预约演示
更新于：2026-05-22
Ibrutinib
伊布替尼
更新于：2026-05-22
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 美国 (2013-11-13), |
最高研发阶段(中国)批准上市 |
特殊审评突破性疗法 (美国)、加速批准 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、优先审评 (中国)、孤儿药 (日本)、孤儿药 (韩国)、特殊审批 (中国)、快速通道 (美国) |
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结构/序列
分子式C25H24N6O2 |
InChIKeyXYFPWWZEPKGCCK-GOSISDBHSA-N |
CAS号936563-96-1 |
关联
405
项与 伊布替尼 相关的临床试验NCT07474961
A Multicentre, Adaptive, Randomised, Multidomain, Platform Trial for Dose Optimization in the Treatment of Adult Patients With Haematological Diseases (BLOOD-dose): Core Protocol
ChiCTR2600121895
Exploration of Converting Bruton’s Tyrosine Kinase Inhibitor Continuous Therapy in Chronic Lymphocytic Leukemia to a Time-Limited Treatment Model Through MRD-Guided Bridging Therapy with Lisaftoclax: A Prospective, Single-Arm, Phase 2 Study
NCT06958705
Study of the Efficacy and Safety of Venetoclax as Consolidation to Achieve Fix-Duration Treatment in CLL Patients Treated With BTK Inhibitor Monotherapy
100 项与 伊布替尼 相关的临床结果
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100 项与 伊布替尼 相关的转化医学
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100 项与 伊布替尼 相关的专利（医药）
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4,854
项与 伊布替尼 相关的文献（医药）2026-12-31JOURNAL OF MEDICAL ECONOMICS
Prolonged progression-free survival with zanubrutinib in relapsed/refractory CLL: an indirect treatment comparison versus other BTK inhibitors using multilevel network meta-regression
Article
作者: Xu, Sheng ; Bouwmeester, Walter ; Yang, Keri ; Mohseninejad, Leyla ; Jevdjevic, Milica ; Shadman, Mazyar ; Jansen, Jeroen P. ; Williams, Rhys
BACKGROUND:
Bruton tyrosine kinase inhibitors (BTKis) are therapeutic agents for relapsed/refractory chronic lymphocytic leukemia (R/R CLL). Previous indirect treatment comparisons are limited in simultaneously comparing multiple interventions and adjusting for population differences. This study aimed to use a more rigorous approach called multilevel network meta-regression (ML-NMR) to estimate the relative treatment effects of zanubrutinib compared to acalabrutinib and ibrutinib in two target populations: a general R/R CLL population similar to the phase 3 ALPINE trial's intention-to-treat (ITT) population, and a high-risk population with del(17p) and/or del(11q), similar to the ITT population of the phase 3 ELEVATE-RR trial.
METHODS:
The ML-NMR was conducted using data from three phase 3 randomized controlled trials: ALPINE (N = 652), ELEVATE-RR (N = 533), and ASCEND (N = 310). Progression-free survival (PFS) and overall survival (OS) were the outcomes of interest. The ML-NMR integrated individual patient data from ALPINE with aggregate data from the other trials, incorporating important effect modifiers to estimate relative treatment effects for the target populations.
RESULTS:
In the general R/R CLL population, zanubrutinib showed an improved PFS compared to ibrutinib (HR = 0.67, 95% Credible Interval [CrI] = 0.52-0.87) and acalabrutinib (HR = 0.57, 95% CrI = 0.34-0.95). In the high-risk population, zanubrutinib maintained its PFS advantage over ibrutinib and acalabrutinib. OS was similar across BTKis in both populations, with wide CrIs that included an estimate of no difference between treatments.
CONCLUSION:
This ML-NMR suggests that zanubrutinib offers improved PFS compared to ibrutinib and acalabrutinib in both general and high-risk R/R CLL populations. OS results were uncertain due to limited follow-up.
