{"id":"iv-arsenic-trioxide","safety":{"commonSideEffects":[{"rate":"25-30","effect":"Differentiation syndrome (APL differentiation syndrome)"},{"rate":"40-60","effect":"QT prolongation"},{"rate":"30-40","effect":"Hyperglycemia"},{"rate":"50-70","effect":"Leukocytosis"},{"rate":"50-75","effect":"Nausea and vomiting"},{"rate":"40-60","effect":"Fatigue"},{"rate":"20-30","effect":"Peripheral neuropathy"},{"rate":"10-20","effect":"Hepatotoxicity"}]},"_chembl":{"chemblId":"CHEMBL5483015","moleculeType":"Small molecule","molecularWeight":"197.84"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Arsenic trioxide targets the PML-RARA fusion protein characteristic of acute promyelocytic leukemia (APL), causing its degradation and leading to differentiation of abnormal promyelocytes into mature granulocytes. At higher concentrations, it also triggers apoptosis through mitochondrial pathways and generation of reactive oxygen species. This dual mechanism of differentiation and cell death makes it highly effective in APL and potentially useful in other hematologic malignancies.","oneSentence":"Arsenic trioxide induces differentiation and apoptosis of leukemic cells, particularly in acute promyelocytic leukemia, through multiple pathways including PML-RARA degradation and reactive oxygen species generation.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:17:25.160Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Acute promyelocytic leukemia (APL), newly diagnosed and relapsed/refractory"}]},"trialDetails":[{"nctId":"NCT02339740","phase":"PHASE3","title":"Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia","status":"ACTIVE_NOT_RECRUITING","sponsor":"Children's Oncology Group","startDate":"2015-07-21","conditions":"Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA","enrollment":158},{"nctId":"NCT07348107","phase":"PHASE1","title":"ATRA and SDK002 in Combination With Chemotherapy and Anti-PD-1 Inhibitor in Patients With Advanced Pancreatic Ductal Adenocarcinoma.","status":"NOT_YET_RECRUITING","sponsor":"Daniel Breadner","startDate":"2026-02-15","conditions":"Advanced Pancreatic Ductal Adenocarcinoma","enrollment":10},{"nctId":"NCT07296445","phase":"PHASE3","title":"A Trial to Investigate Whether Oral Arsenic Trioxide Is Similar to Intravenous Arsenic Trioxide in Pharmacokinetics, Safety, and Efficacy (LATITUDE/SDKARS-301)","status":"NOT_YET_RECRUITING","sponsor":"SDK Therapeutics, Inc.","startDate":"2026-01","conditions":"Acute Promyelocytic Leukemia (APL), Acute Promyelocytic Leukaemia, Acute Promyelocytic Leukemia With PML-RARA","enrollment":120},{"nctId":"NCT01409161","phase":"PHASE2","title":"Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia","status":"RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2011-10-05","conditions":"Acute Promyelocytic Leukemia With PML-RARA","enrollment":151},{"nctId":"NCT06882031","phase":"PHASE1","title":"Evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution Under Fasting and Fed Conditions, to Compare Intravenous Arsenic Trioxide, in Acute Promyelocytic Leukemia","status":"COMPLETED","sponsor":"SDK Therapeutics, Inc.","startDate":"2025-03-11","conditions":"Acute Promyelocytic Leukemia (APL)","enrollment":12},{"nctId":"NCT06670222","phase":"PHASE1","title":"Oral Arsenic (ATO) in Low-risk Myelodysplastic Syndromes (MDS)","status":"RECRUITING","sponsor":"Groupe Francophone des Myelodysplasies","startDate":"2025-07-22","conditions":"Low-risk Myelodysplastic Syndromes","enrollment":24},{"nctId":"NCT03503864","phase":"PHASE2","title":"Phase II Study of Combined Chemotherapy With Arsenic Trioxide in Stage 4/M Neuroblastoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Yang Li","startDate":"2017-06-12","conditions":"Neuroblastoma","enrollment":80},{"nctId":"NCT06933394","phase":"PHASE2","title":"Arsenic Trioxide With MAPK Inhibitors and Chemotherapy for Stage 4/M