{"id":"jadenu","rwe":[],"tags":[],"safety":{"boxedWarnings":["WARNING: RENAL FAILURE, HEPATIC FAILURE, and GASTROINTESTINAL HEMORRHAGE Renal Failure JADENU can cause acute renal failure and death, particularly in patients with comorbidities and those who are in the advanced stages of their hematologic disorders. Evaluate baseline renal function prior to starting or increasing JADENU dosing in all patients. JADENU is contraindicated in adult and pediatric patients with eGFR less than 40 mL/min/1.73 m 2 . Measure serum creatinine in duplicate prior to initia"],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[{"effect":"Diarrhea","drugRate":"","severity":"common","organSystem":""},{"effect":"Vomiting","drugRate":"","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"","severity":"common","organSystem":""},{"effect":"Abdominal pain","drugRate":"","severity":"common","organSystem":""},{"effect":"Skin rashes","drugRate":"","severity":"common","organSystem":""},{"effect":"Increases in serum creatinine","drugRate":"","severity":"common","organSystem":""},{"effect":"Rash","drugRate":"","severity":"common","organSystem":""}],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[{"effect":"Drug-induced hepatitis","drugRate":"","severity":"serious"},{"effect":"Elevations in serum glutamic-pyruvic transaminase (SGPT)/ALT greater than 5 times ULN","drugRate":"6%","severity":"serious"},{"effect":"Henoch Schönlein purpura","drugRate":"","severity":"serious"},{"effect":"Glycosuria/proteinuria","drugRate":"","severity":"serious"},{"effect":"Increases in serum creatinine greater than 33% above baseline","drugRate":"38%","severity":"serious"}]},"trials":[],"_chembl":{"chemblId":"CHEMBL550348","moleculeType":"Small molecule","molecularWeight":"373.37"},"aliases":["deferasirox tablets"],"patents":[],"pricing":[],"offLabel":[],"timeline":[],"_dailymed":{"setId":"fee89140-fff1-4443-9f42-24ac004fcda1","title":"JADENU (DEFERASIROX) TABLET, FILM COATED JADENU (DEFERASIROX) GRANULE [NOVARTIS PHARMACEUTICALS CORPORATION]"},"ecosystem":[],"mechanism":{},"_scrapedAt":"2026-03-28T01:57:24.443Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"references":[],"biosimilars":[],"competitors":[],"dataSources":[],"indications":{"approved":[],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT07352878","phase":"","title":"Evaluation of the Quality of Life in Patients With Chronic Iron Overload Due to Hemoglobinopathies in Greece.","status":"NOT_YET_RECRUITING","sponsor":"Elpen Pharmaceutical Co. Inc.","startDate":"2026-04-15","conditions":"Thalassemia, Iron Overload","enrollment":150},{"nctId":"NCT07292259","phase":"PHASE2","title":"Combination of Thalidomide and Hydroxyuria in Transfusion Dependent Thalasemmia","status":"RECRUITING","sponsor":"Pakistan Blood and Marrow Transplant (PBMT) Group","startDate":"2024-01-01","conditions":"Transfusion Dependent Beta Thalassemia","enrollment":150},{"nctId":"NCT06784336","phase":"PHASE2","title":"Phase II Study of Resistant Potato Starch Plus Deferasirox to Improve Outcomes in Patients Undergoing Allogeneic Stem Cell Transplantation","status":"RECRUITING","sponsor":"University of Michigan Rogel Cancer Center","startDate":"2025-10-15","conditions":"Allogeneic Stem Cell Transplant","enrollment":50},{"nctId":"NCT07023666","phase":"PHASE2","title":"Early Screening and Treatment of Heart Complication in Sickle Cell Disease","status":"RECRUITING","sponsor":"Inova Health Care Services","startDate":"2025-10-07","conditions":"Sickle Cell Disease","enrollment":100},{"nctId":"NCT07157722","phase":"PHASE3","title":"Evaluating the Effect of N-Acetyl Cysteine and Alpha Lipoic Acid in Patients With Beta Thalassemia","status":"NOT_YET_RECRUITING","sponsor":"Tanta University","startDate":"2025-08-30","conditions":"Beta Thalassemia","enrollment":66},{"nctId":"NCT04423237","phase":"","title":"Risk Factors and Measures to Prevent Liver and Pancreas Complications in Pediatric Patients After HSCT","status":"COMPLETED","sponsor":"University of Pisa","startDate":"2020-09-30","conditions":"Iron Overload","enrollment":39},{"nctId":"NCT06964971","phase":"NA","title":"Treatment of Transfusion-dependent Nonsevere Aplastic Anemia With Luspatercept: a Multicenter Prospective Clinical Study","status":"NOT_YET_RECRUITING","sponsor":"The First Affiliated Hospital of Zhejiang Chinese Medical University","startDate":"2025-05-20","conditions":"Transfusion-dependent Non-severe Aplastic Anemia","enrollment":90},{"nctId":"NCT04053933","phase":"","title":"Observational