{"site":"Epitalon Rx","url":"https://epithalonrx.com","format":"evidence-manifest/v1","claim_count":70,"claims":[{"id":"clm-001","text":"Epitalon is the synthetic tetrapeptide Ala-Glu-Asp-Gly (AEDG), PubChem CID 219042, molecular formula C14H22N4O9, molecular weight 390.35, CAS 307297-39-8, UNII O65P17785G.","source_url":"https://pubchem.ncbi.nlm.nih.gov/compound/219042","grade":"chemical-reference","grade_label":"Chemical reference","used_on":["https://epithalonrx.com/entity","https://epithalonrx.com/facts","https://epithalonrx.com/monograph","https://epithalonrx.com/llms"]},{"id":"clm-002","text":"Nearly everything published about epitalon comes from the research network that created it: 111 of the 167 records returned by a four-term Europe PMC query, or 66.5 percent, carry Khavinson or Anisimov as an author or name the St. Petersburg Institute of Bioregulation and Gerontology in the affiliation.","source_url":"https://europepmc.org/search?query=TITLE_ABS%3A%22epitalon%22","grade":"analytical","grade_label":"Analytical study","used_on":["https://epithalonrx.com","https://epithalonrx.com/monograph","https://epithalonrx.com/facts","https://epithalonrx.com/comparisons","https://epithalonrx.com/limits"]},{"id":"clm-003","text":"No laboratory outside that network has published a study in which epitalon was administered to a human being.","source_url":"https://europepmc.org/search?query=TITLE_ABS%3A%22epitalon%22","grade":"analytical","grade_label":"Analytical study","used_on":["https://epithalonrx.com","https://epithalonrx.com/monograph","https://epithalonrx.com/studies","https://epithalonrx.com/faq","https://epithalonrx.com/limits"]},{"id":"clm-004","text":"Khavinson personally is a named author on 100 of the 167 archived records, which is 59.9 percent of the literature on this compound.","source_url":"https://europepmc.org/search?query=TITLE_ABS%3A%22epitalon%22","grade":"analytical","grade_label":"Analytical study","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/facts"]},{"id":"clm-005","text":"The archived corpus is 167 records: 112 in English, 52 in Russian, 1 in Ukrainian and 2 with no language stated.","source_url":"https://europepmc.org/search?query=TITLE_ABS%3A%22epitalon%22","grade":"analytical","grade_label":"Analytical study","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/facts","https://epithalonrx.com"]},{"id":"clm-006","text":"At least 6 of the 167 records are not about the peptide at all: the string AEDG is also an underwater sensor-network routing protocol, an abbreviation for an aqueous plant extract, and a gonococcal serovar designation.","source_url":"https://europepmc.org/search?query=TITLE_ABS%3A%22epitalon%22","grade":"analytical","grade_label":"Analytical study","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/methodology","https://epithalonrx.com/honesty_log"]},{"id":"clm-007","text":"Epitalon is a pineal tetrapeptide: it was derived from Epithalamin, a peptide preparation extracted from the pineal gland, by identifying a short active sequence.","source_url":"https://europepmc.org/article/MED/8010617","grade":"review","grade_label":"Review or guideline","used_on":["https://epithalonrx.com/entity","https://epithalonrx.com/monograph"]},{"id":"clm-008","text":"PubChem's own synonym list for the tetrapeptide includes Epithalamin and Epithalamine, so the conflation between the synthetic peptide and the pineal extract is present in the chemical databases themselves.","source_url":"https://pubchem.ncbi.nlm.nih.gov/compound/219042","grade":"chemical-reference","grade_label":"Chemical reference","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/faq","https://epithalonrx.com/honesty_log"]},{"id":"clm-009","text":"Epitalon as sold in the United States is a lyophilized powder in a sealed vial, reconstituted by the buyer with bacteriostatic water and injected subcutaneously.","source_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12411320/","grade":"review","grade_label":"Review or guideline","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/tools"]},{"id":"clm-010","text":"In the best-designed rodent lifespan study of epitalon, the peptide did not change mean lifespan.","source_url":"https://europepmc.org/article/MED/14501183","grade":"animal","grade_label":"Animal","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies","https://epithalonrx.com/faq","https://epithalonrx.com/comparisons"]},{"id":"clm-011","text":"The same study did find a 13.3 percent increase in the lifespan of the last 10 percent of survivors, a 12.3 percent increase in maximum lifespan, 17.1 percent fewer chromosome aberrations and a 6-fold reduction in leukemia with no change in total tumor