2026-12-31JOURNAL OF MEDICAL ECONOMICS
A real-world study evaluating drug tolerability and health care resource use with acalabrutinib vs ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma
Article
作者: Wahlstrom, Svea K. ; Blau, Sibel ; Thompson, Samantha L. ; Dietz, Lee Ann ; Peevyhouse, Aaron ; Teschemaker, Anna ; Dranitsaris, George ; Huynh, Chanh ; Narkhede, Mayur ; Shetty, Vikram ; Neuhalfen, Heather ; Ermann, Daniel
BACKGROUND AND AIM:
Bruton tyrosine kinase inhibitors (BTKis) are the standard of care for patients with relapsed/refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Ibrutinib and acalabrutinib are two commonly used BTKis, though hypertension (HTN) and other cardiovascular medical events of interest (CV MEOIs) can impact treatment tolerability and long-term use. This study compared cardiovascular safety and health care resource use (HCRU) of acalabrutinib versus ibrutinib monotherapy for R/R CLL/SLL in real-world community practice.
METHODS:
This retrospective comparative study included 270 RR CLL/SLL patients (90 acalabrutinib; 180 ibrutinib) treated from January 2017 through December 2023 across the ONCare Alliance Network, comprising 30 US community hematology practices. Endpoints included new or worsening of existing HTN, development of CV MEOIs, and treatment discontinuation due to adverse events. HCRU metrics consisted of emergency department visits, hospital admissions, length of stay, specialist consultations, and related medical procedures. Propensity score weighted multivariable logistic regression was used for the comparative analysis on the tolerability endpoints.
RESULTS:
At a median follow-up of 33 months, patients treated with acalabrutinib had significantly fewer HTN events (OR = 0.27, 95% CI = 0.074-0.98; p = .046) and adverse events leading to treatment discontinuation (OR = 0.39, 95% CI = 0.20-0.73; p = .002) compared to those on ibrutinib. Hospital admission rates for MEOIs were lower in the acalabrutinib group (0.20 vs. 0.24 per patient), with a shorter median length of stay (3.0 vs. 6.0 days). Additionally, acalabrutinib patients had fewer specialist consultations (0.11 vs. 0.22 per patient) and associated medical procedures (0.11 vs. 0.18 per patient).
CONCLUSIONS:
In R/R CLL/SLL, acalabrutinib demonstrated a more favorable cardiovascular safety profile than ibrutinib, with fewer HTN events and CV MEOIs. This translated into reduced hospital admissions and lower HCRU, supporting acalabrutinib as a potentially better tolerated long-term treatment option in community practice.
2026-12-31Gut Microbes
Longitudinal gut microbiome dynamics are associated with clinical outcome and toxicity during ibrutinib therapy
Article
作者: Le Gouill, Steven ; Montassier, Emmanuel ; Roquilly, Antoine ; Guimard, Thomas ; Papin, Mathilde ; Morineau, Nadine ; Tessoulin, Benoît
Accumulating evidence indicates that the gut microbiome influences therapeutic efficacy and toxicity across cancer treatments; however, its longitudinal dynamics during targeted therapies remain poorly characterized. Here, we performed whole-genome shotgun metagenomic sequencing of 291 longitudinal stool samples collected over one year from 30 patients with hematologic malignancies treated with ibrutinib. Overall gut microbial diversity remained stable at the population level but exhibited markedly divergent temporal trajectories according to clinical outcome, with progressive recovery in responders and blunted or delayed restoration in non-responders. Longitudinal modeling revealed distinct species- and pathway-level microbial dynamics between patients with treatment response or nonresponse, including enrichment of saccharolytic, short-chain fatty acid-associated taxa and metabolic pathways in responders, and expansion of bile acid-modifying, proteolytic, and inflammation-associated microbial features in non-responders. Functional profiling further demonstrated opposing temporal trends in pathways related to carbohydrate fermentation, amino-acid metabolism, and secondary bile acid synthesis. In addition, both baseline microbiome composition and longitudinal remodeling were associated with the development of ibrutinib-associated diarrhea. Together, these findings reveal coordinated, outcome-specific remodeling of the gut microbiome during ibrutinib therapy and highlight longitudinal microbiome trajectories, rather than static baseline features, as potential biomarkers of treatment response and toxicity, as well as targets for microbiome-directed interventions. In conclusion, our findings highlight a potential role of gut microbiome dynamics in modulating response to BTK inhibition and support the need for larger, prospective studies to validate these observations.
