If you have been reading about bioregulator and want a single page that covers the useful parts, this is it: definitions, context, how it is studied, and the questions that come up repeatedly.
Updated 2025-11-24. Numbers and descriptions here follow the published literature rather than marketing material.
Regulatory status varies by country and is not harmonized. Epitalon is not an approved drug in major Western jurisdictions. In some countries it is sold as a research chemical, and in others it has appeared in products marketed for other categories. This inconsistent status means that purity, labeling accuracy, and documentation differ widely between suppliers, and verification of identity and purity through independent analysis is the usual way buyers assess a given lot.
Epitalon appears in the literature primarily through a small number of research groups, most of them associated with the St. Petersburg Institute of Bioregulation and Gerontology. Publications describe cell culture experiments, animal studies, and a limited number of small human studies. Independent replication outside this network is sparse. As a result, reviews of the topic usually separate descriptive reports of observed effects from the question of whether those effects generalize, and they note the difficulty of comparing studies that use different preparations and endpoints.
The four residues give epitalon a molecular formula of C14H22N4O9 and a molecular weight near 390.35 daltons. The presence of two acidic residues, glutamate and aspartate, makes the free peptide strongly acidic, while the alanine and glycine ends provide neutral, nonpolar character. This combination produces a molecule with substantial water solubility. Because there are no cysteine, methionine, or tryptophan residues, the peptide lacks the most common oxidation-sensitive side chains, which simplifies handling compared with many longer peptides.
The proposed relationship between epitalon and pineal function is a central part of its background. Khavinson's group reported that short peptides corresponding to regions of larger pineal proteins could influence gene expression in cells. Epitalon was framed as a synthetic analogue of an active fragment rather than a direct isolation product. Whether the tetrapeptide reproduces the effects of the parent extract is an open question, because comparative studies are limited and the parent extract itself is not a single defined substance.
Interest in epitalon is usually discussed within the broader field of short peptide bioregulators, a category that includes other synthetic di-, tri-, and tetrapeptides studied by the same research group. These compounds share a common rationale: that small fragments of tissue-derived proteins can retain biological activity and can be produced reproducibly. The category as a whole remains outside mainstream pharmacological consensus, and epitalon specifically has a limited presence in independent, non-Russian research literature, which shapes how its evidence base is described.
| Property | Value | Notes |
|---|---|---|
| Purity assessment | RP-HPLC | Reported as percent area, often ≥95% |
| Identity confirmation | Mass spectrometry | Observed mass compared with ~390 Da |
| Typical storage temperature | -20 °C or below | Lyophilized powder, desiccated |
| Reconstitution solvent | Sterile water or buffer | Acidic residues aid dissolution |
| Common synonyms | AEDG; epithalon | Spelling varies in literature |
Identity testing for epitalon relies on reversed-phase high-performance liquid chromatography for purity and mass spectrometry for mass confirmation. Because the sequence contains no tryptophan or tyrosine, ultraviolet detection at 280 nanometres is insensitive, so chromatographic methods usually monitor absorbance near 214 nanometres, where the peptide backbone absorbs. Electrospray ionisation or matrix-assisted laser desorption/ionisation then checks the intact mass against the expected value near 390 daltons. Peptide mapping or amino acid analysis after acid hydrolysis can supplement these measurements, although such confirmatory work is seldom reported on commercial certificates of analysis.
Stability of the tetrapeptide follows ordinary peptide chemistry rather than any unusual structural feature. The aspartate-glycine pair is prone to aspartimide formation under mildly basic or neutral conditions, and deamidation can follow, altering both mass and chromatographic retention. Dry lyophilised powder kept at or below minus twenty degrees Celsius is the usual handling recommendation, with repeated freeze-thaw cycles avoided. Once dissolved in neutral aqueous buffer, degradation proceeds over days to weeks depending on pH and temperature, while acidic conditions generally slow the aspartimide route. A formal stability-indicating study has not been published in the indexed literature.
