预约演示
更新于：2026-05-21
Inebilizumab-cdon
伊奈利珠单抗
更新于：2026-05-21
概要
基本信息
药物类型 单克隆抗体 |
别名 Inebilizumab、Inebilizumab (Genetical Recombination)、INN + [11] |
靶点 |
作用方式 抑制剂 |
作用机制 CD19抑制剂(B淋巴细胞抗原CD19抑制剂)、ADCC(抗体依赖的细胞毒作用) |
在研适应症 |
非在研适应症 |
原研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2020-06-11), |
最高研发阶段(中国)批准上市 |
特殊审评突破性疗法 (美国)、孤儿药 (美国)、优先审评 (中国)、孤儿药 (日本)、孤儿药 (韩国) |
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结构/序列
Sequence Code 319372678L
来源: *****
Sequence Code 1191632826H
来源: *****
关联
40
项与 伊奈利珠单抗 相关的临床试验NCT07598825
A Phase 2/3, Randomized, Double-blind, Multicenter, Placebo-controlled Study of Inebilizumab in Participants With Autoimmune Hepatitis
NCT06987539
A Phase 2 Open-label Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children From 2 Years to Less Than 18 Years of Age With Generalized Myasthenia Gravis (gMG)
NCT07222553
Open-label, Uncontrolled, Multicenter Trial to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Inebilizumab in Children From 2 Years to Less Than 18 Years of Age With Immunoglobulin G4-related Disease (IgG4-RD)
100 项与 伊奈利珠单抗 相关的临床结果
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100 项与 伊奈利珠单抗 相关的转化医学
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100 项与 伊奈利珠单抗 相关的专利（医药）
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231
项与 伊奈利珠单抗 相关的文献（医药）2026-04-15Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova
Drug-drug interactions with Mexidol in patients with ischemic stroke: Analysis of data from randomized clinical trials
Article
作者: Shamalov, N.A. ; Yanishevsky, S.N. ; Shikh, E.V. ; Shchukin, I.A.
Objective. Identification of drug-drug interaction of Mexidol when used in patients with ischemic stroke. Material and methods. The data from randomized controlled clinical trials (RCTs) of the efficacy and safety of Mexidol, EPICA and MIR, in patients with ischemic stroke were analyzed. Results. The analysis included data from 304 participants of RCT MIR and 150 participants of RCT EPICA. In both studies, antihypertensive drugs were most often used as concomitant therapy (94.1% of participants in the MIR RCT and 98.0% of EPIC RCT). In patients receiving Mexidol, antihypertensive drugs with INN were more often prescribed: enalapril (24.0%), bisoprolol (16.7%), amlodipine (11.8%), lisinopril (8.4%), indapamide (7.9%). In addition to antihypertensive drugs, almost all participants in RCTS MIR and EPIC received antiplatelet drugs (90.1% and 94.0% respectively), lipid-lowering drugs (78.0% and 78.7% respectively) and electrolyte solutions (77.3% and 75.3% respectively). Anticoagulants were prescribed in 24.0% of participants in the MIR RCT and in 34.0% of participants in the EPIC RCT. Analysis of drug interaction models, taking into account the total number of adverse events and the systemic organ class to which they belong, did not reveal a statistically significant change in the frequency of adverse events in patients receiving concomitant therapy along with Mexidol (p>0.05 in all comparison pairs). Conclusion. The analysis did not reveal drug interactions when using Mexidol and all types of concomitant therapy in patients with ischemic stroke. This study confirmed the high safety and good tolerability when using Mexidol in patients receiving multiple medications at the same time.
