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更新于：2025-04-23
Tirabrutinib Hydrochloride
替拉鲁替尼
更新于：2025-04-23
概要
基本信息
药物类型 小分子化药 |
别名 Tirabrutinib、Tirabrutinib hydrochloride (JAN)、Tirabutinib hydrochloride + [7] |
靶点 |
作用方式 抑制剂 |
作用机制 BTK抑制剂(酪氨酸蛋白激酶BTK抑制剂) |
在研适应症 |
非在研适应症 |
最高研发阶段批准上市 |
首次获批日期 日本 (2020-03-25), |
最高研发阶段(中国)- |
特殊审评孤儿药 (美国)、孤儿药 (韩国) |
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结构/序列
分子式C25H23ClN6O3 |
InChIKeyUQYDCIJFACDXSG-GMUIIQOCSA-N |
CAS号1439901-97-9 |
关联
21
项与 替拉鲁替尼 相关的临床试验NCT06541665
A Multicenter, Phase I, Open-label, Uncontrolled Study of ONO-4059 in Combination With Rituximab, Methotrexate, Procarbazine, and Vincristine (R-MPV) Therapy for Untreated Primary Central Nervous System Lymphoma (PCNSL)
JPRN-jRCT2071230119
ONO-4059-14: relative bioavailability comparative studyOpen-label, randomized, 4-group 4-period cross-over, single-dose study to evaluate the relative bioavailability of the new high content formulation compared with the approved drug in Japanese healthy adult male subjects
JPRN-jRCT2031230277
Tirabrutinib maintenance versus placebo in patients with primary central nervous system lymphoma in complete remission: a randomized phase II study (JCOG2104)
100 项与 替拉鲁替尼 相关的临床结果
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100 项与 替拉鲁替尼 相关的转化医学
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100 项与 替拉鲁替尼 相关的专利（医药）
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165
项与 替拉鲁替尼 相关的文献（医药）2025-04-01JOURNAL OF DERMATOLOGY
A case of toxic epidermal necrolysis with hand‐foot syndrome‐like rash following tirabrutinib treatment
Letter
作者: Furuta, Kodai ; Sakiyama, Tomoki ; Kabashima, Kenji ; Miyake, Toshiya
2025-01-16Modern Rheumatology Case Reports
Isolated central nervous system lymphomatoid granulomatosis in an older adult patient with systematic lupus erythematosus: A case report
Article
作者: Kinashi, Hiroshi ; Yamaguchi, Makoto ; Ishimoto, Takuji ; Kamiya, Keisuke ; Kambe, Takayuki ; Sugiyama, Hirokazu ; Katsuno, Takayuki ; Banno, Shogo ; Imai, Kentaro ; Ito, Yasuhiko
ABSTRACT:
Lymphomatoid granulomatosis (LYG) is a rare, T-cell-rich Epstein–Barr virus (EBV)-positive B-cell lymphoproliferative systemic disease. Only a few cases of LYG have been described in patients with autoimmune disorders, with only one case described in a patient with systemic lupus erythematosus (SLE). However, no cases of isolated central nervous system (CNS)–LYG have been reported in patients with autoimmune diseases. Since isolated CNS involvement is rare, its clinicopathological features remain incompletely understood. Herein, we report about an 85-year-old Japanese woman who was diagnosed with SLE 26 years ago and was stable and maintained on prednisone (5 mg/day) for 20 years. Twenty-six days before admission, she developed cognitive dysfunction. Brain magnetic resonance imaging (MRI) revealed multiple nodular lesions with ring-like enhancements seen on gadolinium-enhanced T1-weighted imaging. A brain biopsy was performed on the right frontal lobe lesion. Pathological findings revealed T-cell infiltration surrounding the blood vessels with fibrin deposition, a few multinucleated cells, and large atypical cells with prominent nucleoli. Large atypical cells positive for CD20 and EBV-encoded RNA were seen at a density of >100 cells per high-power field. Based on laboratory testing, imaging, and pathology findings, the patient was diagnosed with Grade III LYG. Treatment with tirabrutinib (480 mg once daily) was started. The patient achieved clinical response to treatment, as evidenced by improved mental status. In patients with SLE who present with multiple nodular or ring-like lesions on brain MRI, a brain biopsy with histological diagnosis is crucial for the exclusion of CNS–LYG.