Study Towards the Impact of Newly Started Treatment in MDS on QoL","status":"COMPLETED","sponsor":"University Hospital, Antwerp","startDate":"2019-08-01","conditions":"Myelodysplastic Syndromes","enrollment":70},{"nctId":"NCT03387475","phase":"PHASE2","title":"Evaluating Low-dose Deferasirox (DFX) in Patients With Low-risk MDS Resistant or Relapsing After ESA Agents","status":"COMPLETED","sponsor":"University Hospital, Grenoble","startDate":"2018-02-20","conditions":"Myelodysplasia","enrollment":39},{"nctId":"NCT03203850","phase":"PHASE2","title":"Study to Evaluate the Efficacy and Safety of Deferasirox Film-coated Tablet Versus Phlebotomy in Patients With Hereditary Hemochromatosis (HH)","status":"TERMINATED","sponsor":"Novartis Pharmaceuticals","startDate":"2018-01-11","conditions":"Hereditary Hemochromatosis","enrollment":45},{"nctId":"NCT02435212","phase":"PHASE2","title":"Study to Evaluate Treatment Compliance, Efficacy and Safety of an Improved Deferasirox Formulation (Granules) in Pediatric Patients (2-<18 Years Old) With Iron Overload","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2015-10-21","conditions":"Transfusion-dependent Anemia","enrollment":224},{"nctId":"NCT06509581","phase":"NA","title":"Vitamin E Supplementation for Children With Transfusion Dependent Beta Thalassemia on Different Iron Chelation Regimen","status":"COMPLETED","sponsor":"Ain Shams University","startDate":"2021-07-05","conditions":"Beta-Thalassemia","enrollment":180},{"nctId":"NCT06468423","phase":"NA","title":"Comparison of Deferasirox and Desferoxamine in Patients of β-Thalassemia Major With Iron Overload","status":"COMPLETED","sponsor":"RESnTEC, Institute of Research","startDate":"2023-01-01","conditions":"Pateints of β-thalassemia Major With Iron Overload","enrollment":142},{"nctId":"NCT06215287","phase":"","title":"Survey to Assess Physicians' Knowledge of Exjade Posology and Biological Monitoring Recommendations as Described in the Educational Materials","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2024-01-12","conditions":"Chronic Iron Overload","enrollment":400},{"nctId":"NCT01892644","phase":"PHASE2","title":"Treatment of Iron Overload With Deferasirox (Exjade) in Hereditary Hemochromatosis and Myelodysplastic Syndrome","status":"WITHDRAWN","sponsor":"Haukeland University Hospital","startDate":"2013-05","conditions":"Hemochromatosis, Myelodysplastic Syndromes","enrollment":""},{"nctId":"NCT00749515","phase":"PHASE4","title":"Pilot Study for Patients With Poor Response to Deferasirox","status":"COMPLETED","sponsor":"Boston Children's Hospital","startDate":"2008-03","conditions":"Transfusion-dependent Hemachromatosis, Thalassemia Major, Sickle Cell Disease","enrollment":15},{"nctId":"NCT01376622","phase":"","title":"Changes in Pituitary Iron and Volume With Deferasirox","status":"COMPLETED","sponsor":"Children's Hospital Los Angeles","startDate":"2008-11","conditions":"Iron Overload","enrollment":130},{"nctId":"NCT00419770","phase":"PHASE2","title":"The Deferasirox-AmBisome Therapy for Mucormycosis (DEFEAT Mucor) Study","status":"COMPLETED","sponsor":"Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center","startDate":"2007-10","conditions":"Mucormycosis","enrollment":20},{"nctId":"NCT05392101","phase":"PHASE2","title":"Low Dose Iron Chelation as TReatment of Oxidative Damage in Sickle Cell Disease","status":"COMPLETED","sponsor":"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","startDate":"2021-07-20","conditions":"Sickle Cell Disease","enrollment":12},{"nctId":"NCT01370980","phase":"","title":"Collaborative Seamless Care in Oncology : Measure and Reinforce Safety and Adherence to Oral Cancer Treatment","status":"COMPLETED","sponsor":"Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland","startDate":"2010-07","conditions":"Cancer","enrollment":43},{"nctId":"NCT03920657","phase":"PHASE2","title":"Early and Low Dose Deferasirox (3.5 mg/kg FCT) to Suppress NTBI and LPI as Early Intervention to Prevent Tissue Iron Overload in Lower Risk MDS","status":"TERMINATED","sponsor":"Fondazione Italiana Sindromi Mielodisplastiche-ETS","startDate":"2019-10-04","conditions":"Myelodysplastic Syndromes","enrollment":11},{"nctId":"NCT03637556","phase":"PHASE2","title":"Pilot Study to Assess the Safety, PK and Iron Chelating Activity of DST-0509 (Deferasirox) in Thalassemia Patients Refractory to Chelation","status":"COMPLETED","sponsor":"DisperSol Technologies, LLC","startDate":"2019-08-20","conditions":"Thalassemia