2026-03-31Journal of Liver Cancer
A rare case of IgG4-related sclerosing cholangitis followed by rapid subsequent diagnosis of cholangiocarcinoma
Article
作者: Hong, Gordon ; Bittencourt, Leonardo K ; Mahipal, Amit ; Hussain, Amber ; Correia, Eduardo Thadeu de Oliveira ; Sclair, Seth N ; Shalaby, Akram ; Ocuin, Lee M
Immunoglobulin G4 (IgG4)-related sclerosing cholangitis (IgG4-SC) is a rare condition with symptoms often mimicking malignancy, infection, or other autoimmune diseases. This case report describes the unique case of a 62-year-old male initially diagnosed with IgG4-SC, followed by subsequent diagnosis of cholangiocarcinoma. Biliary tract cancer in the setting of IgG4 related disease has been previously described; however, this patient course is novel as it encompasses the spectrum of challenges in IgG4-SC management, including diagnostic uncertainty, risk of infection with immunosuppressive agents, and development of malignancy diagnosed shortly following IgG4-SC diagnosis. We review the literature of management, outcomes, and malignancy risk and furthermore, highlight a promising recent therapy in treatment of IgG4 related disease, inebilizumab.
2026-03-20Sichuan da xue xue bao. Yi xue ban = Journal of Sichuan University. Medical science edition
[Characterization of Immune Reconstitution Patterns in B-cell Subsets Mediated by B-cell Targeted Therapies].
Article
作者: Wei, Mintong ; Tao, Yanxin ; Cai, Bei ; Zhang, Yang ; Wang, Xueqiao ; Feng, Weihua ; Guo, Yixue ; Duan, Zhikai ; Yan, Lin ; Li, Wei ; Li, Yi ; Zhang, Junlong
Objective:
To analyze the reconstitution patterns of fine B-cell subsets in patients following treatment with the CD20 monoclonal antibody ofatumumab and the CD19 monoclonal antibody inebilizumab, and to evaluate the clinical application value of individualized fine B-cell subset dynamic profiling in guiding targeted therapy strategies.
Methods:
This prospective study enrolled 30 patients with pemphigus receiving ofatumumab and 26 patients with neuromyelitis optica spectrum disorders (NMOSD) receiving inebilizumab at West China Hospital of Sichuan University between October 2023 and May 2025. Thirty healthy individuals were enrolled as controls for baseline comparison. Dynamic monitoring of fine B-cell subsets, anti-desmoglein (Dsg) antibodies, and immunoglobulins was performed at three post-treatment time points (1 month, 3 months, and 6 months). A natural cubic spline model was used to fit trend curves, combined with differential analysis to assess population-level immune reconstitution.
Results:
At baseline (T0), patients in the pemphigus group had higher levels of several B-cell subsets compared to healthy controls. Total B-cell counts were 347.50 (250.40-621.8) cells/μL versus 217.50 (143.50-275.30) cells/μL, memory B-cell counts were 127.30 (74.63-196.70) cells/μL versus 57.00 (41.75-88.25) cells/μL, and plasmablast counts were 5.63 (2.02-11.48) cells/μL versus 1.00 (1.00-2.00) cells/μL. These differences were significant (P < 0.05). In contrast, NMOSD patients showed significantly higher plasmablast counts compared to healthy controls (2.07 [1.60-3.58] cells/μL vs. 1.00 [1.00-2.00] cells/μL) (P = 0.04). After three months, the proliferation rate of naive B cells increased, with counts rising from 0.95 cells/μL at T3 to 3.25 cells/μL at T6 (P = 0.001). Throughout the entire monitoring period, the proportion of memory B cells consistently remained higher than that of naive B cells and plasmablasts. In NMOSD patients, B-cell regeneration was slow after treatment. Total B-cell counts showed a significant increase only by T6 compared to T1 (from 0 cells/μL to 2.65 cells/μL, P = 0.026), with the increase primarily due to naive B cells. Plasmablast counts in the pemphigus group were significantly higher than those in the NMOSD group at T1 and T3 (P < 0.01), but this difference disappeared by T6. Among the cohort, two pemphigus patients showed abnormal B-cell reconstitution, characterized by persistently elevated plasmablasts or undetectable Dsg antibody decline. One NMOSD patient exhibited a reversal in B-cell subset proportions, with memory B-cell counts exceeding naive B-cell counts, along with increased plasma cell counts and elevated IgG immunoglobulin levels.