Neuroblastoma","status":"RECRUITING","sponsor":"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","startDate":"2025-05-01","conditions":"Neuroblastoma","enrollment":92},{"nctId":"NCT03318016","phase":"PHASE1","title":"Arsenic Trioxide With Cyclophosphamide in Patients With Relapsed/Refractory Acute Myeloid Leukemia","status":"TERMINATED","sponsor":"University of Colorado, Denver","startDate":"2017-12-15","conditions":"Acute Myeloid Leukemia, Relapsed/Refractory Acute Myeloid Leukemia","enrollment":5},{"nctId":"NCT04996030","phase":"PHASE1","title":"A Study for Oral SY-2101 for Participants With Acute Promyelocytic Leukemia","status":"SUSPENDED","sponsor":"Syros Pharmaceuticals","startDate":"2021-09-17","conditions":"Acute Promyelocytic Leukemia","enrollment":16},{"nctId":"NCT06088030","phase":"PHASE2","title":"Arsenic Trioxide Combined With Chemotherapy for the Treatment of p53-mutated Pediatric Cancer","status":"RECRUITING","sponsor":"Yang Li","startDate":"2023-12-13","conditions":"Pediatric Cancer, Li-Fraumeni Syndrome, p53 Mutations","enrollment":50},{"nctId":"NCT05721872","phase":"PHASE1, PHASE2","title":"Efficacy, Tolerability and Safety of Intravenous D-VC With ATO in Patients With Advanced/Metastatic Colorectal Cancer","status":"UNKNOWN","sponsor":"Nazarbayev University","startDate":"2023-02-15","conditions":"Colorectal Cancer, Metastatic Colorectal Cancer","enrollment":38},{"nctId":"NCT00551460","phase":"PHASE2","title":"S0535, Gemtuzumab and Combination Chemotherapy in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia","status":"COMPLETED","sponsor":"SWOG Cancer Research Network","startDate":"2007-11-15","conditions":"Leukemia","enrollment":78},{"nctId":"NCT00866918","phase":"PHASE3","title":"Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia","status":"COMPLETED","sponsor":"Children's Oncology Group","startDate":"2009-03-09","conditions":"Childhood Acute Promyelocytic Leukemia With PML-RARA, Myeloid Neoplasm","enrollment":106},{"nctId":"NCT00482833","phase":"PHASE3","title":"Phase III Trial in Acute Promyelocytic Leukemia Patients","status":"COMPLETED","sponsor":"Gruppo Italiano Malattie EMatologiche dell'Adulto","startDate":"2007-08","conditions":"Leukemia","enrollment":276},{"nctId":"NCT02200978","phase":"PHASE4","title":"A Study for Improving the Outcome of Childhood Acute Promyeloid Leukemia","status":"COMPLETED","sponsor":"South China Children's Leukemia Group","startDate":"2011-09","conditions":"Childhood Acute Promyelocytic Leukemia","enrollment":176},{"nctId":"NCT02966301","phase":"PHASE2","title":"Treatment of Chronic Graft Versus Host Disease With Arsenic Trioxide","status":"COMPLETED","sponsor":"Medsenic","startDate":"2016-12","conditions":"Chronic Graft-Versus-Host Disease, Immune System Diseases","enrollment":21},{"nctId":"NCT02190695","phase":"PHASE2","title":"Leukemia SPORE Phase II DAC Study for R/R and Elderly Acute AML and MDS","status":"COMPLETED","sponsor":"Fox Chase Cancer Center","startDate":"2013-04-01","conditions":"Acute Myeloid Leukemia, Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia","enrollment":92},{"nctId":"NCT00469209","phase":"PHASE1, PHASE2","title":"Velcade, Trisenox, Vitamin C and Melphalan for Myeloma Patients","status":"COMPLETED","sponsor":"M.D. Anderson Cancer Center","startDate":"2006-06","conditions":"Myeloma","enrollment":60},{"nctId":"NCT04489706","phase":"NA","title":"Arsenic Trioxide in Recurrent and Metastatic Ovarian Cancer and Endometrial Cancer With P53 Mutation","status":"UNKNOWN","sponsor":"Ruijin Hospital","startDate":"2020-06-28","conditions":"Ovarian Cancer, Endometrial Cancer","enrollment":20},{"nctId":"NCT00571116","phase":"PHASE1","title":"Disulfiram Plus Arsenic Trioxide In Patients With Metastatic Melanoma and at Least One Prior Systemic Therapy","status":"TERMINATED","sponsor":"University of California, Irvine","startDate":"2006-09","conditions":"Metastatic Melanoma","enrollment":9},{"nctId":"NCT00413166","phase":"PHASE2","title":"All-trans Retinoic Acid, and Arsenic +/- Idarubicin","status":"COMPLETED","sponsor":"M.D. Anderson Cancer Center","startDate":"2006-12","conditions":"Acute Promyelocytic Leukemia","enrollment":78},{"nctId":"NCT03048344","phase":"PHASE1","title":"A Phase I, Two-part Study to Determine the Recommended Dose and Evaluate the Safety and Tolerability of a Novel Oral Arsenic Trioxide Formulation (ORH-2014) in Subjects With Advanced Hematological Disorders","status":"COMPLETED","sponsor":"Orsenix LLC","startDate":"2016-12-02","conditions":"Advanced Hematological Disorders","enrollment":12},{"nctId":"NCT01397734","phase":"PHASE1","title":"Arsenic Trioxide and Tyrosine Kinase Inhibitors for Chronic Myelogenous Leukemia (CML)","status":"TERMINATED","sponsor":"Beth Israel Deaconess Medical Center","startDate":"2011-09","conditions":"Chronic Myelogenous Leukemia","enrollment":7},{"nctId":"NCT00004149","phase":"PHASE2","title":"Arsenic Trioxide in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Previous Hormone Therapy","status":"COMPLETED","sponsor":"Albert Einstein College of Medicine","startDate":"1999-09","conditions":"Prostate Cancer","enrollment":37},{"nctId":"NCT01791894","phase":"PHASE1, PHASE2","title":"Arsenic Trioxide in Treating Patients With Basal Cell Carcinoma","status":"COMPLETED","sponsor":"Stanford University","startDate":"2013-04","conditions":"Basal Cell Carcinoma of the Skin, Recurrent Skin Cancer","enrollment":5},{"nctId":"NCT01835288","phase":"PHASE2","title":"Arsenic Trioxide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia","status":"WITHDRAWN","sponsor":"Stanford University","startDate":"2013-05","conditions":"Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a)","enrollment":""},{"nctId":"NCT01428128","phase":"PHASE2","title":"Low Dose Arsenic Trioxide as a Potential Chemotherapy Protector","status":"COMPLETED","sponsor":"The University of Texas Health Science Center at San Antonio","startDate":"2011-04","conditions":"Cancer Other Than Leukemia","enrollment":50},{"nctId":"NCT00449137","phase":"PHASE1","title":"Arsenic Trioxide, Fluorouracil, and Leucovorin in Treating Patients With Stage IV Colorectal Cancer That Has Relapsed or Not Responded to Treatment","status":"COMPLETED","sponsor":"University of Miami","startDate":"2005-06","conditions":"Colorectal Cancer","enrollment":13},{"nctId":"NCT00582400","phase":"PHASE2","title":"A Phase II Protocol of Arsenic Trioxide (Trisenox) in Subjects With Advanced Primary Carcinoma of the Liver","status":"TERMINATED","sponsor":"The University of Texas Medical Branch, Galveston","startDate":"2004-09","conditions":"Carcinoma, Hepatocellular","enrollment":9},{"nctId":"NCT01738360","phase":"PHASE2","title":"Phase 2a Study Evaluating the Arsenic Trioxide (ATO) in Systemic Lupus (SLE) (Protocol LUPSENIC)","status":"TERMINATED","sponsor":"Nantes University Hospital","startDate":"2013-07","conditions":"Systemic Lupus","enrollment":11},{"nctId":"NCT00024258","phase":"PHASE2","title":"Arsenic Trioxide in Treating Patients With Advanced Neuroblastoma or Other Childhood Solid Tumors","status":"COMPLETED","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2001-03","conditions":"Brain and Central Nervous System Tumors, Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor","enrollment":22},{"nctId":"NCT00075413","phase":"PHASE2","title":"Arsenic Trioxide in Treating Women With Locally Advanced or Metastatic Breast Cancer","status":"WITHDRAWN","sponsor":"The University of Texas Medical Branch, Galveston","startDate":"2002-11","conditions":"Breast Cancer","enrollment":""},{"nctId":"NCT00274781","phase":"PHASE2","title":"Arsenic Trioxide and Gemtuzumab Ozogamicin in Treating Patients With Advanced Myelodysplastic Syndromes","status":"COMPLETED","sponsor":"The Cleveland Clinic","startDate":"2004-02","conditions":"Leukemia, Myelodysplastic Syndromes","enrollment":30},{"nctId":"NCT00201695","phase":"PHASE2","title":"Liposomal Doxorubicin, Vincristine, & Dexamethasone Plus Arsenic