Drugs / Orelabrutinib
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Orelabrutinib

also known as ICP-022 · Innobruka · Obrutinib

Small molecule targets BTK

Developed for
marginal zone lymphoma · diffuse large B-cell lymphoma · mantle cell lymphoma · primary central nervous system lymphoma · autoimmune thrombocytopenia · chronic lymphocytic leukemia/small lymphocytic lymphoma · central nervous system non-hodgkin lymphoma · follicular lymphoma
+22 more · systemic lupus erythematosus · autoimmune hemolytic anemia · B-cell chronic lymphocytic leukemia · B-cell neoplasm · B-cell non-Hodgkin lymphoma · Burkitt lymphoma · central nervous system cancer · gastric mucosa-associated lymphoid tissue lymphoma · hematopoietic and lymphoid cell neoplasm · high grade B-cell lymphoma · high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement · lymphoma · MALT lymphoma · MCD diffuse large B-cell lymphoma · neuromyelitis optica spectrum disorder with anti-AQP4 antibodies · non-Hodgkin lymphoma · ocular adnexal lymphoma · primary progressive multiple sclerosis · primary thrombocytopenia · relapsing-remitting multiple sclerosis · secondary progressive multiple sclerosis · Waldenstrom macroglobulinemia
Investigated by
Beijing InnoCare Pharma Tech Co., Ltd. · Ruijin Hospital · Second Affiliated Hospital, School of Medicine, Zhejiang University · Peking Union Medical College Hospital · The First Affiliated Hospital of Soochow University · The First Affiliated Hospital with Nanjing Medical University
+135 more · Beijing Tongren Hospital · Fujian Medical University Union Hospital · Qilu Hospital of Shandong University · The First Affiliated Hospital of Anhui Medical University · Affiliated Hospital of Jiaxing University · First Affiliated Hospital of Zhejiang University · Fudan University · Henan Cancer Hospital · Huzhou Central Hospital · Institute of Hematology & Blood Diseases Hospital, China · Second Affiliated Hospital of Wenzhou Medical University · Sun Yat-sen University · The Second Affiliated Hospital of Dalian Medical University · The Second Affiliated Hospital of Jiaxing University · The Third Xiangya Hospital of Central South University · Tianjin Medical University Cancer Institute and Hospital · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Zhejiang Cancer Hospital · Affiliated Hospital of Nantong University · Beijing Hospital · Dongyang People's Hospital · Fei Li · Fifth Affiliated Hospital of Guangzhou Medical University · First Affiliated Hospital of Wenzhou Medical University · First People's Hospital of Hangzhou · Fujian Cancer Hospital · Gansu Cancer Hospital · Huadong Hospital · Huashan Hospital · InnoCare Pharma Inc. · Jiangxi Provincial Cancer Hospital · Nanfang Hospital, Southern Medical University · Ningbo People's Hospital · Peking University People's Hospital · Peking University Third Hospital · Shandong Cancer Hospital and Institute · Shandong University · Shanxi Province Cancer Hospital · Shaoxing Central Hospital · Shaoxing People's Hospital · Taizhou First People's Hospital · Taizhou Hospital · Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University · The Affiliated Hospital of Xuzhou Medical University · The Central Hospital of Lishui City · The First Affiliated Hospital of Nanchang University · The First Affiliated Hospital of Xiamen University · The First Affiliated Hospital of Zhengzhou University · The First Hospital of Jilin University · The People's Hospital of Quzhou · Yantai Yuhuangding Hospital · Yuyao People's Hospital · Zenas BioPharma (USA), LLC · Zhejiang Provincial People's Hospital · Zhejiang Provincial Tongde Hospital · Zhuji People's Hospital of Zhejiang Province · Affiliated Cancer Hospital of Harbin Medical University · Affiliated Hospital of Guilin Medical College · Affiliated Hospital to Academy of Military Medical Sciences · Affiliated Zhongshan Hospital of Dalian University · Air Force Military Medical University, China · Anhui Provincial Cancer Hospital · Beijing Luhe Hospital · Beijing Tiantan Hospital · BioRay Pharmaceutical Co., Ltd. · Cancer Hospital Affiliated to Xinjiang Medical University · Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Capital Medical University · Central South University · Changxing County Traditional Chinese Medicine Hospital · China-Japan Friendship Hospital · Chinese PLA General Hospital · Dongguan People's Hospital · Fifth Affiliated Hospital, Sun Yat-Sen University · all 141 on the full record

