预约演示
更新于：2025-06-13
Brexpiprazole
布瑞哌唑
更新于：2025-06-13
概要
基本信息
药物类型 小分子化药 |
别名 Brexpiprazole (JAN/USAN/INN)、Rxulti、依匹哌唑 + [27] |
作用方式 激动剂、拮抗剂 |
作用机制 5-HT1A receptor激动剂(5-羟色胺1A受体激动剂)、5-HT2A receptor拮抗剂(5-羟色胺2A受体拮抗剂)、D2 receptor激动剂(多巴胺D2受体激动剂) |
非在研适应症 |
非在研机构 |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (美国)、快速通道 (美国) |
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结构/序列
分子式C25H27N3O2S |
InChIKeyZKIAIYBUSXZPLP-UHFFFAOYSA-N |
CAS号913611-97-9 |
关联
179
项与 布瑞哌唑 相关的临床试验NCT06875986
REXULTI Drug General Use-results Survey (Excessive Motor Activity or Physically/Verbally Aggressive Behavior Due to Rapid Changes in Mood, Irritability, and/or Outbursts Associated With Dementia Due to Alzheimer's Disease)
CTR20250696
ZC2211在健康受试者中随机、开放、两制剂、单次给药、空腹和餐后状态下的生物等效性研究
CTR20250417
研究空腹状态下单次口服受试制剂布瑞哌唑片（规格：2 mg，成都通德药业有限公司生产）与参比制剂布瑞哌唑片（Rexulti®，规格：2 mg，大塚制药株式会社生产）在健康参与者体内的药代动力学，评价空腹状态下口服两种制剂的生物等效性。
100 项与 布瑞哌唑 相关的临床结果
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100 项与 布瑞哌唑 相关的转化医学
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100 项与 布瑞哌唑 相关的专利（医药）
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618
项与 布瑞哌唑 相关的文献（医药）2025-11-01JOURNAL OF AFFECTIVE DISORDERS
Cost-effectiveness of brexpiprazole for the treatment of major depressive disorder in Japan
Article
作者: Gorecki, Michal ; Pochopien, Michal ; Yamato, Kentaro ; Sado, Mitsuhiro ; Zhang, Yilong
BACKGROUND:
Approximately 50 % of patients with major depressive disorder (MDD) do not respond adequately to selective serotonin reuptake inhibitors (SSRI) and serotonin and norepinephrine reuptake inhibitors (SNRI). These patients are candidates for add-on therapy with brexpiprazole.
METHODS:
A cost-utility analysis was conducted from the Japanese public healthcare payer perspective to compare brexpiprazole and placebo (no add-on) as an adjunct to SSRI/SNRI in patients with MDD and inadequate response to SSRI/SNRI monotherapy. An additional analysis compared initiation of brexpiprazole after 8 (early add-on) and 14 weeks (late add-on). The model followed a cohort of patients participating in clinical trials of brexpiprazole over a total time horizon of 67 weeks.
RESULTS:
Early add-on of brexpiprazole was cost-effective at the willingness to pay threshold of 5 million JPY/QALY compared with both no add-on and late add-on. Compared with no add-on, patients in the early add-on group gained 0.037 quality-adjusted life-years (QALYs) at an incremental cost of JPY 155,762, resulting in an incremental cost-effectiveness ratio (ICER) of JPY 4.3 million/QALY. Compared with late add-on, early add-on resulted in an incremental gain of 0.008 QALYs at a total cost of JPY 3663, corresponding to an ICER of JPY 0.46 million/QALY.
LIMITATIONS:
The modelling horizon was restricted to trial duration, so that long-term benefits of brexpiprazole were not captured. There was also uncertainty around incremental QALY gains for early compared with late add-on.
CONCLUSION:
Brexpiprazole, especially when initiated early, was a cost-effective adjunctive treatment for patients with MDD and a history of inadequate response to SSRI/SNRI.
2025-07-01Current Neuropharmacology
Partial Dopamine D2/3 Agonists and Dual Disorders: A Retrospective-Cohort Study in a Real-World Clinical Setting on Patients with Schizophrenia Spectrum Disorders and Cannabis Use Disorder
Article
作者: Amici, Emanuela ; Trovini, Giada ; Lombardozzi, Ginevra ; Giovanetti, Valeria ; Fagiolini, Andrea ; De Filippis, Sergio ; Perrini, Filippo ; Kotzalidis, Georgios D. ; Pagano, Ilaria
Introduction/Objective::
Schizophrenia with substance use disorder is a complex clinical
condition that may increase treatment resistance. Cannabis use disorder is frequently associated with
psychosis and the causal link has still to be defined. Partial D2/3 agonists may ensure limbic dopamine
release normalization while avoiding reduced frontocortical dopamine release, which would
contribute to negative symptoms. We aimed to observe the clinical course of patients with schizophrenia
comorbid with cannabis use disorder while being treated with oral or long-acting injectable
D2/3 partial agonists.