Because epitalon has no pharmacopoeial monograph, quality assessment depends on supplier documentation and independent testing. Certificates of analysis typically report a purity figure from a single chromatographic run, a measured mass and sometimes an appearance description, but methods and acceptance criteria are not harmonised across vendors. Third-party laboratories can repeat identity and purity measurements, and mismatches between labelled and measured peptide content have been described for research peptides generally. What constitutes adequate identity confirmation for a molecule of this size stays an open question, since mass agreement alone does not separate closely related sequences.
Epitalon is a synthetic tetrapeptide with the sequence alanine–glutamate–aspartate–glycine, commonly abbreviated AEDG. Its design traces to epithalamin, a peptide fraction prepared from bovine pineal gland extracts that researchers in Saint Petersburg began investigating in the 1970s. The compound has a molecular formula of C14H22N4O9 and a nominal molecular mass near 390 daltons. It holds no approved drug status in the United States or the European Union, and material sold under this name is generally offered as a research chemical rather than a finished pharmaceutical product.
Proposed mechanisms centre on cell-culture observations rather than a defined receptor interaction. Several reports describe increased expression of the telomerase catalytic subunit after exposure of cultured human cells, and the authors attributed the effect to short peptide fragments entering the nucleus and influencing gene transcription. No receptor for the tetrapeptide has been identified, and the free peptide is expected to be degraded rapidly by plasma peptidases. Whether any measurable fraction reaches intact tissues after administration remains an unresolved question rather than an established finding.
The published literature is dominated by a small number of research groups, much of it in Russian-language journals, and independent replication outside those groups is limited. Studies are typically small, use cultured cells or rodent models, and report endpoints that differ between papers, which makes comparison difficult. Large randomised human trials have not appeared in the indexed literature. Questions about absorption, distribution and clearance are therefore still treated as open in reviews that mention the compound.
Stability depends strongly on pH, temperature and the presence of oxygen and trace metals. Cleavage of the backbone proceeds faster under neutral to alkaline conditions, whereas acidic solutions tend to slow that reaction. The aspartate and glutamate side chains can undergo deamidation or imide formation over time, generating closely related impurities. Published stability data specific to epitalon are sparse, so the usable life of a given solution is best regarded as an open question that depends on buffer composition, concentration and storage temperature.
Identity and purity are usually assessed by reversed-phase high-performance liquid chromatography with ultraviolet detection, frequently near 214 nanometers where the peptide bond absorbs. Mass spectrometry, most often with electrospray ionization, confirms the observed molecular mass and helps separate the intact peptide from truncated or modified forms. Amino acid analysis or tandem mass spectrometry can establish residue order. Purity is commonly quoted as an area percentage, yet such values are method-dependent, and comparisons between laboratories require matching column, gradient and detection wavelength.
In its supplied form epitalon is a white to off-white powder, usually lyophilized and often hygroscopic. It dissolves readily in water and in aqueous buffers, and it is commonly handled as the acetate or trifluoroacetate salt to improve stability during purification and drying. The amide backbone is labile in aqueous media, so solutions are less durable than the dry solid. Handling notes in the chemical literature therefore emphasize keeping the powder dry, cool and shielded from light until it is dissolved.
Epitalon is a synthetic tetrapeptide whose sequence is alanine-glutamate-aspartate-glycine, written in single-letter code as AEDG. The four residues are joined by three peptide bonds, giving a linear backbone with no branching and no disulfide bridges. Its calculated molecular mass for the free form is approximately 390.3 daltons, a figure that rises when the compound is supplied as an acetate or trifluoroacetate salt. Because the chain is short, the molecule is defined entirely by its residue order rather than by any folded three-dimensional structure.
The compound is described in the literature as a derivative of epithalamin, a preparation obtained from bovine pineal tissue. Work on this peptide family was carried out mainly by a research group in Saint Petersburg beginning in the 1980s, and the substance was later registered for clinical use in Russia under the name Epitalon. Outside that region it is generally treated as a research chemical rather than an approved medicine. Statements about its biological activity rest on a relatively small number of studies, and independent replication remains limited.
