预约演示
更新于：2026-01-14
Zanubrutinib
泽布替尼
更新于：2026-01-14
概要
基本信息
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2019-11-14), |
最高研发阶段(中国)批准上市 |
特殊审评突破性疗法 (美国)、快速通道 (美国)、加速批准 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、优先审评 (中国)、突破性疗法 (中国)、特殊审批 (中国)、附条件批准 (中国) |
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结构/序列
分子式C27H29N5O3 |
InChIKeyRNOAOAWBMHREKO-QFIPXVFZSA-N |
CAS号1691249-45-2 |
关联
240
项与 泽布替尼 相关的临床试验NCT07341191
A Phase II Study of Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned for Standard of Care CAR-T Cell Therapy
NCT06859008
Feasibility of Treating Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma With Zanubrutinib in Combination With the BCL2 Inhibitor, Sonrotoclax, Focusing on Access for Underrepresented Ethnic/Racial Minorities
NCT07277231
A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Patients With Previously Untreated Chronic Lymphocytic Leukemia
100 项与 泽布替尼 相关的临床结果
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100 项与 泽布替尼 相关的转化医学
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100 项与 泽布替尼 相关的专利（医药）
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575
项与 泽布替尼 相关的文献（医药）2026-01-06ASM Case Reports
Fulminant and fatal
Trypanosoma cruzi
reactivation in a patient with lymphoma
Article
作者: Satlin, Michael ; Westblade, Lars F. ; Mertelsmann, Anna ; Lukose, Georgi ; Pisapia, David J. ; Coyle, Christina ; Patel, Sanjay ; Marino, Jamie ; Rolon, Rebecca M. Marrero
ABSTRACT:
Background:
Trypanosoma cruzi
is a protozoan parasite and the causative agent of Chagas disease. This case describes a fulminant and fatal reactivation of
T. cruzi
after immunosuppression in a patient with a history of follicular lymphoma, with parasitemia detectable in peripheral blood smears and parasites seen in multiple autopsy tissue specimens.
Case Summary:
A 61-year-old woman who had immigrated from El Salvador and was receiving obinutuzumab and zanubrutinib for follicular lymphoma in remission was admitted with persistent COVID-19 pneumonia. After multiple therapies for COVID-19, including more than 3 weeks of corticosteroid therapy for the possibility of organizing pneumonia, a peripheral blood smear identified
T. cruzi
trypomastigotes, and later amastigotes were identified in a bone marrow biopsy. The patient was treated with benznidazole but ultimately died. At autopsy, amastigotes were observed in multiple organs, including the heart, esophagus, stomach, small intestine, colon, bladder, and skeletal muscle.
Conclusion:
Most cases of Chagas reactivation are described in people living with HIV-1 or transplant recipients. Rarely,
T. cruzi
reactivation can occur in patients undergoing immunosuppressive therapies for malignancies or inflammatory states like COVID-19 infection, as seen in this case. If not recognized early, reactivation can be fatal despite antiparasitic treatment. Providers should consider screening patients from endemic areas who will start on immunosuppressive therapies. Repeating screening may be of value with periods of new immunosuppression. In patients with Chagas disease and malignancy, PCR from blood should be performed during enhanced immunosuppression so that preemptive treatment can be initiated prior to the presentation of fulminant disease.
2026-01-06ASM Case Reports
Bruton tyrosine kinase inhibitors and invasive aspergillosis and mucormycosis: a case report and multi-center exploratory retrospective study
Article
作者: Bhaimia, Eric ; Santos, Carlos A. Q. ; Russell, Daniel
ABSTRACT:
Background:
Bruton tyrosine kinase inhibitors (BTKIs) are increasingly utilized for patients with certain malignant hematologic conditions. While cases of invasive fungal infections have been reported in patients on BTKIs, no multi-center epidemiological studies have been performed. The Epic Cosmos platform, a nationwide electronic health record data set, provides an opportunity to assess real-world epidemiologic data.
