{"id":"panobinostat","rwe":[{"pmid":"41879411","year":"2026","title":"Inhibitory effect of vemurafenib combined with panobinostat on human anaplastic thyroid cancer cells.","finding":"","journal":"Pakistan journal of pharmaceutical sciences","studyType":"Clinical Study"},{"pmid":"41871169","year":"2026","title":"Single-cell profiling of HDAC inhibitor-induced EBV lytic heterogeneity defines abortive and refractory states in B lymphoblasts.","finding":"","journal":"PLoS pathogens","studyType":"Clinical Study"},{"pmid":"41838958","year":"2026","title":"A Non-canonical RNA-Binding Function of NQO1 Drives Angiogenesis in Esophageal Squamous Cell Carcinoma via Extracellular Vesicle-Mediated AGRN Transfer.","finding":"","journal":"Cancer research","studyType":"Clinical Study"},{"pmid":"41812823","year":"2026","title":"WEE1 stabilizes MYC to promote therapeutic resistance in esophageal adenocarcinoma.","finding":"","journal":"Cancer letters","studyType":"Clinical Study"},{"pmid":"41808767","year":"2026","title":"High-throughput 3D phenotypic screening identifies repurposed MEK inhibitors as drivers of chondrogenesis for cartilage regeneration.","finding":"","journal":"Frontiers in bioengineering and biotechnology","studyType":"Clinical Study"}],"tags":[{"label":"Histone Deacetylase Inhibitor","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Histone deacetylase 4","category":"target"},{"label":"HDAC4","category":"gene"},{"label":"HDAC2","category":"gene"},{"label":"HDAC5","category":"gene"},{"label":"L01XH03","category":"atc"},{"label":"Oral","category":"route"},{"label":"Capsule","category":"form"},{"label":"LOE Approaching","category":"status"},{"label":"Multiple myeloma","category":"indication"},{"label":"Primary cutaneous T-cell lymphoma","category":"indication"},{"label":"Secura","category":"company"},{"label":"Approved 2010s","category":"decade"},{"label":"Antineoplastic Agents","category":"pharmacology"},{"label":"Enzyme Inhibitors","category":"pharmacology"},{"label":"Histone Deacetylase Inhibitors","category":"pharmacology"}],"phase":"marketed","safety":{"safetySignals":[{"llr":250.334,"date":"","count":153,"signal":"Platelet count decreased","source":"DrugCentral FAERS","actionTaken":"Reported 153 times (LLR=250)"},{"llr":237.116,"date":"","count":132,"signal":"Malignant neoplasm progression","source":"DrugCentral FAERS","actionTaken":"Reported 132 times (LLR=237)"},{"llr":229.313,"date":"","count":281,"signal":"Diarrhoea","source":"DrugCentral FAERS","actionTaken":"Reported 281 times (LLR=229)"},{"llr":138.912,"date":"","count":122,"signal":"Thrombocytopenia","source":"DrugCentral FAERS","actionTaken":"Reported 122 times (LLR=139)"},{"llr":107.888,"date":"","count":166,"signal":"Death","source":"DrugCentral FAERS","actionTaken":"Reported 166 times (LLR=108)"},{"llr":97.682,"date":"","count":56,"signal":"Plasma cell myeloma","source":"DrugCentral FAERS","actionTaken":"Reported 56 times (LLR=98)"},{"llr":56.781,"date":"","count":64,"signal":"White blood cell count decreased","source":"DrugCentral FAERS","actionTaken":"Reported 64 times (LLR=57)"},{"llr":55.433,"date":"","count":45,"signal":"Neutrophil count decreased","source":"DrugCentral FAERS","actionTaken":"Reported 45 times (LLR=55)"},{"llr":52.774,"date":"","count":22,"signal":"Concomitant disease aggravated","source":"DrugCentral FAERS","actionTaken":"Reported 22 times (LLR=53)"},{"llr":51.115,"date":"","count":12,"signal":"Morganella infection","source":"DrugCentral FAERS","actionTaken":"Reported 12 times (LLR=51)"},{"llr":50.744,"date":"","count":63,"signal":"Disease progression","source":"DrugCentral FAERS","actionTaken":"Reported 63 times (LLR=51)"},{"llr":44.881,"date":"","count":11,"signal":"Bronchial haemorrhage","source":"DrugCentral