incidence.","source_url":"https://europepmc.org/article/MED/14501183","grade":"animal","grade_label":"Animal","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies","https://epithalonrx.com/tools"]},{"id":"clm-012","text":"Two rat lifespan studies found no change in mean lifespan under a normal light cycle; effects appeared only in animals whose lifespan had already been shortened by disrupted illumination.","source_url":"https://europepmc.org/article/MED/18856211","grade":"animal","grade_label":"Animal","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies","https://epithalonrx.com/faq"]},{"id":"clm-013","text":"The strongest positive lifespan result, 13.5 percent longer mean lifetime in HER-2/neu transgenic mice, was produced at a published dose of 1 mg subcutaneously, roughly a thousand times higher than the 0.1 to 1 microgram doses used in every neighbouring study.","source_url":"https://europepmc.org/article/MED/12459848","grade":"animal","grade_label":"Animal","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies","https://epithalonrx.com/tools","https://epithalonrx.com/honesty_log"]},{"id":"clm-014","text":"In the same transgenic mice, tumor-free lifetime was 34.2 percent longer and the number of animals without breast tumors rose 3.7-fold.","source_url":"https://europepmc.org/article/MED/12459848","grade":"animal","grade_label":"Animal","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies"]},{"id":"clm-015","text":"In a mainstream oncology journal, epitalon reduced mammary tumor number and size in HER-2/neu mice while the comparison peptide Vilon significantly increased cancer incidence in the same experiment.","source_url":"https://europepmc.org/article/MED/12209581","grade":"animal","grade_label":"Animal","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies"]},{"id":"clm-016","text":"In chemically induced colon carcinogenesis, epitalon cut tumors per rat from 4.1 to 2.7, but carcinomas still developed in 90 to 100 percent of animals in every group.","source_url":"https://europepmc.org/article/MED/12049808","grade":"animal","grade_label":"Animal","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies"]},{"id":"clm-017","text":"In one-year-old C3H/He mice, epitalon reduced the number of animals with malignant tumors, and no metastases were found in treated animals against 3 of 9 tumor-bearing controls.","source_url":"https://europepmc.org/article/MED/16634527","grade":"animal","grade_label":"Animal","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies"]},{"id":"clm-018","text":"Epitalon reduced chromosome aberrations by 17.9 to 30.1 percent across three mouse strains, where melatonin in drinking water had no effect in the same experiment.","source_url":"https://europepmc.org/article/MED/12360351","grade":"animal","grade_label":"Animal","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies"]},{"id":"clm-019","text":"In senescent rhesus monkeys, epitalon was reported to stimulate evening melatonin synthesis and normalize the cortisol rhythm.","source_url":"https://europepmc.org/article/MED/11524632","grade":"animal","grade_label":"Animal","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies"]},{"id":"clm-020","text":"The telomerase claim originates in a single 2003 experiment: adding epithalon to telomerase-negative human fetal fibroblast culture induced expression of the telomerase catalytic subunit, telomerase activity and telomere elongation.","source_url":"https://europepmc.org/article/MED/12937682","grade":"in-vitro","grade_label":"In vitro","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies","https://epithalonrx.com/faq","https://epithalonrx.com/comparisons","https://epithalonrx.com"]},{"id":"clm-021","text":"That experiment was in a dish of human fetal lung fibroblasts, not in a person.","source_url":"https://europepmc.org/article/MED/12937682","grade":"in-vitro","grade_label":"In vitro","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies","https://epithalonrx.com/faq","https://epithalonrx.com/comparisons"]},{"id":"clm-022","text":"The phrase overcoming the Hayflick limit traces to one follow-up experiment in which treated fibroblasts made 10 extra divisions past the control's limit of 34 passages.","source_url":"https://europepmc.org/article/MED/15455129","grade":"in-vitro","grade_label":"In vitro","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies","https://epithalonrx.com/faq","https://epithalonrx.com/comparisons"]},{"id":"clm-023","text":"In 2025, twenty-two years after the original claim, an independent laboratory at Brunel University London reproduced dose-dependent telomere lengthening in human cell lines, through hTERT and telomerase in normal cells and through alternative lengthening of telomeres in cancer