Major","enrollment":25},{"nctId":"NCT02993224","phase":"PHASE2","title":"Open-label, Multicenter Study Assessing Preference for Deferasirox Film-coated Tablet Compared to Dispersible Tablet","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2017-07-27","conditions":"Transfusion-dependent Thalassemia, Non-transfusion-dependent Thalassemia","enrollment":148},{"nctId":"NCT00110266","phase":"PHASE2","title":"Study of Deferasirox for Treatment of Transfusional Iron Overload in Myelodysplastic Patients","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2005-07-25","conditions":"Myelodysplastic Syndrome, Iron Overload","enrollment":176},{"nctId":"NCT00901199","phase":"PHASE2","title":"Combined Chelation Therapy in Patients With Transfusion Dependent Thalassemia and Iron Overload","status":"COMPLETED","sponsor":"Elliott Vichinsky","startDate":"2007-09","conditions":"Thalassemia, Iron Overload","enrollment":22},{"nctId":"NCT01254227","phase":"PHASE2","title":"Efficacy and Safety of Deferasirox in Combination With Deferoxamine Followed by Deferasirox Monotherapy in Severe Cardiac Iron Overload","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2011-01","conditions":"Cardiac Iron Overload","enrollment":60},{"nctId":"NCT00845871","phase":"PHASE4","title":"Palatability and Tolerability of Deferasirox Taken With Meals, With Different Liquids or Crushed and Added to Food","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2009-05","conditions":"Transfusional Hemosiderosis","enrollment":65},{"nctId":"NCT00631163","phase":"PHASE2","title":"Efficacy and Safety of Deferasirox in Patients With Chronic Anemia and Transfusional Hemosiderosis","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2007-10","conditions":"Chronic Anemia, Transfusional Hemosiderosis","enrollment":102},{"nctId":"NCT00117507","phase":"PHASE4","title":"Study for the Treatment of Transfusional Iron Overload in Myelodysplastic Patients","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2005-09","conditions":"Myelodysplastic Syndromes, Iron Overload","enrollment":24},{"nctId":"NCT00447694","phase":"PHASE2","title":"Cardiac T2* in Beta-thalassemia Patients on Deferasirox Treatment","status":"COMPLETED","sponsor":"Novartis","startDate":"2006-02","conditions":"Beta-thalassemia, Iron Overload","enrollment":30},{"nctId":"NCT01927913","phase":"PHASE2","title":"Treatment of Iron Overload Requiring Chelation Therapy","status":"WITHDRAWN","sponsor":"Shire","startDate":"2014-11-20","conditions":"Transfusional Iron Overload, Iron Overload, Iron Chelation","enrollment":""},{"nctId":"NCT01825512","phase":"PHASE3","title":"Efficacy/Safety Study of Deferiprone Compared to Deferasirox in Paediatric Patients","status":"COMPLETED","sponsor":"Consorzio per Valutazioni Biologiche e Farmacologiche","startDate":"2014-03-17","conditions":"Chronic Iron Overload","enrollment":435},{"nctId":"NCT04292314","phase":"PHASE2, PHASE3","title":"Hydroxy Urea, Omega 3, Nigella Sativa,Honey on Oxidative Stress and Iron Chelation in Pediatric Major Thalassemia","status":"COMPLETED","sponsor":"Beni-Suef University","startDate":"2019-11-01","conditions":"Iron Overload, Oxidative Stress, Thalassemia Major","enrollment":350},{"nctId":"NCT00560820","phase":"PHASE1","title":"Phase I Study to Examine the Effect of Deferasirox on Renal Hemodynamics in β-thalassemia Patients With Transfusional Iron Overload","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2007-09","conditions":"β-thalassemia, Transfusional Iron Overload","enrollment":11},{"nctId":"NCT00432627","phase":"PHASE1","title":"Impact of Hepatic Impairment on the Pharmacokinetics of Deferasirox.","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2006-12","conditions":"Hepatic Impairment","enrollment":24},{"nctId":"NCT00940602","phase":"PHASE2","title":"Myelodysplastic Syndromes (MDS) Event Free Survival With Iron Chelation Therapy Study","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2010-03-22","conditions":"Myelodysplastic Syndromes","enrollment":225},{"nctId":"NCT01058369","phase":"PHASE2","title":"Exjade-Early-Trial","status":"TERMINATED","sponsor":"University of Erlangen-Nürnberg Medical School","startDate":"2010-04","conditions":"Myelodysplastic Syndromes","enrollment":2},{"nctId":"NCT03372083","phase":"PHASE4","title":"Safety Study of Crushed Deferasirox Film Coated Tablets in Pediatric Patients With Transfusional Hemosiderosis","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2018-01-16","conditions":"Iron