FAERS","actionTaken":"Reported 11 times (LLR=45)"},{"llr":44.335,"date":"","count":116,"signal":"Pneumonia","source":"DrugCentral FAERS","actionTaken":"Reported 116 times (LLR=44)"},{"llr":43.109,"date":"","count":15,"signal":"Plasmacytoma","source":"DrugCentral FAERS","actionTaken":"Reported 15 times (LLR=43)"},{"llr":42.571,"date":"","count":60,"signal":"Febrile neutropenia","source":"DrugCentral FAERS","actionTaken":"Reported 60 times (LLR=43)"}],"drugInteractions":[{"url":"/drug/cyp2d6-substrates","drug":"CYP2D6 Substrates","action":"Use caution","effect":"Strong CYP2D6 Inducers - CYP2D6 Substrates","source":"DrugCentral","drugSlug":"cyp2d6-substrates"}],"commonSideEffects":[{"effect":"Diarrhea","drugRate":"","severity":"common","organSystem":""},{"effect":"Fatigue","drugRate":"60%","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"","severity":"common","organSystem":""},{"effect":"Peripheral edema","drugRate":"","severity":"common","organSystem":""},{"effect":"Decreased appetite","drugRate":"","severity":"common","organSystem":""},{"effect":"Pyrexia","drugRate":"","severity":"common","organSystem":""},{"effect":"Vomiting","drugRate":"","severity":"common","organSystem":""},{"effect":"Thrombocytopenia","drugRate":"","severity":"common","organSystem":""},{"effect":"Lymphopenia","drugRate":"","severity":"common","organSystem":""},{"effect":"Leukopenia","drugRate":"","severity":"common","organSystem":""},{"effect":"Neutropenia","drugRate":"","severity":"common","organSystem":""},{"effect":"Anemia","drugRate":"","severity":"common","organSystem":""},{"effect":"Hypophosphatemia","drugRate":"","severity":"common","organSystem":""},{"effect":"Hypokalemia","drugRate":"","severity":"common","organSystem":""},{"effect":"Hyponatremia","drugRate":"","severity":"common","organSystem":""},{"effect":"Increased creatinine","drugRate":"","severity":"common","organSystem":""}],"specialPopulations":{"Lactation":"It is not known whether FARYDAK is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse drug reactions in nursing infants, decide whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.","Pregnancy":"FARYDAK can cause fetal harm when administered to pregnant woman. Panobinostat was teratogenic in rats and rabbits. If FARYDAK is used during pregnancy or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus.","Geriatric use":"Patients over 65 years of age had higher frequency of selected adverse events and of discontinuation of treatment due to adverse events. In patients over 65 years of age, the incidence of deaths not related to disease progression was 9% in patients >=65 years of age compared to % in patients <65.","Paediatric use":"The safety and efficacy of FARYDAK in children has not been established.","Hepatic impairment":"Hepatic impairment can increase panobinostat exposure. Reduce FARYDAK dose in patients with mild or moderate hepatic impairment. Avoid use in patients with severe hepatic impairment."},"seriousAdverseEvents":[{"effect":"Pneumonia","drugRate":"18%","severity":"serious"},{"effect":"Diarrhea","drugRate":"11%","severity":"serious"},{"effect":"Thrombocytopenia","drugRate":"7%","severity":"serious"},{"effect":"Fatigue","drugRate":"6%","severity":"serious"},{"effect":"Sepsis","drugRate":"6%","severity":"serious"},{"effect":"Death","drugRate":"8%","severity":"serious"},{"effect":"Infection","drugRate":"","severity":"serious"},{"effect":"Hemorrhage","drugRate":"","severity":"serious"}]},"trials":[],"aliases":[],"company":"Secura","patents":[{"applNo":"N205353","source":"FDA Orange Book","status":"Active","expires":"Jun 13, 2028","useCode":"U-1669","territory":"US","drugProduct":false,"patentNumber":"8883842","drugSubstance":false},{"applNo":"N205353","source":"FDA Orange Book","status":"Active","expires":"Jan 