== Effectiveness == Drug companies nearly universally believe the ODA to be a success. Before Congress enacted the ODA in 1983 only 38 drugs were approved in the USA specifically to treat orphan diseases. In the US, from January 1983 to June 2004, a total of 1,129 different orphan drug designations have been granted by the Office of Orphan Products Development (OOPD) and 249 orphan drugs have received marketing authorization. In contrast, the decade prior to 1983 saw fewer than ten such products come to market. From the passage of the ODA in 1983 until May 2010, the FDA approved 353 orphan drugs and granted orphan designations to 2,116 compounds. As of 2010, 200 of the roughly 7,000 officially designated orphan diseases have become treatable. In 2010, drugmaker Pfizer established a division to focus specifically on the development of orphan drugs as other large pharmaceutical companies focused greater efforts on the orphan drug research. Some critics have questioned whether orphan drug legislation was the real cause of this increase (claiming that many of the new drugs were for disorders that were already being researched anyway, and would have had drugs developed regardless of the legislation), and whether the ODA has really stimulated the production of truly non-profitable drugs; the act also received some criticism for allowing some pharmaceutical companies to make a large profit off of drugs that have a small market but still sell for a high price.
== History == Clinical and Vaccine Immunology (CVI) was originally launched in 1994 as Clinical and Diagnostic Laboratory Immunology. Dr. Steven D. Douglas was the Founding Editor and served as Editor in Chief until 2004. The focus and intent of the journal was to serve the new ASM Division V, Clinical and Diagnostic Immunology. Douglas was succeeded by Dr. Susan F. Plaeger, CVI's Editor in Chief until 2013. Under Plaeger's leadership, and in response to ASM members' feedback, the journal expanded its scope to include the growing field of veterinary and human vaccines. In 2006, the ASM Publications Board approved the new name Clinical and Vaccine Immunology, to reflect the inclusion of vaccine research as well as clinical immunology. The reorganization allowed CVI to attract high-quality research papers in the areas of clinical immunology and vaccinology while maintaining its interest in laboratory immunology and diagnostics. Since then, the journal has enjoyed a sustained increase in citations and impact factor. Areas of interest for CVI include microbial immunology, clinical immunology and immune mechanisms (in health and disease), veterinary immunology, and all aspects of vaccine research: development and evaluation, adjuvants, immune modulators and antigen-delivery systems, vaccine implementation, and clinical trials. The journal serves ASM members and the broad research community with the high scientific and editorial standards of the ASM Journals and the society itself.
== Clinical applications == In 2013, Aileron Therapeutics, which was co-founded by Verdine, Walensky and Taylor, completed the first stapled peptide clinical trial with their growth-hormone-releasing hormone agonist ALRN-5281. As of 2019, Aileron Therapeutics is developing another candidate, sulanemadlin (ALRN-6924), in a Phase 2a trial that assesses the combination of sulanemadlin and Pfizer's palbociclib for the treatment of patients with MDM2-amplified cancers, and a Phase 1b/2 clinical trial to evaluate sulanemadlin as a myelopreservative agent to protect against chemotherapy-induced toxicities.
==== Japan ==== Oxycodone is a restricted drug in Japan. Its import and export are strictly restricted to specially designated organizations having a prior permit to import it. In a high-profile case an American who was a top Toyota executive living in Tokyo, who claimed to be unaware of the law, was arrested for importing oxycodone into Japan.
Sources: en.wikipedia.org
=== United States === The rate of obesity among children and adolescents in the United States has nearly tripled between the early 1980s and 2000. It has, however, not changed significantly between 2000 and 2006, with the most recent statistics showing a level just over 17 percent. In 2008, the rate of overweight and obese children in the United States was 32%, and had stopped climbing. In 2011, a national cohort study of infants and toddlers found that nearly one-third of US children were overweight or obese at nine months and two years old. In a follow-up study, infant weight status (healthy and obese) was strongly associated with preschool weight status.
