{"id":"atra-arsenic","safety":{"commonSideEffects":[{"rate":"10-25","effect":"Differentiation syndrome (APL syndrome)"},{"rate":"20-30","effect":"Leukocytosis"},{"rate":"10-20","effect":"Hepatotoxicity"},{"rate":"5-15","effect":"QT prolongation"},{"rate":"20-40","effect":"Nausea and vomiting"},{"rate":"10-20","effect":"Headache"},{"rate":"5-10","effect":"Peripheral neuropathy"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"ATRA binds to retinoic acid receptors and promotes differentiation of abnormal promyelocytes into mature granulocytes. Arsenic trioxide induces apoptosis of leukemic cells and triggers degradation of the pathogenic PML-RARA fusion protein characteristic of APL. The synergistic combination achieves high cure rates with reduced toxicity compared to chemotherapy alone.","oneSentence":"ATRA (all-trans retinoic acid) induces differentiation of leukemic cells while arsenic trioxide causes apoptosis and degradation of the PML-RARA fusion protein, together achieving complete remission in acute promyelocytic leukemia.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:42:50.714Z","_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":"NCT07187505","phase":"NA","title":"Venetoclax Combined With ATRA and ATO in Hyperleukocytic Acute Promyelocytic Leukemia","status":"ACTIVE_NOT_RECRUITING","sponsor":"Anhui Medical University","startDate":"2025-07-01","conditions":"Acute Promyelocytic Leukemia (APL)","enrollment":28},{"nctId":"NCT04687176","phase":"PHASE2","title":"Frontline Oral Arsenic Trioxide for APL","status":"RECRUITING","sponsor":"The University of Hong Kong","startDate":"2021-01-01","conditions":"Acute Promyelocytic Leukemia","enrollment":100},{"nctId":"NCT06982274","phase":"PHASE2","title":"Oral Arsenic With ATRA for Newly Diagnosed Patients With Acute Promyelocytic Leukemia","status":"RECRUITING","sponsor":"Instituto do Cancer do Estado de São Paulo","startDate":"2023-10-20","conditions":"Acute Promyelocytic Leukemia (APL)","enrollment":115},{"nctId":"NCT03031249","phase":"PHASE1, PHASE2","title":"Efficacy and Safety of ATO Plus ATRA in Nucleophosmin-1 Mutated Acute Myeloid Leukemia","status":"ENROLLING_BY_INVITATION","sponsor":"Institute of Hematology & Blood Diseases Hospital, China","startDate":"2017-02-08","conditions":"AML","enrollment":80},{"nctId":"NCT02688140","phase":"PHASE3","title":"Study for Patients With Newly Diagnosed, High-risk Acute Promyelocytic Leukemia","status":"COMPLETED","sponsor":"Technische Universität Dresden","startDate":"2016-06","conditions":"Acute Promyelocytic Leukemia","enrollment":135},{"nctId":"NCT05881265","phase":"PHASE2","title":"Treatment of Chidamide and Venetoclax for Retinoic Acid and Arsenic Resistant Acute Promyelocytic Leukemia","status":"RECRUITING","sponsor":"Shanghai Jiao Tong University School of Medicine","startDate":"2023-05-15","conditions":"APL","enrollment":30},{"nctId":"NCT04793919","phase":"PHASE2","title":"Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia","status":"RECRUITING","sponsor":"Associazione Italiana Ematologia Oncologia Pediatrica","startDate":"2019-10-09","conditions":"Acute Promyelocytic Leukemia","enrollment":89},{"nctId":"NCT04897490","phase":"","title":"RWE of 1st Line Treatment With ATO/ATRA for Adult APL","status":"RECRUITING","sponsor":"Grupo Argentino de Tratamiento de la Leucemia Aguda","startDate":"2021-03-01","conditions":"Promyelocytic Leukemia, Adult Acute","enrollment":50},{"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":"NCT05497310","phase":"PHASE1, PHASE2","title":"Effectiveness and Safety of Therapy Based on Attenuated ATO Plus Low-Dose ATRA in Patients With APL","status":"UNKNOWN","sponsor":"Hospital Universitario Dr. Jose E. Gonzalez","startDate":"2022-07-01","conditions":"Promyelocytic Leukemia","enrollment":15},{"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":"NCT03624270","phase":"PHASE2","title":"Oral Arsenic Trioxide for Newly Diagnosed Acute Promyelocytic Leukaemia","status":"UNKNOWN","sponsor":"The University of Hong Kong","startDate":"2018-08-15","conditions":"Acute Promyelocytic Leukemia","enrollment":60},{"nctId":"NCT02551718","phase":"NA","title":"High Throughput Drug Sensitivity Assay and Genomics- Guided Treatment of Patients With Relapsed or Refractory Acute Leukemia","status":"COMPLETED","sponsor":"University of Washington","startDate":"2015-09-11","conditions":"Recurrent Acute Leukemia of Ambiguous Lineage, Recurrent Acute Lymphoblastic Leukemia, Recurrent Acute Myeloid Leukemia","enrollment":34},{"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":"NCT05297123","phase":"PHASE1","title":"Treatment of Acute Myeloid Leukemia With Arsenic and All-trans Retinoid Acid","status":"UNKNOWN","sponsor":"First Affiliated Hospital Xi'an Jiaotong University","startDate":"2019-02-03","conditions":"Acute Myeloid Leukemia","enrollment":30},{"nctId":"NCT03751917","phase":"","title":"Long-term Safety Study of Arsenic Trioxide in Newly Diagnosed, Low-to-intermediate Risk Acute Promyelocytic Leukemia","status":"UNKNOWN","sponsor":"Gruppo Italiano Malattie EMatologiche dell'Adulto","startDate":"2020-04-14","conditions":"Acute