endpoint definition and no control group. The orphan designation of 2010 rested on this work.
Laboratory, not clinical Studies that incubate human blood cells in a tube are regularly presented as human evidence. In one, lymphocytes from 11 men changed telomere length significantly in 7 of them. Five grew longer, by 41, 55, 156, 18 and 76 per cent; two grew shorter, by 37 and 15 per cent [21]. The men themselves received nothing.
Human lymphocytes from 11 male donors, incubated with the peptide outside the body; only the seven donors with a significant change are shown. Source [21].
Melatonin and the body clock
Animal data In old rhesus monkeys, a daily injection into the muscle over 10 days raised evening melatonin more than fourfold. Evening cortisol fell by about 30 per cent [14]. Young animals showed no melatonin change. Blood was drawn only on the last day, and sleep was never recorded [1].
Animal data The contradiction sits in the same literature. A Paris laboratory perfused isolated pineal glands from young and old rats. It saw no effect on melatonin release, nor on release driven by a stimulant drug [13]. Khavinson and Anisimov are co-authors of that negative paper.
Lifespan and tumours in animals
Animal data In female CBA mice, average survival rose 5.3 per cent (p<0.05) [22]. In SHR mice there was no effect on average lifespan at all. Only the last tenth of survivors lived 13.3 per cent longer (p<0.01), and maximum lifespan rose 12.3 per cent [23].
Animal data The same SHR study reports results that are usually left out. Total spontaneous tumour incidence did not change, and only leukaemia became rarer, by a factor of 6.0. Chromosome damage in bone marrow fell 17.1 per cent (p<0.05) [23].
Animal data In fruit flies the gain was 11 to 16 per cent. The authors stress that it did not depend on the dose across four orders of magnitude [12].
Animal data The tumour results run in several directions. In mice bred to develop breast tumours the peptide lowered tumour number and size (p<0.05) [24]. A companion paper reported 34.2 per cent longer tumour-free life [25].
Animal data In a chemically driven bowel cancer model, 90 to 100 per cent of animals still developed tumours. Only the count per rat fell, from 4.1 to 2.7 [26]. In a bladder model there was no effect at all [27].
Animal data Two control findings deserve as much attention as the results. In the breast tumour model, the comparison peptide vilon increased tumour incidence and shortened the time to onset [24]. In irradiated rats, Epitalon suppressed blood cell and lymphocyte formation in the spleen [28].
What is still unknown
- Everything about the human body's handling of it. No half-life, no bioavailability, no clearance, no metabolites, in any species [1].
- Whether the telomere effect happens in a person at all. It has been seen in dishes only, never in a living human [5], [6].
- Toxicity beyond single doses. No acute toxicity study, no repeat-dose study, no reproductive toxicology and no two-year cancer study exist [1].
- The injected route. Not one human study has used the subcutaneous route the market sells [1].
- Genotoxicity properly assessed. The available work used one fixed dose, female animals only, four per group, and reused the same control data for a different peptide [1], [29].
- Immune reactions and aggregation. Never examined, although both matter for anything injected [1].
Side effects and safety
There is no side effect profile, because no study has ever looked for one. The FDA states that its search of the published literature identified no clinical studies assessing the safety of Epitalon in humans [1].
- No adverse event reports on file. The FDA adverse event database held zero entries by 8 December 2025, and the food complaint system zero by 5 December 2025 [1]. Reporting is voluntary and compounders rarely report, so this is silence rather than reassurance.
- The one randomised study recorded no safety data. Twenty people, twenty days, nothing collected [1], [3].
- A cancer concern built into the mechanism. The FDA argues that keeping telomerase switched on could let cells slip past the point at which they normally stop dividing. Long telomeres are associated with higher cancer risk generally [1].
- Cancer cells lengthened their telomeres by the route cancers use. In the 2025 replication, the two breast cancer lines did so through alternative lengthening [5].
- A suppressive effect on blood formation in rats. Epitalon held back blood cell and lymphocyte production in the spleen, unlike its sister peptide, which promoted recovery [28].
- Immunogenicity is untested. An injected peptide can provoke antibodies, and impurities or clumps make that more likely. No study of either exists for this substance [1].
