{"id":"fotemustine","rwe":[],"tags":[{"label":"fotemustine","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"L01AD05","category":"atc"},{"label":"Active","category":"status"},{"label":"Antineoplastic Agents","category":"pharmacology"}],"phase":"discontinued","safety":{"safetySignals":[{"llr":78.662,"date":"","count":11,"signal":"Tonsillar haemorrhage","source":"DrugCentral FAERS","actionTaken":"Reported 11 times (LLR=79)"},{"llr":70.112,"date":"","count":22,"signal":"Acute myeloid leukaemia","source":"DrugCentral FAERS","actionTaken":"Reported 22 times (LLR=70)"},{"llr":58.122,"date":"","count":24,"signal":"Mucosal inflammation","source":"DrugCentral FAERS","actionTaken":"Reported 24 times (LLR=58)"}],"commonSideEffects":[{"effect":"Tonsillar haemorrhage","drugRate":"LLR 79","severity":"common"},{"effect":"Acute myeloid leukaemia","drugRate":"LLR 70","severity":"common"},{"effect":"Mucosal inflammation","drugRate":"LLR 58","severity":"common"}]},"trials":[],"aliases":[],"patents":[],"pricing":[],"allNames":"muphoran","offLabel":[],"synonyms":["fotemustine","muphoran","mustophorane"],"timeline":[],"approvals":[],"brandName":"Muphoran","ecosystem":[],"mechanism":{"modality":"Small Molecule","drugClass":"fotemustine","explanation":"Imagine your DNA as a long, twisted ladder. Fotemustine is like a chemical that goes in and links the rungs of the ladder together, making it hard for the cell to make copies of itself and function properly. This ultimately leads to cell death.","oneSentence":"Fotemustine works by cross-linking DNA, thereby inhibiting DNA replication and transcription.","technicalDetail":"Fotemustine exerts its cytotoxic effects through the formation of interstrand cross-links in DNA, which prevents DNA replication and transcription, ultimately leading to cell death."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1249","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=FOTEMUSTINE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=FOTEMUSTINE","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T11:39:14.822758","biosimilars":[],"competitors":[{"drugName":"carmustine","drugSlug":"carmustine","fdaApproval":"1977-03-07","genericCount":11,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"lomustine","drugSlug":"lomustine","fdaApproval":"1976-08-04","genericCount":1,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"streptozocin","drugSlug":"streptozocin","fdaApproval":"1982-05-07","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"uracil mustard","drugSlug":"uracil-mustard","fdaApproval":"1962-09-13","patentStatus":"Unknown","relationship":"same-class"}],"genericName":"fotemustine","indications":{"approved":[],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"carmustine","brandName":"carmustine","genericName":"carmustine","approvalYear":"1977","relationship":"same-class"},{"drugId":"lomustine","brandName":"lomustine","genericName":"lomustine","approvalYear":"1976","relationship":"same-class"},{"drugId":"streptozocin","brandName":"streptozocin","genericName":"streptozocin","approvalYear":"1982","relationship":"same-class"},{"drugId":"uracil-mustard","brandName":"uracil mustard","genericName":"uracil mustard","approvalYear":"1962","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT00560118","phase":"PHASE2","title":"Fotemustine in Treating Patients With Metastatic Melanoma","status":"TERMINATED","sponsor":"Institut du Cancer de Montpellier - Val d'Aurelle","startDate":"2003-08-08","conditions":["Melanoma (Skin)"],"enrollment":12,"completionDate":"2008-08-31"},{"nctId":"NCT01827605","phase":"PHASE3","title":"A Phase III Multicenter, Randomized Study Comparing RIT Vs ASCT in Patients With Relapsed/Refractory (FL)","status":"UNKNOWN","sponsor":"Fondazione Italiana Linfomi - ETS","startDate":"2012-01","conditions":["Relapsed Follicular Lymphoma"],"enrollment":159,"completionDate":"2024-01"},{"nctId":"NCT01359956","phase":"PHASE3","title":"Fotemustine and Dacarbazine Versus Dacarbazine +/- Alpha Interferon in Advanced Malignant Melanoma","status":"COMPLETED","sponsor":"National Cancer Institute, Naples","startDate":"2002-04","conditions":["Malignant Melanoma","Recurrent Melanoma"],"enrollment":269,"completionDate":"2011-02"},{"nctId":"NCT05647954","phase":"PHASE3","title":"A Study of HX008 Plus Transcatheter Arterial Chemoembolization (TACE) in the First-Line Treatment of Subjects With Stage IV (M1c) Melanoma That is Metastatic to the Liver","status":"UNKNOWN","sponsor":"Taizhou Hanzhong biomedical