{"slug":"thymosin-alpha-1","seoKey":"thymosinalpha1","inn":"thymalfasin","displayName":"Thymosin Alpha-1","codes":["Tα1","TA-1","L03AX25"],"synonyms":["thymalfasin","Thymosin alpha-1","Thymosin alpha 1","Tα1","Ta1","timalfasina","thymalfasinum","thymosin alpha-1 acetate","胸腺法新"],"legalClass":"rx","identifiers":{"cas":"62304-98-7","pubchemCid":16130571,"unii":"W0B22ISQ1C","inchikey":"NZVYCXVTEHPMHE-ZSUJOUNUSA-N","chemblId":"CHEMBL2103979","wikidataQid":"Q20817234","formula":"C129H215N33O55","molecularWeight":3108.3,"sequence":"Ac-SDAAVDTSSEITTKDLKEKKEVVEEAEN"},"approvals":[{"market":"US","status":"not_approved","note":"Not approved in any dosage form. Three independent primary queries on 2026-09-17 returned no record, each alongside a working control query that did return one. The substance is nevertheless registered by several suppliers as a bulk ingredient, four of those registrations carrying the marketing category for human prescription compounding. The regulatory direction on compounding is against it: on 2024-12-04 an advisory committee voted 4 to 17 against adding the substance to the list of bulk drug substances usable under section 503A, and repeated the vote with the same result for the acetate form. The parallel list for outsourcing facilities places it in category 3, nominated without adequate support.","source":"https://api.fda.gov/drug/drugsfda.json?search=openfda.substance_name:%22THYMALFASIN%22"},{"market":"EU","status":"not_approved","date":"1993-04-27","note":"No centralised European authorisation exists: a full-text search of the agency's medicines dataset on 2026-09-17 returned no match, against a working control query. ONE member state has a national authorisation. Italy authorised the product on 1993-04-27, last renewed in May 2008, and it is expressly prescription-only there. Its indication text consists of a single use, an adjuvant to influenza vaccination in immunocompromised people, and paediatric use is expressly excluded. In the other 26 member states the substance is not an authorised medicine.","source":"https://www.ema.europa.eu/en/documents/report/medicines-output-medicines-report_en.xlsx"},{"market":"DE","status":"not_approved","note":"Not approved: there is neither a centralised European authorisation nor a national one, so no marketable finished medicinal product exists. The substance is not named in the prescription-only annex, which changes nothing, because an unauthorised medicine may not be placed on the market at all. It is likewise absent from the annex to the anti-doping act, whose only thymosin entry is thymosin beta-4 and its derivatives.","source":"https://www.gesetze-im-internet.de/amvv/anlage_1.html"},{"market":"UK","status":"not_approved","note":"Not approved. The compendium of authorised product information answered the query on 2026-09-17 with 'No search results', against a control query returning 44 matches. CAVEAT: the regulator's own product register returns its result list only through client-side scripting and could not be read from the working environment, so this negative finding rests on the compendium rather than on the register itself.","source":"https://www.medicines.org.uk/emc/search?q=thymalfasin"},{"market":"AU","status":"not_approved","note":"No registration identified, and the substance is not scheduled. The full text of the Poisons Standard of June 2026 was searched on 2026-09-17: the only thymosin entry is thymosin beta-4, in Schedule 4 and in Appendix D, and the alphabetical sequence runs straight from thymol to that entry, so an entry for this substance would have been visible. CAVEAT: the register of therapeutic goods was unreachable from the working environment, so a registration is not positively excluded, merely not demonstrable. Not being scheduled is not a clearance: an unregistered therapeutic good may not be supplied or advertised there in any case.","source":"https://www.legislation.gov.au/F2026L00633/asmade/2026-05-28/text/original/epub/OEBPS/document_1/document_1.html"},{"market":"CA","status":"not_approved","note":"Not approved. Two active-ingredient queries of the drug product database on 2026-09-17, for the international name and for the biochemical one, both returned an empty list, while a control query returned several matches with strengths. The interface was therefore working.","source":"https://health-products.canada.ca/api/drug/activeingredient/?ingredientname=thymalfasin"},{"market":"CH","status":"not_approved","note":"Not approved; the substance appears in none of the published lists of authorised human medicines. The extended workbook, 29,625 text cells, was searched on 2026-09-17 for four spellings with no match, against a control substance found with several composition lines in the same file.","source":"https://www.swissmedic.ch/swissmedic/en/home/services/listen_neu.html"}],"devStage":"approved","strongestEvidence":"meta_analysis","wada":{"status":"not_listed","listYear":2026,"source":"https://www.wada-ama.org/en/prohibited-list"},"trials":[{"nct":"NCT02867267","name":"TESTS — sepsis, 28-day all-cause mortality (primary endpoint not met)","phase":"Phase 3","n":1106,"status":"COMPLETED"},{"nct":"NCT01178996","name":"Added to standard antiviral treatment in hepatitis C non-responders (primary endpoint not met)","phase":"Phase 3","n":552,"status":"COMPLETED"},{"nct":"NCT02473406","name":"TRACE — predicted severe necrotising pancreatitis (primary endpoint not met)","phase":"Phase 4","n":508,"status":"COMPLETED"},{"nct":"NCT02366247","name":"A pegylated derivative plus adefovir in chronic hepatitis B (no results published)","phase":"Phase 3","n":463,"status":"UNKNOWN"},{"nct":"NCT00711620","name":"ETASS — severe sepsis, single-blind and without placebo","n":361,"status":"COMPLETED"},{"nct":"NCT05339529","name":"PANDA II — organ function after aortic dissection surgery (completed, results unpublished)","n":600,"status":"COMPLETED"},{"nct":"NCT04428008","name":"Prevention of covid-19 in dialysis patients, unblinded against an untreated control group","phase":"Phase 2","n":194,"status":"COMPLETED"},{"nct":"NCT01031966","name":"Boosting the response to H1N1 vaccination in end-stage renal disease","phase":"Phase 2","n":120,"status":"COMPLETED"},{"nct":"NCT06821100","name":"Boosting the covid-19 booster response in older adults (the only active US trial)","phase":"Phase 1","n":75,"status":"RECRUITING"},{"nct":"NCT04487444","name":"Covid-19 (terminated)","phase":"Phase 2","n":56,"status":"TERMINATED"}],"sameAs":["https://www.wikidata.org/wiki/Q20817234","https://pubchem.ncbi.nlm.nih.gov/compound/16130571","https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2103979/"],"lastVerified":"2026-09-17","version":"1.0","published":true,"locale":"en","title":"Thymosin Alpha-1: what the trials show, status and safety","summary":"Thymosin Alpha-1 is a fully synthetic 28-amino-acid peptide, and a prescription medicine in Italy and China. Its Italian licence covers one use: boosting the response to influenza vaccination in people with weak immune defences. It is licensed for hepatitis nowhere, and the figure of thirty-plus approving countries comes from a company report. The three largest trials missed their primary endpoint.","updated":"2026-09-17","url":"https://mypep.app/peptides/thymosin-alpha-1"}