- Certificates of analysis fall short. Those the FDA found report purity only, with no limits for peptide-related impurities, aggregates, microbial load, endotoxins or residual solvents [1].
The claim of no side effects circulates widely. It traces to a Russian-language abstract whose full text the FDA could not obtain, and which states no route, dose, duration, participant count or method of recording harm [1], [30].
Doses used in studies
The doses below are simply what the cited studies gave, listed so that the results can be understood. They are not advice on how to use anything.
Almost every line below is a cell culture, a fly, a mouse, a rat, a rabbit or a monkey. Exactly one line describes people, and that study measured neither sleep nor safety.
| Study | Model | Dose | Route | Duration | Ref |
|---|---|---|---|---|---|
| Ivko 2021, the only randomised study | 20 women aged 40 to 50, night shift | 0.5 mg per day | Spray under the tongue | 20 days | [3] |
| Khavinson 2002, retinal disease | People with retinal degeneration | Not reported | Injection behind the eye | Not reported | [20] |
| Khavinson 2003, first telomerase report | Human foetal lung fibroblasts | 50 ng/ml | Culture medium | 4 days | [6] |
| Al-Dulaimi 2025, independent replication | Human cell lines 21NT, BT474, HMEC, IBR.3 | 0.1, 0.2, 0.5 and 1 µg/ml | Culture medium | 4 days, and 3 weeks at 1 µg/ml | [5] |
| Djeridane 2003, negative result | Isolated rat pineal glands | 1 to 100 µM | Perfusion fluid | Single exposure | [13] |
| Goncharova 2001, monkeys | Female rhesus monkeys, old and young | 2 µg/kg | Into the muscle | 10 days | [14] |
| Anisimov 2001, lifespan | Female CBA mice, 50 per group | 0.1 µg per animal | Under the skin | 5 days a month, from 6 months of age | [22] |
| Anisimov 2003, lifespan | Female SHR mice, 54 per group | 1.0 µg per animal | Under the skin | 5 days a month, from 3 months of age | [23] |
| Anisimov 2002, bowel cancer model | Male LIO rats, 80 animals | 1 µg per animal | Under the skin | 5 days a week | [26] |
| Yue 2022, egg cells | Mouse egg cells after ovulation | 0.1 mM, about 39 µg/ml | Culture medium | 6, 12 and 24 hours | [31] |
| Lapina 2005, tissue distribution | Pregnant rabbit, day 29 | 30 µg/kg, single dose | Into a vein | Read one hour later | [32] |
| Nominations to the FDA, both withdrawn | Proposed human use in insomnia | 10 mg/ml and 3,000 µg/ml | Under the skin, proposed | Not specified | [1] |
Two cautions apply. The numbers cannot even be compared with one another reliably. One paper from the same group in the same mouse model prints 1 mg where every other prints 1 µg, most likely a thousand-fold translation error [25]. Without any data on how the body handles the substance, scaling an animal dose to a person is not possible.
What sellers advertise sits far outside all of this. In December 2025 the FDA recorded 5 to 10 mg a day on seller pages. The goods came as vials of 10, 20, 25 and 50 mg, capsules of 3 and 3.3 mg, and an oral spray [1].
That is ten to twenty times the only daily amount ever given in a controlled study. It is also given by a route no human study has used.
Development and approval status
From a cattle extract to the FDA proposal of 2026
- 1980s-1990sEpithalamin, the cattle pineal extract, is used and studied in RussiaEpitalon is later worked out from its amino acid make-up, refs [1], [7]
- 2000First Epitalon paper appears in PubMedLifespan of fruit flies, gain of 11 to 16 per cent, not dose-dependent, ref [12]
- 2003Telomerase and longer telomeres reported in human cells in a dishFour days in culture, reported in a three-page note, ref [6]
- 2010Orphan drug designation granted for retinitis pigmentosaGranted 2 September 2010 on an uncontrolled case series, ref [1]
- 2016That designation is withdrawnRevoked 6 January 2016; nothing replaced it, ref [1]
- 2025Independent laboratory reproduces the telomere finding in vitroBrunel University London, plus alternative lengthening in cancer lines, ref [5]
- 2026FDA proposes excluding Epitalon from the 503A compounding listAssessment dated 12 May, advisory meeting 24 July, refs [1], [4]
The agency put two proposals to its Pharmacy Compounding Advisory Committee on 24 July 2026, one for the free base and one for the acetate. Both were against inclusion [4].
