{"slug":"epitalon","seoKey":"epitalon","displayName":"Epitalon","codes":["AEDG"],"synonyms":["epithalon","Epithalone","AEDG peptide","Ala-Glu-Asp-Gly","H-Ala-Glu-Asp-Gly-OH","L-alanyl-L-alpha-glutamyl-L-alpha-aspartyl-glycine","epithalamin (a DIFFERENT substance: the bovine pineal extract, carried as a synonym on the same database record)"],"identifiers":{"cas":"307297-39-8","pubchemCid":219042,"unii":"O65P17785G","inchikey":"HGHOBRRUMWJWCU-FXQIFTODSA-N","wikidataQid":"Q27285389","formula":"C14H22N4O9","molecularWeight":390.35,"sequence":"AEDG"},"legalClass":"research_chemical","approvals":[{"market":"US","status":"not_approved","note":"Not approved in any indication and no pharmacopoeial monograph. The regulator proposed in July 2026 that neither the free base nor the acetate be included on the compounding bulks list, citing insufficient physicochemical characterisation, unclear nomenclature and an absence of human safety data.","source":"https://www.fda.gov/media/193345/download"},{"market":"EU","status":"not_approved","note":"No centralised marketing authorisation, no assessment report and no orphan status. No monograph in the European Pharmacopoeia. The absence of an authorisation was separately verified for seven member states in the US assessment document.","source":"https://www.ema.europa.eu/en/medicines?search_api_fulltext=epitalon"},{"market":"DE","status":"not_approved","note":"No national or EU marketing authorisation, so there is no approved indication, no summary of product characteristics and no officially reviewed dosing. Confirmed as a negative finding in the US country screening on 2026-09-07.","source":"https://www.fda.gov/media/193345/download"},{"market":"UK","status":"not_approved","note":"No marketing authorisation; recorded as a negative finding in the US country screening on 2026-09-07.","source":"https://products.mhra.gov.uk/search/?search=epitalon"},{"market":"AU","status":"not_approved","note":"No marketing authorisation; recorded as a negative finding in the US country screening on 2026-09-07. Absence of an entry is not a clearance: unregistered therapeutic goods remain regulated.","source":"https://www.tga.gov.au/resources/artg"},{"market":"CA","status":"not_approved","note":"No marketing authorisation; recorded as a negative finding in the US country screening on 2026-09-07.","source":"https://health-products.canada.ca/api/drug/activeingredient/?ingredientname=epitalon"},{"market":"CH","status":"not_approved","note":"No marketing authorisation. The substance has been identified analytically in seized illicit pharmaceutical preparations in Europe, which is a market finding and not a regulatory status.","source":"https://www.swissmedicinfo.ch/"}],"devStage":"preclinical","strongestEvidence":"rct_phase2","wada":{"status":"prohibited","section":"S0","listYear":2026,"source":"https://www.wada-ama.org/en/prohibited-list"},"trials":[],"sameAs":["https://www.wikidata.org/wiki/Q27285389","https://pubchem.ncbi.nlm.nih.gov/compound/219042"],"lastVerified":"2026-09-07","version":"1.0","published":true,"locale":"en","title":"Epitalon: what the studies show, status and safety","summary":"Epitalon is a synthetic chain of four amino acids, worked out in St Petersburg from a cattle pineal gland extract. Only three published reports exist in which a person received it. The one randomised study ran 20 days and measured neither sleep nor safety. In July 2026 the FDA proposed keeping it off the pharmacy compounding list.","updated":"2026-09-07","url":"https://mypep.app/peptides/epitalon"}