17, 2028","useCode":"","territory":"US","drugProduct":true,"patentNumber":"7989494","drugSubstance":true}],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=PANOBINOSTAT","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:21:50.578611+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T00:21:50.577471+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:21:58.426044+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T00:21:50.596836+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=PANOBINOSTAT","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:21:59.179994+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL483254/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:21:59.650063+00:00"}},"allNames":"farydak","offLabel":[],"synonyms":["farydak","panobinostat lactate","panobinostat lactate anhydrous","panobinostat","LBH-589","LBH589"],"timeline":[{"date":"2015-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from NOVARTIS PHARMS CORP to Secura"},{"date":"2015-02-23","type":"positive","source":"DrugCentral","milestone":"FDA approval (Novartis Pharms 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dipropionate","slug":"alclometasone-dipropionate","company":""},{"name":"amcinonide","slug":"amcinonide","company":"Astellas"},{"name":"betamethasone","slug":"betamethasone","company":""},{"name":"betamethasone benzoate","slug":"betamethasone-benzoate","company":"Parke Davis"}],"globalPrevalence":null}],"mechanism":{"target":"Histone deacetylase 4","novelty":"Follow-on","targets":[{"gene":"HDAC4","source":"DrugCentral","target":"Histone deacetylase 4","protein":"Histone deacetylase 4"},{"gene":"HDAC2","source":"DrugCentral","target":"Histone deacetylase 2","protein":"Histone deacetylase 2"},{"gene":"HDAC5","source":"DrugCentral","target":"Histone deacetylase 5","protein":"Histone deacetylase 5"},{"gene":"HDAC6","source":"DrugCentral","target":"Histone deacetylase 6","protein":"Histone deacetylase 6"},{"gene":"HDAC1","source":"DrugCentral","target":"Histone deacetylase 1","protein":"Histone deacetylase 1"},{"gene":"HDAC3","source":"DrugCentral","target":"Histone deacetylase 3","protein":"Histone deacetylase 3"},{"gene":"HDAC9","source":"DrugCentral","target":"Histone deacetylase 9","protein":"Histone deacetylase 9"},{"gene":"HDAC7","source":"DrugCentral","target":"Histone deacetylase 7","protein":"Histone deacetylase 7"},{"gene":"HDAC11","source":"DrugCentral","target":"Histone deacetylase 11","protein":"Histone deacetylase 11"},{"gene":"BRD4","source":"DrugCentral","target":"Bromodomain-containing protein 4","protein":"Bromodomain-containing protein 4"}],"moaClass":"Cytochrome P450 2D6 Inhibitors","modality":"Small Molecule","drugClass":"Histone Deacetylase Inhibitor","explanation":"","oneSentence":"","technicalDetail":"Farydak inhibits histone deacetylase 4 (HDAC4) through a competitive binding mechanism, leading to increased acetylation of histones and altered gene expression, which ultimately results in the induction of apoptosis and inhibition of cell proliferation in cancer cells."},"commercial":{"launchDate":"2015","_launchSource":"DrugCentral (FDA 2015-02-23, NOVARTIS PHARMS CORP)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4682","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=PANOBINOSTAT","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=PANOBINOSTAT","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_emaChecked":true,"_enrichedAt":"2026-03-30T15:15:13.329807","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:22:01.535920+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"vorinostat","drugSlug":"vorinostat","fdaApproval":"2006-10-06","patentExpiry":"May 16, 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Panobinostat (LBH589) in