The use assessed was insomnia, and the proposed form was an injection under the skin [33]. Both nominations had already been withdrawn, and the agency brought the matter forward anyway [1].
Four reasons carried the proposal. The substance is poorly characterised. No pharmacy was found actually compounding it. There is no evidence of benefit in insomnia, and there are no human safety data at all [1].
The committee vote could not be verified for this page, because no meeting minutes were available on 7 September 2026 [34]. A proposal is not a final decision.
| Market | Status | Note | Ref |
|---|---|---|---|
| United States | Not approved | Exclusion from the compounding list proposed | [1], [4] |
| European Union | Not approved | No entry, no orphan status | [1] |
| Germany | Not approved | No national or European authorisation | [1] |
| United Kingdom | Not approved | Checked as a negative finding | [1] |
| Australia | Not approved | Absence is not permission | [1] |
| Canada | Not approved | Checked as a negative finding | [1] |
| Japan | Not approved | Not in the pharmacopoeia | [1] |
Russia is the one place this page leaves open. The literature describes epithalamin, the extract, as a Russian medicine, and calls Epitalon a synthetic analogue of that medicine, which is not a claim of its own registration [35]. A direct query to the Russian state register on 7 September 2026 returned no usable result, so nothing is asserted here [1].
The substance also turns up where medicines should not. A Belgian public health institute identified Epitalon in two seized illegal preparations in 2015 [36]. A compounding pharmacy in Kentucky and its owner pleaded guilty over the unlawful distribution of products containing it between 25 October 2018 and 1 April 2020 [37].
Anti-doping
Epitalon is prohibited in sport at all times, in and out of competition. Category S0 of the 2026 Prohibited List covers, in its own words, "any pharmacological substance… with no current approval by any governmental regulatory health authority for human therapeutic use" [8]. In plain terms, that is anything drug-like no health authority anywhere allows doctors to use.
The substance is not printed on the list by name. Searches of the 2025 and 2026 lists for epitalon, epithalon and AEDG return nothing [8]. The ban follows from its status, so the absence is not a loophole.
Everything in category S0 also counts as a specified substance. No validated method for detecting Epitalon in blood or urine has been published. The wider picture is at peptides banned in sport.
Compared with related peptides
Epitalon is usually sold alongside other peptides that promise something about ageing or sleep. What separates them is how far each has actually travelled.
| Peptide | What it targets | Status | Strongest result in its own record | Ref |
|---|---|---|---|---|
| Epitalon | Telomerase, proposed; no receptor identified | Approved nowhere; no registered trial | Telomeres lengthened in normal human cells in a dish, in step with the dose | [2], [5] |
| FOXO4-DRI | The contact between the proteins FOXO4 and p53 | Laboratory stage; registry search returned zero on 7 September 2026 | Not covered by the sources on this page | [2] |
| MOTS-c | Energy signalling from the cell powerhouses | No verified trial in people | No results | [38] |
| DSIP, listed as emideltide | Sleep, proposed | Assessed by the same FDA committee on 24 July 2026, also for insomnia | Not covered by the sources on this page | [4], [33] |
Two things stand out. Epitalon and FOXO4-DRI share a marketing story about ageing and share the same evidence problem: the whole case rests on cells in dishes, with nothing registered anywhere [2], [5]. MOTS-c is no further along: no trial of it in people can be verified either [38].
The comparison with DSIP is the closer one. It appears on the FDA agenda under its international name, emideltide, and both substances went to the same advisory committee on the same day, for the same proposed use in insomnia [4], [33]. In Epitalon's case, the FDA found no preclinical study of sleep behaviour and no clinical study in people with insomnia, which is why the efficacy question never got started [1].
