Epitalon (Epithalon) peptide: what the mouse, cell and Russian extract studies show, and what has never been tested in people
What 170 indexed publications and 5 randomized trials actually state about epitalon, sentence by sentence, each tied to its source and labeled by the kind of evidence it is.
At a glance
What Epitalon is, and how it differs from Epithalamin
Epitalon is a peptide in the bioregulator short peptides class (telomerase activation claimed; mechanism unconfirmed). Europe PMC indexes 170 publications naming it or a listed alias in a title or abstract, including 5 randomized controlled trials and 5 clinical trials of any design, as of . The strongest evidence tier in that literature is human clinical trials.
This page reports what those studies state, sentence by sentence, with each statement tied to its source and labeled by the kind of evidence it is. It does not recommend use, and it does not translate study doses into anything personal.
What the evidence level means
Publication counts show what is indexed, not how strong the evidence is. The ledger below separates human clinical records from preclinical, analytical, and in-vitro work.
Interpretation boundary: An indexed publication count is a discovery measure. It does not establish efficacy, safety, approval, or a personal treatment plan.
Epitalon in two minutes
What it is. A synthetic four-amino-acid peptide, Ala-Glu-Asp-Gly, designed in St Petersburg from the composition of Epithalamin, a bovine pineal extract used as a Soviet medicine. Also spelled Epithalon.
What the research actually shows. 170 indexed publications. In cells it lengthens telomeres, in normal cells through telomerase and in breast-cancer cells through the ALT pathway. In 54 mice injected monthly for life, mean lifespan did not change, total tumours did not change, the longest-lived 10% lived 13% longer and leukaemia was six times rarer. Every human result in the ledger is for the extract Epithalamin or a related complex, not the synthetic peptide.
The confusion at the centre. Pages that cite 'human studies of Epitalon' are citing Epithalamin: a cervical-cancer trial where it was one of five treatments, a coronary-disease rhythm study, and melatonin restoration in elderly people.
Status. Not approved anywhere; reported to be on FDA's 2023 compounding category 2 list; caught by WADA's S0 rule.
Where the evidence is thinnest. In people: no study has given synthetic Epitalon at a stated dose, measured a telomere, or recorded a side effect.
Editorial synthesis Written from general pharmacology, the development record and what is commonly reported; not a cited finding. Cited findings on this page carry their own tier.
How Epitalon is thought to work: telomerase, histones and the pineal gland
Written from general pharmacology and the development record, and marked as editorial synthesis; the measurements behind it are quoted in the biomarker section.
- Editorial synthesis from general knowledge
- Editorial synthesis from general knowledge
- Editorial synthesis from general knowledge
Epitalon vs Epithalamin: which studies are about which
The two names are used interchangeably online. They are different substances with different evidence, and sorting the studies by name changes the picture.
| Substance | What it is | Human studies | Animal and cell studies |
|---|---|---|---|
| Epithalamin | Polypeptide extract of bovine pineal gland; a registered Soviet and Russian medicine given by injection at milligram doses | Cervical cancer (100 patients, randomized, 100 mg IM as one of five components); elderly coronary patients (6 courses, 30 months, immune and cortisol rhythms); free-radical review; melatonin restoration in the elderly (cited, not in ledger) | Hypoxia in rats (2.5 mg intraperitoneal); free radicals in aged rats |
| Epitalon (AEDG) | Single synthetic tetrapeptide modelled on the extract's amino-acid composition | None at a stated dose. One in vitro study used cultured cells from tuberculosis patients | Lifelong mouse study; senescence-accelerated mice; rat colon cancer; rat cortex and pineal (intranasal); rat intestine (oral); thymocytes; telomeres in human cell lines; oocytes; retinal cells; gingival stem cells; tobacco plants |
| Pineamin | A newer pineal polypeptide complex | 55 elderly patients: night melatonin metabolite up 1.9-fold after a 100 mg course | — |
The practical consequence: the dosing, the ten-day courses and the melatonin claim belong to the extract. The telomere and lifespan claims belong to the peptide, in cells and mice. Nothing belongs to both.
Editorial synthesis Written from general pharmacology, the development record and what is commonly reported; not a cited finding. Cited findings on this page carry their own tier.
What happened in the human studies?
This record's ledger holds 4 primary human studies, of which 1 is a trial. Few enough to show in full: each card quotes what its abstract reported about Epitalon. Read them before any other section on this page.
-
As a consequence, short-term results improved by 18.8% in cases tumor size under T3; end-results--by 14%.
Sourcepmid-10532103· quoted verbatim from the abstract -
Issues related to the immunopharmacological effect and clinical use of natural and synthetic peptide thymomimetics (thymalin, thymogen, vilon, epithalamin, cortexin) and peptide bioregulators from cartilaginous (sigumir, chondrolux) and other tissues in case of trauma, as well as inflammatory, inflammatory and other pathological processes of tissues of the oral cavity and maxillofacial region.
Sourcepmid-32362097· quoted verbatim from the abstract -
Similar effect was obtained early for medical drug Epithalamin.