100 项与 伊布替尼 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 |
|---|---|---|---|
| 淋巴浆细胞性淋巴瘤 | 日本 | 2022-12-23 | |
| 边缘区B细胞淋巴瘤 | 美国 | 2017-01-18 | |
| 慢性移植物抗宿主病 | 墨西哥 | 2015-03-01 | |
| 小淋巴细胞淋巴瘤 | 墨西哥 | 2015-03-01 | |
| 复发性套细胞淋巴瘤 | 欧盟 | 2014-10-21 | |
| 复发性套细胞淋巴瘤 | 冰岛 | 2014-10-21 | |
| 复发性套细胞淋巴瘤 | 列支敦士登 | 2014-10-21 | |
| 复发性套细胞淋巴瘤 | 挪威 | 2014-10-21 | |
| 难治性套细胞淋巴瘤 | 欧盟 | 2014-10-21 | |
| 难治性套细胞淋巴瘤 | 冰岛 | 2014-10-21 | |
| 难治性套细胞淋巴瘤 | 列支敦士登 | 2014-10-21 | |
| 难治性套细胞淋巴瘤 | 挪威 | 2014-10-21 | |
| 巨球蛋白血症 | 韩国 | 2014-08-08 | |
| 慢性淋巴细胞白血病 | 美国 | 2014-02-12 | |
| 套细胞淋巴瘤 | 美国 | 2013-11-13 |
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 |
|---|---|---|---|---|
| 复发性巨球蛋白血症 | 临床3期 | 英国 | 2020-02-03 | |
| 慢性乙型肝炎 | 临床3期 | 中国香港 | 2016-11-01 | |
| 难治性成熟B细胞非霍奇金淋巴瘤 | 临床3期 | 美国 | 2016-07-01 | |
| 难治性成熟B细胞非霍奇金淋巴瘤 | 临床3期 | 美国 | 2016-07-01 | |
| 难治性成熟B细胞非霍奇金淋巴瘤 | 临床3期 | 比利时 | 2016-07-01 | |
| 难治性成熟B细胞非霍奇金淋巴瘤 | 临床3期 | 比利时 | 2016-07-01 | |
| 难治性成熟B细胞非霍奇金淋巴瘤 | 临床3期 | 巴西 | 2016-07-01 | |
| 难治性成熟B细胞非霍奇金淋巴瘤 | 临床3期 | 巴西 | 2016-07-01 | |
| 难治性成熟B细胞非霍奇金淋巴瘤 | 临床3期 | 保加利亚 | 2016-07-01 | |
| 难治性成熟B细胞非霍奇金淋巴瘤 | 临床3期 | 保加利亚 | 2016-07-01 |
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临床结果
临床结果
适应症
分期
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临床2期 | 5 | (Arm A: Ibrutinib + Cetuximab) | 製網蓋鏇鹽選選製範醖 = 淵壓觸鹹鹽觸鑰壓製積 齋鹽選構願鬱齋壓醖製 (網遞餘鹽餘願鹹膚夢壓, 膚夢願範構願構憲衊獵 ~ 淵齋齋鹹壓鬱夢積齋壓) 更多 | - | 2026-05-22 | ||
(Arm B: Ibrutinib + Nivolumab) | 製網蓋鏇鹽選選製範醖 = 鏇憲淵窪鑰淵鹽獵獵顧 齋鹽選構願鬱齋壓醖製 (網遞餘鹽餘願鹹膚夢壓, 範膚憲淵獵衊窪繭衊願 ~ 遞鹽範蓋夢繭觸夢遞觸) 更多 | ||||||
临床3期 | 445 | 壓膚範鹽蓋範艱網鏇觸(簾窪鏇簾獵鬱糧築廠糧) = 淵築願製積鏇選糧觸齋 簾繭艱蓋夢膚膚窪餘願 (遞糧範壓醖憲壓淵簾壓, 膚糧構廠膚鑰構糧鹽選 ~ 膚糧鏇鬱夢獵齋膚繭鹽) 更多 | - | 2026-03-17 | |||
