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Epithalamine

Also known as Epithalamin, Epitalamin, pineal peptide preparation, polypeptide pineal extract

Bovine pineal gland extract from the Khavinson programme and the source material from which Epitalon was derived.

preclinical Immune & longevity research chemical

At a glance

Category
Immune & longevity
Status
research chemical
Made from
animal-derived Crude low-molecular-weight extract of the pineal gland of cattle.
Route
intramuscular and subcutaneous in the published studies; intraperitoneal in animal work
Half-life
No published pharmacokinetics in humans or animals. For a mixture of unprotected peptides, plasma survival is presumably short; any half-life figure quoted for it has no primary source and could not be meaningful for a mixture in any case.
Molecular weight
No single value can be given. Epithalamine is a mixture of peptides, generally specified as fractions below roughly 10 kDa, with no standardised composition and no identified active constituent. Batch-to-batch variation is inherent to the product and is not characterised in the published work.

Epithalamine is a crude low-molecular-weight extract of bovine pineal gland, not a defined molecule. It held a pharmaceutical registration in Russia under the Soviet and Russian approval systems, alongside its thymic counterpart Thymalin. That registration reflects a national procedure of that era and not a dossier assessed by EMA or FDA; the preparation is not approved anywhere in the EU or US. The related capsule products (Endoluten and the Cytomax range) are registered in Russia as food supplements under the BAD notification regime, which involves no efficacy assessment. PeptideX has not been able to open the Russian register from outside Russia to confirm this, so the registration should be read as an unverified claim rather than an established fact. Epithalamine is frequently conflated with Epitalon, the synthetic tetrapeptide AEDG that was derived from it - they are not the same substance, and the distinction matters because most of the human outcome claims attached to Epitalon were actually generated with this extract.

Doping status: Not listed by name; as a non-approved substance it falls under S0 and is therefore prohibited at all times

Checked against the WADA 2026 Prohibited List. For a specific product and country, Global DRO is the lookup athletes are expected to use — the List names substances, not brand names.

Frequently sold or discussed under the name Epitalon, which is the synthetic tetrapeptide and contains no animal material; the two are not interchangeable, and grey-market 'Epithalamin' has no verifiable animal sourcing.

This is a short entry. There is little or no published research on this compound, so there is correspondingly little to report. Empty dosing or reconstitution sections mean no credible figures exist — not that they were left out.

Mechanism of action

Epithalamine belongs to Khavinson's 'peptide bioregulator' programme at the St Petersburg Institute of Bioregulation and Gerontology, which holds that short peptides extracted from an organ selectively restore the function of that same organ by entering nuclei and directing gene expression. That premise of tissue specificity is the central and least substantiated assumption of the whole programme: there is no accepted mechanism by which short peptides, chemically indistinguishable from ordinary proteolytic breakdown fragments found throughout the body, would navigate selectively to one organ and bind sequence-specifically to promoter DNA. The same objection applies here as to Epitalon, with an additional problem: as a crude extract, even the identity of the supposed bioregulator is unknown.

The specific claims made for Epithalamine are that it raises pineal and serum melatonin, restores circadian rhythmicity, and acts as an antioxidant, with the antioxidant property offered as the explanation for reported lifespan effects across three species. The Anisimov group also proposed effects on gonadotropin regulation and on tumour incidence. Because the preparation is an undefined mixture, none of these effects can be attributed to a molecule, which means the mechanism is not testable in the ordinary way - a hypothesis about a preparation rather than about a compound. Khavinson's group later synthesised the tetrapeptide Ala-Glu-Asp-Gly (Epitalon) as the proposed active constituent; the evidence that this tetrapeptide accounts for the extract's reported activity is itself an inference from within the same programme.

What the research shows

A body of animal lifespan work spanning fruit flies, mice and rats, all from the same Russian research tradition, plus the widely cited human mortality claim - in which Epithalamine was co-administered with Thymalin. Nothing has been independently replicated outside the originating group in over three decades. The human figures are not credible on their face.

Research in humans

The principal human claim is Khavinson and Morozov (Neuro Endocrinology Letters, 2003): 266 people over 60, followed for 6 to 8 years, treated with Thymalin and/or Epithalamine, with reported mortality reductions of roughly 1.6 to 2.1 fold for the single preparations and 4.1 fold for the combination of Epithalamine plus Thymalin over six years of annual courses 4. Two things must be said about this. First, the largest reported effect belongs to the combination, so it cannot be attributed to Epithalamine alone 4 - and the same paper is cited as evidence for Thymalin, for Epithalamine and, by extension in marketing material, for Epitalon. Second, the numbers are simply not believable: a 4.1-fold mortality reduction in an elderly cohort exceeds anything medicine has achieved, more than statins, antihypertensives and smoking cessation combined. No independent group has reproduced any part of this. There are additional Russian clinical reports in ophthalmology, endocrinology and oncology, generally small, uncontrolled and not internationally indexed.