Common misconceptions
- "Epitalon and epithalamin are the same thing." They are not. Epithalamin is an extract of cattle pineal glands; Epitalon is one synthetic peptide derived from its composition. The FDA writes that the two are different substances, and set aside seven submitted articles for confusing them [1]. PubChem nonetheless lists Epithalamin as a synonym under the Epitalon entry, which keeps the mix-up alive in databases [9].
- "Longer life has been proven in people." Those results come from epithalamin. They cover 266 older people over 6 to 8 years, with mortality reported 1.6 to 1.8 times lower [7]. A 12-year study reported 28 per cent fewer deaths [39], and a 15-year follow-up compared 39 patients with 40 controls [40]. Neither was blinded or independently repeated.
- "Epitalon lengthens telomeres in humans." It lengthens them in cell cultures [5], [6]. The study most often cited as human proof incubated blood cells from 11 men in a tube. Telomeres shortened in two of them and did not change at all in four [21].
- "The FDA gave it orphan drug status, so it must be sound." That designation was granted on 2 September 2010 and withdrawn on 6 January 2016 [1]. It is a development incentive, not an approval and not a verdict on whether something works. It rested on a case series with no control group [20].
- "The Khavinson peptides are a well-researched class." Of 244 PubMed records surveyed for this page, the large majority carry Khavinson or Anisimov as an author [41]. Most sit in a handful of closely associated journals. Genuinely independent work is thin, and one clear example returned a negative result [13].
- "Epitalon is a naturally occurring peptide." It was constructed by design, not isolated from tissue. The claim that the sequence occurs in the pineal complex rests on one paper by the same group in 2017 [10]. Even the independent 2025 study repeats it, which shows how an unconfirmed claim spreads [5].
Frequently asked questions
Has Epitalon ever been tested in a registered clinical trial?
No. A search of the ClinicalTrials.gov registry on 7 September 2026 returned zero records for epitalon, for epithalon, for epithalamin and for AEDG. The FDA searched PubMed, Embase and Cochrane as well and found exactly three published reports in which a person received the peptide.
Does Epitalon lengthen telomeres in people?
There is no evidence that it does. Telomere lengthening has only been shown in cells growing in a dish, first by the inventors in 2003 and independently at Brunel University London in 2025. The study most often quoted as human proof took blood from 11 men and treated the cells in a tube. The men themselves received nothing.
What is the difference between Epitalon and epithalamin?
Epithalamin is an extract of cattle pineal glands, a mixture of many peptides. Epitalon is a single synthetic four-part peptide worked out from that mixture. The FDA states plainly that the two are different substances. It set aside seven of the submitted articles because they were about epithalamin.
Do the studies showing fewer deaths in older people apply to Epitalon?
No. The long follow-up studies in 266 older people, and the 12-year and 15-year follow-ups in heart patients, all used epithalamin, the cattle extract. They also come from a single research partnership, report no blinding, and have never been repeated by anyone outside it.
Is Epitalon approved as a medicine anywhere?
No approval has been identified in the United States, the European Union, Germany, the United Kingdom, Australia, Canada or Japan. There is no monograph in any of the three major pharmacopoeias. Whether either substance is registered in Russia could not be verified, so this page does not claim it either way.
What did the FDA decide about Epitalon in 2026?
On 24 July 2026 the agency proposed to its Pharmacy Compounding Advisory Committee that neither Epitalon free base nor Epitalon acetate should go on the 503A list. Both nominations had already been withdrawn by the people who filed them. The committee vote itself could not be verified, and a proposal is not a final decision.
What is known about the safety of Epitalon?
Almost nothing. No clinical study has examined it, and no data exist on how the body absorbs or clears it in any species. There is no repeat-dose toxicity work and no two-year cancer study. The FDA also raised a mechanistic cancer concern, because switching telomerase on for long periods could let cells escape their normal limit.
Is Epitalon banned in sport?
Yes, at all times, in and out of competition. It falls under category S0 of the 2026 Prohibited List, which covers any drug-like substance that no health authority currently approves for human use. Epitalon is not printed on the list by name, and that absence is not a loophole.
Why is Epitalon sometimes spelled Epithalon?