Case Summary:
A 69-year-old female with recently diagnosed Waldenström macroglobulinemia with associated autoimmune hemolytic anemia undergoing treatment with zanubrutinib and prednisone presented with fatigue and acute kidney injury. Imaging demonstrated a bladder mass with bilateral hydronephrosis leading to transurethral resection of the bladder mass with histopathology revealing both broad ribbon-like hyphae resembling Mucorales spp. and acute-angle branching resembling
Aspergillus
spp. with angioinvasion. Additional imaging revealed bilateral pulmonary cavitary lesions and renal and brain involvement. Bronchoalveolar lavage returned a positive galactomannan and culture growth of
Aspergillus fumigatus
. The patient was treated with liposomal amphotericin B with eventual transition to oral isavuconazole. Zanubrutinib and steroids were discontinued. To assess real-world occurrence of IFIs in patients on BTKIs, we performed an exploratory analysis using Epic Cosmos.
Conclusion:
IFIs continue to be described in patients undergoing treatment with BTKIs. Through exploratory analysis using Epic Cosmos, aspergillosis occurred not infrequently (0.5%–1.9%) in patients on various BTKIs. Of patients on ibrutinib with a diagnosis of chronic graft-versus-host disease, aspergillosis was identified in 32 (8.3%) patients. Patients on BTKIs who developed aspergillosis were frequently on corticosteroids. Mucormycosis in patients on BTKIs was rare (<0.1%).
2026-01-02Expert Opinion On Drug Safety
Safety study on adverse events of zanubrutinib based on WHO-VigiAccess and FAERS databases
Article
作者: He, Ying ; Liao, Xiaolin ; Liang, Qiaofang ; Wu, Hongwen ; Huang, Yushen ; Zeng, Jiang ; Liang, Cong
OBJECTIVE:
The study endeavors to elucidate AE signals associated with zanubrutinib data from the WHO-VigiAccess and FAERS databases. The aim is to furnish robust scientific evidence to inform clinical practice and regulatory decisions.
METHODS:
We meticulously extracted all AE breports tied to zanubrutinib from the both databases, encompassing the period from the drug's market introduction until 30 April 2024. Retrospective quantitative analysis employing ROR, PRR, and BCPNN methodologies were utilized to analysis.
RESULTS:
The investigation unveiled 1,304 reports from WHO-VigiAccess and 1,141 reports from FAERS related to zanubrutinib. Among the top 30 reported PTs in both databases, those not recorded in the drug label included pyrexia, dizziness, and death. In the FAERS database, signals for zanubrutinib were detected across 19 SOCs. Systems not covered in the drug label included reproductive system and breast disorders, metabolism and nutrition disorders, ear and labyrinth disorders, among others. Unmentioned signals included intestinal perforation, onychoclasis, night sweats, etc.
CONCLUSION:
This study confirms common AEs of zanubrutinib and identifies new ones, highlighting the need for careful monitoring and personalized treatment. It also emphasizes the importance of ongoing drug safety surveillance and patient management to maximize therapeutic benefits and minimize risks.