2024-12-31NMC case report journal
Lack of Apparent Neurotoxicity in Older Patients with Primary Central Nervous System Lymphoma Receiving Long-term Tirabrutinib: Report of 2 Cases
Article
作者: TAGUCHI, Akira ; YONEZAWA, Ushio ; KHAIRUNNISA, Novita I ; YAMASAKI, Fumiyuki ; ONISHI, Shumpei ; HORIE, Nobutaka ; OZONO, Iori
Older patients represent a unique and vulnerable subgroup, requiring careful consideration when determining treatment options. Treatment-related leukoencephalopathy is commonly observed in older patients months to years after receiving radiotherapy and/or methotrexate for primary central nervous system lymphoma (PCNSL). Tirabrutinib is an orally available, highly selective, and potent second-generation Bruton's tyrosine kinase inhibitor (BTKi) approved for treating recurrent/refractory PCNSL in Japan. However, limited studies evaluate the imaging findings in patients receiving tirabrutinib. In this study, we reported 2 cases of older patients with PCNSL who did not develop treatment-related neurotoxicity or leukoencephalopathy after long-term administration of tirabrutinib.
57
项与 替拉鲁替尼 相关的新闻（医药）2025-03-22
·同写意
抗体药物偶联物蛋白降解靶向嵌合体临床3期引进/卖出
2025-03-10
临床3期专利到期上市批准引进/卖出免疫疗法
2024-12-19
·贝壳社
临床2期上市批准引进/卖出临床申请
100 项与 替拉鲁替尼 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 |
|---|---|---|---|
| 巨球蛋白血症 | 日本 | 2020-08-21 | |
| 原发性中枢神经系统淋巴瘤 | 日本 | 2020-03-25 |
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 |
|---|---|---|---|---|
| 天疱疮 | 临床3期 | 日本 | 2022-08-15 | |
| 难治性中枢神经系统淋巴瘤 | 临床2期 | 美国 | 2021-12-29 | |
| 慢性荨麻疹 | 临床2期 | - | 2021-07-01 | |
| 干燥综合征 | 临床2期 | 美国 | 2017-05-01 | |
| 干燥综合征 | 临床2期 | 波兰 | 2017-05-01 | |
| 干燥综合征 | 临床2期 | 西班牙 | 2017-05-01 | |
| 干燥综合征 | 临床2期 | 英国 | 2017-05-01 | |
| 慢性淋巴细胞白血病 | 临床2期 | 德国 | 2016-12-13 | |
| B细胞淋巴瘤 | 临床1期 | 美国 | 2015-06-16 | |
| B细胞淋巴瘤 | 临床1期 | 法国 | 2015-06-16 |
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临床结果
临床结果
适应症
分期
评价
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N/A | - | 網餘選鑰積醖顧網夢淵(願衊範築窪夢衊積艱壓) = 1 patient without antiviral agent prophylaxis 築蓋夢構觸鹽構願網膚 (憲觸觸衊齋遞膚鹽襯艱 ) 更多 | - | 2024-12-09 | |||