Epitalon, Epithalon and Epithalone are three transliterations of the same Russian name for the same tetrapeptide, and PubChem lists them under one entry. The FDA treats the inconsistent naming as a real problem rather than a curiosity, and it is one of the two reasons the agency calls the substance poorly characterised.
Sources
- FDA. Briefing document for the Pharmacy Compounding Advisory Committee, meeting of 23 to 24 July 2026: substance review of Epitalon (free base) and Epitalon acetate, dated 12 May 2026. Retrieved 7 September 2026. https://www.fda.gov/media/193345/download
- ClinicalTrials.gov API v2. Queries for "epitalon", "epithalon", "epithalamin", "AEDG" and "FOXO4-DRI"; each returned totalCount 0. Retrieved 7 September 2026. https://clinicaltrials.gov/api/v2/studies
- Ivko OM, Linkova NS, Ilina AR, Sharova AA, Ryzhak GA (2021). AEDG peptide regulation of the expression of human circadian rhythm genes upon accelerated aging of the pineal gland. Advances in Gerontology 11(1):53-58. Russian original PMID 33280326
- FDA. Introductory briefing volume, Pharmacy Compounding Advisory Committee, 23 to 24 July 2026; items 11 and 12 propose that Epitalon free base and Epitalon acetate not be included on the 503A list; the agenda for 24 July lists emideltide, Epitalon and semax. Retrieved 7 September 2026. https://www.fda.gov/media/193342/download
- Al-Dulaimi S, Thomas R, Matta S, Roberts T (2025). Epitalon increases telomere length in human cell lines through telomerase upregulation or ALT activity. Biogerontology 26(5):178. PMID 40908429. DOI 10.1007/s10522-025-10315-x. Correction: Biogerontology 27(1):1. PMID 41240216. DOI 10.1007/s10522-025-10326-8
- Khavinson VKh, Bondarev IE, Butyugov AA (2003). Epithalon peptide induces telomerase activity and telomere elongation in human somatic cells. Bulletin of Experimental Biology and Medicine 135(6):590-592. PMID 12937682. DOI 10.1023/a:1025493705728
- Khavinson VKh, Morozov VG (2003). Peptides of pineal gland and thymus prolong human life. Neuro Endocrinology Letters 24(3-4):233-240. PMID 14523363
- World Anti-Doping Agency. The 2026 Prohibited List, in force from 1 January 2026, section S0. Full-text checks of the 2025 and 2026 lists for "epitalon", "epithalon" and "AEDG" returned no match. Retrieved 7 September 2026. https://www.wada-ama.org/en/prohibited-list
- PubChem. Compound CID 219042, "Epitalon". Formula C14H22N4O9, 390.35 g/mol, InChIKey HGHOBRRUMWJWCU-FXQIFTODSA-N, UNII O65P17785G. Retrieved 7 September 2026. https://pubchem.ncbi.nlm.nih.gov/compound/219042
- Khavinson VK, Kopylov AT, Vaskovsky BV, Ryzhak GA et al. (2017). Identification of peptide AEDG in the polypeptide complex of the pineal gland. Bulletin of Experimental Biology and Medicine. PMID 29124531. DOI 10.1007/s10517-017-3922-8
- Wikidata. Item Q27285389, epitalon. Retrieved 7 September 2026. https://www.wikidata.org/wiki/Q27285389
- Khavinson VK, Izmaylov DM, Obukhova LK, Malinin VV (2000). Effect of epitalon on the lifespan increase in Drosophila melanogaster. Mechanisms of Ageing and Development 120(1-3):141-149. PMID 11087911. DOI 10.1016/s0047-6374(00)00217-7
- Djeridane Y, Khavinson VKh, Anisimov VN, Touitou Y (2003). Effect of a synthetic pineal tetrapeptide (Ala-Glu-Asp-Gly) on melatonin secretion by the pineal gland of young and old rats. Journal of Endocrinological Investigation 26. PMID 12809170. DOI 10.1007/BF03345159
- Goncharova ND, Khavinson VKh, Lapin BA (2001). Regulatory effect of epithalon on production of melatonin and cortisol in old monkeys. Bulletin of Experimental Biology and Medicine. PMID 11550036. DOI 10.1023/a:1017928925177