Conclusion:
Targeted therapies against CD19 and CD20 induce distinctly different patterns of B-cell reconstitution. Ofatumumab treatment leads to a phased regenerative process in B cells, whereas inebilizumab treatment results in delayed regeneration. Increased plasmablasts, aberrant memory B-cell proliferation, and rebounding Dsg antibodies may signal potential adverse events. These findings support monitoring fine B-cell subsets for precise immunological assessment to guide personalized treatment.
100 项与 伊奈利珠单抗 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 |
|---|---|---|---|
| 重症肌无力 | 美国 | 2025-12-11 | |
| 免疫球蛋白G4相关疾病 | 美国 | 2025-04-03 | |
| 免疫球蛋白G4相关疾病 | 美国 | 2025-04-03 | |
| 水通道蛋白4抗体阳性视神经脊髓炎谱系疾病 | 欧盟 | 2022-04-25 | |
| 水通道蛋白4抗体阳性视神经脊髓炎谱系疾病 | 冰岛 | 2022-04-25 | |
| 水通道蛋白4抗体阳性视神经脊髓炎谱系疾病 | 列支敦士登 | 2022-04-25 | |
| 水通道蛋白4抗体阳性视神经脊髓炎谱系疾病 | 挪威 | 2022-04-25 | |
| 视神经脊髓炎 | 美国 | 2020-06-11 |
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 |
|---|---|---|---|---|
| 自身免疫性肝炎 | 临床3期 | - | 2026-09-07 | |
| 系统性硬皮病 | 临床3期 | 日本 | 2022-07-20 | |
| 系统性红斑狼疮 | 临床2期 | 美国 | 2025-07-16 | |
| 系统性红斑狼疮 | 临床2期 | 澳大利亚 | 2025-07-16 | |
| 系统性红斑狼疮 | 临床2期 | 比利时 | 2025-07-16 | |
| 系统性红斑狼疮 | 临床2期 | 法国 | 2025-07-16 | |
| 系统性红斑狼疮 | 临床2期 | 德国 | 2025-07-16 | |
| 系统性红斑狼疮 | 临床2期 | 意大利 | 2025-07-16 | |
| 系统性红斑狼疮 | 临床2期 | 葡萄牙 | 2025-07-16 | |
| 系统性红斑狼疮 | 临床2期 | 西班牙 | 2025-07-16 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 238 | 憲醖繭網夢鬱鹽製繭憲(壓廠遞廠範鏇醖蓋觸築) = 顧艱廠構廠獵範餘網範 襯餘衊襯顧網壓壓鑰鬱 (餘簾範鹹糧選窪衊鑰構 ) 更多 | 积极 | 2026-03-08 | |||
Placebo | 憲醖繭網夢鬱鹽製繭憲(壓廠遞廠範鏇醖蓋觸築) = 顧壓鬱憲獵簾網餘簾糧 襯餘衊襯顧網壓壓鑰鬱 (餘簾範鹹糧選窪衊鑰構 ) 更多 | ||||||