Trials 102 · started per year

today
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2018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 17 trials
Phase 1 NCT07574073 Jun 2026 → May 2028 expected autoimmune hemolytic anemia, autoimmune thrombocytopenia Qi deng Not yet recruiting No outcome recorded
Phase 1 NCT05684653 Mar → Dec 2023 Beijing InnoCare Pharma Tech Co., Ltd. Unknown No outcome recorded
Phase 1 NCT05728658 Mar 2023 → Aug 2025 overdue hematopoietic and lymphoid cell neoplasm Beijing InnoCare Pharma Tech Co., Ltd. Recruiting No outcome recorded
Phase 1 NCT05660720 Nov 2022 → Jun 2023 Beijing InnoCare Pharma Tech Co., Ltd. Unknown No outcome recorded
Phase 1 NCT05316857 Dec 2021 → Jan 2022 Beijing InnoCare Pharma Tech Co., Ltd. Completed No outcome recorded
Phase 1 NCT05036577 Oct 2021 → Dec 2023 overdue primary central nervous system lymphoma Huashan Hospital Active not recruiting No outcome recorded
Phase 1 NCT03189017 Jul 2017 → Feb 2018 rheumatoid arthritis, systemic lupus erythematosus Innocare Pharma Australia Pty Ltd Completed No outcome recorded
Phase 1/28 trials
Phase 1/2 NCT05124028 Dec 2021 → Mar 2022 autoimmune thrombocytopenia Peking University People's Hospital Unknown No outcome recorded
Phase 1/2 NCT05021770 Dec 2021 → Dec 2022 non-Hodgkin lymphoma, primary central nervous system lymphoma Huiqiang Huang Unknown No outcome recorded
Phase 1/2 NCT04831658 Mar 2021 → Sep 2023 primary central nervous system lymphoma Mingzhi Zhang Unknown No outcome recorded
Phase 1/2 NCT04304040 Jul 2020 → Dec 2025 B-cell non-Hodgkin lymphoma Beijing InnoCare Pharma Tech Co., Ltd. Unknown No outcome recorded
Phase 1/2 NCT04305197 Jul 2020 → Apr 2022 systemic lupus erythematosus Beijing InnoCare Pharma Tech Co., Ltd. Completed No outcome recorded
Phase 1/2 NCT04014205 Nov 2019 → Jun 2026 overdue B-cell neoplasm Beijing InnoCare Pharma Tech Co., Ltd. Active not recruiting No outcome recorded
Phase 1/2 NCT03493217 Apr 2018 → Dec 2022 chronic lymphocytic leukemia/small lymphocytic lymphoma Beijing InnoCare Pharma Tech Co., Ltd. Unknown No outcome recorded
Phase 1/2 NCT03494179 Apr 2018 → Apr 2020 mantle cell lymphoma Beijing InnoCare Pharma Tech Co., Ltd. Completed No outcome recorded
Phase 264 trials
Phase 2 NCT07677813 Jun 2026 → Dec 2029 expected MCD diffuse large B-cell lymphoma Ou Bai, MD/PHD Not yet recruiting No outcome recorded
Phase 2 NCT07554898 Apr 2026 → Feb 2028 expected MALT lymphoma Zhejiang Cancer Hospital Recruiting No outcome recorded
Phase 2 NCT07585747 Apr 2026 → Dec 2029 expected follicular lymphoma Institute of Hematology & Blood Diseases Hospital, China Not yet recruiting No outcome recorded
Phase 2 NCT07400250 Apr → Oct 2026 expected autoimmune thrombocytopenia Peking Union Medical College Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07453368 Mar 2026 → Mar 2027 expected autoimmune hemolytic anemia Peking Union Medical College Hospital Recruiting No outcome recorded
Phase 2 NCT07680933 Mar 2026 → Jun 2027 expected diffuse large B-cell lymphoma The Affiliated Hospital of Xuzhou Medical University Recruiting No outcome recorded
Phase 2 NCT07410520 Feb 2026 → Dec 2028 expected central nervous system non-hodgkin lymphoma The First Affiliated Hospital with Nanjing Medical University Recruiting No outcome recorded
Phase 2 NCT07441993 Jan 2026 → Dec 2027 expected marginal zone lymphoma Institute of Hematology & Blood Diseases Hospital, China Recruiting No outcome recorded
Phase 2 NCT07499271 Jan 2026 → Dec 2027 expected diffuse large B-cell lymphoma The First Affiliated Hospital of Soochow University Recruiting No outcome recorded
Phase 2 NCT07372365 Oct 2025 → Apr 2028 expected marginal zone lymphoma The First Affiliated Hospital of Soochow University Recruiting No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT07185373 Oct 2025 → Sep 2028 expected primary central nervous system lymphoma Huashan Hospital Not yet recruiting No outcome recorded