cells.","source_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12411320/","grade":"in-vitro","grade_label":"In vitro","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies","https://epithalonrx.com/faq","https://epithalonrx.com/comparisons","https://epithalonrx.com","https://epithalonrx.com/limits"]},{"id":"clm-024","text":"The same independent paper reports telomere shortening at its lowest concentration in one cancer line, names its main limitation as being a two-dimensional in vitro study, and calls for in vivo animal work.","source_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12411320/","grade":"in-vitro","grade_label":"In vitro","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies","https://epithalonrx.com/limits","https://epithalonrx.com/faq"]},{"id":"clm-025","text":"That independent replication carries a published correction replacing three figures, issued about two months after publication; it is a correction, not a retraction.","source_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12619744/","grade":"in-vitro","grade_label":"In vitro","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies","https://epithalonrx.com/honesty_log"]},{"id":"clm-026","text":"A 2025 Italian-led paper found epitalon restored wound healing in a high-glucose-injured human retinal cell line, and concluded that more work is needed to confirm both benefit and safety.","source_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12356729/","grade":"in-vitro","grade_label":"In vitro","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies"]},{"id":"clm-027","text":"An independent Chinese group reported that 0.1 mM epitalon reduced reactive oxygen species and spindle defects in mouse oocytes aged in vitro.","source_url":"https://europepmc.org/article/MED/35413689","grade":"in-vitro","grade_label":"In vitro","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies"]},{"id":"clm-028","text":"An independent Korean group reported that epitalon-activated telomerase improved bovine oocyte maturation and post-thaw embryo development.","source_url":"https://europepmc.org/article/MED/39788414","grade":"in-vitro","grade_label":"In vitro","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies"]},{"id":"clm-029","text":"In fruit flies, epitalon extended adult lifespan 11 to 16 percent with no dose-response across five orders of magnitude of concentration.","source_url":"https://europepmc.org/article/MED/11087911","grade":"animal","grade_label":"Animal","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies"]},{"id":"clm-030","text":"Zero records in the epitalon literature carry a Randomized Controlled Trial publication tag, and there are zero meta-analyses and zero systematic reviews.","source_url":"https://europepmc.org/search?query=TITLE_ABS%3A%22epitalon%22","grade":"absence-of-evidence","grade_label":"Absence of evidence","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies","https://epithalonrx.com/facts","https://epithalonrx.com","https://epithalonrx.com/faq"]},{"id":"clm-031","text":"The study most often cited as proof that epitalon lengthens human telomeres is a dish experiment on lymphocytes from 11 men, in which telomere length increased in 5 donors and decreased in 2.","source_url":"https://europepmc.org/article/MED/31761987","grade":"in-vitro","grade_label":"In vitro","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies","https://epithalonrx.com/faq","https://epithalonrx.com/comparisons"]},{"id":"clm-032","text":"That study describes its result as a tendency toward normalization, with telomeres rising in donors below the group mean and falling in donors above it, which is not the same claim as lengthening.","source_url":"https://europepmc.org/article/MED/31761987","grade":"in-vitro","grade_label":"In vitro","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies"]},{"id":"clm-033","text":"There is no human study in which epitalon was given to people and their telomeres were then measured.","source_url":"https://europepmc.org/search?query=TITLE_ABS%3A%22epitalon%22","grade":"absence-of-evidence","grade_label":"Absence of evidence","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/faq","https://epithalonrx.com/limits","https://epithalonrx.com/comparisons"]},{"id":"clm-040","text":"The mortality-reduction result behind almost every longevity claim made for epitalon comes from a study of Epithalamin, the pineal peptide extract, not of epitalon the tetrapeptide.","source_url":"https://europepmc.org/article/MED/14523363","grade":"human-obs","grade_label":"Human observational","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies","https://epithalonrx.com","https://epithalonrx.com/faq","https://epithalonrx.com/comparisons"]},{"id":"clm-041","text":"That study reported mortality reductions of 