{"id":"ono-4059","safety":{"commonSideEffects":[{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Neutropenia"},{"rate":null,"effect":"Thrombocytopenia"},{"rate":null,"effect":"Anemia"},{"rate":null,"effect":"Hyperglycemia"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"PI3K is a key enzyme in cell survival and proliferation pathways frequently dysregulated in cancer. By inhibiting PI3K, ONO-4059 reduces downstream signaling through AKT and mTOR, leading to reduced cell survival and growth. This mechanism is particularly relevant in hematologic malignancies and solid tumors with PI3K pathway activation.","oneSentence":"ONO-4059 is a small-molecule inhibitor of phosphoinositide 3-kinase (PI3K) that blocks PI3K signaling to suppress tumor cell proliferation and survival.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:24:23.180Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Relapsed or refractory lymphoma"},{"name":"Other hematologic malignancies"}]},"trialDetails":[{"nctId":"NCT07104032","phase":"PHASE3","title":"IGNITE: Study of Tirabrutinib vs Rituximab/Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)","status":"RECRUITING","sponsor":"Ono Pharmaceutical Co. Ltd","startDate":"2026-03","conditions":"Relapsed/Refractory Primary Central Nervous System Lymphoma","enrollment":132},{"nctId":"NCT03740529","phase":"PHASE1, PHASE2","title":"A Study of Oral LOXO-305 in Patients With Previously Treated CLL/SLL or NHL","status":"COMPLETED","sponsor":"Loxo Oncology, Inc.","startDate":"2019-03-15","conditions":"Chronic Lymphocytic Leukemia, Waldenstrom Macroglobulinemia, Mantle Cell Lymphoma","enrollment":803},{"nctId":"NCT06696716","phase":"PHASE3","title":"ONO-4059 Study in Patients With Steroid-resistant Pemphigus","status":"RECRUITING","sponsor":"Ono Pharmaceutical Co. Ltd","startDate":"2022-08-15","conditions":"Pemphigus, Steroid-resistant Pemphigus","enrollment":34},{"nctId":"NCT04947319","phase":"PHASE2","title":"Study of Tirabrutinib (ONO-4059) in Patients With Primary Central Nervous System Lymphoma (PROSPECT Study)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Ono Pharmaceutical Co. Ltd","startDate":"2021-12-29","conditions":"Refractory Primary Central Nervous System Lymphoma, Primary CNS Lymphoma","enrollment":119},{"nctId":"NCT03162536","phase":"PHASE1, PHASE2","title":"A Study of Nemtabrutinib (MK-1026) in Participants With Relapsed or Refractory Hematologic Malignancies (ARQ 531-101/MK-1026-001)","status":"ACTIVE_NOT_RECRUITING","sponsor":"ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)","startDate":"2017-06-26","conditions":"Lymphoma, B-Cell, Small Lymphocytic Lymphoma, Chronic Lymphocytic Leukemia","enrollment":190},{"nctId":"NCT02457598","phase":"PHASE1","title":"Dose Escalation and Dose Expansion Study of Tirabrutinib in Combination With Other Targeted Anti-cancer Therapies in Adults With B-cell Malignancies","status":"TERMINATED","sponsor":"Gilead Sciences","startDate":"2015-06-16","conditions":"B-cell Malignancies","enrollment":203},{"nctId":"NCT06541665","phase":"PHASE1","title":"Phase I Study Evaluating Tolerability, Safety, Pharmacokinetics, and Efficacy of Combined ONO-4059 and R-MPV Therapy for PCNSL","status":"ACTIVE_NOT_RECRUITING","sponsor":"Ono Pharmaceutical Co. Ltd","startDate":"2024-05-17","conditions":"Primary Central Nervous System Lymphoma","enrollment":20},{"nctId":"NCT02457559","phase":"PHASE1","title":"Study to Assess the Long-term Safety and Efficacy of Tirabrutinib in Adults With Relapsed/Refractory B-cell Malignancies","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2015-09-10","conditions":"Relapsed/Refractory B-cell Malignancies","enrollment":29},{"nctId":"NCT02968563","phase":"PHASE2","title":"Study to Evaluate the Safety and Efficacy of the Combination of Tirabrutinib and Idelalisib With and Without Obinutuzumab in Adults With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2016-12-13","conditions":"Chronic Lymphocytic Leukemia","enrollment":35},{"nctId":"NCT02983617","phase":"PHASE2","title":"Safety and Efficacy of the Combination of Tirabrutinib and Entospletinib With and Without Obinutuzumab in Adults With Chronic Lymphocytic Leukemia (CLL)","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2017-04-06","conditions":"Chronic Lymphocytic Leukemia","enrollment":36},{"nctId":"NCT04827589","phase":"PHASE2","title":"Study to Evaluate the Efficacy, Safety, and Tolerability of Tirabrutinib in Participants With Antihistamine-Resistant Chronic Spontaneous Urticaria","status":"WITHDRAWN","sponsor":"Gilead Sciences","startDate":"2021-07","conditions":"Chronic Spontaneous Urticaria","enrollment":""},{"nctId":"NCT01659255","phase":"PHASE1","title":"Study to Evaluate the Safety and Tolerability of Tirabrutinib (ONO/GS-4059) Given as Monotherapy in Participants With Relapsed/Refractory NHL and CLL","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2012-08-17","conditions":"Non Hodgkins Lymphoma, Chronic Lymphocytic Leukaemia","enrollment":90},{"nctId":"NCT03100942","phase":"PHASE2","title":"Study to Assess Safety and Efficacy of Filgotinib, Lanraplenib and Tirabrutinib in Adults With Active Sjogren's Syndrome","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2017-05-01","conditions":"Sjogren's Syndrome","enrollment":152},{"nctId":"NCT02626026","phase":"PHASE1","title":"Study to Evaluate Safety and Pharmacokinetics of GS-4059 (Tirabrutinib) in Healthy Volunteers and Participants With Rheumatoid Arthritis (RA)","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2016-01-26","conditions":"Rheumatoid Arthritis","enrollment":42}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":14,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Tirabrutinib hydrochloride","Tirabrutinib Hydrochloride"],"phase":"phase_3","status":"active","brandName":"ONO-4059","genericName":"ONO-4059","companyName":"Ono Pharmaceutical Co. Ltd","companyId":"ono-pharmaceutical-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"ONO-4059 is a small-molecule inhibitor of phosphoinositide 3-kinase (PI3K) that blocks PI3K signaling to suppress tumor cell proliferation and survival. Used for Relapsed or refractory lymphoma, Other hematologic malignancies.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}