Phase 313 trials
Phase 3 NCT07559331 Apr 2026 → Apr 2027 expected primary thrombocytopenia Shandong University Recruiting No outcome recorded
Phase 3 NCT07299019 Mar 2026 → Jun 2030 expected secondary progressive multiple sclerosis Zenas BioPharma (USA), LLC Recruiting No outcome recorded
Phase 3 NCT07067463 Mar 2026 → Jun 2030 expected primary progressive multiple sclerosis Zenas BioPharma (USA), LLC Recruiting No outcome recorded
Phase 3 NCT06496308 Jul 2024 → Jul 2027 expected mantle cell lymphoma Ruijin Hospital Recruiting No outcome recorded
Phase 3 NCT06082102 Dec 2023 → Aug 2028 expected marginal zone lymphoma Beijing InnoCare Pharma Tech Co., Ltd. Recruiting No outcome recorded
Phase 3 NCT06004856 Oct 2023 → Dec 2025 autoimmune thrombocytopenia Beijing InnoCare Pharma Tech Co., Ltd. Unknown No outcome recorded
Phase 3 NCT05234684 Nov 2022 → Jul 2024 diffuse large B-cell lymphoma Beijing InnoCare Pharma Tech Co., Ltd. Unknown No outcome recorded
Phase 3 NCT05351346 Jun 2022 → Jun 2026 diffuse large B-cell lymphoma Ruijin Hospital Unknown No outcome recorded
Phase 3 NCT05051891 Dec 2021 → Jun 2025 mantle cell lymphoma Beijing InnoCare Pharma Tech Co., Ltd. Completed No outcome recorded
Phase 3 NCT05334238 Dec 2021 → May 2024 primary central nervous system lymphoma Ruijin Hospital Unknown No outcome recorded
Phase 41 trial
Phase 4 NCT07355699 Nov 2025 → Sep 2027 expected marginal zone lymphoma Beijing Tongren Hospital Recruiting No outcome recorded
Phase not applicable8 trials
NCT07191431 Sep 2025 → Sep 2027 expected central nervous system non-hodgkin lymphoma Ruijin Hospital Recruiting No outcome recorded
NCT07257510 Aug 2025 → Aug 2028 expected mantle cell lymphoma Peking University Third Hospital Recruiting No outcome recorded
NCT07072208 Nov 2024 → May 2027 expected diffuse large B-cell lymphoma The First Affiliated Hospital of Soochow University Recruiting No outcome recorded
NCT06478472 Jun 2024 → Jun 2027 expected marginal zone lymphoma The First Affiliated Hospital of Xiamen University Recruiting No outcome recorded
NCT05784987 Apr 2023 → Jan 2024 diffuse large B-cell lymphoma The First Affiliated Hospital with Nanjing Medical University Unknown No outcome recorded
NCT05809180 Jan 2023 → Jul 2025 diffuse large B-cell lymphoma The First Affiliated Hospital of Soochow University Unknown No outcome recorded
NCT05284175 Apr 2022 → Aug 2023 neuromyelitis optica spectrum disorder with anti-AQP4 antibodies Peking Union Medical College Hospital Unknown No outcome recorded
NCT04441450 Jul → Aug 2019 Beijing InnoCare Pharma Tech Co., Ltd. Completed No outcome recorded
Also used as a comparator or background therapy in 6 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 22 trials
Phase 2 NCT07350850 Comparator Dec 2025 → Dec 2028 expected primary central nervous system lymphoma Tongji Hospital Recruiting No outcome recorded
Phase 2 NCT06958705 Background Dec 2025 → Dec 2027 expected chronic lymphocytic leukemia/small lymphocytic lymphoma The First Affiliated Hospital with Nanjing Medical University Recruiting No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT06378138 Background May 2024 → Nov 2030 expected hematopoietic and lymphoid cell neoplasm Beijing InnoCare Pharma Tech Co., Ltd. Recruiting No outcome recorded
Phase 32 trials
Phase 3 NCT07377578 Comparator Feb 2026 → May 2031 expected mantle cell lymphoma Guangzhou Lupeng Pharmaceutical Company LTD. Recruiting No outcome recorded
Phase 3 NCT06363994 Comparator May 2024 → Jun 2031 expected mantle cell lymphoma InnoCare Pharma Inc. Recruiting No outcome recorded
Phase 41 trial
Phase 4 NCT06134284 Background Jan 2023 → Dec 2026 expected marginal zone lymphoma Lixia Sheng Recruiting No outcome recorded

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 109 sources stand behind the page.