1.6 to 1.8 fold in the Epithalamin group, 2.0 to 2.1 fold with Thymalin, 2.5 fold with both, and 4.1 fold in a subgroup given both annually for six years.","source_url":"https://europepmc.org/article/MED/14523363","grade":"human-obs","grade_label":"Human observational","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies","https://epithalonrx.com/faq"]},{"id":"clm-042","text":"The authors of that study are the developers of both preparations, working at the institute that created them.","source_url":"https://europepmc.org/article/MED/14523363","grade":"human-obs","grade_label":"Human observational","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies","https://epithalonrx.com/limits"]},{"id":"clm-043","text":"The one randomized study in this family enrolled 79 elderly coronary patients, 39 treated with epithalamin courses and 40 controls, and reported significantly lower mortality over 15 years of follow-up.","source_url":"https://europepmc.org/article/MED/22451889","grade":"human-rct","grade_label":"Human RCT","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies","https://epithalonrx.com/faq","https://epithalonrx.com/comparisons"]},{"id":"clm-044","text":"That paper's title attributes the preparation to the pituitary gland while its own abstract attributes it to the pineal gland.","source_url":"https://europepmc.org/article/MED/22451889","grade":"human-rct","grade_label":"Human RCT","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies","https://epithalonrx.com/honesty_log"]},{"id":"clm-045","text":"In healthy elderly subjects, epithalamin raised night-time melatonin only in those whose pineal activity was already low, and melatonin tended to fall in subjects with normal pineal function.","source_url":"https://europepmc.org/article/MED/15452611","grade":"human-trial","grade_label":"Human trial","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies","https://epithalonrx.com/faq"]},{"id":"clm-046","text":"A 30-month observation of chronic coronary patients given six epithalamin courses reported retained seasonal rhythms of thymic serum factor and hydrocortisone.","source_url":"https://europepmc.org/article/MED/18214303","grade":"human-obs","grade_label":"Human observational","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies"]},{"id":"clm-047","text":"Five records in the epithalamin literature carry a Randomized Controlled Trial tag, against zero in the epitalon literature.","source_url":"https://europepmc.org/search?query=TITLE_ABS%3A%22epitalon%22","grade":"analytical","grade_label":"Analytical study","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies","https://epithalonrx.com/facts","https://epithalonrx.com/comparisons","https://epithalonrx.com"]},{"id":"clm-050","text":"The only record in the epitalon literature carrying a Clinical Trial tag is a 2002 retinitis pigmentosa report that gives no patient count, no control group and no outcome measure, and reports rat and human results in the same abstract.","source_url":"https://europepmc.org/article/MED/12195242","grade":"human-trial","grade_label":"Human trial","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies","https://epithalonrx.com/faq","https://epithalonrx.com/comparisons"]},{"id":"clm-051","text":"The elderly melatonin work that names epitalon alongside epithalamin reports a normalizing effect in people with reduced pineal function and is published in Russian.","source_url":"https://europepmc.org/article/MED/17969590","grade":"human-obs","grade_label":"Human observational","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies"]},{"id":"clm-052","text":"The chromatin work in cells from people aged 76 to 80 was done in cultured lymphocytes; the peptide never entered a person.","source_url":"https://europepmc.org/article/MED/14647006","grade":"in-vitro","grade_label":"In vitro","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies"]},{"id":"clm-053","text":"Independent Georgian groups reproduced protective effects on genome instability in lymphocyte cultures from tuberculosis and breast cancer patients, and in the tuberculosis study one endpoint improved while chromosome fragility did not.","source_url":"https://europepmc.org/article/MED/24323970","grade":"in-vitro","grade_label":"In vitro","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies"]},{"id":"clm-054","text":"The clearest independent corroboration in human cells is a 2006 Tbilisi State University study of chromatin decondensation in lymphocytes from people aged 75 to 88, and it is still a cell-culture experiment.","source_url":"https://europepmc.org/article/MED/16705247","grade":"in-vitro","grade_label":"In vitro","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies"]},{"id":"clm-060","text":"The