- Khavinson VKh, Shataeva LK, Chernova AA (2003 onwards). Work on peptide binding to double-stranded DNA. PMID 14666197; PMID 17152370
- Khavinson VK, Linkova NS, Rudskoy AI, Petukhov MG (2023). Feasibility of transport of 26 biologically active ultrashort peptides via LAT and PEPT family transporters. PMID 36979488
- Kozina LS, Arutjunyan AV, Khavinson VKh (2007 and 2008). Antioxidant properties of geroprotective peptides of the pineal gland, and the later statement that these peptides show no direct antioxidant activity. PMID 17317455; PMID 18239817
- Khavinson VKh, Bondarev IE, Butyugov AA, Smirnova TD (2004). Peptide promotes overcoming of the division limit in human somatic cell. Bulletin of Experimental Biology and Medicine 137:503-506. PMID 15455129. DOI 10.1023/b:bebm.0000038164.49947.8c
- Khavinson V, Linkova N, Ivko O (2021). AEDG peptide regulates the expression of circadian genes Clock, Cry2, Csnk1e in human immune cells. World Heart Journal 13(1):189-191. Not indexed in PubMed; accessed through the FDA reference list.
- Khavinson V, Razumovsky M, Trofimova S, Grigorian R, Razumovskaya A (2002). Pineal-regulating tetrapeptide epitalon improves eye retina condition in retinitis pigmentosa. Neuro Endocrinology Letters 23(4):365-368. PMID 12195242
- Khavinson VK, Pendina AA, Efimova OA, Tikhonov AV et al. (2019). Effect of peptide AEDG on telomere length and mitotic index of PHA-stimulated human blood lymphocytes. Bulletin of Experimental Biology and Medicine. PMID 31761987. DOI 10.1007/s10517-019-04664-0
- Anisimov VN, Khavinson VK, Mikhalski AI, Yashin AI (2001). Effect of synthetic thymic and pineal peptides on biomarkers of ageing, survival and spontaneous tumour incidence in female CBA mice. Mechanisms of Ageing and Development 122(1):41-68. PMID 11163623. DOI 10.1016/s0047-6374(00)00184-6
- Anisimov VN, Khavinson VKh, Popovich IG, Zabezhinski MA et al. (2003). Effect of epitalon on biomarkers of aging, life span and spontaneous tumor incidence in female Swiss-derived SHR mice. Biogerontology. PMID 14501183. DOI 10.1023/a:1025114230714
- Anisimov VN, Khavinson VK, Provinciali M, Alimova IN et al. (2002). Inhibitory effect of the peptide epitalon on the development of spontaneous mammary tumors in HER-2/neu transgenic mice. International Journal of Cancer. PMID 12209581. DOI 10.1002/ijc.10570
- Anisimov VN, Khavinson VKh, Alimova IN, Semchenko AV et al. (2002). Epithalon decelerates aging and suppresses development of breast adenocarcinomas in transgenic her-2/neu mice. Biogerontology. PMID 12459848. DOI 10.1023/a:1021104819170
- Anisimov VN, Khavinson VKh, Popovich IG, Zabezhinski MA (2002). Inhibitory effect of peptide epitalon on colon carcinogenesis induced by 1,2-dimethylhydrazine in rats. Cancer Letters. PMID 12049808. DOI 10.1016/s0304-3835(02)00090-3
- Pliss GB, Mel'nikov AS, Malinin VV, Khavinson VKh (2001). Effect of vilon and epithalone on induction and growth of induced bladder neoplasms in rats. PMID 11785104
- Khavinson VKh, Yuzhakov VV, Kvetnoi IM, Malinin VV (2001). Immunohistochemical and morphometric analysis of effects of vilon and epithalon on functional morphology of radiosensitive organs. Bulletin of Experimental Biology and Medicine. PMID 11427924. DOI 10.1023/a:1017676104877
- Rosenfeld SV, Togo EF, Mikheev VS, Popovich IG et al. (2002). Effect of epithalon on the incidence of chromosome aberrations in senescence-accelerated mice. Bulletin of Experimental Biology and Medicine. PMID 12360351. DOI 10.1023/a:1015899003974
- Korkushko OV, Lapin BA, Goncharova ND, Khavinson VKh et al. (2007). Normalizing effect of the pineal gland peptides on the daily melatonin rhythm in old monkeys and elderly people. Advances in Gerontology 20(1):74-85, in Russian. PMID 17969590