== Characterization of inorganic compounds == Because of the diverse range of elements and the correspondingly diverse properties of the resulting derivatives, inorganic chemistry is closely associated with many methods of analysis. Older methods tended to examine bulk properties such as the electrical conductivity of solutions, melting points, solubility, and acidity. With the advent of quantum theory and the corresponding expansion of electronic apparatus, new tools have been introduced to probe the electronic properties of inorganic molecules and solids. Often these measurements provide insights relevant to theoretical models. Commonly encountered techniques are:
For example, Pablo Morillo, commander in chief of the expeditionary force sent to South America, reported that he had only 2,000 European soldiers under his command in 1820; in other words, only half the soldiers of his expeditionary force were European. It is estimated that in the Battle of Maipú only a quarter of the royalist forces were European soldiers, in the Battle of Carabobo about a fifth, and in the Battle of Ayacucho less than 1% was European. The American militias reflected the racial make-up of the local population. For example, in 1820 the royalist army in Venezuela had 843 white (español), 5,378 Casta, and 980 Indigenous soldiers.
Sources: en.wikipedia.org
Short-chain scorpion toxins constitute the largest group of potassium (K+) channel-blocking peptides. An important physiological role of the KCNA3 channel, also known as KV1.3, is to help maintain large electrical gradients for the sustained transport of ions such as Ca2+ that controls T lymphocyte (T cell) proliferation. Thus KV1.3 blockers could be potential immunosuppressants for the treatment of autoimmune disorders (such as rheumatoid arthritis, inflammatory bowel disease, and multiple sclerosis). The venom of Uroplectes lineatus is clinically important in dermatology. Several scorpion venom toxins have been investigated for medical use. Chlorotoxin from the deathstalker scorpion (Leiurus quinquestriatus); the toxin blocks small-conductance chloride channels; Maurotoxin from the venom of the Tunisian Scorpio maurus blocks potassium channels. Some antimicrobial peptides in the venom of Mesobuthus eupeus; meucin-13 and meucin-18 have extensive cytolytic effects on bacteria, fungi, and yeasts, while meucin-24 and meucin-25 selectively kill Plasmodium falciparum and inhibit the development of Plasmodium berghei, both malaria parasites, but do not harm mammalian cells.
== Diagnosis == Chorea is distinctive, if the health care provider is familiar with it. The diagnosis is then made by the typical acute onset in the weeks following a sore throat or other minor infection, plus evidence of inflammation (raised CRP and/or ESR) and evidence of recent streptococcal infection. To confirm recent streptococcal infection:
Copper-free click chemistry is being explored for use in synthesizing PET imaging agents which must be made quickly with high purity and yield in order to minimize isotopic decay before the compounds can be administered. Both the high rate constants and the bioorthogonality of SPAAC are amenable to PET chemistry.
Sources: en.wikipedia.org
Identity is normally confirmed by mass spectrometry, which checks the measured mass against the expected value near 390 daltons. Reverse-phase high-performance liquid chromatography is used alongside it to assess purity. Amino acid analysis can provide additional composition data.
The powder is generally kept refrigerated or frozen, protected from light and moisture. Vials should reach room temperature before opening to prevent condensation. Reconstituted solutions are usually stored cold and used within a limited window because dilute solutions can degrade or support microbial growth.
Epitalon is not an approved drug in major Western regulatory jurisdictions. Its legal status differs between countries, and it is often distributed as a research chemical. This means product documentation and purity vary considerably between suppliers.
Epitalon is a synthetic tetrapeptide composed of four amino acids: alanine, glutamate, aspartate, and glycine. It is written as Ala-Glu-Asp-Gly. The free peptide has a molecular weight of about 390 daltons and is normally supplied as a lyophilized powder.