Trioxide in Untreated Symptomatic Multiple Myeloma","status":"COMPLETED","sponsor":"Ohio State University Comprehensive Cancer Center","startDate":"2004-07","conditions":"Multiple Myeloma","enrollment":12},{"nctId":"NCT00504764","phase":"PHASE4","title":"Treatment of Relapsed Promyelocytic Leukemia With Arsenic Trioxide (ATO)","status":"COMPLETED","sponsor":"PETHEMA Foundation","startDate":"2007-07","conditions":"Acute Promyelocytic Leukemia","enrollment":60},{"nctId":"NCT00093483","phase":"PHASE1","title":"Arsenic Trioxide, Cytarabine, and Idarubicin in Treating Patients With Acute Myeloid Leukemia","status":"COMPLETED","sponsor":"Roswell Park Cancer Institute","startDate":"2002-04","conditions":"Leukemia","enrollment":61},{"nctId":"NCT00590603","phase":"PHASE1","title":"Trisenox, Ascorbic Acid and Bortezomib in Patients With Relapsed/Refractory Multiple Myeloma","status":"TERMINATED","sponsor":"Duke University","startDate":"2008-07","conditions":"Multiple Myeloma","enrollment":25},{"nctId":"NCT00053222","phase":"PHASE2","title":"Arsenic Trioxide in Treating Patients With Pancreatic Cancer That Has Not Responded to Gemcitabine","status":"COMPLETED","sponsor":"University of Chicago","startDate":"2003-02","conditions":"Pancreatic Cancer","enrollment":13},{"nctId":"NCT00003395","phase":"PHASE1","title":"Arsenic Trioxide in Treating Patients With Advanced Hematologic Cancer","status":"COMPLETED","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"1998-04","conditions":"Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm","enrollment":""},{"nctId":"NCT00005069","phase":"PHASE2","title":"Arsenic Trioxide in Treating Patients With Metastatic Kidney Cancer","status":"COMPLETED","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2000-01","conditions":"Kidney Cancer","enrollment":""},{"nctId":"NCT01861912","phase":"PHASE2, PHASE3","title":"Arsenic Trioxide TACE and Intravenous Administration in Unresectable Hepatocellular Carcinoma","status":"UNKNOWN","sponsor":"Guangdong Provincial People's Hospital","startDate":"2013-06","conditions":"Carcinoma, Hepatocellular","enrollment":258},{"nctId":"NCT00003934","phase":"PHASE3","title":"Tretinoin, Cytarabine, and Daunorubicin Hydrochloride With or Without Arsenic Trioxide Followed by Tretinoin With or Without Mercaptopurine and Methotrexate in Treating Patients With Acute Promyelocytic Leukemia","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"1999-06","conditions":"Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Promyelocytic Leukemia (M3), Childhood Acute Promyelocytic Leukemia (M3)","enrollment":420},{"nctId":"NCT00671697","phase":"PHASE1","title":"Decitabine, Arsenic Trioxide and Ascorbic Acid for Myelodysplastic Syndromes and Acute Myeloid Leukemia","status":"COMPLETED","sponsor":"Washington University School of Medicine","startDate":"2008-05","conditions":"Myelodysplastic Syndromes and Leukemia, Myeloid, Acute","enrollment":13},{"nctId":"NCT00009867","phase":"PHASE2","title":"Arsenic Trioxide in Treating Patients With Urothelial Cancer","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"2000-12","conditions":"Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter, Recurrent Urethral Cancer, Transitional Cell Carcinoma of the Bladder","enrollment":35},{"nctId":"NCT00045565","phase":"PHASE1","title":"Arsenic Trioxide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Malignant Glioma","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"2002-10","conditions":"Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma","enrollment":30},{"nctId":"NCT00661544","phase":"PHASE1, PHASE2","title":"Arsenic Trioxide With Ascorbic Acid and Melphalan for Myeloma Patients","status":"COMPLETED","sponsor":"M.D. Anderson Cancer Center","startDate":"2004-03","conditions":"Multiple Myeloma, Stem Cell Transplantation","enrollment":48},{"nctId":"NCT00075426","phase":"PHASE2","title":"Arsenic Trioxide in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer","status":"COMPLETED","sponsor":"The