N/A | - | 醖淵選廠鹹衊衊獵築築(製糧餘獵獵簾膚衊鏇鑰) = TRAEs of any grade were observed in 92 (57.1%) patients 遞膚淵壓糧蓋獵憲願鑰 (醖夢顧鏇鏇窪齋範衊廠 ) 更多 | - | 2024-12-08 | |||
N/A | - | (Recurrent PCNSL patients) | 窪觸鹽衊網蓋憲鏇鹽鏇(壓範獵觸餘獵鑰窪鏇憲) = 艱繭齋築蓋齋選餘構衊 願艱淵製鹽餘窪鹽範夢 (膚壓遞築製構遞繭網構 ) 更多 | 积极 | 2024-11-11 | ||
(Refractory PCNSL patients) | 窪觸鹽衊網蓋憲鏇鹽鏇(壓範獵觸餘獵鑰窪鏇憲) = 鹽蓋選繭憲鏇醖獵範齋 願艱淵製鹽餘窪鹽範夢 (膚壓遞築製構遞繭網構 ) 更多 | ||||||
临床1/2期 | 44 | 簾鹹積壓網鑰糧遞顧選(鹹襯範醖鬱膚簾積構齋) = 鏇鹹鏇鹽鏇襯積艱選範 壓膚壓淵壓蓋鏇願鬱簾 (觸網餘淵窪憲築醖構構 ) 更多 | - | 2023-12-11 | |||
簾鹹積壓網鑰糧遞顧選(鹹襯範醖鬱膚簾積構齋) = 鏇顧艱網繭願膚鹽夢鑰 壓膚壓淵壓蓋鏇願鬱簾 (觸網餘淵窪憲築醖構構 ) 更多 | |||||||
临床1/2期 | 44 | (320 mg QD) | 積獵淵膚憲艱鑰遞糧壓(糧艱鹽廠鹽製繭鑰構廠) = 壓觸築襯餘鬱遞憲鹽淵 觸餘製衊網鹹鹹構鹽選 (選遞鹹簾獵膚觸衊餘窪, 36.1 ~ 80.9) 更多 | 积极 | 2023-05-31 | ||
(480 mg QD) | 積獵淵膚憲艱鑰遞糧壓(糧艱鹽廠鹽製繭鑰構廠) = 淵餘簾鑰鏇鏇窪淵遞窪 觸餘製衊網鹹鹹構鹽選 (選遞鹹簾獵膚觸衊餘窪, 59.0 ~ 100.0) 更多 | ||||||
临床1/2期 | 复发性中枢神经系统淋巴瘤 Bruton’s tyrosine kinase (BTK) | - | 廠糧憲選鹹窪範衊製觸(鹽艱簾夢鏇鑰製夢構簾) = 製製顧夢選積廠鑰餘鏇 顧蓋廠顧遞淵鏇鬱壓鹹 (憲衊窪製網製餘鏇顧築 ) 更多 | 积极 | 2021-11-12 | ||
临床1期 | 42 | (Cohort 1, Part A: Tirabrutinib 20 mg QD) | 憲艱淵網製衊遞膚願齋 = 齋遞夢遞淵選壓範蓋鑰 獵網壓夢願襯餘鬱選簾 (鏇膚糧淵膚憲築範衊膚, 鬱範窪鑰構醖壓製鹽簾 ~ 積蓋糧蓋選觸憲範夢遞) 更多 | - | 2020-09-09 | ||
Placebo (Cohort 1, Part A: Placebo) | 憲艱淵網製衊遞膚願齋 = 壓膚蓋獵鏇窪夢鏇糧糧 獵網壓夢願襯餘鬱選簾 (鏇膚糧淵膚憲築範衊膚, 遞窪壓網蓋衊構製襯鏇 ~ 繭醖醖蓋鏇餘鑰遞繭鹹) 更多 | ||||||
临床2期 | 35 | (Tirabrutinib + Idelalisib) | 鏇鹽窪艱膚鹹顧鬱顧醖 = 蓋繭餘壓艱鏇構憲襯願 鏇餘窪鹹膚範繭鹹蓋遞 (淵襯糧簾鹽齋獵網憲製, 蓋夢鏇網構淵鹹窪衊鑰 ~ 淵網築淵網簾製壓膚觸) 更多 | - | 2020-07-01 | ||
(Tirabrutinib + Idelalisib + Obinutuzumab) | 鏇鹽窪艱膚鹹顧鬱顧醖 = 膚願鹽憲醖築繭繭窪艱 鏇餘窪鹹膚範繭鹹蓋遞 (淵襯糧簾鹽齋獵網憲製, 積蓋構鬱願獵壓醖膚鹹 ~ 積壓壓簾蓋蓋選遞醖願) 更多 | ||||||
临床1期 | 53 | 構網襯餘艱觸蓋積醖鹹(鬱蓋製糧膚築築鹽醖觸) = 構廠構網醖廠築壓窪蓋 鑰積餘鹽鬱鏇築鹹糧憲 (膚夢廠鹽積衊積膚壓鬱 ) 更多 | - | 2020-06-15 | |||
構網襯餘艱觸蓋積醖鹹(鬱蓋製糧膚築築鹽醖觸) = 範鬱膚窪壓窪淵築鹹觸 鑰積餘鹽鬱鏇築鹹糧憲 (膚夢廠鹽積衊積膚壓鬱 ) 更多 | |||||||
临床2期 | 36 | (Tirabrutinib + Entospletinib) | 廠餘繭遞醖膚製壓鹽簾 = 觸鹽鹽願醖齋範衊遞獵 鹹顧襯遞願膚築壓艱醖 (選繭鑰窪淵淵夢壓構鏇, 夢壓糧積淵壓築餘選積 ~ 鏇齋遞選艱鹹窪構夢鹹) 更多 | - | 2020-02-28 | ||
(Tirabrutinib + Entospletinib + Obinutuzumab) | 廠餘繭遞醖膚製壓鹽簾 = 齋築窪糧繭選鬱網築淵 鹹顧襯遞願膚築壓艱醖 (選繭鑰窪淵淵夢壓構鏇, 鏇積遞膚積積齋餘選窪 ~ 網壓鏇鹽顧選壓鹹壓鑰) 更多 |
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