{"slug":"dihexa","seoKey":"dihexa","displayName":"Dihexa","codes":["PNB-0408","ATH-1001"],"synonyms":["N-hexanoic-Tyr-Ile-(6)-aminohexanoic amide","Hexanoyl-Tyr-Ile-Ahx-NH2","fosgo-AM","Dihexa acetate","L-Isoleucinamide, N-(1-oxohexyl)-L-tyrosyl-N-(6-amino-6-oxohexyl)-"],"legalClass":"research_chemical","identifiers":{"cas":"1401708-83-5","pubchemCid":129010512,"unii":"9WYX65A5C2","inchikey":"XEUVNVNAVKZSPT-JTJYXVOQSA-N","wikidataQid":"Q21098991","formula":"C27H44N4O5","molecularWeight":504.7,"sequence":"Hexanoyl-Tyr-Ile-Ahx-NH2"},"approvals":[{"market":"US","status":"not_approved","note":"Not approved in any dosage form for any indication, and not a controlled substance. Four independent queries on 2026-09-15 came back empty: the drug approval records, the product labelling archive and the enforcement records all returned no entry for the substance, while control queries for approved medicines on the same endpoints returned results, and a full-text search of the federal controlled-substances list found no match while control terms in the same document were found. The one named regulatory entry worldwide sits on the agency's page for bulk substances that may present significant safety risks, page status 22 April 2026: the acetate salt appears there under nominations that were withdrawn, not in the category table itself, and the agency records that it has identified no human exposure data for the substance by any route and lacks important information on its safety. That is not a clearance. Without a listing for compounding, an unapproved active ingredient may not lawfully be compounded at all.","source":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-nominated-use-compounding-under-section-503a-federal-food-drug-and-cosmetic-act"},{"market":"EU","status":"not_approved","note":"No authorisation, neither central nor national, no orphan designation and no registered clinical trial. The European trial register returned no match on 2026-09-15 in either of its two parts, while a control query for an approved medicine in the same register returned 95 results. The agency's medicines search returned no match; its site-wide full-text search answered with HTTP 401 on that date and was not evaluable. The 2026 index of anatomical-therapeutic-chemical codes has no entry for the substance or for its prodrug, while a control term in the same index returned two. Since no application and no trial was ever registered, the general authorisation requirement applies in full.","source":"https://www.clinicaltrialsregister.eu/ctr-search/search?query=dihexa"},{"market":"DE","status":"not_approved","note":"Not an authorised medicine and no finished product on the market, which follows from the absence of any European or national authorisation. Advertising to the public is therefore prohibited, and placing it on the market requires an authorisation it does not have. Separately checked and worth stating plainly: the substance is NOT in the annex to the anti-doping act. The full text of that annex was read on 2026-09-15; its growth-factor section names only mecasermin, insulin-like growth factor analogues, mechano growth factors and thymosin beta-4 with its derivatives, hepatocyte growth factor does not appear at all, and the closing clause extends the list only to salts, esters, ethers, isomers, complexes and derivatives of the substances named, with no open similarity clause of the kind the sporting list uses. Control terms in the same document were found. The criminal-law position and the sporting position therefore diverge here.","source":"https://www.gesetze-im-internet.de/antidopg/anlage.html"},{"market":"UK","status":"not_approved","note":"No authorised medicine and not a controlled drug. A direct query of the products register was not evaluable on 2026-09-15, because results load by script and the page returned only a loading placeholder, so no primary document from the regulator is on file. The negative finding therefore rests on the absence of any product in every other register checked, on the absence of an anatomical-therapeutic-chemical code and on the fact that no clinical trial of the substance was ever registered anywhere. An unauthorised medicinal product may not be supplied to consumers.","source":"https://products.mhra.gov.uk/search/?search=dihexa"},{"market":"AU","status":"not_approved","note":"Not named in the 2026 poisons standard, the full text having been searched on 2026-09-15 for the substance name, its development code and the target growth factor with no match, while control terms in the same document were found. The absence of a listing is not availability: an injectable unapproved substance with a therapeutic purpose may not be imported, advertised or supplied without clearance. Worth noting for the classification: the same standard names whole growth-factor classes by name, including fibroblast, insulin-like and epidermal growth factors, follistatin and thymosin beta-4, and hepatocyte growth factor is not among them, nor is there an open catch-all for peptides. A full-text query of the register of therapeutic goods timed out on that date over two access routes, so no register finding is on file.","source":"https://www.legislation.gov.au/F2026L00633/asmade"},{"market":"CA","status":"not_approved","note":"No authorised medicine. The active-ingredient endpoint of the national drug product database returned an empty array on 2026-09-15, while a control query for an approved medicine on the same endpoint returned several records with strengths, so the negative finding is verified. Import and supply would require an authorisation or a clinical trial application.","source":"https://health-products.canada.ca/api/drug/activeingredient/?ingredientname=dihexa"},{"market":"CH","status":"not_approved","note":"No authorisation. The regulator's search function was unreachable on 2026-09-15 and returned an error page, so no primary document on this substance is on file; the negative finding is derived from the absence of any authorisation worldwide. What was read instead is the joint enforcement notice of the medicines agency, the customs authority and the national anti-doping body of 22 June 2026: of 46 parcels of questionable peptide preparations checked, 23 were held back, 21 of them classified as doping substances and 2 as medicinal products, and around 80 percent of the parcels came from one country. The notice states expressly that labelling a product as a research chemical, as not for human use or as a supplement changes nothing if it is intended for human use. It names no individual substances, so it is context rather than a finding on this one.","source":"https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/schwerpunktaktion-peptide-2026.html"}],"devStage":"discontinued","strongestEvidence":"animal","wada":{"status":"prohibited","section":"S2.3","listYear":2026,"source":"https://www.wada-ama.org/en/prohibited-list"},"trials":[],"sameAs":["https://pubchem.ncbi.nlm.nih.gov/compound/129010512","https://www.wikidata.org/wiki/Q21098991"],"lastVerified":"2026-09-15","version":"1.0","published":true,"locale":"en","title":"Dihexa: what the studies show, status and safety","summary":"Dihexa is a synthetic molecule derived from angiotensin IV, designed to strengthen a growth-factor signal in the brain. No registered study has ever given it to a person. Its phosphate form, fosgonimeton, was tested in 554 people with Alzheimer's disease and made no difference, after which development stopped. The paper that established the mechanism was retracted in April 2025 for falsified figures, and the first description of Dihexa carries an unresolved Notice of Concern.","updated":"2026-09-15","url":"https://mypep.app/peptides/dihexa"}