FieldValueCited text
Known as Orelabrutinib “This study was an open-label, single-arm, phase 1/2 trial evaluating orelabrutinib combined with an anti-programmed cell death protein-1 (PD-1) antibody and a non-methotrexate...” PMID 41485126 Jan 2026
96

“During the induction therapy phase, patients will receive 90 mg/m2 of bendamustine and 375 mg/m2 zuberitamab from cycles 1 to 3, followed by 150 mg of orelabrutinib and 375...” NCT07008053

“This study aims to select Zuberitamab, a human-mouse chimeric anti-CD20 monoclonal antibody, and the BTKi Orelabrutinib as combination therapy options.” NCT07574073

“Covalent BTK inhibitor (Ibrutinib 560 mg qd, Zanubrutinib 160 mg bid, or Orelabrutinib 150 mg qd) orally on Days 1-21.” NCT07350850

Orelabrutinib is a newly developed BTK inhibitor with high selectivity and have received its approval in China.” NCT05020392

“First-line Treatment of PCNSL With the Combination of Orelabrutinib, Rituximab, and Methotrexate (ORM Regimen)” NCT06454266

Orelabrutinib 50mg per tablet 150mg orally per day from Days 1 to 21 of each cycle” NCT07072208

Orelabrutinib 150mg, po, gd, D1-D28, every 28 days, cycle 1-12” NCT06985472

NCT06566807

NCT07377578

NCT06478472

NCT05390749

NCT05381506

NCT07199296

NCT07247383

NCT05728658

NCT06476899

NCT06901999

NCT06004856

NCT07372365

NCT06290817

NCT04711148

NCT07677813

NCT04899427

NCT04304040

NCT07400250

NCT05124028

NCT07022223

NCT06134284

NCT06513234

NCT05926427

NCT05316857

NCT06363994

NCT07559331

NCT07448324

NCT05036577

NCT07272499

NCT05549284

NCT07410520

NCT06516978

NCT05014100

NCT05688696

NCT07585747

NCT05076097

NCT06647940

NCT07078500

NCT07206264

NCT07299019

NCT07680933

NCT06082102

NCT04961515

NCT05978739

NCT05021770

NCT05020288

NCT05918276

NCT06700798

NCT06701357

NCT07480863

NCT06228963

NCT06793189

NCT05784987

NCT06958705

NCT06504940

NCT05051891

NCT04989621

NCT05322733

NCT07499271

NCT07208981

NCT05334238

NCT07554898

NCT06530511

NCT06503276

NCT05600660

NCT07257510

NCT07355699

NCT05491044

NCT07191431

NCT05234684

NCT05351346

NCT04014205

NCT05660720

NCT06656221

NCT07185373

NCT05232149

NCT05684653

NCT06496308

NCT05284175

NCT07453368

NCT05498259

NCT07067463

NCT06583837

NCT05809180

NCT06454968

NCT05933967

NCT05097443

NCT07441993

NCT06378138

Known as ICP-022 “Orelabrutinib (ICP-022)” NCT07247383
12

“Orelabrutinib (ICP-022)” NCT04014205

NCT03494179

NCT03493217

NCT04305197

NCT04438044

NCT03189017

NCT04441450

NCT04438005

NCT05209620

NCT04578613

NCT04440059

NCT03797456

Known as Innobruka ChEMBL registry synonym — accepted as the source's own label CHEMBL4650321
Known as Obrutinib “Orelabrutinib + rituximab for a total of 6 cycles of 28 days each Obrutinib (O) 150mg oral d1-28 Rituximab (R) 375mg/m2 IV d0” NCT06478472
Action Inhibit “novel BTK inhibitor” NCT04014205
Modality Small molecule “highly selective oral small-molecule BTK inhibitor” NCT07441993
Route Oral oral single and multiple escalating dose administration” NCT03189017
Target BTK “novel BTK inhibitor” NCT04014205