{"id":"icp-022","safety":{"commonSideEffects":[{"rate":null,"effect":"Infection"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Hemorrhage"},{"rate":null,"effect":"Atrial fibrillation"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"BTK is a critical enzyme in the B-cell receptor signaling pathway and is overactive in many B-cell lymphomas and leukemias. By inhibiting BTK, ICP-022 reduces proliferation and survival of malignant B cells while also modulating the tumor microenvironment. This mechanism has demonstrated efficacy in chronic lymphocytic leukemia and other B-cell malignancies.","oneSentence":"ICP-022 is a Bruton's tyrosine kinase (BTK) inhibitor that blocks BTK signaling to suppress B-cell and myeloid cell activation in hematologic malignancies.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:48:13.055Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Chronic lymphocytic leukemia (CLL)"},{"name":"Small lymphocytic lymphoma (SLL)"},{"name":"Mantle cell lymphoma (MCL)"}]},"trialDetails":[{"nctId":"NCT07247383","phase":"PHASE2","title":"Orelabrutinib Plus Low-Dose Radiotherapy Or Rituximab For Ocular Adnexal MALT Lymphoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Second Affiliated Hospital, School of Medicine, Zhejiang University","startDate":"2025-09-19","conditions":"Marginal Zone Lymphoma of Ocular Adnexal, Marginal Zone Lymphoma(MZL)","enrollment":39},{"nctId":"NCT06700798","phase":"PHASE2","title":"Orelabrutinib Combined With Rituximab Versus R-CVP in the Untreated MZL： A Randomized, Open Phase II Trial","status":"RECRUITING","sponsor":"Fei Li","startDate":"2024-12-01","conditions":"Marginal Zone Lymphoma(MZL)","enrollment":90},{"nctId":"NCT05209620","phase":"PHASE2","title":"Orelabrutinib Combined With Pemetrexed For Relapsed/Refractory Central Nervous System Lymphoma","status":"RECRUITING","sponsor":"Henan Cancer Hospital","startDate":"2021-12-21","conditions":"Central Nervous System Lymphoma","enrollment":30},{"nctId":"NCT04438005","phase":"PHASE2","title":"A Study of ICP-022 in Patients With R/R DLBCL","status":"COMPLETED","sponsor":"Beijing InnoCare Pharma Tech Co., Ltd.","startDate":"2020-05-07","conditions":"Diffuse Large B Cell Lymphoma","enrollment":3},{"nctId":"NCT03797456","phase":"PHASE2","title":"A Study to Evaluate ICP-022 in Patients With R/R Marginal Zone Lymphoma (MZL)","status":"COMPLETED","sponsor":"Beijing InnoCare Pharma Tech Co., Ltd.","startDate":"2019-04-01","conditions":"MZL","enrollment":111},{"nctId":"NCT04440059","phase":"PHASE2","title":"A Study of ICP-022 in the Treatment of Recurrent or Refractory Waldenstrom Macroglobulinemia","status":"COMPLETED","sponsor":"Beijing InnoCare Pharma Tech Co., Ltd.","startDate":"2019-08-10","conditions":"Waldenstrom's Macroglobulinemia Recurrent, Waldenstrom's Macroglobulinemia Refractory","enrollment":47},{"nctId":"NCT05234684","phase":"PHASE3","title":"A Study of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With MCD Subtype Diffuse Large B-cell Lymphoma","status":"UNKNOWN","sponsor":"Beijing InnoCare Pharma Tech Co., Ltd.","startDate":"2022-11-02","conditions":"Diffuse Large B Cell Lymphoma (DLBCL)","enrollment":150},{"nctId":"NCT05495828","phase":"","title":"Orelabrutinib Therapy in Patients With r/r B-cell Lymphoma Intolerant to Other Bruton Tyrosine Kinase Inhibitors","status":"UNKNOWN","sponsor":"Peking University People's Hospital","startDate":"2023-11-10","conditions":"B-cell Lymphoma","enrollment":30},{"nctId":"NCT05926427","phase":"PHASE2","title":"Orelabrutinib Combined With Rituximab and Chemotherapy for Relapsed/Refractory B-Cell Lymphoma Patients With Central Nervous System Involvement","status":"RECRUITING","sponsor":"Ruijin