Sourcepmid-28849889· quoted verbatim from the abstract -
On the other hand, the rhythms of changes in the thymic serum factor and hydrocortisone were retained in patients with chronic coronary disease after 6 courses of epithalamin by the optimal protocol (period of observation 30 months) and blood T cell count increased in the fall.
Sourcepmid-18214303· quoted verbatim from the abstract
What did the studies find?
Outcomes in mice, rats and cell cultures, plus a handful of Russian human studies of the parent extract Epithalamin. No randomized trial of Epitalon itself in people exists, and no human study has measured telomere length. One row per primary study in this record's ledger. Fields are read from each paper's indexing and abstract. "Analytical method" marks papers about detecting or measuring the compound rather than about its effects.
| Study | Design | n | Species | Dose | Route | Duration | Reported outcome | Tier |
|---|---|---|---|---|---|---|---|---|
| Vishnevskaia 1999 | Randomized controlled trial | 100 | Humans | 100 mg | intramuscular | 3 year | As a consequence, short-term results improved by 18.8% in cases tumor size under T3; end-results--by 14%. | Human clinical trial |
| Pinelis 2020 | Human study | — | Humans | — | oral | — | — | Observational, human |
| Trofimova 2017 | Human study | — | Humans | — | — | — | — | Observational, human |
| Labunets 2007 | Human study | — | Humans | — | — | — | On the other hand, the rhythms of changes in the thymic serum factor and hydrocortisone were retained in patients with chronic coronary disease after 6 courses of epithalamin by the optimal protocol (period of… | Observational, human |
| Zhang 2026 | Animal study | — | Mice | — | — | — | Of these, LCP2 expression was significantly reduced in the plasma of R/R NKTCL patients and in chemoresistant cells, correlating inversely with senescence marker SA-β-gal. | Animal, preclinical |
| Yue 2022 | Animal study | — | Mice | — | — | — | We found that 0.1mM Epitalon reduced intracellular reactive oxygen species. | Animal, preclinical |
| Kozina 2008 | Animal study | — | Rats | — | — | — | They also elevate the stationary level of intracellular reactive oxygen species and at the same time decrease (all excepting epitalon) percent of dead cells in neuronal population. | Animal, preclinical |
| Il'ina 2008 | Animal study | — | Rats | — | — | — | The maximal number of significant changes in antioxidant system parameters was found under continuous light exposure. | Animal, preclinical |
| Sibarov 2007 | Animal study | — | Rats | — | intranasal | — | At least the first peak of increased neuron activity following exposure to epitalon was found to be associated with the direct action of the peptide on cortical cells. | Animal, preclinical |
| Anisimov 2005 | Animal study | — | Mice | — | subcutaneous | — | The mean life span of the 10% of the last survivors among treated SAMP-1 was shorter than that of SAMR-1, aging rate increased and mortality doubling time decreased. | Animal, preclinical |
| Kossoy 2003 | Animal study | — | Rats | — | — | 6 months; 5 weeks | Mitotic activity of tumor cells was significantly inhibited by Epitalon when the treatment was given throughout the experiment (group 2). | Animal, preclinical |
| Anisimov 2003 | Animal study | 54 | Mice | — | subcutaneous | — | We also found that treatment with Epitalon did not influence total spontaneous tumor incidence, but inhibited the development of leukemia (6.0-fold), as compared with the control group. | Animal, preclinical |
| Sibarov 2002 | Animal study | — | Rats | — | intranasal | — | The dilation of capillaries and pericapillary space induced by an osmotic stress was partially reduced by the intranasal infusions of Epitalon. | Animal, preclinical |
| Khavinson 2002 | Animal study | — | Mice | — | — | — | The investigation demonstrated that Epitalon increased thymocyte proliferative activity, both enhanced under rotation stress and suppressed under combined one. | Animal, preclinical |
| Khavinson 2002 | Animal study | — | Rats | — | oral | 1 month | Glycine absorption increased only in the proximal intestinal segment under the effect of Epithalon. | Animal, preclinical |
| Khavinson 2001 | Animal study | — | Rats | — | — | — | — | Animal, preclinical |
| Zamorskiĭ 2000 | Animal study | — | Rats | — | — | — | Administration of epithalamin caused an increase of pineal cGMP. | Animal, preclinical |
| Zamors'kyĭ 1999 | Animal study | — | Rats | 2.5 mg | intraperitoneal | — | The melatonin and epithalamin administration against the background of acute hypoxia prevented an acute hypoxia inducing decrease in the activity of Na+, K(+)-ATPase as well as increased in the activity of… | Animal, preclinical |
| Al-Dulaimi 2025 | In vitro study | — | Humans | — | — | — | Epitalon has been the subject of several anti-aging studies however, quantitative data on the biomolecular pathway leading to telomere length increase, hTERT mRNA expression, telomerase enzyme activity, and ALT… | Mechanistic, in vitro |