Overload","enrollment":44},{"nctId":"NCT04515680","phase":"","title":"Endocrine Function During Deferasirox Therapy","status":"COMPLETED","sponsor":"University of Campania Luigi Vanvitelli","startDate":"2016-11-02","conditions":"Iron Overload, Transfusion-dependent Thalassemia, Endocrine; Complications","enrollment":426},{"nctId":"NCT02943668","phase":"PHASE2","title":"Deferasirox in Treating Patients With Very Low, Low, or Intermediate-Risk Red Blood Cell Transfusion Dependent Anemia or Myelodysplastic Syndrome","status":"TERMINATED","sponsor":"Fred Hutchinson Cancer Center","startDate":"2017-03-02","conditions":"Anemia, Myelodysplastic Syndrome","enrollment":2},{"nctId":"NCT02233504","phase":"EARLY_PHASE1","title":"Pilot Study to Assess Hematologic Response in Patients With Acute Myeloid Leukemia or High Risk Myelodysplastic Syndromes Undergoing Monotherapy With Exjade (Deferasirox)","status":"COMPLETED","sponsor":"Abramson Cancer Center at Penn Medicine","startDate":"2014-08","conditions":"High Risk MDS or AML Patients","enrollment":25},{"nctId":"NCT02720536","phase":"PHASE3","title":"Extended Evaluation of Deferasirox Film-coated Tablet (FCT) Formulation","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2016-08-16","conditions":"Chronic Iron Overload","enrollment":53},{"nctId":"NCT02341495","phase":"PHASE2","title":"Deferasirox, Cholecalciferol, and Azacitidine in the Treatment of Newly Diagnosed AML Patients Over 65","status":"TERMINATED","sponsor":"Elizabeth Henry","startDate":"2013-02","conditions":"Acute Myeloid Leukemia","enrollment":4},{"nctId":"NCT00171821","phase":"PHASE3","title":"A Study Assessing the Efficacy and Safety of Deferasirox in Patients With Transfusion-dependent Iron Overload","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2005-04","conditions":"Transfusion-dependent Iron Overload","enrollment":1784},{"nctId":"NCT01459718","phase":"PHASE2","title":"Safety and Efficacy of Deferasirox in Combination With Desferoxamine in β-thalassaemia Patients With Severe Cardiac Iron Overload","status":"TERMINATED","sponsor":"Novartis Pharmaceuticals","startDate":"2011-01","conditions":"Transfusion-dependent β-thalassemia Patients, Cardiac Iron Overload","enrollment":32},{"nctId":"NCT01709838","phase":"PHASE4","title":"Efficacy and Safety Study of Deferasirox in Patients With Non-transfusion Dependent Thalassemia","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2012-12-06","conditions":"Non-transfusion Dependent Thalassemia","enrollment":134},{"nctId":"NCT03133169","phase":"","title":"Erythrocyte Glutamine Level Relation to Pulmonary Hypertension Risk in Beta Thalassemia Major Children","status":"COMPLETED","sponsor":"Assiut University","startDate":"2017-06-01","conditions":"Thalassemia in Children, Pulmonary Hypertension, Hemolysis","enrollment":80},{"nctId":"NCT01818726","phase":"PHASE4","title":"Safety and Efficacy of Exjade in the Treatment of Transfusion-dependent Iron Overload in Aplastic Anemia Patients","status":"TERMINATED","sponsor":"Novartis Pharmaceuticals","startDate":"2014-06-23","conditions":"Aplastic Anemia","enrollment":15},{"nctId":"NCT01159067","phase":"PHASE2","title":"Deferasirox for Treating Patients Who Have Undergone Allogeneic Stem Cell Transplant and Have Iron Overload","status":"TERMINATED","sponsor":"City of Hope Medical Center","startDate":"2010-07","conditions":"Iron Overload, Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission","enrollment":1},{"nctId":"NCT01709032","phase":"PHASE1, PHASE2","title":"Combination Deferasirox and Deferiprone for Severe Iron Overload in Thalassemia","status":"COMPLETED","sponsor":"Children's Hospital of Philadelphia","startDate":"2012-09","conditions":"Thalassemia Major With Severe Transfusional Iron Overload","enrollment":9},{"nctId":"NCT01868477","phase":"PHASE2","title":"Combination Study of Deferasirox and Erythropoietin in Patients With Low- and Int-1-risk Myelodysplastic Syndrome.","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2014-01-28","conditions":"Low and Int 1-risk Myelodysplastic Syndrome","enrollment":28},{"nctId":"NCT01273766","phase":"PHASE2","title":"Deferasirox in Treating Iron Overload Caused By Blood Transfusions in Patients With Hematologic Malignancies","status":"COMPLETED","sponsor":"Wake Forest University Health Sciences","startDate":"2011-01","conditions":"Acute Undifferentiated Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission","enrollment":16},{"nctId":"NCT03659084","phase":"","title":"Study of