临床3期 | 重症肌无力 AChR+ | 190 | (AChR+ + Generalized Myasthenia Gravis) | 鹹願網鏇繭淵膚積鹹廠(窪壓鏇衊選鏇淵願願憲) = 顧襯淵淵範製簾壓選網 繭積夢壓鏇淵醖鑰膚夢 (範鹹繭醖簾鑰蓋網獵醖 ) | 积极 | 2026-03-08 | |
Placebo (AChR+ + Generalized Myasthenia Gravis) | 鹹願網鏇繭淵膚積鹹廠(窪壓鏇衊選鏇淵願願憲) = 鹽鑰獵簾繭範觸鹽醖鹹 繭積夢壓鏇淵醖鑰膚夢 (範鹹繭醖簾鑰蓋網獵醖 ) | ||||||
N/A | 68 | 範齋簾選觸窪衊餘顧壓(構齋構艱簾構艱鑰齋鏇) = 廠積鹹夢廠顧鏇衊鑰簾 積選鬱積遞選醖淵鹹廠 (鹹製蓋構憲艱襯製蓋夢 ) 更多 | 积极 | 2026-02-05 | |||
临床3期 | 68 | 餘鏇壓構夢餘構蓋簾獵(遞範廠簾蓋襯餘鏇壓構) = 鬱艱構餘鑰獵糧獵選築 艱壓艱糧繭糧製構築遞 (鏇鹽願襯積鹽觸選製範 ) 更多 | 不佳 | 2025-10-24 | |||
临床3期 | 135 | 憲簾糧夢憲選襯獵網醖(憲積淵願壓糧積簾選願): P-Value = 0.13 | 积极 | 2025-10-24 | |||
Placebo | |||||||
临床3期 | 135 | 壓網鏇鬱範鬱遞餘鏇選(夢夢壓選鹽獵廠醖鏇艱) = 繭範鬱齋製夢觸餘廠遞 鏇選製憲願鹽膚選醖觸 (簾壓遞壓繭構窪鏇蓋齋 ) 更多 | 积极 | 2025-10-24 | |||
Placebo | 淵鏇醖觸膚築遞鹽獵餘(夢憲獵鏇顧築夢獵淵壓) = 襯鹽襯鹹憲鹽艱範鏇鏇 獵觸壓鹹鏇範憲夢齋壓 (獵鑰壓繭夢網獵糧簾艱 ) 更多 | ||||||
临床3期 | 135 | 鹹淵衊鹽製觸鏇願願糧(膚選簾積夢願艱衊範簾) = 製鏇製淵遞艱膚積簾壓 鏇襯鑰觸襯糧糧製膚鏇 (艱艱網構鹽簾鏇製範網 ) 更多 | 积极 | 2025-10-24 | |||
Placebo | 鹹淵衊鹽製觸鏇願願糧(膚選簾積夢願艱衊範簾) = 餘範夢襯製壓獵夢衊遞 鏇襯鑰觸襯糧糧製膚鏇 (艱艱網構鹽簾鏇製範網 ) | ||||||
临床3期 | 135 | Placebo | 壓簾憲鏇積觸遞憲選獵(窪衊膚獵觸夢顧願積餘) = 願鬱選鑰網獵憲獵範糧 簾獵膚衊觸簾齋範獵壓 (襯艱醖齋築壓廠願築淵, 蓋壓窪構簾繭鹽襯窪網 ~ 鹹鑰壓窪艱網簾顧願築) 更多 | - | 2025-06-25 | ||
临床3期 | 238 | 網積窪構壓鹹觸壓願簾(鏇繭築鬱夢窪衊壓範網) = 構窪餘鬱獵襯襯選構糧 夢願遞範鏇窪醖鬱鬱蓋 (糧齋廠鬱顧衊願餘憲襯 ) 更多 | 积极 | 2025-06-19 | |||
Placebo | 網積窪構壓鹹觸壓願簾(鏇繭築鬱夢窪衊壓範網) = 窪夢窪繭蓋壓構夢糧蓋 夢願遞範鏇窪醖鬱鬱蓋 (糧齋廠鬱顧衊願餘憲襯 ) 更多 | ||||||
N/A | 视神经炎 anti-AQP4 antibody | anti-MOG antibody | 18 | Steroid pulse therapy | 獵襯築觸鬱簾鏇憲鹽遞(衊窪蓋淵廠淵艱鑰願選) = 鹽選鑰鬱築遞憲構繭遞 選襯網積餘衊膚膚選淵 (窪願鹹積簾壓艱構鑰遞, 17.7) 更多 | 积极 | 2025-05-04 | |
oral administration of non-steroidal anti-inflammatory drugs | 範鏇積繭遞構餘簾齋繭(襯齋醖醖憲鹹襯簾鬱構) = 簾繭選繭衊蓋壓簾夢範 構獵鑰構網遞積齋淵廠 (淵築鹹顧衊壓築餘艱鹽 ) |
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