| Gatta 2025 | In vitro study | — | Humans | — | — | — | These findings support using the antioxidant agent Epitalon as a promising therapeutic strategy for DR to improve retinal wound healing compromised by hyperglycemia. | Mechanistic, in vitro |
| Avolio 2022 | In vitro study | — | Humans | — | — | — | Lastly, by incubating the THP1 cells, treated with the peptides, on a layer of activated endothelial cells (HUVECs activated by LPS), we observed a reduction in cell adhesion, a typical pro-inflammatory mechanism. | Mechanistic, in vitro |
| Khavinson 2020 | In vitro study | — | Humans | — | — | — | AEDG peptide increased Nestin, GAP43, β Tubulin III and Doublecortin mRNA expression by 1.6-1.8 times in hGMSCs. | Mechanistic, in vitro |
| Fedoreyeva 2017 | In vitro study | — | — | — | — | — | Exogenous short biologically active peptides epitalon (Ala-Glu-Asp-Gly), bronchogen (Ala-Glu-Asp-Leu), and vilon (Lys-Glu) at concentrations 10 -7 -10 -9 M significantly influence growth, development, and… | Mechanistic, in vitro |
| Dzhokhadze 2013 | In vitro study | — | Humans | — | — | — | As for epithalon, it appears that was shown a pronounced protective effect after treatment, on the test of chromosome aberrations, by reducing both overall mean frequency aberrant cells and indicators for all… | Mechanistic, in vitro |
Doses reported in studies
Each entry is a sentence quoted from the study's abstract, with the study's design, sample size and year in front of it. Comparator doses in the same sentence are not attributed to epitalon.
- Source
pmid-14501183 - Source
pmid-15909815 - Source
pmid-12964022 - Source
pmid-17955380 - Source
pmid-10532103 - Source
pmid-35413689
Every Epitalon and Epithalamin dose in the literature, in one table
Every figure here was given to an animal, added to a culture, or is the extract in a Russian trial. No human dose of synthetic Epitalon exists.
| Study | Substance and model | Route and dose | Schedule | What was found |
|---|---|---|---|---|
| Anisimov 2003 | Epitalon; 54 female SHR mice | Subcutaneous, 1 mcg per mouse (about 30 to 40 mcg/kg) | 5 consecutive days a month, from 3 months of age for life | Mean lifespan unchanged; last 10% lived 13.3% longer; chromosome aberrations down 17%; leukaemia 6-fold rarer; total tumours unchanged |
| Anisimov 2005 | Epitalon; senescence-accelerated mice | Subcutaneous, 1 mcg per mouse | 5 times a week, monthly | Prevented irregular oestrous cycles; no effect on weight, food or temperature |
| Kossoy 2003 | Epitalon; rats with chemically induced colon cancer | Subcutaneous, 1 mcg | 5 times a week for 6 months, or during initiation or promotion only | Tumour-cell mitotic activity inhibited |
| Sibarov 2007 | Epitalon; anaesthetised rats | Intranasal, 30 ng per rat | Single | Cortical neuron firing 2 to 2.5-fold within 5 to 7 minutes |
| Sibarov 2002 | Epitalon; stressed rats | Intranasal; dose not stated | Repeated, last 2 hours before sampling | C-Fos rose in pinealocytes under stress only |
| Khavinson 2002 | Epitalon; rats | Oral; dose not stated | One month | Glycine absorption up in the proximal intestine |
| Vishnevskaia 1999 | Epithalamin; 100 women with advanced cervical cancer | Intramuscular, 100 mg, with chemotherapy and radiotherapy | Course within combined treatment | Combined therapy improved outcomes; the extract's own contribution cannot be separated |
| Trofimova 2017 | Pineamin; 55 elderly patients | Course dose 100 mg | Course | Night melatonin metabolite 1.9-fold higher |
| Al-Dulaimi 2025; Yue 2022; Gatta 2025 | Epitalon; human cell lines, mouse oocytes, retinal cells | In culture; 0.1 mM in oocytes; others dose-dependent | Hours to days | Telomere lengthening; less reactive oxygen; wound closure restored |
Figures for this compound circulate on forums and vendor pages. None has been tested in a human study, so none is reproduced here; the table holds every dose a study actually administered. The mouse dose, scaled by body weight, is a fraction of a milligram for an adult; the courses that circulate are hundreds of times larger and were never given to any animal in a study.
Editorial synthesis Written from general pharmacology, the development record and what is commonly reported; not a cited finding. Cited findings on this page carry their own tier.
Side effects: what is known, and the telomerase question
No human study of Epitalon recorded adverse events. What exists is the lifelong mouse study, which its authors read as evidence of safety, and the theoretical concern that anything raising telomerase in cancer cells raises. Events and their frequency as each study reported them, with the denominator where the abstract gives one.
- Source
pmid-14501183 - Source
pmid-40908429 - Editorial synthesis from general knowledge
Who Epitalon is discussed for, and the cautions that recur
Studied: mice and rats, for lifespan, tumours and pineal function; human cells, for telomeres. Studied with the extract: elderly Russian patients with coronary disease or low melatonin, and women with advanced cervical cancer. Community: people seeking longevity, better sleep or 'telomere health'.