the Outcome of Patients With Acute Myeloblastic Leukemia and Myelodysplastic Syndrome Receiving Iron Chelation Therapy After Allogeneic Hematopoietic Stem Cell Transplantation","status":"UNKNOWN","sponsor":"Hospices Civils de Lyon","startDate":"2016-04","conditions":"Myeloid Leukemia, Myelodysplastic Syndromes","enrollment":150},{"nctId":"NCT02663752","phase":"PHASE2","title":"A Phase II Pilot Study to Assess the Presence of Molecular Factors Predictive for Hematologic Response in Myelodysplastic Syndrome Patients Receiving Deferasirox Therapy.","status":"TERMINATED","sponsor":"Novartis Pharmaceuticals","startDate":"2016-05-30","conditions":"Myelodysplastic Syndrome","enrollment":1},{"nctId":"NCT02854722","phase":"PHASE2","title":"The Deferasirox-calcium-vitamin D3 Therapy for Postmenopausal Osteoporosis (PMOP)","status":"UNKNOWN","sponsor":"Second Affiliated Hospital of Soochow University","startDate":"2018-01-15","conditions":"Postmenopausal Osteoporosis","enrollment":10},{"nctId":"NCT02038816","phase":"PHASE2","title":"Azacitidine Plus Deferasirox (ICL670) in Higher Risk Myelodysplastic Syndromes (MDS)","status":"TERMINATED","sponsor":"Sunnybrook Health Sciences Centre","startDate":"2014-03","conditions":"Myelodysplastic Syndromes","enrollment":1},{"nctId":"NCT01718366","phase":"PHASE1, PHASE2","title":"A Study of Combined Deferasirox, Vitamin D and Azacytidine in High Risk MDS","status":"UNKNOWN","sponsor":"Groupe Francophone des Myelodysplasies","startDate":"2013-02","conditions":"MDS","enrollment":50},{"nctId":"NCT00602446","phase":"PHASE2","title":"Deferasirox in Treating Patients With Iron Overload After Undergoing a Donor Stem Cell Transplant","status":"TERMINATED","sponsor":"Masonic Cancer Center, University of Minnesota","startDate":"2007-08","conditions":"Breast Cancer, Iron Overload, Leukemia","enrollment":4},{"nctId":"NCT03358498","phase":"","title":"Quality of Life and Treatment Satisfaction in β-Thalassemia Patients Receiving Deferasirox","status":"UNKNOWN","sponsor":"Assiut University","startDate":"2017-12-01","conditions":"β-thalassemia","enrollment":75},{"nctId":"NCT00067080","phase":"PHASE2","title":"Safety of ICL670 vs. Deferoxamine in Sickle Cell Disease Patients With Iron Overload Due to Blood Transfusions","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2003-05","conditions":"Anemia, Sickle Cell","enrollment":195},{"nctId":"NCT00061763","phase":"PHASE2","title":"Study of Deferasirox in Iron Overload From Beta-thalassemia Unable to be Treated With Deferoxamine or Chronic Anemias","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2003-05","conditions":"Beta-thalassemia, Myelodysplastic Syndromes, Fanconi Syndrome","enrollment":175},{"nctId":"NCT02125877","phase":"PHASE2","title":"Phase II Study to Investigate the Benefits of an Improved Deferasirox Formulation (Film-coated Tablet)","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2014-07-08","conditions":"Chronic Iron Overload Due to Transfusion-dependant Anemias","enrollment":173},{"nctId":"NCT02065492","phase":"PHASE2, PHASE3","title":"Amlodipine for Myocardial Iron in Thalassemia","status":"COMPLETED","sponsor":"Aga Khan University","startDate":"2014-02","conditions":"Thalassemia","enrollment":20},{"nctId":"NCT00481143","phase":"PHASE4","title":"Efficacy and Safety of Deferasirox in Patients With Myelodysplastic Syndrome and Transfusion-dependent Iron Overload","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2007-05","conditions":"Myelodysplastic Syndromes, Transfusion Dependent Iron Overload","enrollment":63},{"nctId":"NCT02761395","phase":"NA","title":"Study of The Therapeutic Benefits of Al-hijamah in Children With Beta Thalassemia Major","status":"UNKNOWN","sponsor":"Tanta University","startDate":"2015-11","conditions":"AL-Hijama in Thalassmia Major","enrollment":60},{"nctId":"NCT02069886","phase":"PHASE4","title":"Effect of Deferasirox on Endocrine Complications in Subjects With Transfusion Dependent Thalassemia","status":"WITHDRAWN","sponsor":"Novartis Pharmaceuticals","startDate":"2014-12","conditions":"Thalassemia (Transfusion Delendent)","enrollment":""},{"nctId":"NCT01724138","phase":"PHASE4","title":"An Open Label Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Efficacy of Deferasirox Administered to Chinese Patients With β-thalassemia Major Aged From 2 to Less Than 6 Years Old","status":"WITHDRAWN","sponsor":"Novartis Pharmaceuticals","startDate":"2013-06","conditions":"β-thalassemia