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Advise pregnant women of the potential risk to fetus.","Geriatric use":"No overall differences in safety were observed between patients 65 years and older and younger patients.","Paediatric use":"The safety and effectiveness of PEPAXTO have not been established in pediatric patients."}},"trials":[],"aliases":[],"company":"Oncopeptides Ab","patents":[{"source":"FDA Orange Book via DrugCentral","expires":"2032-04-25","territory":"US","patentNumber":"10285946"},{"source":"FDA Orange Book via DrugCentral","expires":"2032-04-25","territory":"US","patentNumber":"10322182"},{"source":"FDA Orange Book via DrugCentral","expires":"2032-04-25","territory":"US","patentNumber":"10543274"},{"source":"FDA Orange Book via DrugCentral","expires":"2032-04-25","territory":"US","patentNumber":"10869928"},{"source":"FDA Orange Book via DrugCentral","expires":"2032-04-25","territory":"US","patentNumber":"11344622"},{"source":"FDA Orange Book via DrugCentral","expires":"2024-06-25","territory":"US","patentNumber":"6992207"}],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=MELPHALAN FLUFENAMIDE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:24:15.883103+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T03:24:14.024779+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:24:21.291558+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T03:24:15.950937+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=MELPHALAN FLUFENAMIDE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:24:22.304592+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL4303060/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:24:23.017664+00:00"}},"allNames":"pepaxto","offLabel":[],"synonyms":["melphalan flufenamide","melphalan flufenamide hydrochloride","pepaxto","melflufen","J1","CK 1535"],"timeline":[{"date":"2021-02-26","type":"positive","source":"DrugCentral","milestone":"FDA approval (Oncopeptides Ab)"},{"date":"2022-08-17","type":"positive","source":"DrugCentral","milestone":"EMA approval (Oncopeptides Ab)"}],"aiSummary":"Pepaxto (MELPHALAN FLUFENAMIDE) is a small molecule alkylating drug originally developed by ONCOPEPTIDES AB. It is used to treat relapsed or refractory multiple myeloma, a type of blood cancer. Pepaxto works by interfering with the growth and survival of cancer cells. It is a patented medication, with its commercial status currently owned by ONCOPEPTIDES AB. 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