No human study of the peptide set exclusion criteria. The cautions below come from the mechanism and from what was never measured:
- Cancer, present or past. Telomerase activation and, in breast-cancer cells, ALT activation are the two ways tumours escape the limit on cell division. The mouse study found fewer leukaemias; the cell study found cancer cells lengthening their telomeres. No human data resolve this.
- Anyone reading the extract's trials as their own evidence. Epithalamin's human studies were in specific elderly and oncology populations, at milligram doses of a mixture, in Russia; none transfers to synthetic Epitalon at any dose.
- Pregnancy and fertility. The peptide altered oestrous function in mice and protected mouse oocytes in culture; nothing in people.
- Sleep expectations. No human sleep or melatonin measurement exists for the peptide; the same gap holds for DSIP, the other sleep peptide it is paired with.
- Injection technique and vial content. Research-chemical vials are unverified; the mouse dose was 1 microgram, so any vial sold for human use is dosed by convention, not by data.
- Tested athletes. Unapproved substances are prohibited under WADA S0 at all times.
Editorial synthesis Written from general pharmacology, the development record and what is commonly reported; not a cited finding. Cited findings on this page carry their own tier.
Biomarkers measured in studies
Laboratory and clinical measures the studies report tracking, including which hormones did and did not change.
-
At least the first peak of increased neuron activity following exposure to epitalon was found to be associated with the direct action of the peptide on cortical cells.
Sourcepmid-17955380· quoted verbatim from the abstract -
Melatonin or epitalon treatment was followed by longer mean and maximum survival in the 10% of the last survivors among SAMP-1.
Sourcepmid-15909815· quoted verbatim from the abstract -
The results of this study show that treatment with Epitalon did not influence food consumption, body weight or mean life span of mice.
Sourcepmid-14501183· quoted verbatim from the abstract -
All animals were intranasally administered with Epitalon, the last infusion made in two hours before the biopsy.
Sourcepmid-12500171· quoted verbatim from the abstract -
The effects of a single-shot intraperitoneally administration of melatonin in a dose of 1 mg per kg body weight and epithalamin in a dose of 2.5 mg per kg body weight on the activities of Na+, K(+)-ATPase and 5'-nucleotidase were investigated in the forebrain of juvenile male white rats under the acute hypobaric hypoxia.
Sourcepmid-10820844· quoted verbatim from the abstract -
Epitalon has been the subject of several anti-aging studies however, quantitative data on the biomolecular pathway leading to telomere length increase, hTERT mRNA expression, telomerase enzyme activity, and ALT activation have not been extensively studied in different cell types.
Sourcepmid-40908429· quoted verbatim from the abstract
Reported timelines
Onset, peak and duration figures as each study reported them.
- Source
pmid-17955380 - Source
pmid-14501183
What is measured over time, and what is not
The time course in the literature spans minutes, in rat cortex after an intranasal dose, to a lifetime, in the mouse study where the only differences appeared at the end of life. Nothing was measured in between that a person would notice. The extract's human studies ran 30 months with six courses and reported the persistence of immune and cortisol rhythms, not how anyone felt. 'How long does Epitalon take to work' therefore has no human answer; the honest one is that the mouse outcomes took a lifetime to show and were modest.
Editorial synthesis Written from general pharmacology, the development record and what is commonly reported; not a cited finding. Cited findings on this page carry their own tier.
Study durations
Treatment and follow-up periods as stated in each abstract.
- Source
pmid-14501183 - Source
pmid-12964022 - Source
pmid-18214303 - Durations stated: 3 year
The adjuvant polychemotherapy component was thought to be responsible for a 25.4% increase in one-year survival and 12.5%--in 3-year survival.
Sourcepmid-10532103· quoted verbatim from the abstract
Routes: what the studies used
Subcutaneous in the lifelong mouse studies, intranasal in rat brain and pineal studies, oral in one rat absorption study, intramuscular for the extract in the Russian cancer trial. No human study states a route for synthetic Epitalon. Routes of administration named in each study.
- administration by intramuscular route reported
The modality also included immunotherapy with epithalamin 100 mg, intramuscularly, neoadjuvant intraarterial polychemotherapy with 5-fluorouracil 2 g/m2 and cisplatin 100 mg/m2, concurrent radiotherapy with an interval and 4-6 courses of adjuvant polychemotherapy.
Sourcepmid-10532103· quoted verbatim from the abstract - administration by oral route reported
Issues related to the immunopharmacological effect and clinical use of natural and synthetic peptide thymomimetics (thymalin, thymogen, vilon, epithalamin, cortexin) and peptide bioregulators from cartilaginous (sigumir, chondrolux) and other tissues in case of trauma, as well as inflammatory, inflammatory and other pathological processes of tissues of the oral cavity and maxillofacial region.
Sourcepmid-32362097· quoted verbatim from the abstract - administration by intranasal route reported
Intranasal administration of epitalon was selected as a noninvasive means of applying the agent to the CNS by bypassing the blood-brain barrier.