Promyelocytic Leukemia","enrollment":100},{"nctId":"NCT01404949","phase":"PHASE2","title":"Combined Tretinoin and Arsenic Trioxide for Patients With Newly Diagnosed Acute Promyelocytic Leukemia Followed by Risk-Adapted Postremission Therapy","status":"COMPLETED","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2011-07","conditions":"Acute Promyelocytic Leukemia","enrollment":17},{"nctId":"NCT02899169","phase":"PHASE3","title":"Treatment of Non-high-risk Acute Promyelocytic Leukemia (APL) With Realgar-Indigo Naturalis Formula (RIF)","status":"UNKNOWN","sponsor":"First Affiliated Hospital Xi'an Jiaotong University","startDate":"2016-09-01","conditions":"Acute Promyelocytic Leukemia","enrollment":110},{"nctId":"NCT01191541","phase":"PHASE4","title":"Cytarabine (Ara-C) in Children With Acute Promyelocytic Leukemia (APL)","status":"COMPLETED","sponsor":"Xiaofan Zhu","startDate":"2010-05","conditions":"Leukemia","enrollment":65},{"nctId":"NCT02788201","phase":"PHASE2","title":"Genomic Based Assignment of Therapy in Advanced Urothelial Carcinoma","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"2017-03-27","conditions":"Urothelial Carcinoma, Bladder Cancer, Urinary Bladder Neoplasms","enrollment":8},{"nctId":"NCT04175587","phase":"PHASE3","title":"Randomized,International Multi-center Clinical Trial of RIF Plus RA for Non-high-risk APL","status":"UNKNOWN","sponsor":"Peking University People's Hospital","startDate":"2019-12-01","conditions":"Acute Promyelocytic Leukaemia","enrollment":109},{"nctId":"NCT02312037","phase":"","title":"Expanded Access /Compassionate Use Protocol For Relapsed Or Refractory CD33 Positive AML Patients In The USA Without Access To Comparable Or Alternative Therapy","status":"NO_LONGER_AVAILABLE","sponsor":"Pfizer","startDate":"","conditions":"CD33 Positive Acute Myelogenous Leukemia","enrollment":""},{"nctId":"NCT01987297","phase":"PHASE4","title":"Combined Retinoic Acid,Arsenic Trioxide and Chemo for Newly-diagnosed APL","status":"UNKNOWN","sponsor":"Shanghai Jiao Tong University School of Medicine","startDate":"2012-06","conditions":"Acute Promyelocytic Leukemia","enrollment":738},{"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":"NCT00852709","phase":"PHASE1","title":"Phase I Dose-Escalation Trial of Clofarabine Followed by Escalating Doses of Fractionated Cyclophosphamide in Children With Relapsed or Refractory Acute Leukemias","status":"TERMINATED","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","startDate":"2007-09-01","conditions":"Myelodysplastic Syndrome, Acute Myeloid Leukemia, Myeloproliferative Disorders","enrollment":35},{"nctId":"NCT00528450","phase":"PHASE2","title":"Tretinoin and Arsenic Trioxide With or Without Idarubicin in Treating Patients With Acute Promyelocytic Leukemia","status":"TERMINATED","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2007-09","conditions":"Leukemia","enrollment":1},{"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":"NCT00276601","phase":"PHASE2","title":"Combination Chemotherapy in Treating Patients With Acute Promyelocytic Leukemia","status":"COMPLETED","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","startDate":"2004-10","conditions":"Leukemia","enrollment":""},{"nctId":"NCT00378365","phase":"PHASE3","title":"Acute Promyelocytic Leukemia 2006 (APL)","status":"UNKNOWN","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2006-10","conditions":"Leukemia, Promyelocytic, Acute","enrollment":800},{"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":"NCT00520208","phase":"PHASE2","title":"Safety, Efficacy, & Pharmacokinetic Study of Tamibarotene to Treat Patients With Relapsed or Refractory APL","status":"COMPLETED","sponsor":"CytRx","startDate":"2007-09","conditions":"Acute Promyelocytic Leukemia","enrollment":15},{"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":"NCT00016159","phase":"PHASE2","title":"Chemotherapy Plus Monoclonal Antibody in Treating Patients With Acute Promyelocytic Leukemia","status":"COMPLETED","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2000-11","conditions":"Leukemia","enrollment":35},{"nctId":"NCT00675870","phase":"PHASE2","title":"Study of NRX 195183 Therapy for Patients With Relapsed or Refractory Acute Promyelocytic Leukemia","status":"UNKNOWN","sponsor":"NuRx Pharmaceuticals, Inc.","startDate":"2008-04","conditions":"Acute Promyelocytic Leukemia","enrollment":65}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":42,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["retinoic acid + arsenic trioxide"],"phase":"marketed","status":"active","brandName":"ATRA+Arsenic","genericName":"ATRA+Arsenic","companyName":"Shanghai Jiao Tong University School of Medicine","companyId":"shanghai-jiao-tong-university-school-of-medicine","modality":"Small molecule","firstApprovalDate":"","aiSummary":"ATRA (all-trans retinoic acid) induces differentiation of leukemic cells while arsenic trioxide causes apoptosis and degradation of the PML-RARA fusion protein, together achieving complete remission in acute promyelocytic leukemia. 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}}