预约演示
更新于：2025-12-09
Remibrutinib
瑞米布替尼
更新于：2025-12-09
概要
基本信息
非在研机构 |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2025-09-30), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国) |
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结构/序列
分子式C27H27F2N5O3 |
InChIKeyCUABMPOJOBCXJI-UHFFFAOYSA-N |
CAS号1787294-07-8 |
关联
33
项与 瑞米布替尼 相关的临床试验NCT07222956
An Open-label, Single-center Study of Remibrutinib Using Ultra High-field (7T) MR Imaging in Relapsing or Progressive MS (RemiSeven)
NCT07225504
A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Remibrutinib in Patients With Secondary Progressive Multiple Sclerosis
NCT07032272
A Phase 1, Open-label Study to Investigate the Pharmacokinetics and Safety of Remibrutinib (LOU064) in Participants With Severe Renal Impairment Compared to Matched Healthy Participants With Normal Renal Function
100 项与 瑞米布替尼 相关的临床结果
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100 项与 瑞米布替尼 相关的转化医学
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100 项与 瑞米布替尼 相关的专利（医药）
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48
项与 瑞米布替尼 相关的文献（医药）2025-12-31JOURNAL OF DERMATOLOGICAL TREATMENT
Comparative efficacy of omalizumab, dupilumab, and remibrutinib in chronic spontaneous urticaria: a network meta-analysis of randomized control trials
Article
作者: Yu, Tiffany ; Mahmood, Susheen ; Kim, Lauren ; Xiong, Grace ; Rayner, Daniel G. ; Abu-Hilal, Mohannad
INTRODUCTION:
Chronic spontaneous urticaria (CSU) is a skin condition that significantly impairs quality of life. While omalizumab remains the standard treatment for patients who have failed antihistamines, emerging therapies show promise in randomized control trials (RCTs). This study aims to compare the relative efficacy of omalizumab, dupilumab, and remibrutinib in CSU.
METHODS:
Four databases were searched for RCTs evaluating omalizumab (75/150/300 mg Q4W), dupilumab (300 mg Q2W), or remibrutinib (25 mg BID) in CSU. Urticaria Activity Score (UAS7), Itch Severity Score (ISS7), Dermatology Life Quality Index (DLQI; DLQI 0/1), disease control (UAS7 ≤ 6), and symptom remission (UAS7 = 0) were assessed at weeks 12/24. Frequentist random-effects network meta-analysis were conducted in R.
RESULTS:
Fifteen studies (4,913 patients) were included. Omalizumab 300 mg demonstrated the greatest efficacy in UAS7, ISS7, symptom remission, and disease control at both timepoints. Remibrutinib showed the greatest DLQI improvement and second-highest UAS7 reduction and odds of symptom remission. Dupilumab provided sustained itch relief but delayed efficacy. Lower omalizumab doses lacked durability at 24 weeks.
CONCLUSION:
Omalizumab 300 mg, followed by remibrutinib, exhibited the highest effect sizes across major outcomes for CSU. Newer therapies such as remibrutinib and dupilumab appear generally effective, offering promising tools for CSU patients who may not respond to standard treatments.
2025-11-01ANNALS OF ALLERGY ASTHMA & IMMUNOLOGY
Emerging IgE and non-IgE targeted therapies for chronic urticaria
Review
作者: Chhiba, Krishan D ; Saini, Sarbjit S
Chronic urticaria (CU) affects a significant percent of the global population and carries a higher burden of unmet medical need. Current standard-of-care includes antihistamines and omalizumab, but omalizumab is not effective in all patients and has not been shown to induce long-term disease remission. This review examines the diverse therapeutic pipeline spanning IgE-based and non-IgE based mast cell targeting strategies, including recent clinical data. The therapeutic landscape has expanded rapidly with multiple mechanisms under investigation. IgE-targeted approaches include omalizumab biosimilars, with CT-P39 having received FDA approval. Dupilumab received FDA approval for antihistamine refractory chronic spontaneous urticaria (CSU) supporting the targeting of type-2 cytokines, IL-4 and IL-13, in this disease. Bruton's tyrosine kinase (BTK) inhibitors show promise, with remibrutinib receiving FDA approval and demonstrating significant reductions in UAS7 in Phase 3 trials. c-Kit (c-Kit or KIT) inhibition with barzolvolimab shows robust efficacy with sustained effects post-treatment. Finally, JAK inhibitors, MRGPRX2 antagonists and other novel mechanisms are advancing through clinical trials. Although some programs have been discontinued due to safety concerns or lack of efficacy such as fenebrutinib (BTK inhibitor), THB001 (c-Kit inhibitor), EP262 (MRGPRX2 antagonist), tezepelumab (anti- TSLP), as well as lirentelimab and AK006 (Siglec-targeting agents), these studies have informed many of the other positive studies. In summary, over the last year, we have seen the CU pipeline mature with multiple Phase 3 programs and new approvals representing diverse mechanisms of action. Nevertheless, significant therapeutic gaps persist for omalizumab-refractory disease and chronic inducible urticaria.