Sourcepmid-17955380· quoted verbatim from the abstract - administration by subcutaneous route reported
(prone) and SAMR-1 (resistant) were exposed 5 times a week monthly to melatonin (with drinking water 20mg/ml during the night hours) or to s.c. injections of epitalon (Ala-Glu-Asp-Gly) at a single dose 1mkg/mouse.
Sourcepmid-15909815· quoted verbatim from the abstract - administration by subcutaneous route reported
From the age of 3 months until their natural deaths, female outbred Swiss-derived SHR mice were subcutaneously injected on 5 consecutive days every month with 0.1 ml of normal saline (control) or with 1.0 microg/mouse (approximately 30-40 microg/kg) of tetrapeptide Epitalon (Ala-Glu-Asp-Gly) dissolved in 0.1 ml saline.
Sourcepmid-14501183· quoted verbatim from the abstract - administration by intranasal route reported
The content of C-Fos protein was tested in rat pinealocytes in the norm and stress and in case of intranasal administration of Epitalon (Ala-Glu-Asp-Gly), which regulated pineal secretion processes, presumably, via protooncogenes.
Sourcepmid-12500171· quoted verbatim from the abstract
Weight-normalized doses, as published
Per-kilogram figures exactly as each study published them, for the species it studied.
- Source
pmid-14501183
Weight-normalized figures above are reproduced exactly as each study published them, for the species it studied. Dose does not scale linearly with body mass between species: metabolic rate, clearance and receptor density differ, and regulatory guidance uses allometric, not proportional, conversion. A mg/kg figure from a rat study is a fact about that rat study and nothing else.
What people report outside the literature
Forum reports are experiences, not evidence. The ten-day cycles people describe come from the Russian Epithalamin protocols, not from any study of the synthetic peptide. What circulates in user communities and clinic marketing, reported so a reader knows the figures and their origin. None of it has been tested in a trial, and none of it is a suggestion.
- Editorial synthesis from general knowledge
Reconstitution mathematics
Lyophilised peptide is supplied as a mass in a vial and dissolved in a stated volume of diluent. Two figures follow from that and nothing else:
- Concentration = mass in vial ÷ diluent volume. A 5 mg vial in 2 mL is 2.5 mg/mL, or 2,500 mcg/mL.
- Volume for a given mass = that mass ÷ concentration. 250 mcg at 2,500 mcg/mL is 0.1 mL. On a U-100 insulin syringe, where 1 mL is 100 units, that is 10 units.
Study doses on this page are quoted as published, in the units the authors used. Converting between mcg, mg and IU, or between a mass and a syringe volume, is arithmetic; deciding a mass is not, and this page does not do it. The reconstitution calculator performs the conversion with the formula shown.
Reading a certificate of analysis
A certificate of analysis is a laboratory report on one batch. Reading it means checking four things in order.
- Identity. Mass spectrometry should report an observed molecular mass matching the peptide's theoretical mass within the instrument's stated tolerance. A certificate with no mass spectrometry, or one that lists only the expected value, has not confirmed identity.
- Purity. HPLC purity is the area of the main peak as a share of all peaks, at a stated wavelength. It says nothing about what the other peaks are, and it is not a measure of quantity.
- Quantity. Net peptide content, by amino acid analysis or UV, is the fraction of the vial's mass that is peptide rather than counter-ions and water. A 5 mg vial at 80% net content holds 4 mg of peptide, and every concentration figure above changes accordingly.
- Provenance. The batch number on the certificate should match the vial, the laboratory should be named and independent of the seller, and the test date should be recent.
This page rates no supplier and links to none. It describes how to read the document.
Equipment described in studies
Published human studies of injectable peptides report the same small set of materials: single-use insulin syringes with fixed needles, most often U-100 with 29 to 31 gauge needles; bacteriostatic water or sterile water for injection as diluent, with the choice stated in the methods; alcohol swabs; and refrigerated storage of reconstituted solution. Animal studies more often report intraperitoneal or intragastric administration and state the vehicle used. Where a study in this record's ledger names its materials or vehicle, that sentence appears under storage or routes above; where it does not, nothing is assumed here.
Storage and handling
No storage or stability study of Epitalon for human use is indexed. Vendor sheets follow general practice for lyophilised peptides. The developers' hydrogel and iontophoresis papers concern delivery formats, not storage.
Editorial synthesis Written from general pharmacology, the development record and what is commonly reported; not a cited finding. Cited findings on this page carry their own tier.
Common mistakes in how Epitalon is discussed
- Merging Epitalon with Epithalamin. Every human result cited for the peptide belongs to the extract. Sorting the studies by name is the single most useful thing a reader can do; the same confusion recurs with Pinealon and its parent complex.
- Saying it extends lifespan. In the one lifelong study, mean lifespan did not change. The gain was in the last 10% of survivors and in maximum lifespan.
