{"id":"epitalon","name":"Epitalon","aliases":["Epithalon","Epithalone","AEDG peptide"],"url":"https://lyoresearch.com/compounds/epitalon","class":{"id":"longevity-compounds","name":"Mitochondrial, antioxidant and longevity compounds","url":"https://lyoresearch.com/classes/longevity-compounds"},"summary":"Epitalon is a synthetic four-amino-acid peptide (Ala-Glu-Asp-Gly) developed in St Petersburg in the 1980s and promoted for longevity on the basis of telomerase activation in cell culture and lifespan effects in mice. The human evidence comes from one research group, is uncontrolled, and much of it used Epithalamin — a pineal-gland extract — rather than the synthetic peptide sold under the name. It is not approved anywhere.","overall_grade":"D","overall_grade_meaning":"no human evidence","human_trials":"Uncontrolled, single group","regulatory_status":"Not approved","molecule":{"formula":"C14H22N4O9","molecular_weight":"390.35","cas":"307297-39-8","pubchem_cid":219042,"note":null},"pharmacokinetics":{"basis":"none","route":"Injected or intranasal as sold; no human PK study","half_life":"No human pharmacokinetic data","licensed_regimen":null,"product":null,"source":null},"outcomes":[{"outcome":"Lifespan / mortality","grade":"D","grade_meaning":"no human evidence","effect_size":"not measurable","adverse":false,"human_studies":"Uncontrolled, single group","evidence":"A 12–15-year observational follow-up of elderly patients from one institute reported lower mortality with Epithalamin (the extract) plus thymus extract. No randomisation, no blinding, and not the synthetic peptide.","references":[{"citation":"Khavinson VKh, Morozov VG. Peptides of pineal gland and thymus prolong human life.","where":"Neuro Endocrinol Lett, 2003;24:233–240","url":"https://pubmed.ncbi.nlm.nih.gov/?term=Khavinson+Morozov+peptides+pineal+thymus+prolong+human+life+2003"}]},{"outcome":"Telomerase activation","grade":"D","grade_meaning":"no human evidence","effect_size":"not measurable","adverse":false,"human_studies":"Cell culture only","evidence":"Telomerase activity and telomere lengthening reported in cultured human fibroblasts. Never measured in a living person.","references":[{"citation":"Khavinson VKh, et al. Peptide promotes overcoming of the division limit in human somatic cell.","where":"Bull Exp Biol Med, 2003;135:503–506","url":"https://pubmed.ncbi.nlm.nih.gov/?term=Khavinson+epitalon+telomerase+human+somatic+cell+2003"}]},{"outcome":"Melatonin / sleep","grade":"D","grade_meaning":"no human evidence","effect_size":"not measurable","adverse":false,"human_studies":"Small uncontrolled","evidence":"Small studies from the same group report restored night-time melatonin in elderly subjects; uncontrolled and unreplicated.","references":[{"citation":"Korkushko OV, et al. Geroprotective effect of epithalamine (pineal gland peptide preparation) in elderly subjects with accelerated aging.","where":"Bull Exp Biol Med, 2006;142:356–359","url":"https://pubmed.ncbi.nlm.nih.gov/?term=Korkushko+epithalamine+elderly+accelerated+aging+2006"}]},{"outcome":"Safety in humans","grade":"D","grade_meaning":"no human evidence","effect_size":"not measurable","adverse":true,"human_studies":"None systematic","evidence":"No adverse-event data collected to modern standards. Unknown is not the same as safe.","references":[]}],"regions":[{"region":"European Union","status":"Unauthorised medicinal product","note":"No marketing authorisation in any member state. Supplying it for human use is an offence under national medicines law; 'research use only' labels do not change that. Epithalamin products are authorised in Russia only."},{"region":"United States","status":"Not approved; compounding under review","note":"Removed from FDA's Category 2 list on 22 April 2026; the Pharmacy Compounding Advisory Committee recommended it for the 503A bulks list in July 2026 (recommended 24 July 2026). Not on the list yet and not an approved drug. Sold otherwise as an unapproved 'research chemical'."},{"region":"United Kingdom","status":"Unlicensed medicine","note":"Not licensed by the MHRA. Selling or supplying it is an offence under the Human Medicines Regulations 2012; importing a small quantity purely for personal use is not itself an offence, but consignments are seized."},{"region":"Australia","status":"Schedule 4, unapproved","note":"Prescription-only substance not on the ARTG. Possession without a prescription is an offence; imports without a prescription are seized."},{"region":"Canada","status":"Not authorised","note":"No Drug Identification Number; selling it is illegal. Residents cannot import prescription drugs by mail."},{"region":"Sport (WADA)","status":"Prohibited at all times","note":"Not named, but unapproved anywhere, so it falls under S0 (non-approved substances)."}],"faq":[{"q":"Does epitalon extend lifespan?","a":"In mice, some studies from one group report modest lifespan effects. In humans there is no controlled evidence. The often-cited 12–15-year follow-up used Epithalamin, a pineal extract, not the synthetic peptide, and had no control group."},{"q":"Does epitalon lengthen telomeres?","a":"In cultured cells, one group has reported telomerase activation. It has never been measured in people taking the peptide."},{"q":"Is epitalon safe?","a":"Unknown. No systematic safety data exist. If it did activate telomerase in vivo, that would be a reason for caution, not reassurance."}],"references":[{"cite":"Khavinson VKh, Morozov VG. Peptides of pineal gland and thymus prolong human life.","where":"Neuro Endocrinol Lett, 2003;24:233–240","url":"https://pubmed.ncbi.nlm.nih.gov/?term=Khavinson+Morozov+peptides+pineal+thymus+prolong+human+life+2003","note":"Uncontrolled long-term observation with Epithalamin (extract) and Thymalin."},{"cite":"Khavinson VKh, et al. Peptide promotes overcoming of the division limit in human somatic cell.","where":"Bull Exp Biol Med, 2003;135:503–506","url":"https://pubmed.ncbi.nlm.nih.gov/?term=Khavinson+epitalon+telomerase+human+somatic+cell+2003","note":"Cell-culture telomerase and telomere findings."},{"cite":"Korkushko OV, et al. Geroprotective effect of epithalamine (pineal gland peptide preparation) in elderly subjects with accelerated aging.","where":"Bull Exp Biol Med, 2006;142:356–359","url":"https://pubmed.ncbi.nlm.nih.gov/?term=Korkushko+epithalamine+elderly+accelerated+aging+2006","note":"Uncontrolled; Epithalamin extract, not the synthetic peptide."}],"last_reviewed":"2026-09-02","literature_searched_to":"2026-09-02","changelog":[{"date":"2026-09-02","note":"Full page. Separated evidence for the synthetic peptide from evidence for the Epithalamin extract; added telomerase, melatonin and safety rows."},{"date":"2026-09-01","note":"Initial publication."}],"license":"CC BY 4.0 — cite as “LYO Research” with a link.","methodology":"https://lyoresearch.com/methodology"}