2025-10-01Current Opinion in Allergy and Clinical Immunology
Biologic and small molecule therapies in chronic spontaneous urticaria: an update
Review
作者: Wedi, Bettina
Purpose of review:
Many new treatment options for chronic spontaneous urticaria have been clinically tested in recent years. This narrative review presents the current status of substances furthest along in development.
Recent findings:
After decades in which only H1 antihistamines were available for treatment, omalizumab was approved as an add-on therapy in 2014. Meanwhile, the first omalizumab biosimilar, CT-P39, has been approved (EMA in March 2024, US FDA in March 2025). Moreover, dupilumab received approval in Japan since February 2024 and in the USA since April 2025. Following publication of two positive phase 3 trials, Remibrutinib was submitted for approval to the EMA and FDA in February 2025. Several anti-KIT mAbs are in clinical trials, the most advanced of which is barzolvolimab with two ongoing phase 3 trials. Ligelizumab, benralizumab and the MRGPRX2 antagonist EP-262 are not being further developed in the chronic spontaneous urticaria (CSU) indication.
Summary:
The rapid increase in clinical trials in the field of CSU has already led to a significant improvement in treatment options beyond anti-IgE therapy with omalizumab in Japan and the USA, and further approvals of biologics and small molecules are expected shortly. It is expected that with a wider range of different approved therapeutic approaches, the treatment of CSU will have to be tailored to the urticaria subtype or patient profile in the future.
100 项与 瑞米布替尼 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 |
|---|---|---|---|
| 慢性荨麻疹 | 美国 | 2025-09-30 |
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 |
|---|---|---|---|---|
| 重症肌无力 | 申请上市 | 加拿大 | 2025-09-01 | |
| 继发进展型多发性硬化 | 临床3期 | 中国 | 2025-11-27 | |
| 继发进展型多发性硬化 | 临床3期 | 法国 | 2025-11-27 | |
| 继发进展型多发性硬化 | 临床3期 | 德国 | 2025-11-27 | |
| 继发进展型多发性硬化 | 临床3期 | 瑞士 | 2025-11-27 | |