- Treating telomere lengthening as unambiguously good. The 2025 study found cancer cells lengthening telomeres through ALT. Longer telomeres in a tumour are the tumour's advantage.
- Quoting a ten-day course as a study protocol. The ten-day pattern is the extract's Russian regimen. No study gave synthetic Epitalon to a person on any schedule.
- Calling it a melatonin booster. The melatonin restoration was measured after Epithalamin and Pineamin, not after Epitalon, and in rats the peptide changed pineal activity only under stress.
- Reading gene-expression results as specificity. Epitalon changes gene expression in thymocytes, stem cells and tobacco plants alike, which argues for a broad chemical effect rather than a targeted one.
Editorial synthesis Written from general pharmacology, the development record and what is commonly reported; not a cited finding. Cited findings on this page carry their own tier.
Epitalon vs Epithalamin, Pinealon, melatonin and DSIP
| Substance | What it is | Human evidence | Status |
|---|---|---|---|
| Epitalon | Synthetic tetrapeptide AEDG | None at a stated dose; telomeres in cells; lifespan in mice | Research chemical; reported FDA category 2; WADA S0 |
| Epithalamin | Bovine pineal polypeptide extract | Russian trials in elderly and oncology patients at 100 mg courses | Registered medicine in Russia; not approved elsewhere |
| Pinealon | Sibling tripeptide Glu-Asp-Arg from the same programme; 17 indexed publications | 2 non-randomized Russian studies in older adults | Supplement in Russia; research chemical elsewhere |
| Melatonin | The pineal hormone the extract was shown to restore | Dozens of randomized sleep trials | Prescription medicine in the EU and UK; supplement in the US; no record on this site |
| DSIP | Nine-amino-acid sleep peptide of disputed origin; 559 indexed publications | 16 small intravenous studies, split on sleep | Research chemical; reported FDA category 2 |
The pairings that circulate, Epitalon with Pinealon or with DSIP, have no study behind them in any species. The one comparison with data is Epitalon against its own extract, and the data favour the extract, because the extract is the one that was given to people.
Editorial synthesis Written from general pharmacology, the development record and what is commonly reported; not a cited finding. Cited findings on this page carry their own tier.
Regulatory status: not approved, and named in FDA's 2023 compounding action
Registry facts only. Jurisdiction-level status, compounding categories and sport prohibitions need their own cited documents before they appear here.
- Editorial synthesis from general knowledge · primary document to be added to the ledger
Open questions and limitations
What is genuinely unknown, stated plainly. A missing field is not evidence that the outcome is safe, effective, or established.
- No human study has given synthetic Epitalon at a stated dose or measured a telomere, melatonin or an adverse event after it.
- Whether telomere lengthening through the ALT pathway in cancer cells has any consequence in a person is untested in either direction.
- The elderly melatonin study and FDA's 2023 compounding notice are cited from summaries and are not yet in the ledger. Khavinson 2003, which reported telomerase induction and telomere elongation in human somatic cells, was added to it on 29 September 2026 (pmid-12937682).
Questions people ask
Does Epitalon help sleep?
No human study has measured sleep. The sleep reputation rests on the pineal origin of the sequence and on Russian studies in which the extract Epithalamin, and a related complex, Pineamin, raised night-time melatonin excretion in elderly people. Whether synthetic Epitalon does the same in people has not been tested.
What is Epitalon?
Epitalon (also spelled Epithalon; sequence Ala-Glu-Asp-Gly, AEDG) is a synthetic tetrapeptide designed by Vladimir Khavinson's group in St Petersburg from the amino-acid composition of Epithalamin, a bovine pineal extract used in Soviet and Russian medicine. It is studied for telomerase activation, melatonin restoration and lifespan in animals and cells; no randomized human trial of the peptide itself exists.
What is the half-life of Epitalon?
Not measured in people. No pharmacokinetic study of Epitalon is indexed for any species in the ledger. In rats, intranasal doses changed cortical neuron firing within five to seven minutes, which says it acts quickly, not how long it lasts. Figures quoted online are guesses.
Can Epitalon be taken orally?
One rat study gave Epitalon by mouth and measured intestinal absorption of glucose and glycine, so the route has been used in an animal for a different question. No study has measured whether oral Epitalon reaches the blood or has any effect in people; a four-amino-acid peptide would be expected to be largely digested.
Does Epitalon cause or prevent cancer?
Both directions have animal data and neither has human data for the peptide. In 54 mice injected monthly for life, total tumour incidence did not change and leukaemia fell sixfold; in a rat colon-cancer model it slowed tumour cell proliferation. Against that, a 2025 cell study found it lengthened telomeres in breast-cancer lines through the ALT pathway, which is the mechanism cancers use to keep dividing. The one human trial is of the extract Epithalamin added to cervical-cancer treatment.
Does Epitalon make you look younger?
No study has measured skin, appearance or any visible marker of ageing in people. The anti-ageing claim rests on telomere lengthening in cell cultures, on a 13% extension of maximum lifespan in one mouse study that did not change mean lifespan, and on Russian reports about the extract Epithalamin.