Hospital","startDate":"2023-08-10","conditions":"CNS Lymphoma","enrollment":25},{"nctId":"NCT04578613","phase":"PHASE3","title":"ICP-022 Versus Chlorambucil Combined With Rituximab in the Treatment of Untreated CLL/SLL","status":"UNKNOWN","sponsor":"Beijing InnoCare Pharma Tech Co., Ltd.","startDate":"2021-01-08","conditions":"Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma","enrollment":218},{"nctId":"NCT03494179","phase":"PHASE1, PHASE2","title":"A Study to Evaluate ICP-022 in Patients With R/R Mantle Cell Lymphoma (MCL)","status":"UNKNOWN","sponsor":"Beijing InnoCare Pharma Tech Co., Ltd.","startDate":"2018-04-02","conditions":"Mantle Cell Lymphoma","enrollment":120},{"nctId":"NCT04014205","phase":"PHASE1, PHASE2","title":"A Study of Tyrosine Kinase Inhibitor Orelabrutinib (ICP-022) in Patients With r/r B-Cell Malignancies","status":"UNKNOWN","sponsor":"Beijing InnoCare Pharma Tech Co., Ltd.","startDate":"2019-11-18","conditions":"Part 1：r/r B-cell Malignancies, Part 2：B-cell Malignancies","enrollment":81},{"nctId":"NCT04305197","phase":"PHASE1, PHASE2","title":"A Study of ICP-022 in Patients With Systemic Lupus Erythematosus (SLE)","status":"COMPLETED","sponsor":"Beijing InnoCare Pharma Tech Co., Ltd.","startDate":"2020-07-09","conditions":"Systemic Lupus Erythematosus","enrollment":60},{"nctId":"NCT04438044","phase":"PHASE2","title":"A Study to Evaluate ICP-022 in Patients With R/R PCNSL and SCNSL","status":"UNKNOWN","sponsor":"Beijing InnoCare Pharma Tech Co., Ltd.","startDate":"2019-06-18","conditions":"PCNSL, Secondary Central Nervous System Lymphoma","enrollment":61},{"nctId":"NCT03493217","phase":"PHASE1, PHASE2","title":"A Study to Evaluate ICP-022 in Patients With CLL/ SLL","status":"UNKNOWN","sponsor":"Beijing InnoCare Pharma Tech Co., Ltd.","startDate":"2018-04-17","conditions":"CLL/SLL","enrollment":100},{"nctId":"NCT05322733","phase":"PHASE2","title":"Orelabrutinib and Obinutuzumab Plus FC Regimen in Treating Newly Diagnosed CLL/SLL","status":"UNKNOWN","sponsor":"The First Affiliated Hospital with Nanjing Medical University","startDate":"2022-04-15","conditions":"Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma","enrollment":25},{"nctId":"NCT05020288","phase":"PHASE2","title":"A Clinical Trial of the Orelabrutinib in the Management of Refractory ITP","status":"UNKNOWN","sponsor":"Shandong University","startDate":"2021-09-01","conditions":"Immune Thrombocytopenia, Bruton's Tyrosine Kinase","enrollment":40},{"nctId":"NCT04441450","phase":"NA","title":"ADME Study of [14C]ICP-022 in Healthy Males","status":"COMPLETED","sponsor":"Beijing InnoCare Pharma Tech Co., Ltd.","startDate":"2019-07-01","conditions":"Healthy Volunteers","enrollment":6},{"nctId":"NCT03189017","phase":"PHASE1","title":"A Phase I Study of ICP-022 in Healthy Subjects","status":"COMPLETED","sponsor":"Innocare Pharma Australia Pty Ltd","startDate":"2017-07-03","conditions":"Systemic Lupus Erythematosus, Rheumatoid Arthritis","enrollment":64}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Orelabrutinib","orelabrutinib"],"phase":"phase_3","status":"active","brandName":"ICP-022","genericName":"ICP-022","companyName":"Beijing InnoCare Pharma Tech Co., Ltd.","companyId":"beijing-innocare-pharma-tech-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"ICP-022 is a Bruton's tyrosine kinase (BTK) inhibitor that blocks BTK signaling to suppress B-cell and myeloid cell activation in hematologic malignancies. Used for Chronic lymphocytic leukemia (CLL), Small lymphocytic lymphoma (SLL), Mantle cell lymphoma (MCL).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":9,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}