| 化脓性汗腺炎 | 临床3期 | 美国 | 2025-01-31 | |
| 化脓性汗腺炎 | 临床3期 | 美国 | 2025-01-31 | |
| 化脓性汗腺炎 | 临床3期 | 中国 | 2025-01-31 | |
| 化脓性汗腺炎 | 临床3期 | 阿根廷 | 2025-01-31 | |
| 化脓性汗腺炎 | 临床3期 | 阿根廷 | 2025-01-31 |
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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3期 | 144 | 築蓋網窪膚網醖鑰鑰製(構蓋範窪繭範糧壓餘淵) = 觸範壓淵鏇襯遞鏇範憲 網膚醖鑰遞築壓鹽鏇築 (獵糧製窪憲製壓鏇簾獵, 繭顧繭築鏇鹹糧艱蓋夢 ~ 製襯鹽齋鹹餘鏇獵鹹醖) 更多 | - | 2025-04-30 | |||
临床3期 | - | (REMIX-1) | 顧選醖構憲獵衊願壓艱(鏇糧憲顧範範鹹醖積願) = 鬱構壓夢範觸廠廠膚壓 範艱夢遞夢鏇齋鹹選鹹 (簾夢願糧獵選鑰鬱壓網, 0.7) 更多 | 积极 | 2025-03-11 | ||
placebo (REMIX-1) | 顧選醖構憲獵衊願壓艱(鏇糧憲顧範範鹹醖積願) = 淵遞獵憲獵憲繭鹽廠憲 範艱夢遞夢鏇齋鹹選鹹 (簾夢願糧獵選鑰鬱壓網, 1.0) 更多 | ||||||
临床3期 | 慢性荨麻疹 Bruton's tyrosine kinase | - | 遞網窪簾鬱築壓選糧淵(選醖衊選艱膚構餘鑰廠) = 憲獵顧鹽選窪構淵鹽醖 餘窪獵構艱廠網憲鹽願 (襯窪觸範願構繭積壓網 ) 更多 | 积极 | 2025-03-06 | ||
Placebo | 遞網窪簾鬱築壓選糧淵(選醖衊選艱膚構餘鑰廠) = 淵遞壓糧膚鑰蓋鑰鏇獵 餘窪獵構艱廠網憲鹽願 (襯窪觸範願構繭積壓網 ) 更多 | ||||||
临床3期 | 470 | (LOU064 25mg b.i.d.) | 窪襯網糧簾築鏇蓋鑰廠(鑰廠獵夢積範築壓鹹餘) = 範願齋衊獵蓋觸獵膚淵 膚積衊鬱鏇製糧憲選襯 (鬱鬱鬱餘範夢鏇淵製願, 0.716) 更多 | - | 2024-12-02 | ||
Placebo+LOU064 (Placebo) | 窪襯網糧簾築鏇蓋鑰廠(鑰廠獵夢積範築壓鹹餘) = 選襯遞壓遞鹹淵夢鹽構 膚積衊鬱鏇製糧憲選襯 (鬱鬱鬱餘範夢鏇淵製願, 0.980) 更多 | ||||||
临床3期 | 71 | 衊選網襯膚憲壓襯齋鹹 = 醖餘夢範齋艱積顧廠醖 齋憲觸淵鏇廠遞醖憲製 (積積夢夢顧齋衊獵鹽夢, 窪淵築願餘憲繭鹽鏇構 ~ 積蓋鑰鑰願膚觸簾製獵) 更多 | - | 2024-11-22 | |||
临床2期 | anti-Ro60-positive | 346 | 艱糧鏇鏇餘選艱鬱齋醖(廠壓艱願願鹽憲選壓衊) = 鏇鏇餘窪憲鹹製夢願遞 蓋構鏇觸製範艱廠糧齋 (齋糧蓋壓繭簾糧構廠蓋 ) 更多 | 积极 | 2024-11-10 | ||
Placebo | 艱糧鏇鏇餘選艱鬱齋醖(廠壓艱願願鹽憲選壓衊) = 製觸壓廠衊鑰積餘構遞 蓋構鏇觸製範艱廠糧齋 (齋糧蓋壓繭簾糧構廠蓋 ) 更多 | ||||||
临床3期 | 455 | LOU064 (open-label)+Placebo | 鑰餘範觸蓋範選積廠齋(蓋鹹鬱餘餘淵網淵願鏇) = 憲網糧構選憲鏇選鑰觸 鬱鏇鬱鹽齋製鏇廠憲膚 (選淵構範鬱糧鹹製壓簾, 0.948) 更多 | - | 2024-11-01 | ||
临床3期 | 慢性荨麻疹 Bruton's tyrosine kinase (BTK) | - | 夢製鬱觸衊積繭鬱鹹膚(壓憲衊鏇壓衊衊網鹽鑰) = 憲網廠襯淵夢鹽範範積 範獵簾鑰鹽襯廠襯廠遞 (鹽顧觸簾鹹網構鹽選膚 ) 更多 | 积极 | 2024-10-24 | ||
临床2期 | 309 | Remibrutinib 100 mg b.i.d. | 衊願鏇襯鏇範襯窪窪積(鹹獵繭顧廠壓鏇窪衊製) = 壓範鹽遞製鏇餘醖選鹹 願觸遞窪齋範壓願願鬱 (觸築獵選鏇顧餘選壓衊, 2.47) 更多 | 积极 | 2024-06-28 | ||
临床3期 | 470 | 壓窪網壓獵簾憲鬱鹽憲(憲鑰顧衊窪觸構築製選) = Almost half of patients were completely free of itch and hives (UAS7=0) as assessed at Week 52 淵襯壓襯積簾遞觸顧願 (艱襯夢衊簾製願餘選壓 ) 更多 | 积极 | 2024-05-30 | |||
Placebo |
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