- Yue X, Liu SL, Guo JN, Meng TG et al. (2022). Epitalon protects against post-ovulatory aging-related damage of mouse oocytes in vitro. Aging (Albany NY). PMID 35413689. DOI 10.18632/aging.204007
- Lapina EA, Nazarova LA, Petrova OP, Sibarov DA et al. (2005). Fluorescent microscopic study of epithalon binding in maternal and fetal rabbit tissues. Bulletin of Experimental Biology and Medicine. PMID 16224563. DOI 10.1007/s10517-005-0359-2
- FDA. Meeting announcement, Pharmacy Compounding Advisory Committee, 23 to 24 July 2026; uses evaluated for Epitalon: insomnia; considered on 24 July alongside emideltide and semax. Retrieved 7 September 2026. https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026
- FDA. Question list for the Pharmacy Compounding Advisory Committee, 23 to 24 July 2026, item 6: separate votes on Epitalon free base and Epitalon acetate. No meeting minutes were available on 7 September 2026. Retrieved 7 September 2026. https://www.fda.gov/media/193711/download
- Goncharova ND, Vengerin AA, Khavinson VKh, Lapin BA (2005). Pineal peptides restore the age-related disturbances in hormonal functions of the pineal gland and the pancreas. Experimental Gerontology 40. PMID 15664732. DOI 10.1016/j.exger.2004.10.004
- Vanhee C, Moens G, Van Hoeck E, Deconinck E (2015). Identification of the small research tetra peptide epitalon in two illegal pharmaceutical preparations. Drug Testing and Analysis. PMID 25535022. DOI 10.1002/dta.1771
- United States Attorney's Office, Eastern District of Kentucky. Nicholasville compounding pharmacy and its owner plead guilty to unlawful distribution. Cited by the FDA in footnotes 29 and 89. https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-unlawful-distribution
- ClinicalTrials.gov. NCT07505745, registry entry claiming a phase 2 study of MOTS-c for insulin sensitivity in adults with prediabetes and overweight or obesity; sponsor Hudson Biotech, whose further entries describe themselves as mock, example or fictional records, so the entry is not counted here as a trial. Retrieved 7 September 2026. https://clinicaltrials.gov/study/NCT07505745
- Korkushko OV, Khavinson VKh, Shatilo VB, Antonyuk-Shcheglova IA (2006). Geroprotective effect of epithalamine in elderly subjects with accelerated aging. Bulletin of Experimental Biology and Medicine 142(3):356-359. PMID 17426848. DOI 10.1007/s10517-006-0365-z
- Korkushko OV, Khavinson VKh, Shatilo VB, Antonyk-Sheglova IA (2011). Peptide geroprotector inhibits rapid aging of elderly people: results of 15-year follow-up. Bulletin of Experimental Biology and Medicine 151(3):366-369. PMID 22451889. DOI 10.1007/s10517-011-1332-x
- PubMed E-utilities. Survey of 244 unique records across seven search strategies for epitalon, epithalon, epithalamin, Ala-Glu-Asp-Gly peptide, AEDG peptide, Khavinson peptide telomerase and pineal peptide preparation epithalamin; 160 relate specifically to Epitalon or AEDG. Retrieved 7 September 2026. https://pubmed.ncbi.nlm.nih.gov/
Cite this page
Every fact on this page was checked on 7 September 2026, and the register searches behind the status table were run on that date. For a substance whose record consists largely of searches that came back empty, the date of those searches is part of the finding.
myPeptides Research & Editing. (2026). Epitalon: what the studies show, status and safety. Version 1.0, 7 September 2026. myPeptides Peptide Register. Retrieved from https://mypep.app/peptides/epitalon
How pages in this register are compiled and graded is described under methodology; the full register is at peptides.