co. LTD","startDate":"2022-12-31","conditions":["Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms"],"enrollment":350,"completionDate":"2025-06-30"},{"nctId":"NCT04831658","phase":"PHASE1,PHASE2","title":"A Prospective Clinical Study of BTK Inhibitor, PD-1 and Formustine in the First-line Treatment of Primary Central Nervous System Lymphoma","status":"UNKNOWN","sponsor":"Mingzhi Zhang","startDate":"2021-03-29","conditions":["Primary Central Nervous System Lymphoma"],"enrollment":40,"completionDate":"2024-09-15"},{"nctId":"NCT05274139","phase":"PHASE2","title":"Treatment of Primary CNS Lymphoma ( FTD )","status":"COMPLETED","sponsor":"Mingzhi Zhang","startDate":"2017-03-02","conditions":["Primary CNS Lymphoma (PCNSL)"],"enrollment":20,"completionDate":"2019-03-02"},{"nctId":"NCT04083066","phase":"PHASE4","title":"Open Randomized Prospective Clinical Study of R-FPD Versus R-MAD Regimen in the Treatment of Primary Central Nervous System Lymphoma","status":"UNKNOWN","sponsor":"Mingzhi Zhang","startDate":"2019-09-05","conditions":["Primary Central Nervous System Lymphoma"],"enrollment":20,"completionDate":"2024-04-01"},{"nctId":"NCT01069627","phase":"PHASE2","title":"A Study of Avastin (Bevacizumab) in Combination With Fotemustine in Patients With Metastatic Melanoma","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2006-12","conditions":["Malignant Melanoma"],"enrollment":20,"completionDate":"2009-07"},{"nctId":"NCT01474239","phase":"PHASE2","title":"A Study of Avastin (Bevacizumab) And Fotemustine in Patients With Recurrent Glioblastoma","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2011-11","conditions":["Glioblastoma Multiforme"],"enrollment":91,"completionDate":"2013-12"},{"nctId":"NCT01983124","phase":"PHASE2","title":"Vemurafenib + Fotemustine to Treat Advanced Melanoma Patients With V600BRAF Mutation Recurred While on Vemurafenib","status":"COMPLETED","sponsor":"Paola Queirolo","startDate":"2013-02","conditions":["Malignant Melanoma Stage IV"],"enrollment":31,"completionDate":"2015-09"},{"nctId":"NCT01960192","phase":"PHASE4","title":"Treatment of Primary CNS Lymphoma","status":"UNKNOWN","sponsor":"Mingzhi Zhang","startDate":"2012-06","conditions":["Primary CNS Lymphoma (PCNSL)"],"enrollment":50,"completionDate":"2020-06"},{"nctId":"NCT02460068","phase":"PHASE3","title":"A Study of Fotemustine(FTM) Vs FTM and Ipilimumab (IPI) or IPI and Nivolumab in Melanoma Brain Metastasis","status":"UNKNOWN","sponsor":"Italian Network for Tumor Biotherapy Foundation","startDate":"2012-12","conditions":["Brain Metastases"],"enrollment":168,"completionDate":"2020-01"},{"nctId":"NCT01654692","phase":"PHASE2","title":"A Combination of Ipilimumab and Fotemustine for Treat Unresectable Locally Advanced or Metastatic Melanoma","status":"COMPLETED","sponsor":"Italian Network for Tumor Biotherapy","startDate":"2010-06","conditions":["Metastatic Malignant Melanoma"],"enrollment":86,"completionDate":"2014-09"},{"nctId":"NCT00110123","phase":"PHASE3","title":"Intravenous or Hepatic Arterial Infusion of Fotemustine in Treating Patients With Unresectable Liver Metastases From Eye Melanoma","status":"TERMINATED","sponsor":"European Organisation for Research and Treatment of Cancer - EORTC","startDate":"2005-01","conditions":["Intraocular Melanoma","Metastatic Cancer"],"enrollment":171,"completionDate":""}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"NDDF":"005271","UNII":"GQ7JL9P5I2","CHEBI":"CHEBI:131848","INN_ID":"5982","UMLSCUI":"C0060696","ChEMBL_ID":"CHEMBL549386","KEGG_DRUG":"D07255","DRUGBANK_ID":"DB04106","PUBCHEM_CID":"104799","SNOMEDCT_US":"697996006","MESH_SUPPLEMENTAL_RECORD_UI":"C054368"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[],"pharmacokinetics":{"source":"DrugCentral","halfLife":"0.38 hours","clearance":"18.5 mL/min/kg","volumeOfDistribution":"0.62 L/kg"},"publicationCount":382,"therapeuticAreas":["Other"],"atcClassification":{"source":"DrugCentral","atcCode":"L01AD05","allCodes":["L01AD05"]},"biosimilarFilings":[],"recentPublications":[],"companionDiagnostics":[],"genericManufacturerList":[],"status":"discontinued","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Muphoran (Fotemustine) is a small molecule chemotherapeutic agent developed by Ipsen, currently owned by Ipsen. It is used to treat hairy cell leukemia. The exact target of Fotemustine is unknown, but it is classified as a nitrosourea compound. It has a short half-life of 0.38 hours. Fotemustine is patented and its commercial status is not off-patent.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":false,"safety":true,"trials":true,"score":3}}