Has Epitalon been tested in humans?
Not the synthetic peptide at a stated dose. The human studies cited for it are of Epithalamin, the bovine pineal extract it was modelled on: a randomized cervical-cancer trial where the extract was one of five treatments, a 30-month study of immune and cortisol rhythms in elderly coronary patients, and melatonin restoration in elderly people. One in vitro study used cultured cells from tuberculosis patients.
Does Epitalon lengthen telomeres?
In cell cultures, yes. The developers reported telomerase activation in human fibroblasts in 2003, and an independent 2025 study confirmed dose-dependent telomere lengthening in normal cells through hTERT and telomerase, while finding that breast-cancer cell lines lengthened their telomeres through the ALT pathway instead. No human study has measured telomere length after Epitalon.
Does Epitalon extend lifespan?
In the one lifelong study, 54 female mice injected on five days a month from age three months showed no change in mean lifespan. The last 10% of survivors lived 13.3% longer and maximum lifespan was 12.3% longer, chromosome aberrations fell 17% and leukaemia was six times rarer. Total tumour incidence did not change. No human lifespan data exist.
Is there an Epitalon dose?
For people, no. The mouse dose was 1 microgram per mouse, about 30 to 40 micrograms per kilogram, subcutaneously on five consecutive days a month; rats received 1 microgram five times a week or 30 nanograms intranasally. The extract Epithalamin was given at 100 mg intramuscular courses in Russian trials. The milligram courses that circulate for the peptide come from the extract's regimen and were never studied.
What are the side effects of Epitalon?
Unmeasured in people. The lifelong mouse study found no effect on weight, food intake or total tumours. The open question is mechanistic: an agent that activates telomerase or the ALT pathway in cells that already have cancer may help the cancer, and no study has looked for that in a person. Forum complaints are limited to injection-site reactions and vivid dreams.
Is Epitalon the same as Epithalamin?
No. Epithalamin is a polypeptide extract of bovine pineal gland, a registered Russian medicine given at milligram doses. Epitalon is a single synthetic tetrapeptide designed from the extract's amino-acid composition and given to animals at micrograms. Their evidence does not transfer either way.
Does Epitalon raise melatonin?
In people, the melatonin data are for the extract Epithalamin and the complex Pineamin, which raised night-time melatonin excretion 1.9-fold in 55 elderly patients. For the peptide, rats showed pineal activation only under stress and none in the normal state; no human melatonin measurement after Epitalon exists.
Is Epitalon FDA approved?
No. It has never been approved anywhere. It is reported to have been placed in category 2 of FDA's interim 503A bulk-substances list in September 2023, which bars compounding; check the live list.
Is Epitalon banned in sport?
It is not named on the WADA Prohibited List, but as a substance with no regulatory approval it falls under the list's S0 category, prohibited at all times.
Can Epitalon be taken as a nasal spray?
Rats have received it intranasally, at 30 nanograms per animal, with cortical neurons firing within minutes and pineal cells responding under stress. No human study has used any route, so nothing is known about nasal absorption or effect in people.
Who developed Epitalon?
Vladimir Khavinson's group at the St Petersburg Institute of Bioregulation and Gerontology, in the 1990s, from the composition of the Soviet pineal extract Epithalamin. Most of the literature is theirs; independent work since 2020 includes the Italian cell studies and the 2025 telomere study in London.
Which species has Epitalon been studied in?
Mice, for lifespan, tumours and oocytes; rats, for colon cancer, cortex, pineal gland and intestine; human cell lines, for telomeres, retinal cells, monocytes and gingival stem cells; and tobacco plants, where it also changed gene expression. No human has received it in a published study at a stated dose.
Sources
Full citations. Every claim above links to one of these by its id.
- 1Epitalon and Epithalamin in Regenerative and Longevity Medicine: Mechanisms, Evidence, and Translational Gaps
doi-10-20944-preprints202609-0801-v1· · preprint - 2From Cellular Aging to Tissue Protection: Epitalon in Regenerative and Longevity Medicine
doi-10-20944-preprints202607-2123-v1· · preprint - 3LCP2 mediates SUV39H1-driven cellular senescence-related chemoresistance in natural killer/T-cell lymphoma.
pmid-42209466· · peer-reviewed - 4Epitalon increases telomere length in human cell lines through telomerase upregulation or ALT activity.
pmid-40908429· · peer-reviewed - 5Epitalon increases telomere length in human cell lines through telomerase upregulation or ALT activity
doi-10-21203-rs-3-rs-7066545-v1· · preprint - 6The Antioxidant Tetrapeptide Epitalon Enhances Delayed Wound Healing in an in Vitro Model of Diabetic Retinopathy.
pmid-40493162· · peer-reviewed - 7Overview of Epitalon-Highly Bioactive Pineal Tetrapeptide with Promising Properties.
pmid-40141333· · peer-reviewed - 8Epitalon protects against post-ovulatory aging-related damage of mouse oocytes in vitro .