Animal and lab research

Anisimov, Mylnikov and Khavinson (Mechanisms of Ageing and Development, 1998) reported that Epithalamine increased mean lifespan by 11-31% in female Drosophila melanogaster, SHR mice, C3H/Sn mice and LIO rats, with mortality rate reductions of around 52% in flies and rats 1. Anisimov, Bondarenko and Khavinson (Annals of the New York Academy of Sciences, 1992) reported increased lifespan together with raised pineal and serum melatonin in old rats. Earlier work from the same tradition (1979) reported that a polypeptide pineal extract at 0.1 or 0.5 mg per animal per day increased female rat lifespan by 10 and 25% 3. Consistency across four species is superficially impressive; consistency across four species from one laboratory using one uncharacterised preparation is a different claim, and the second reading is the applicable one until someone outside the group reproduces it.

Caveats. Every element of the case originates from one research programme. The human mortality study cannot be assessed: randomisation method, allocation concealment and blinding are not verifiable; treated participants received annual injection courses and therefore repeated clinical contact the control group did not, which alone can manufacture large apparent mortality differences; attrition over six to eight years is not reported; there was no registered protocol or pre-specified primary endpoint. The preparation is an undefined animal extract whose composition can vary between batches, so even the originating laboratory cannot guarantee it is testing the same thing twice. Much of the literature is Russian-language and in journals with limited external scrutiny. There is no internationally assessable toxicology, carcinogenicity or reproductive toxicity programme. Finally, material sold online as 'Epithalamin' has unverifiable content and unverifiable animal sourcing.

What it is used for

  • Presented as a geroprotector and pineal 'bioregulator' - a claim the evidence does not support
  • Co-administered with Thymalin in the Khavinson mortality study, which is the source of the widely repeated lifespan claims for this whole family of products 4
  • Studied for melatonin and circadian rhythm regulation - the underlying report is a rat study from the originating group, which described raised pineal and serum melatonin alongside increased lifespan in old animals 2 - and in Russian oncology and ophthalmology series
  • Self-administered in courses on the grey market, without a validated indication or dose

Dosing

  • No defensible dose can be stated. In the animal work, figures such as 0.1 or 0.5 mg per rat per day appear, from a 1979 report of a 10 and 25% lifespan increase in female rats 3; the Khavinson human protocol used annual courses of intramuscular injection alongside Thymalin, but the doses reported for that study belong to the combination and not to Epithalamine as a standalone treatment 4.
  • Because Epithalamine is an extract rather than a defined molecule, a dose in milligrams is not a reliable measure of biological activity: the same 10 mg can differ in composition between batches and suppliers.
  • There is no dose-finding study, no maximum tolerated dose, no human pharmacokinetics and no dose-response curve.
  • Epithalamine and Epitalon are not interchangeable, and a dose for one is not a dose for the other 5.

These figures describe what the literature and published protocols report. They are not advice and not a dosing instruction.

Protocols

Annual geroprotection course (Khavinson protocol, as it circulates)

user protocol — not validated

Source: user protocols and vendor material, following the Khavinson course structure

This is not a validated schedule. It is a pattern that circulates among users and sellers, reproduced because it is what people actually follow — not because it has been tested. No trial established these doses, this interval or this duration, and nobody is checking what is in the vial. Treat every number below as an assertion, not a finding.

Days 1-1010 mg per day by intramuscular injection is the figure that circulates
Repeatannually, for several years

In the published work Epithalamine was given in annual courses alongside Thymalin, so no dose in that research belongs to Epithalamine on its own. It is a crude bovine pineal extract, not the synthetic tetrapeptide Epitalon: 10 mg is a mass of extract whose composition varies between batches, and a dose for one substance is not a dose for the other.

Schedules are reproduced as their source states them. Units, IU and milligrams explains why the figures are not interchangeable between products.

Reconstitution

Storage
Lyophilised powder is stored refrigerated and protected from light. The Russian product information for preparations of this class directs that the solution be used immediately after reconstitution with saline.

No reconstitution protocol is given here, because doing so would imply a validated dose exists. Note additionally that a bovine tissue extract carries a higher risk of residual proteins provoking an allergic reaction than a synthetic peptide, and that for grey-market material the origin of the animal starting material cannot be traced.

Safety

Side effects

  • Allergic reactions, including in principle anaphylaxis - this is foreign animal protein and is the main predictable risk
  • Injection site pain and redness
  • The published Russian reports mention few adverse effects, but that reflects the absence of systematic safety monitoring in small uncontrolled series and is not evidence of safety
  • No internationally assessable toxicology, carcinogenicity or reproductive toxicity programme has been performed

Do not use if

  • Hypersensitivity to bovine proteins
  • Active, past or suspected malignancy - the claimed mechanisms are proliferative and transcriptional, and the oncological consequences are unstudied
  • Pregnancy and breastfeeding - no data
  • Children and adolescents - no data; interference with pineal and melatonin biology during development has not been studied
  • Autoimmune disease - unstudied immunological effects of a foreign tissue extract

Interactions

Not studied. Additive effects with melatonin or other chronobiotics are conceivable given the claimed pineal mechanism, and the published human work co-administered Epithalamine with Thymalin without any attempt to separate their effects 4. There are no pharmacokinetic interaction studies, and for an extract with unidentified active constituents such a study would be difficult to design.

Sources