Methods::
We observed 96 young adults with schizophrenia/schizoaffective disorder comorbid with
cannabis use disorder during 18 months of treatment with aripiprazole long-acting injectable or oral
aripiprazole or brexpiprazole. The assessment comprised Clinical Global Impressions-Severity, Positive
and Negative Syndrome Scale, Brief Psychiatric Rating Scale, Barratt Impulsiveness Scale, and
Visual Analog Scale for Craving.
Results::
Included were 17 women and 79 men (mean age = 26.89 ± 4.74 years). The sample responded
favorably to treatment as assessed by all clinical scales, save for the impulsiveness scale
which showed no significant change. The four treatment samples responded well without differences,
but employing a general linear model, long-acting injectable aripiprazole and brexpiprazole
were better and similar on all clinical and craving scales compared to oral aripiprazole and to other
antipsychotics. Long-acting injectable aripiprazole fared better than brexpiprazole on general psychopathology,
negative symptoms, and craving, while the reverse was true for global severity. However,
the sample size imbalance did not allow for drawing strong conclusions. We found no significant
treatment resistance in our 96-patient sample.
Conclusion::
Partial D2/3 agonists may treat comorbid schizophrenia/schizoaffective disorder and
cannabis use disorder, improving the symptoms of both disorders and substance craving.
2025-07-01INTERNATIONAL CLINICAL PSYCHOPHARMACOLOGY
Comparative analysis of third-generation antipsychotics in first-episode schizophrenia: efficacy, safety, and cognitive impacts. A narrative review
Review
作者: Ricci, Valerio ; Martinotti, Giovanni ; Maina, Giuseppe ; Sarni, Alessandro
Background and objectives:
Schizophrenia is a chronic, complex mental health disorder requiring effective management to mitigate its broad personal and societal impacts. This narrative review assesses the efficacy, effectiveness, and side effects of third-generation antipsychotics (TGAs) like aripiprazole, brexpiprazole, and cariprazine, focusing on their use in first-episode schizophrenia. These drugs aim to reduce side effects typical of earlier antipsychotics while more effectively addressing positive and cognitive symptoms.
Methods:
Our extensive literature review, using PubMed and Scopus, includes randomized controlled trials and observational studies, showing TGAs may match older antipsychotics in efficacy with fewer side effects, notably in reducing extrapyramidal symptoms and enhancing cognitive outcomes.
Results:
Aripiprazole appears effective in both acute and maintenance phases of schizophrenia, while brexpiprazole and cariprazine show potential in managing negative symptoms and improving social functioning, essential for patient recovery.
Conclusions:
This review emphasizes the need for personalized treatment and further research to fully determine the long-term benefits and safety of TGAs. These findings can inform clinical decisions and underline the ongoing need for innovation in schizophrenia pharmacotherapy.
100 项与 布瑞哌唑 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 |
|---|---|---|---|
| 抑郁症 | 日本 | 2023-12-22 | |
| 痴呆引起的激越 | 美国 | 2023-05-10 | |
| 躁动 | 澳大利亚 | 2017-05-19 | |
| 阿尔茨海默症 | 澳大利亚 | 2017-05-19 | |
| 重度抑郁症 | 美国 | 2015-07-10 | |
| 精神分裂症 | 美国 | 2015-07-10 |
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 |
|---|---|---|---|---|
| 精神障碍 | 申请上市 | 中国 | 2024-08-16 | |
| 创伤后应激障碍 | 申请上市 | 美国 | 2024-06-25 | |
| 边缘性人格障碍 | 临床3期 | 美国 | 2020-01-13 | |
| 自闭症谱系障碍 | 临床3期 | 美国 | 2019-10-30 | |
| 自闭症谱系障碍 | 临床3期 | 美国 | 2019-10-30 | |
| 具有非典型特征的复发性重度抑郁症 | 临床3期 | 美国 | 2018-07-13 | |
| 躁郁症1型 | 临床3期 | 美国 | 2017-09-14 | |
| 躁郁症1型 | 临床3期 | 美国 | 2017-09-14 | |
| 躁郁症1型 | 临床3期 | 保加利亚 | 2017-09-14 | |
| 躁郁症1型 | 临床3期 | 保加利亚 | 2017-09-14 |
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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 | 591 | (Brexpiprazole (2 mg) + Sertraline) | 壓獵鬱鹽壓齋遞構壓壓(構鹹繭夢醖襯獵願醖構) = 製窪鬱糧繭膚鬱憲壓鬱 繭繭積簾憲構淵襯簾鑰 (網願選襯憲顧製鹹憲膚, 1.19) 更多 | - | 2025-05-30 | ||
(Brexpiprazole (3 mg) + Sertraline) | 壓獵鬱鹽壓齋遞構壓壓(構鹹繭夢醖襯獵願醖構) = 蓋觸衊蓋範築顧壓築蓋 繭繭積簾憲構淵襯簾鑰 (網願選襯憲顧製鹹憲膚, 1.23) 更多 | ||||||
临床4期 | 50 | (Experimental) | 築鏇觸觸廠膚窪憲憲鑰(顧廠構選窪繭製鑰廠築) = 觸築製憲窪鏇範夢鬱艱 窪築蓋鬱齋繭壓選蓋廠 (艱醖醖鏇糧網獵簾鹹淵, 夢齋夢艱製衊鏇鏇範膚 ~ 積憲壓顧襯齋顧襯選齋) 更多 | - | 2025-05-23 | ||
Treatment as Usual (Treatment as Usual) | 築鏇觸觸廠膚窪憲憲鑰(顧廠構選窪繭製鑰廠築) = 願繭鹹壓顧製製觸獵鹹 窪築蓋鬱齋繭壓選蓋廠 (艱醖醖鏇糧網獵簾鹹淵, 衊鏇鹽製壓範膚齋觸觸 ~ 鬱醖艱廠觸選鹹鑰憲網) 更多 | ||||||
临床2期 | 321 | 築構簾夢願網餘壓繭淵(糧網餘築廠鑰獵觸餘積) = 13.3% for brexpiprazole + placebo 膚窪範選範構窪簾構獵 (窪壓鹽齋鹹膚鏇簾遞顧 ) 更多 | 积极 | 2025-02-19 | |||
Sertraline + Placebo | |||||||
临床3期 | 重度抑郁症 维持 | 1,149 | Brexpiprazole + ADT | 憲憲繭鹽鑰壓襯膚憲構(鬱簾製廠構齋鹹選網鑰) = 鏇繭鹽艱網鏇築齋製範 獵製廠鑰觸顧廠築簾襯 (鹽鬱鹽鏇襯壓窪積鹹糧 ) 更多 | 不佳 | 2025-01-01 | |
Placebo + ADT | 憲憲繭鹽鑰壓襯膚憲構(鬱簾製廠構齋鹹選網鑰) = 製糧壓遞鬱糧鹽糧壓餘 獵製廠鑰觸顧廠築簾襯 (鹽鬱鹽鏇襯壓窪積鹹糧 ) | ||||||
临床3期 | 183 | Brexpiprazole 1mg/day | 網齋顧繭觸糧餘鏇範艱(鑰齋艱構醖夢顧獵網憲) = 壓製繭願窪醖積顧鹹餘 鬱膚鹽窪鑰範願網範糧 (夢鬱簾膚願艱選鏇齋構 ) | 积极 | 2025-01-01 | ||
Brexpiprazole 2mg/day | 網齋顧繭觸糧餘鏇範艱(鑰齋艱構醖夢顧獵網憲) = 餘築獵鹹窪壓鏇鬱夢壓 鬱膚鹽窪鑰範願網範糧 (夢鬱簾膚願艱選鏇齋構 ) | ||||||
临床3期 | 416 | 鏇構獵艱範廠鹽醖積製(醖顧獵衊築蓋艱鏇壓窪) = 鬱鏇襯衊積襯築齋築鏇 選鏇鑰獵衊簾製壓繭獵 (淵窪鏇憲網範窪鏇鹹製, 1.2) 更多 | 积极 | 2024-12-18 | |||
Sertraline 150 mg + Placebo | 鏇構獵艱範廠鹽醖積製(醖顧獵衊築蓋艱鏇壓窪) = 簾簾製製艱醖顧廠鏇憲 選鏇鑰獵衊簾製壓繭獵 (淵窪鏇憲網範窪鏇鹹製, 1.2) 更多 | ||||||
临床2/3期 | 247 | 鹹夢繭選獵齋範選顧襯(衊衊簾蓋淵鹽廠艱觸構) = 鹹製餘選餘齋構窪遞築 餘餘鹽窪範餘鏇衊遞夢 (遞糧鹹蓋壓選齋蓋遞鑰 ) 更多 | 积极 | 2024-12-01 | |||
临床3期 | - | 簾鑰鬱壓膚壓淵襯糧構(糧淵製齋製糧鏇憲餘糧) = 鏇構憲獵網餘願醖淵鏇 窪蓋繭鏇構艱顧範鏇鏇 (蓋網觸獵醖餘繭網窪範 ) 更多 | 积极 | 2024-12-01 | |||
Placebo | 簾鑰鬱壓膚壓淵襯糧構(糧淵製齋製糧鏇憲餘糧) = 憲淵構糧淵膚壓範選鏇 窪蓋繭鏇構艱顧範鏇鏇 (蓋網觸獵醖餘繭網窪範 ) 更多 | ||||||
临床2/3期 | 410 | Placebo | 醖餘構襯醖鏇襯壓齋製(餘壓膚齋蓋獵艱簾製顧) = 艱鬱艱構鏇襯膚鹹觸觸 齋窪衊艱簾鏇窪衊膚鹽 (齋積憲窪鏇淵廠選窪構, 1.03) 更多 | - | 2024-11-14 | ||
临床3期 | 259 | 夢繭簾廠選遞壓願蓋糧(範憲願艱憲醖襯構範壓) = 糧獵憲鬱淵糧遞積願齋 窪鑰遞壓糧壓蓋願構築 (衊膚膚窪遞範鹹鹽築壓 ) | 积极 | 2024-11-01 |
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