Patients With Sickle Cell Disease","status":"RECRUITING","sponsor":"Abdullah Kutlar","startDate":"2010-11","conditions":["Sickle Cell Disease"],"enrollment":18,"completionDate":"2027-01"},{"nctId":"NCT04804709","phase":"PHASE1","title":"Non-Invasive Focused Ultrasound (FUS) With Oral Panobinostat in Children With Progressive Diffuse Midline Glioma (DMG)","status":"TERMINATED","sponsor":"Columbia University","startDate":"2021-07-28","conditions":["Diffuse Intrinsic Pontine Glioma","Diffuse Pontine and Thalamic Gliomas","Diffuse Midline Glioma, H3 K27M-Mutant"],"enrollment":5,"completionDate":"2022-03-31"},{"nctId":"NCT01324635","phase":"PHASE1","title":"Panobinostat and Stereotactic Radiation Therapy in Treating Patients With Brain Tumors","status":"TERMINATED","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University","startDate":"2012-05","conditions":["Recurrent Glioma","High-grade Meningioma","Brain Metastasis"],"enrollment":17,"completionDate":"2016-10"},{"nctId":"NCT01543763","phase":"PHASE1","title":"Pazopanib in Combination With PCI-24781 in Patients With Metastatic Solid Tumors","status":"COMPLETED","sponsor":"Pamela Munster","startDate":"2012-06-25","conditions":["Metastatic Solid Tumors"],"enrollment":90,"completionDate":"2024-12-31"},{"nctId":"NCT02506959","phase":"PHASE2","title":"Panobinostat, Gemcitabine Hydrochloride, Busulfan, and Melphalan Before Stem Cell Transplant in Treating Patients With Refractory or Relapsed Multiple Myeloma","status":"COMPLETED","sponsor":"M.D. Anderson Cancer Center","startDate":"2015-09-14","conditions":["Plasma Cell Leukemia","Plasmacytoma","Recurrent Plasma Cell Myeloma","Refractory Plasma Cell Myeloma"],"enrollment":83,"completionDate":"2024-06-03"},{"nctId":"NCT04315064","phase":"EARLY_PHASE1","title":"Infusion of Panobinostat (MTX110) Into the Fourth Ventricle in Children and Adults with Recurrent Medulloblastoma","status":"COMPLETED","sponsor":"The University of Texas Health Science Center, Houston","startDate":"2020-04-21","conditions":["Medulloblastoma"],"enrollment":2,"completionDate":"2023-05-02"},{"nctId":"NCT04897880","phase":"PHASE2","title":"A Study of Panobinostat in Pediatric Patients With Solid Tumors Including MRT/ATRT","status":"TERMINATED","sponsor":"Australian & New Zealand Children's Haematology/Oncology Group","startDate":"2019-01-09","conditions":["Rhabdoid Tumor","Atypical Teratoid/Rhabdoid Tumor","Malignant Rhabdoid Tumor","Recurrent Brain Tumor, Childhood"],"enrollment":25,"completionDate":"2024-05-08"},{"nctId":"NCT05324501","phase":"PHASE1","title":"A Study of Intra-tumoral Administered MTX110 in Patients With Recurrent Glioblastoma","status":"TERMINATED","sponsor":"Biodexa Pharmaceuticals","startDate":"2022-10-19","conditions":["Recurrent Glioblastoma"],"enrollment":4,"completionDate":"2024-09-10"},{"nctId":"NCT02654990","phase":"PHASE2","title":"Panobinostat/Bortezomib/Dexamethasone in Relapsed or Relapsed-and-refractory Multiple Myeloma","status":"COMPLETED","sponsor":"pharmaand GmbH","startDate":"2016-04-27","conditions":["Multiple Myeloma"],"enrollment":248,"completionDate":"2022-08-15"},{"nctId":"NCT04956302","phase":"PHASE1","title":"Panobinostat in Combination With Daratumumab, Bortezomib and Dexamethasone for the Treatment of Relapsed/Refractory Multiple Myeloma","status":"TERMINATED","sponsor":"Abdullah Khan","startDate":"2021-09-27","conditions":["Recurrent Plasma Cell Myeloma","Refractory Plasma Cell Myeloma"],"enrollment":1,"completionDate":"2022-06-16"},{"nctId":"NCT02717455","phase":"PHASE1","title":"Trial of Panobinostat in Children With Diffuse Intrinsic Pontine Glioma","status":"COMPLETED","sponsor":"Pediatric Brain Tumor 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Solid Neoplasm","Metastatic Pancreatic