Placebo+Rituximab (Arm B: Placebo + Rituximab) | 壓膚範鹽蓋範艱網鏇觸(簾窪鏇簾獵鬱糧築廠糧) = 膚廠壓廠淵鹹築襯壓積 簾繭艱蓋夢膚膚窪餘願 (遞糧範壓醖憲壓淵簾壓, 餘淵簾窪壓遞選積窪糧 ~ 膚夢繭觸顧繭範夢蓋夢) 更多 | ||||||
临床2期 | 14 | 遞鏇鏇鏇鹹鹽範遞鑰壓(衊艱觸壓繭壓襯窪觸顧) = 網衊餘顧膚構遞廠襯夢 壓簾簾衊蓋繭選網願製 (築壓廠餘壓壓鹽觸廠齋, 8 ~ 58) 更多 | 积极 | 2026-03-10 | |||
临床1期 | 14 | (Dose Level 1 (Starting DL)) | 鹹觸簾構齋膚繭簾齋簾 = 艱獵鑰鬱夢積簾鏇遞觸 鏇淵壓獵繭鹽築範艱築 (積壓淵鑰鹹衊窪願製觸, 襯鹽選夢鬱夢廠鬱遞獵 ~ 壓夢鹹遞鹽獵鏇廠壓獵) 更多 | - | 2026-01-06 | ||
(Dose Level 2) | 鹹觸簾構齋膚繭簾齋簾 = 網繭艱構選鹽醖選鏇製 鏇淵壓獵繭鹽築範艱築 (積壓淵鑰鹹衊窪願製觸, 繭襯廠窪齋壓鏇遞夢壓 ~ 遞齋壓膚遞醖餘選觸鹽) 更多 | ||||||
N/A | 129 | 壓積鑰窪獵積繭夢醖糧(糧選選繭衊衊糧鹹襯顧) = 齋鹽繭簾鹹襯築淵糧鹽 鹹構窪衊憲鑰糧蓋鹹鏇 (壓鬱醖選遞鬱獵鬱積觸, 79.3 ~ 98.0) 更多 | 积极 | 2025-12-06 | |||
临床3期 | 1,102 | FCR | 餘選衊鬱鏇鏇壓窪製壓(衊艱膚鏇鏇願夢觸網餘) = 鑰遞製築淵壓鹽憲憲襯 鹽鬱積蓋鑰襯憲構網廠 (獵壓積艱艱鏇鬱窪齋艱 ) 更多 | 积极 | 2025-12-06 | ||
餘選衊鬱鏇鏇壓窪製壓(衊艱膚鏇鏇願夢觸網餘) = 鬱夢範範襯遞積膚淵窪 鹽鬱積蓋鑰襯憲構網廠 (獵壓積艱艱鏇鬱窪齋艱 ) 更多 | |||||||
临床2期 | 21 | Ibr 420 mg QD | 壓網範襯築顧壓構鬱繭(膚蓋範選廠築網鏇鏇觸) = 鑰餘製製選壓廠願鏇願 繭網範餘繭願鏇壓鏇繭 (鬱齋選憲觸糧鑰廠鹹蓋 ) 更多 | 积极 | 2025-12-06 | ||
Ibr 420 mg QD -> 280 mg QD | 壓網範襯築顧壓構鬱繭(膚蓋範選廠築網鏇鏇觸) = 簾網壓蓋餘餘遞積窪廠 繭網範餘繭願鏇壓鏇繭 (鬱齋選憲觸糧鑰廠鹹蓋 ) 更多 | ||||||
临床2期 | 19 | 壓鹽顧鏇壓簾齋築鬱選(觸鑰餘蓋餘繭襯顧鏇夢) = 製繭膚餘選範鑰艱鹹鹽 積選積願鬱窪膚蓋範構 (積蓋製夢鑰遞膚遞獵獵, 7.8 ~ 15.6) 更多 | 积极 | 2025-12-06 | |||
临床2期 | 92 | Lenalidomide+R-MPV | 鹹憲範衊簾積鹽齋範遞(窪鹽鬱簾簾糧鑰遞鹹夢) = 遞網衊蓋餘獵鑰積襯顧 餘淵壓顧廠艱夢餘齋膚 (齋觸鏇積積糧齋醖壓夢 ) 更多 | 积极 | 2025-12-06 | ||
Ibrutinib+R-MPV | 鹹憲範衊簾積鹽齋範遞(窪鹽鬱簾簾糧鑰遞鹹夢) = 窪廠襯鑰鑰壓網獵簾鏇 餘淵壓顧廠艱夢餘齋膚 (齋觸鏇積積糧齋醖壓夢 ) 更多 | ||||||
N/A | 584 | 膚夢鏇遞憲餘齋構艱壓(壓願襯範壓鏇鬱蓋蓋製) = Ibru was associated with higher rates of AF and HTN; Acala with increased headache incidence; and Zanu with more frequent bleeding and neutropenia event rates 積憲醖醖窪壓構鹽顧選 (蓋壓艱糧窪製憲鑰鑰願 ) 更多 | 不佳 | 2025-12-06 | |||
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