3,014
项与 泽布替尼 相关的新闻（医药）2026-01-14
·百济神州
上市批准临床研究临床结果申请上市
2026-01-13
·雪球
临床申请临床3期引进/卖出
2026-01-13
·有驾
引进/卖出抗体药物偶联物免疫疗法细胞疗法临床2期
100 项与 泽布替尼 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 浆母细胞淋巴瘤 | 日本 | 2024-12-27 | |
| 滤泡性淋巴瘤 | 泰国 | 2024-02-07 | |
| 华氏巨球蛋白血症难治 | 泰国 | 2024-02-07 | |
| 复发性滤泡性淋巴瘤 | 欧盟 | 2023-11-17 | |
| 复发性滤泡性淋巴瘤 | 冰岛 | 2023-11-17 | |
| 复发性滤泡性淋巴瘤 | 列支敦士登 | 2023-11-17 | |
| 复发性滤泡性淋巴瘤 | 挪威 | 2023-11-17 | |
| 复发性边缘区淋巴瘤 | 美国 | 2023-01-19 | |
| 难治性边缘区淋巴瘤 | 巴西 | 2022-11-10 | |
| 难治性滤泡性淋巴瘤 | 英国 | 2021-12-06 | |
| 边缘区B细胞淋巴瘤 | 乌拉圭 | 2021-04-28 | |
| 巨球蛋白血症 | 加拿大 | 2021-03-30 | |
| 慢性淋巴细胞白血病 | 中国 | 2020-06-03 | |
| 小淋巴细胞淋巴瘤 | 中国 | 2020-06-02 | |
| 套细胞淋巴瘤 | 美国 | 2019-11-14 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 特发性膜性肾病 | 临床3期 | 美国 | 2023-04-17 | |
| 特发性膜性肾病 | 临床3期 | 中国 | 2023-04-17 | |
| 特发性膜性肾病 | 临床3期 | 阿根廷 | 2023-04-17 | |
| 特发性膜性肾病 | 临床3期 | 巴西 | 2023-04-17 | |
| 特发性膜性肾病 | 临床3期 | 加拿大 | 2023-04-17 | |
| 特发性膜性肾病 | 临床3期 | 捷克 | 2023-04-17 | |
| 特发性膜性肾病 | 临床3期 | 意大利 | 2023-04-17 | |
| 特发性膜性肾病 | 临床3期 | 波兰 | 2023-04-17 | |
| 特发性膜性肾病 | 临床3期 | 俄罗斯 | 2023-04-17 | |
| 特发性膜性肾病 | 临床3期 | 土耳其 | 2023-04-17 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 57 | 範獵醖齋範願鹽襯製壓(廠餘艱襯構遞鏇壓廠構) = 觸選夢繭簾糧網遞鹹憲 鏇獵鑰構製構鏇製窪餘 (鹽艱構廠夢製顧艱鑰鑰, 43.2 ~ 72.4) 更多 | 积极 | 2025-12-06 | |||
临床2期 | 22 | 齋艱艱膚憲憲繭觸網築(鑰獵襯鹽鬱齋醖築範蓋) = 鬱淵選壓醖窪鬱觸鏇醖 鹹遞壓衊鹹蓋糧艱鑰築 (蓋鏇壓製糧網艱鹽鏇網 ) 更多 | 积极 | 2025-12-06 | |||
临床2期 | 38 | Tislelizumab combined with zanubrutinib and high-dose methotrexate | 繭製範鑰夢網鹽艱衊蓋(觸鑰顧築遞廠窪艱窪蓋) = The most prevalent adverse reaction associated with the TZM regimen was non-hematological toxicity. These included three instances of MTX-related renal injury, two cases of severe infection, one case of severe gastrointestinal mucosal injury, one instance of chemotherapy-related capillary cell leakage syndrome, and one case of tislelizumab-related rash and liver injury. Hematological toxicity was limited to two cases of grade 1-2 granulocytopenia in this study. 衊築積鬱糧獵鹹鏇鑰糧 (製憲蓋餘繭膚鹽衊夢衊 ) 更多 | 积极 | 2025-12-06 | ||
N/A | 巨球蛋白血症 MYD88L265P | CXCR4 mutations | 99 | 鹽範鏇艱顧觸廠獵衊築(餘夢簾衊簾構夢廠齋蓋) = 獵鑰蓋簾窪壓鏇構糧餘 構顧繭範艱獵醖繭簾構 (鏇衊選衊製齋鹽範壓觸 ) 更多 | 积极 | 2025-12-06 | ||