Major","enrollment":""},{"nctId":"NCT01948817","phase":"PHASE2","title":"Deferasirox BID (Twice a Day) in Transfusion Dependent Thalassemia Patients With Inadequate Response to High Doses","status":"WITHDRAWN","sponsor":"Novartis Pharmaceuticals","startDate":"2014-02","conditions":"Focus on Transfusion Dependent Thalassemia Patients Who Are Inadequate Responders to Deferasirox > 35mg/kgQD","enrollment":""},{"nctId":"NCT02159040","phase":"PHASE2","title":"Phase II Study to Evaluate Overall Response in Patients With Higher Risk Myelodysplastic Syndromes (MDS) Treated With Azacitidine With or Without Deferasirox.","status":"TERMINATED","sponsor":"Novartis Pharmaceuticals","startDate":"2014-09-11","conditions":"High Risk MDS","enrollment":1},{"nctId":"NCT00390858","phase":"PHASE2","title":"A 4-year Extension Study to Core 1-year Study of Iron Chelation Therapy With Deferasirox in β-thalassemia Major Pediatric Patients With Transfusional Iron Overload.","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2003-09","conditions":"Transfusional Iron Overload, β-thalassemia Major, Pediatric Rare Anemia","enrollment":40},{"nctId":"NCT01326845","phase":"PHASE4","title":"Myelodysplastic Syndrome (MDS) Gastrointestinal (GI) Tolerability Study","status":"TERMINATED","sponsor":"Novartis Pharmaceuticals","startDate":"2011-12","conditions":"Myelodysplastic Syndrome, Transfusional Iron Overload","enrollment":12},{"nctId":"NCT00171171","phase":"PHASE3","title":"A Study of Long-term Treatment With Deferasirox in Patients With Beta-thalassemia and Transfusional Hemosiderosis","status":"COMPLETED","sponsor":"Novartis","startDate":"2004-05","conditions":"Beta-Thalassemia, Hemosiderosis","enrollment":252},{"nctId":"NCT00564941","phase":"PHASE4","title":"Evaluating the Efficacy of Deferasirox in Transfusion Dependent Chronic Anaemias (Myelodysplastic Syndrome, Beta-thalassaemia Patients) With Chronic Iron Overload","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2007-12","conditions":"Myelodysplastic Syndromes, Beta-Thalassemia","enrollment":309},{"nctId":"NCT00673608","phase":"PHASE4","title":"Magnetic Resonance Imaging (MRI) Assessments of the Heart and Liver Iron Load in Patients With Transfusion Induced Iron Overload","status":"COMPLETED","sponsor":"Novartis","startDate":"2007-11","conditions":"Hemoglobinopathies, Myelodysplastic Syndromes, Other Inherited or Acquired Anaemia","enrollment":118},{"nctId":"NCT01044186","phase":"PHASE2","title":"A Protocol to Allow Treatment With ICL670 for Patients With or at Risk of Life-threatening Complications of Transfusional Iron Overload Who Are Unable to Tolerate Other Iron Chelators Because of Documented Severe Toxicity","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2003-06","conditions":"Transfusional Iron Overload","enrollment":30},{"nctId":"NCT00981370","phase":"PHASE3","title":"Clinical Importance of Treating Iron Overload in Sickle Cell Disease","status":"TERMINATED","sponsor":"Children's Hospital Los Angeles","startDate":"2009-04","conditions":"Anemia, Sickle Cell, Transfusion Hemosiderosis","enrollment":1},{"nctId":"NCT01250951","phase":"PHASE4","title":"This Study Will Evaluate Efficacy and Safety of Deferasirox in Patients With Myelodysplastic Syndromes (MDS), Thalassemia and Rare Anemia Types Having Transfusion-induced Iron Overload.","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2009-12","conditions":"Myelodysplastic Syndrome, Thalassemia","enrollment":111},{"nctId":"NCT00879242","phase":"PHASE2","title":"Effect of Deferasirox on Patients With Cardiac MRI T2* < 20 Msec","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2009-02","conditions":"Beta Thalassemia Transfusion Dependent","enrollment":20},{"nctId":"NCT00469560","phase":"PHASE3","title":"Safety, Tolerability, and Efficacy of Deferasirox in MDS","status":"COMPLETED","sponsor":"Gruppo Italiano Malattie EMatologiche dell'Adulto","startDate":"2007-06","conditions":"Myelodysplastic Syndromes, Hemosiderosis","enrollment":158},{"nctId":"NCT00654589","phase":"PHASE4","title":"Efficacy and Safety of Oral Deferasirox (20 mg/kg/d) in Pts 3 to 6 Months After Allogeneic Hematopoietic Cell Transplantation Who Present With Iron Overload","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2008-02","conditions":"Iron Overload","enrollment":75},{"nctId":"NCT02474420","phase":"NA","title":"Amlodipine as Adjuvant Treatment to Iron Chelation for Prevention of Cardiac Iron Overload in Thalassemia Patients","status":"UNKNOWN","sponsor":"Kevin