statement that epitalon has no side effects appears inside efficacy papers written by the group that developed it, not in any safety study.","source_url":"https://europepmc.org/article/MED/17969590","grade":"review","grade_label":"Review or guideline","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies","https://epithalonrx.com/faq"]},{"id":"clm-061","text":"The only toxicity observation in the animal file is an incidental sentence in a 6.5-month mouse carcinogenesis study, not a toxicology study.","source_url":"https://europepmc.org/article/MED/16634527","grade":"animal","grade_label":"Animal","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies"]},{"id":"clm-062","text":"FDA states that it lacks sufficient information to know whether epitalon would cause harm if administered to humans, and that compounded drugs containing it may pose risk for immunogenicity due to the potential for aggregation and peptide-related impurities.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/warning_box","https://epithalonrx.com/faq","https://epithalonrx.com","https://epithalonrx.com/studies"]},{"id":"clm-063","text":"One short peptide in the same rodent experiments, Vilon, made cancer outcomes significantly worse, which is why no short peptide can be assumed harmless by class.","source_url":"https://europepmc.org/article/MED/12209581","grade":"animal","grade_label":"Animal","used_on":["https://epithalonrx.com/monograph"]},{"id":"clm-064","text":"The independent 2025 replication found epitalon lengthening telomeres in breast cancer cell lines through alternative lengthening of telomeres, a mechanism cancer cells use to keep dividing.","source_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12411320/","grade":"in-vitro","grade_label":"In vitro","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/studies","https://epithalonrx.com/faq"]},{"id":"clm-070","text":"No human pharmacokinetic study of epitalon has been published: there is no measured half-life, no bioavailability figure for any route, no Cmax and no AUC.","source_url":"https://europepmc.org/search?query=TITLE_ABS%3A%22epitalon%22","grade":"absence-of-evidence","grade_label":"Absence of evidence","used_on":["https://epithalonrx.com/pk","https://epithalonrx.com/monograph","https://epithalonrx.com/facts","https://epithalonrx.com/studies","https://epithalonrx.com/faq","https://epithalonrx.com/tools","https://epithalonrx.com/limits"]},{"id":"clm-071","text":"A ClinicalTrials.gov query for epitalon, epithalon or epithalamin returns zero registered studies.","source_url":"https://clinicaltrials.gov/search?term=epitalon","grade":"absence-of-evidence","grade_label":"Absence of evidence","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/facts","https://epithalonrx.com/studies","https://epithalonrx.com/faq"]},{"id":"clm-072","text":"No FDA-approved product contains epitalon: a Drugs@FDA query for it as an active ingredient returns no matches, and the same query for epithalon also returns no matches.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://epithalonrx.com/entity","https://epithalonrx.com/monograph","https://epithalonrx.com","https://epithalonrx.com/facts","https://epithalonrx.com/faq"]},{"id":"clm-073","text":"Epitalon appears on FDA's compounding safety-risks page in the table of bulk drug substances nominated but withdrawn.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/warning_box","https://epithalonrx.com/facts"]},{"id":"clm-074","text":"Epitalon appears in no category of FDA's interim 503A bulk-substance category list dated May 14, 2026.","source_url":"https://www.fda.gov/media/94155/download","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://epithalonrx.com/monograph"]},{"id":"clm-090","text":"At the July 23 to 24, 2026 Pharmacy Compounding Advisory Committee meeting, FDA proposed that Epitalon (free base) and Epitalon acetate NOT be included on the 503A Bulks List.","source_url":"https://www.fda.gov/media/193342/download","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/warning_box","https://epithalonrx.com","https://epithalonrx.com/facts","https://epithalonrx.com/faq"]},{"id":"clm-091","text":"The briefing document's section for epitalon has a heading reading FDA Evaluation with no text beneath it, so FDA's stated reasons for the epitalon proposal are not in that document.","source_url":"https://www.fda.gov/media/193342/download","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/honesty_log","https://epithalonrx.com/editorial_standards"]},{"id":"clm-092","text":"Both nominations to include epitalon were withdrawn by the nominators, and FDA elected to present the substance to the committee anyway.","source_url":"https://www.fda.gov/media/193342/download","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/honesty_log"]},{"id":"clm-093","text":"Inclusion