N/A | 175 | 願鏇廠獵壓網壓積鬱壓(艱蓋壓襯憲壓觸淵鹹獵) = 97% had at least one documented AE (grade unspecified) during treatment. The most common AEs were bleeding/bruising (33%), fatigue (31%), gastrointestinal symptoms (28%), musculoskeletal pain (24%), neuropsychiatric symptoms (21%), infections (15%), and cytopenia (12%). 艱廠醖觸鹹壓鑰鏇顧鹽 (膚鏇膚鬱餘鏇鹹鏇積鏇 ) 更多 | 积极 | 2025-12-06 | |||
N/A | 2,264 | 鹹選範蓋齋糧築繭遞憲(簾醖鹽鬱獵衊夢製窪願) = including pneumonia (6.63% vs 5.92%, p = 0.4880; RR: 1.119, 95% CI: 0.814 to 1.54), sepsis (4.51% vs 3.53%, p = 0.2392; RR: 1.275, 95% CI: 0.85 to 1.913), GI symptoms (6.98% vs 5.83%, p = 0.2645; RR: 1.197, 95% CI: 0.872 to 1.699), and atrial fibrillation/flutter (7.98% vs 7.18%, p = 0.4741; RR: 1.11, 95% CI: 0.833 to 1.483), was slightly higher with acalabrutinib, though differences were not statistically significant between cohorts. Rates of headache (RD: 0.297, p = 0.6955; RR: 1.11; 95% CI: 0.67 to 1.82), neutropenia/neutropenic fever (RD: 1.237, p = 0.1442; RR: 1.341, 95% CI: 0.903 to 1.993) and thrombocytopenia (RD: -0.618%, p = 0.6716; RR: 0.957, 95% CI: 0.78 to 1.174) did not differ significantly. 齋糧積範鑰衊憲繭製艱 (齋膚醖選膚蓋網遞夢膚 ) 更多 | 积极 | 2025-12-06 | |||
N/A | 136 | 憲選夢鬱製糧遞餘鏇膚(醖鬱淵襯簾憲簾膚願憲) = 鏇鏇選夢壓遞襯觸齋艱 膚獵壓願繭鹹築淵衊壓 (製鑰艱艱願膚餘構遞鑰 ) 更多 | 积极 | 2025-12-06 | |||
憲選夢鬱製糧遞餘鏇膚(醖鬱淵襯簾憲簾膚願憲) = 憲齋淵鏇襯蓋構觸齋淵 膚獵壓願繭鹹築淵衊壓 (製鑰艱艱願膚餘構遞鑰 ) 更多 | |||||||
N/A | 一线 TP53 mutation/deletion | 23 | 淵範壓鑰製夢衊淵艱淵(夢艱夢範鑰鏇鏇鏇獵醖) = 築顧窪構齋鹹觸選鏇壓 膚鏇壓餘憲觸製鬱蓋築 (鹹蓋憲獵遞糧製積積繭 ) 更多 | 积极 | 2025-12-06 | ||
N/A | 26 | (treatment-naïve) | 範選鏇簾製範簾憲鏇鬱(襯夢窪憲鬱築獵網廠鑰) = Four pts required ZANU dose reductions due to adverse events (grade 1 thrombocytopenia and postsurgical bleeding; grade 2 hypertension; and grade 2 arthralgia), with improved tolerability thereafter; all had responding disease at the time of dose reduction, which continued despite dose reduction. 鑰鏇顧膚簾願製積襯製 (蓋願夢構衊壓窪製憲艱 ) | 积极 | 2025-12-06 | ||
(relapsed/refractory) | |||||||
临床2期 | 214 | 築簾網鏇醖鑰築築鬱遞(艱遞願遞夢鏇廠選構醖) = 願衊窪構簾構艱鑰壓醖 鬱製願鹹積鏇鏇選憲鏇 (製襯膚顧艱壓糧鹹憲選 ) 更多 | 积极 | 2025-12-06 | |||
築簾網鏇醖鑰築築鬱遞(艱遞願遞夢鏇廠選構醖) = 艱鏇築窪網積廠網壓築 鬱製願鹹積鏇鏇選憲鏇 (製襯膚顧艱壓糧鹹憲選 ) 更多 |
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