Adenocarcinoma","Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis","Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable","Primary Myelofibrosis","Recurrent Acute Lymphoblastic Leukemia","Recurrent Acute Myeloid Leukemia","Recurrent Chronic Lymphocytic Leukemia","Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Recurrent Hematologic Malignancy","Recurrent Hodgkin Lymphoma","Recurrent Myelodysplastic Syndrome","Recurrent Myelodysplastic/Myeloproliferative Neoplasm","Recurrent Myeloproliferative Neoplasm","Recurrent Non-Hodgkin Lymphoma","Recurrent Plasma Cell Myeloma","Recurrent Small Lymphocytic Lymphoma","Refractory Acute Lymphoblastic Leukemia","Refractory Acute Myeloid Leukemia","Refractory Chronic Lymphocytic Leukemia","Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Refractory Chronic Myelomonocytic Leukemia","Refractory Hematologic Malignancy","Refractory Hodgkin 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Cancer Institute","startDate":"2020-08-10","conditions":["Diffuse Intrinsic Pontine Glioma","Pediatric Brainstem Glioma","Pediatric Brainstem Gliosarcoma, Recurrent","Pediatric Cancer","Pediatric Brain Tumor","Diffuse Glioma"],"enrollment":4,"completionDate":"2024-02-14"},{"nctId":"NCT06240520","phase":"PHASE1,PHASE2","title":"Optimizing Reversal of HIV Latency With Combination Therapy","status":"UNKNOWN","sponsor":"Erasmus Medical Center","startDate":"2024-04","conditions":["Hiv"],"enrollment":49,"completionDate":"2025-10"},{"nctId":"NCT01693601","phase":"PHASE1,PHASE2","title":"Panobinostat and Ruxolitinib In MyElofibrosis (PRIME Trial)","status":"COMPLETED","sponsor":"John Mascarenhas","startDate":"2013-01","conditions":["Myelofibrosis"],"enrollment":15,"completionDate":"2018-05-18"},{"nctId":"NCT01301807","phase":"PHASE1","title":"Panobinostat and Carfilzomib in Treating Participants With Relapsed or Refractory Multiple Myeloma","status":"COMPLETED","sponsor":"M.D. Anderson Cancer 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Oral Panobinostat (LBH589) and Rituximab to Treat Diffuse Large B Cell Lymphoma (DLBCL)","status":"COMPLETED","sponsor":"Sarit Assouline","startDate":"2010-11","conditions":["Diffuse Large B Cell Lymphoma"],"enrollment":42,"completionDate":"2016-12"},{"nctId":"NCT05725200","phase":"PHASE2","title":"Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer","status":"RECRUITING","sponsor":"Oslo University Hospital","startDate":"2022-09-27","conditions":["Metastatic Colorectal Cancer"],"enrollment":40,"completionDate":"2040-12-31"},{"nctId":"NCT04326764","phase":"PHASE3","title":"Panobinostat Maintenance After HSCT fo High-risk AML and MDS","status":"TERMINATED","sponsor":"Goethe University","startDate":"2018-07-24","conditions":["Acute Myeloid Leukaemia (AML)","Myelodysplastic Syndromes (MDS)"],"enrollment":52,"completionDate":"2023-02-13"},{"nctId":"NCT02032810","phase":"PHASE1","title":"Phase I of Histone Deacetylase (HDAC) Inhibitor 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Lee Moffitt Cancer Center and Research Institute","startDate":"2014-01-07","conditions":["Melanoma","Skin Cancer"],"enrollment":17,"completionDate":"2019-09-25"},{"nctId":"NCT02890069","phase":"PHASE1","title":"A Study of PDR001 in Combination With LCL161, Everolimus or Panobinostat","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2016-10-14","conditions":["Colorectal Cancer, Non-small Cell Lung Carcinoma (Adenocarcinoma), Triple Negative Breast Cancer, Renal Cell Carcinoma"],"enrollment":298,"completionDate":"2022-02-22"},{"nctId":"NCT02722941","phase":"PHASE2","title":"Panobinostat (LBH589): Multiple Myeloma - Autologous Hematopoietic Cell Transplantation (HCT)","status":"COMPLETED","sponsor":"H. 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