University of Texas Medical Branch, Galveston","startDate":"2002-11","conditions":"Lung Cancer","enrollment":30},{"nctId":"NCT00006220","phase":"PHASE1, PHASE2","title":"Arsenic Trioxide With or Without Tretinoin in Treating Patients With Hematologic Cancer That Has Not Responded to Previous Therapy","status":"TERMINATED","sponsor":"Washington University School of Medicine","startDate":"1999-06","conditions":"Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm","enrollment":5},{"nctId":"NCT00621023","phase":"PHASE2","title":"Cephalon Decitabine, Arsenic Trioxide and Ascorbic Acid for Myelodysplastic Syndrome","status":"COMPLETED","sponsor":"Duke University","startDate":"2007-11","conditions":"Myelodysplastic Syndrome","enrollment":7},{"nctId":"NCT00005786","phase":"NA","title":"Arsenic Trioxide in Treating Patients With Relapsed or Refractory Lymphoma or Leukemia","status":"TERMINATED","sponsor":"National Cancer Institute (NCI)","startDate":"2001-01","conditions":"Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Prolymphocytic Leukemia","enrollment":25},{"nctId":"NCT00061958","phase":"PHASE2","title":"Arsenic Trioxide in Treating Patients With Advanced Cancer of the Esophagus or Gastroesophageal Junction","status":"TERMINATED","sponsor":"National Cancer Institute (NCI)","startDate":"2003-06","conditions":"Adenocarcinoma of the Esophagus, Stage III Esophageal Cancer, Stage IV Esophageal Cancer","enrollment":50},{"nctId":"NCT00124605","phase":"PHASE1","title":"Arsenic Trioxide and Pamidronate in Treating Patients With Advanced Solid Tumors or Multiple Myeloma","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"2005-04","conditions":"Refractory Multiple Myeloma, Unspecified Adult Solid Tumor, Protocol Specific","enrollment":24},{"nctId":"NCT00006092","phase":"PHASE2","title":"Arsenic Trioxide for Induction Therapy of Adult Patients With Leukemia","status":"TERMINATED","sponsor":"H. Lee Moffitt Cancer Center and Research Institute","startDate":"2000-08","conditions":"Leukemia","enrollment":2},{"nctId":"NCT00513305","phase":"PHASE3","title":"Cytarabine in Combination With Arsenic Trioxide vs. Cytarabine Alone in Elderly Patients With Acute Myeloid Leukemia","status":"TERMINATED","sponsor":"Cephalon","startDate":"2007-10","conditions":"Acute Myeloid Leukemia","enrollment":67},{"nctId":"NCT00803530","phase":"PHASE2","title":"Study of Association of Arsenic Trioxide (ATO) and Ascorbic Acid in Myelodysplastic Syndromes","status":"TERMINATED","sponsor":"Fondazione Italiana Sindromi Mielodisplastiche-ETS","startDate":"2005-09","conditions":"Myelodysplastic Syndromes","enrollment":55},{"nctId":"NCT00850304","phase":"PHASE2","title":"Treatment of Non Promyelocytic Acute Myeloid Leukaemia on Elderly Patients by Low Dose Cytosar Plus Arsenic Trioxide","status":"COMPLETED","sponsor":"Tehran University of Medical Sciences","startDate":"2007-10","conditions":"Leukemia, Myeloid, Acute","enrollment":10},{"nctId":"NCT00196768","phase":"PHASE4","title":"Treatment Protocol for Relapsed Acute Promyelocytic Leukemia (APL) With Arsenic","status":"UNKNOWN","sponsor":"German AML Cooperative Group","startDate":"2005-01","conditions":"Relapsed Acute Promyelocytic Leukemia, Refractory Acute Promyelocytic Leukemia","enrollment":30}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":60,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"IV Arsenic Trioxide","genericName":"IV Arsenic Trioxide","companyName":"SDK Therapeutics, Inc.","companyId":"sdk-therapeutics-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Arsenic trioxide induces differentiation and apoptosis of leukemic cells, particularly in acute promyelocytic leukemia, through multiple pathways including PML-RARA degradation and reactive oxygen species generation. Used for Acute promyelocytic leukemia (APL), newly diagnosed and relapsed/refractory.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}