{"slug":"tb-4","seoKey":"tb4","displayName":"TB-4 (Thymosin β4)","codes":["TB4","Tβ4","RGN-259","RGN-137","RGN-352"],"synonyms":["thymosin beta-4","thymosin beta 4","thymosin β4","full-length thymosin beta-4","timbetasin"],"legalClass":"investigational","identifiers":{"cas":"77642-24-1","unii":"549LM7U24W","sequence":"Ac-SDKPDMAEIEKFDKSKLKKTETQEKNPLPSKETIEQEKQAGES"},"approvals":[{"market":"US","status":"investigational","note":"Clinical development. FDA orphan designation for neurotrophic keratopathy dated 2013-12-31 explicitly remains not FDA approved for that indication; designation is not marketing approval.","source":"https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=416613"},{"market":"EU","status":"unknown","note":"EMA portal retrieved; includes central authorisations only. Compound authorisation status not independently confirmed.","source":"https://www.ema.europa.eu/en/medicines"},{"market":"DE","status":"unknown","note":"PharmNet portal retrieval failed. Compound authorisation status not independently confirmed.","source":"https://www.pharmnet.bund.de/dynamic/en/drug-information-system/index.html"},{"market":"UK","status":"unknown","note":"MHRA portal retrieved; compound authorisation status not independently confirmed.","source":"https://products.mhra.gov.uk/"},{"market":"AU","status":"scheduled","note":"Schedule 4 and Appendix D in the June 2026 Poisons Standard, separately from TB-500. Scheduling is not product approval.","source":"https://www.legislation.gov.au/F2026L00633/asmade/2026-05-28/text/original/epub/OEBPS/document_1/document_1.html"},{"market":"CA","status":"unknown","note":"Health Canada database retrieval failed with HTTP 502. Compound authorisation status not independently confirmed.","source":"https://health-products.canada.ca/dpd-bdpp/index-eng.jsp"},{"market":"CH","status":"unknown","note":"Swissmedic lists portal retrieved; individual authorisation datasets not exhaustively checked.","source":"https://www.swissmedic.ch/swissmedic/en/home/services/listen_neu.html"}],"devStage":"phase3","strongestEvidence":"rct_phase3","wada":{"status":"prohibited","section":"S2.3","listYear":2026,"source":"https://www.wada-ama.org/en/prohibited-list"},"trials":[{"nct":"NCT02974907","name":"ARISE-2","phase":"PHASE3","n":601,"status":"COMPLETED"},{"nct":"NCT03937882","name":"ARISE-3","phase":"PHASE3","n":700,"status":"COMPLETED"},{"nct":"NCT02600429","name":"SEER-1","phase":"PHASE3","n":18,"status":"TERMINATED"},{"nct":"NCT00382174","phase":"PHASE2","n":72,"status":"COMPLETED"},{"nct":"NCT00832091","phase":"PHASE2","n":72,"status":"COMPLETED"}],"sameAs":["https://www.uniprot.org/uniprotkb/P62328/entry","https://precision.fda.gov/ginas/app/ui/substances/549LM7U24W"],"lastVerified":"2026-09-30","version":"1.0","published":true,"locale":"en","title":"TB-4 (thymosin beta-4): trials, status and safety","summary":"TB-4 is full-length thymosin beta-4, a naturally occurring peptide with 43 amino acids. Human studies have tested defined eye drops, skin gels and intravenous preparations. Results are mixed: important eye trials missed their primary endpoints. These findings do not establish a treatment for sports injuries and cannot be assigned to the seven-amino-acid TB-500 fragment.","updated":"2026-09-30","url":"https://mypep.app/peptides/tb-4"}