pmid-35413689· · peer-reviewed - 9Peptides Regulating Proliferative Activity and Inflammatory Pathways in the Monocyte/Macrophage THP-1 Cell Line.
pmid-35408963· · peer-reviewed - 10AEDG Peptide (Epitalon) Stimulates Gene Expression and Protein Synthesis during Neurogenesis: Possible Epigenetic Mechanism.
pmid-32019204· · peer-reviewed - 11[Age features of bioregulatory therapy of dental diseases.]
pmid-32362097· · peer-reviewed - 12Short Exogenous Peptides Regulate Expression of CLE, KNOX1, and GRF Family Genes in Nicotiana tabacum.
pmid-28371610· · peer-reviewed
Show the remaining 21 sources
- 13[Pineamin increased pineal melatonin synthesis in elderly people].
pmid-28849889· · peer-reviewed - 14[Genome instability in pulmonary tuberculosis before and after treatment].
pmid-24323970· · peer-reviewed - 15[Peptide bioregulators: the new class of geroprotectors. Message 2. Clinical studies results].
pmid-24003726· · peer-reviewed - 16[Influence of peptides from pineal gland on thymus function at aging].
pmid-21510076· · peer-reviewed - 17[Biological activity of regulatory peptides in model experiments in vitro].
pmid-18546826· · peer-reviewed - 18
- 19Effects of intranasal administration of epitalon on neuron activity in the rat neocortex.
pmid-17955380· · peer-reviewed - 20Effect of epithalamin on the rhythm of immune and endocrine systems functioning in patients with chronic coronary disease.
pmid-18214303· · peer-reviewed - 21[Effect of epitalon and melatonin on life span and spontaneous carcinogenesis in senescence accelerated mice (SAM)].
pmid-15909815· · peer-reviewed - 22Epitalon and colon carcinogenesis in rats: proliferative activity and apoptosis in colon tumors and mucosa.
pmid-12964022· · peer-reviewed - 23Epithalon peptide induces telomerase activity and telomere elongation in human somatic cells.
pmid-12937682· · peer-reviewed - 24Effect of Epitalon on biomarkers of aging, life span and spontaneous tumor incidence in female Swiss-derived SHR mice.
pmid-14501183· · peer-reviewed - 25Epitalon influences pineal secretion in stress-exposed rats in the daytime.
pmid-12500171· · peer-reviewed - 26Effect of epitalon on interleukin-1beta signal transduction and the reaction of thymocyte blast transformation under stress.
pmid-12500162· · peer-reviewed - 27Effect of Vilon and Epithalon on glucose and glycine absorption in various regions of small intestine in aged rats.
pmid-12420071· · peer-reviewed - 28Peptides and Ageing.
pmid-12374906· · peer-reviewed - 29Modulating effects of epithalamin and epithalon on the functional morphology of the spleen in old pinealectomized rats.
pmid-11865335· · peer-reviewed - 30Effects of pineal peptide preparation Epithalamin on free-radical processes in humans and animals.
pmid-11335874· · peer-reviewed - 31
- 32
- 33[Long-term results of comprehensive treatment for cervical cancer with poor prognosis].
pmid-10532103· · peer-reviewed
Reference card
- Compound
- Epitalon, bioregulator short peptides
- Evidence tier
- Human clinical trial
- Indexed publications
- 170 · 5 RCTs · 5 other clinical trials
- Approval
- no registered development programme found
- Routes reported
- intramuscular, intranasal, intraperitoneal, oral, subcutaneous
- Reviewed
- Adam Mirando, PharmD,
Study figures are as published in each source and are not recommendations. Print or save this card with its date.
Last reviewed and what changed
Newest first. These are the record's own revision dates, and the same dates feed the sitemap.
- · Reviewed by Adam Mirando, PharmD, on 2026-09-29.
- · Khavinson 2003, the telomerase and telomere-elongation study in human somatic cells that the page cited from a summary, is now in the ledger (pmid-12937682).
- · Written under the sequencing rule after research/intents/epitalon.json: guide (8 sections incl. an Epitalon-vs-Epithalamin study table), FAQ to 12 plus 9 from the map, hand-written dose, weight-normalized, duration, timeline and adverse-event claims from the abstracts; mechanism, reported-use and regulatory claims; two misdrafted interactions removed; intent-driven H1 and title with both spellings. Triage: two contextual links added.
- · Claims drafted extractively from 29 ledger sources by scripts/draft_claims.py: 20 claims, 24 evidence-table rows. Status researched -> draft.
- · Claims drafted extractively from 29 ledger sources by scripts/draft_claims.py: 25 claims, 24 evidence-table rows. Status researched -> draft.
- · Claims drafted extractively from 29 ledger sources by scripts/draft_claims.py: 28 claims, 24 evidence-table rows. Status researched -> draft.
- · Metadata refreshed by scripts/fetch_evidence.py --refresh-meta: tier animal-preclinical -> human-clinical-trial.
- · Evidence fetched from Europe PMC and ChEMBL by scripts/fetch_evidence.py; claims not yet written.