H.M. Kuo, MD, MSc, FRCPC","startDate":"2015-06","conditions":"Beta-Thalassemia, Iron Overload","enrollment":60},{"nctId":"NCT01610297","phase":"PHASE4","title":"Post Hematopoietic Stem Cell Transplantation","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2013-09","conditions":"Iron Overload After Hematopoietic Stem Cell Transplantation (HSCT) in Patients With Beta-thalassemia Major","enrollment":27},{"nctId":"NCT02413021","phase":"PHASE1","title":"The Effect of Deferasirox on Response Rate of Acute Leukemia Patients Not Treated by Standard Chemotherapy Regimens","status":"UNKNOWN","sponsor":"Isfahan University of Medical Sciences","startDate":"2016-05","conditions":"Acute Myeloid Leukemia, Acute Lymphoid Leukemia","enrollment":40},{"nctId":"NCT01394029","phase":"","title":"Observation of Patients With Transfusional Hemosiderosis Treatment With Deferasirox","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2011-07","conditions":"Transfusional Hemosiderosis","enrollment":120},{"nctId":"NCT00466063","phase":"","title":"ENTRUST, a 5 Year Surveillance of Children Aged 2 to <6 Years With Transfusional Iron Overload Treated With Deferasirox","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2007-05","conditions":"Anemia","enrollment":108},{"nctId":"NCT01349699","phase":"NA","title":"Effects of Iron Loading and Iron Chelation Therapy on Innate Immunity During Human Endotoxemia","status":"COMPLETED","sponsor":"Radboud University Medical Center","startDate":"2010-02","conditions":"Systemic Inflammatory Process, Anemia","enrollment":30},{"nctId":"NCT01905774","phase":"","title":"Renal Function Among Thalassemia Patients Treated by a Oral Chelator Deferasirox","status":"COMPLETED","sponsor":"HaEmek Medical Center, Israel","startDate":"2011-03","conditions":"Thalassemia, Iron Overload","enrollment":36},{"nctId":"NCT00379483","phase":"PHASE2","title":"Extension Study of Iron Chelation Therapy With Deferasirox in Patients With Transfusional Iron Overload","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2002-07","conditions":"Transfusional Iron Overload","enrollment":66},{"nctId":"NCT00600938","phase":"PHASE2","title":"Evaluating Use of Deferasirox as Compared to Deferoxamine in Treating Cardiac Iron Overload","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2007-11","conditions":"Transfusional Iron Overload, Transfusional Hemosiderosis","enrollment":197},{"nctId":"NCT02198508","phase":"NA","title":"Clinical Trial of Deferasirox Combination Treatment With Deferiprone In Thalassaemia Patients","status":"COMPLETED","sponsor":"China Medical University Hospital","startDate":"2007-07","conditions":"Beta-thalassemia Major","enrollment":13},{"nctId":"NCT00452660","phase":"PHASE4","title":"Evaluation the Effect of Exjade on Oxidative Stress in Low Risk Myelodysplastic Syndrome Patients With Iron Over Load","status":"COMPLETED","sponsor":"Wolfson Medical Center","startDate":"2007-05","conditions":"Myelodysplastic Syndrome","enrollment":21},{"nctId":"NCT00599326","phase":"PHASE3","title":"Pilot Trial of Deferasirox in the Treatment of Porphyria Cutanea Tarda","status":"COMPLETED","sponsor":"University of Texas Southwestern Medical Center","startDate":"2008-01","conditions":"Porphyria Cutanea Tarda","enrollment":10},{"nctId":"NCT00873041","phase":"PHASE2","title":"Efficacy and Safety of Deferasirox in Non-transfusion Dependent Thalassemia Patients With Iron Overload and a One Year Open-label Extension Study","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2008-11","conditions":"Non-transfusion Dependent Thalassemia","enrollment":166},{"nctId":"NCT01874405","phase":"","title":"Retrospective Evaluation of Adult and Pediatric Transfusion-dependent Patients Treated With Deferasirox Therapy","status":"COMPLETED","sponsor":"University of Campania Luigi Vanvitelli","startDate":"2003-03","conditions":"Iron Overload","enrollment":80},{"nctId":"NCT01278056","phase":"PHASE1, PHASE2","title":"The Impact of Deferasirox on Non-Alcoholic-Steatohepatitis","status":"COMPLETED","sponsor":"Crolll Gmbh","startDate":"2010-03","conditions":"Non-alcoholic Steatohepatitis, Increased Iron Storage / Disturbed Distribution","enrollment":5},{"nctId":"NCT01335035","phase":"PHASE4","title":"Open-Label Single-Arm Pilot Study in Adult Allogeneic Hematopoietic Stem Cell Transplant Recipients With Transfusional Iron Overload","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2008-12","conditions":"Iron Overload","enrollment":30},{"nctId":"NCT00061750","phase":"PHASE3","title":"Safety & Efficacy of ICL670 vs. Deferoxamine in Beta-thalassemia Patients With Iron Overload Due to Blood Transfusions","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2003-05","conditions":"Beta-Thalassemia","enrollment":595},{"nctId":"NCT01511848","phase":"PHASE2, PHASE3","title":"Study Of Efficacy,Safety of Combined Deferasirox and Deferiprone Versus Combined Deferiprone and Desferal In Conditions of Iron Overload","status":"UNKNOWN","sponsor":"Ain Shams University","startDate":"2012-02","conditions":"Beta-thalassemia Major, Sickle Cell Disease, Iron Hemosiderosis","enrollment":60},{"nctId":"NCT00171301","phase":"PHASE4","title":"Extension Study of the Efficacy and Safety of Deferasirox Treatment in Beta-thalassemia Patients With Transfusional Hemosiderosis (Study Amended to 2-year Duration)","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2005-06","conditions":"Beta-thalassemia Major, Hemosiderosis, Iron Overload","enrollment":233},{"nctId":"NCT01033747","phase":"PHASE2, PHASE3","title":"Safety and Efficacy of Deferasirox in Patients With Transfusion Dependent Iron Overload - a Non-comparative Extension Study","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2003-02","conditions":"Liver Iron Overload","enrollment":70}],"_emaApprovals":[],"_faersSignals":[{"count":511,"reaction":"DEATH"},{"count":301,"reaction":"DIARRHOEA"},{"count":232,"reaction":"OFF LABEL USE"},{"count":223,"reaction":"SICKLE CELL ANAEMIA WITH CRISIS"},{"count":200,"reaction":"HAEMOGLOBIN DECREASED"},{"count":199,"reaction":"NAUSEA"},{"count":169,"reaction":"FATIGUE"},{"count":143,"reaction":"SERUM FERRITIN INCREASED"},{"count":131,"reaction":"MALAISE"},{"count":126,"reaction":"PYREXIA"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{},"formularyStatus":[],"_approvalHistory":[{"date":"20190524","type":"SUPPL","sponsor":"NOVARTIS PHARMS CORP","applicationNumber":"NDA206910"},{"date":"20180511","type":"SUPPL","sponsor":"NOVARTIS PHARMS CORP","applicationNumber":"NDA206910"},{"date":"20190726","type":"SUPPL","sponsor":"NOVARTIS PHARMS CORP","applicationNumber":"NDA206910"},{"date":"20160812","type":"SUPPL","sponsor":"NOVARTIS PHARMS CORP","applicationNumber":"NDA206910"},{"date":"20180803","type":"SUPPL","sponsor":"NOVARTIS PHARMS CORP","applicationNumber":"NDA206910"},{"date":"20151106","type":"SUPPL","sponsor":"NOVARTIS PHARMS CORP","applicationNumber":"NDA206910"},{"date":"20220211","type":"SUPPL","sponsor":"NOVARTIS PHARMS CORP","applicationNumber":"NDA206910"},{"date":"20181212","type":"SUPPL","sponsor":"NOVARTIS PHARMS CORP","applicationNumber":"NDA206910"},{"date":"20200723","type":"SUPPL","sponsor":"NOVARTIS PHARMS CORP","applicationNumber":"NDA206910"},{"date":"20180216","type":"SUPPL","sponsor":"NOVARTIS PHARMS CORP","applicationNumber":"NDA206910"},{"date":"20180126","type":"SUPPL","sponsor":"NOVARTIS PHARMS CORP","applicationNumber":"NDA206910"},{"date":"20150330","type":"ORIG","sponsor":"NOVARTIS PHARMS CORP","applicationNumber":"NDA206910"},{"date":"20181212","type":"SUPPL","sponsor":"NOVARTIS PHARMS CORP","applicationNumber":"NDA206910"},{"date":"20151022","type":"SUPPL","sponsor":"NOVARTIS PHARMS CORP","applicationNumber":"NDA206910"},{"date":"20151022","type":"SUPPL","sponsor":"NOVARTIS PHARMS CORP","applicationNumber":"NDA206910"},{"date":"20181212","type":"SUPPL","sponsor":"NOVARTIS","applicationNumber":"NDA207968"},{"date":"20181212","type":"SUPPL","sponsor":"NOVARTIS","applicationNumber":"NDA207968"},{"date":"20180216","type":"SUPPL","sponsor":"NOVARTIS","applicationNumber":"NDA207968"},{"date":"20170518","type":"ORIG","sponsor":"NOVARTIS","applicationNumber":"NDA207968"},{"date":"20200723","type":"SUPPL","sponsor":"NOVARTIS","applicationNumber":"NDA207968"},{"date":"20190725","type":"SUPPL","sponsor":"NOVARTIS","applicationNumber":"NDA207968"},{"date":"20180803","type":"SUPPL","sponsor":"NOVARTIS","applicationNumber":"NDA207968"},{"date":"20180511","type":"SUPPL","sponsor":"NOVARTIS","applicationNumber":"NDA207968"},{"date":"20190524","type":"SUPPL","sponsor":"NOVARTIS","applicationNumber":"NDA207968"}],"developmentCodes":[],"ownershipHistory":[],"publicationCount":0,"therapeuticAreas":["Other"],"biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"Jadenu","genericName":"Jadenu","companyName":"DisperSol Technologies, LLC","companyId":"dispersol-technologies-llc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":1,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":false,"safety":true,"trials":true,"score":2}}