on the 503A list would not have made epitalon an approved medicine; the list governs what a compounding pharmacist may use, inside the exemptions from new drug approval, adequate-directions labeling and current good manufacturing practice requirements.","source_url":"https://www.fda.gov/media/193342/download","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/warning_box","https://epithalonrx.com/faq"]},{"id":"clm-094","text":"FDA's four published criteria for evaluating a bulk substance are physical and chemical characterization, safety issues, evidence of effectiveness or lack of effectiveness, and historical use in compounding including references in peer-reviewed medical literature.","source_url":"https://www.fda.gov/media/193342/download","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://epithalonrx.com/monograph"]},{"id":"clm-095","text":"FDA's proposal is a proposal: the agency states it does not intend to issue a final determination until advisory committee input has been considered and all reviews finalized, and that the final determination may be affected by issues not discussed at the meeting.","source_url":"https://www.fda.gov/media/193342/download","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/warning_box","https://epithalonrx.com/copy","https://epithalonrx.com/faq"]},{"id":"clm-096","text":"No committee vote tally for epitalon was posted on FDA's meeting page at the time this pack was built.","source_url":"https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/honesty_log","https://epithalonrx.com/editorial_standards"]},{"id":"clm-080","text":"There is no established human dose of epitalon, and the doses published across the literature disagree with each other by up to four orders of magnitude.","source_url":"https://europepmc.org/search?query=TITLE_ABS%3A%22epitalon%22","grade":"absence-of-evidence","grade_label":"Absence of evidence","used_on":["https://epithalonrx.com/tools","https://epithalonrx.com/monograph","https://epithalonrx.com/facts","https://epithalonrx.com/faq","https://epithalonrx.com/limits"]},{"id":"clm-081","text":"The human records in this literature do not state a dose: the retinitis pigmentosa report, the elderly melatonin work and the epithalamin cohort studies all describe courses without stating milligrams in their abstracts.","source_url":"https://europepmc.org/article/MED/12195242","grade":"absence-of-evidence","grade_label":"Absence of evidence","used_on":["https://epithalonrx.com/tools","https://epithalonrx.com/monograph","https://epithalonrx.com/faq"]},{"id":"clm-082","text":"A vial of epitalon has no product label, no assigned strength and no expiry set by any regulator, so any reconstitution arithmetic depends entirely on numbers printed by the seller.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://epithalonrx.com/tools","https://epithalonrx.com/monograph","https://epithalonrx.com/faq"]},{"id":"clm-083","text":"The independent 2025 replication bought its epitalon from a research-chemical vendor, the same class of supplier a consumer buys from.","source_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12411320/","grade":"in-vitro","grade_label":"In vitro","used_on":["https://epithalonrx.com/monograph","https://epithalonrx.com/faq","https://epithalonrx.com/honesty_log"]},{"id":"clm-100","text":"This site's evidence table has 32 rows, each labeled by species and by provenance, including 5 rows that record documented absences of evidence.","source_url":"https://europepmc.org/search?query=TITLE_ABS%3A%22epitalon%22","grade":"internal-measurement","grade_label":"Internal measurement","used_on":["https://epithalonrx.com","https://epithalonrx.com/copy","https://epithalonrx.com/monograph"]},{"id":"clm-101","text":"This site cites 45 sources: 32 peer-reviewed journal articles, 7 government records, 1 clearly labeled preprint and 5 of this site's own archived searches. That is 86.7 percent peer-reviewed or government, and all 43 unique citation urls returned HTTP 200 on 2026-08-14.","source_url":"https://europepmc.org/search?query=TITLE_ABS%3A%22epitalon%22","grade":"internal-measurement","grade_label":"Internal measurement","used_on":["https://epithalonrx.com","https://epithalonrx.com/copy"]},{"id":"clm-102","text":"Of this site's 32 evidence rows, 21 come from the originating research network or a collaboration involving it, 6 are independent, and 5 are documented absences.","source_url":"https://europepmc.org/search?query=TITLE_ABS%3A%22epitalon%22","grade":"internal-measurement","grade_label":"Internal measurement","used_on":["https://epithalonrx.com","https://epithalonrx.com/monograph","https://epithalonrx.com/copy"]}]}