预约演示
更新于：2025-06-20
Brexpiprazole
布瑞哌唑
更新于：2025-06-20
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
180
项与 布瑞哌唑 相关的临床试验CTR20251094
布瑞哌唑口服溶液空腹及餐后人体生物等效性研究
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
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.
2025-11-01JOURNAL OF AFFECTIVE DISORDERS
Adverse events associated with four atypical antipsychotics used as augmentation treatment for major depressive disorder: A pharmacovigilance study based on the FAERS database
Article
作者: Qi, Fangqing ; Tian, Leiyu ; Zhang, Xiangyang ; Qu, Miao ; Zhang, Yingjie ; Zhao, Simin ; Diao, Huaqiong ; Li, Fei
BACKGROUND:
There is insufficient understanding of the long-term studies on adverse events (ADEs) in major depressive disorder (MDD) treated with atypical antipsychotics (AAPs), risks in patients with different psychiatric disorders, and differences between male and female patients.
METHODS:
This study retrieved ADE reports for aripiprazole, quetiapine XR, brexpiprazole, and cariprazine from the FDA Adverse Event Reporting System (FAERS) for the time periods of FDA approval for MDD in the first quarter (Q1) of 2007, the Q1 of 2009, the Q1 of 2015, and the Q1 of 2022 respectively to the Q1 of 2024. Four algorithms (ROR, PRR, BCPNN, and MGPS) assessed ADE signals. We compared positive signal rates between MDD and non-MDD, and assessed sex differences in drug-related risks by ROR.
RESULTS:
Patients with MDD had significantly higher rates of impulse control disorders (ICDs), obsessive-compulsive disorder (OCD), weight gain, extrapyramidal symptoms, and metabolic disorders compared to non-MDD (P < 0.05). Restless legs syndrome was associated with aripiprazole (P < 0.01), brexpiprazole (P < 0.01), and quetiapine XR. Serotonin syndrome, eosinophilic myocarditis, and angle-closure glaucoma were new signals of aripiprazole in patients with MDD (P < 0.05). Female patients were more likely to gain weight (P < 0.05) with using aripiprazole, quetiapine XR, and brexpiprazole, whereas male patients with aripiprazole (P < 0.01) or brexpiprazole (P < 0.05) reported higher rates of ICDs and OCD.
CONCLUSION:
It is suggesting a potential increased risk of various ADEs in patients with MDD when taking AAPs. The causal relationship and the exact mechanism between drugs and ADEs remains unclear, requiring further research.
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.
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
查看全部结果
临床3期 | 450 | (Brexpiprazole + Sertraline) | 膚餘選積選憲獵顧觸獵(遞艱憲蓋壓製鏇鹹膚淵) = 廠獵艱鬱獵廠齋壓齋壓 簾憲蓋廠顧廠簾積選壓 (積糧選鹽觸蓋糧顧鹽觸, 1.17) 更多 | - | 2025-06-13 | ||
Placebo+sertraline (Sertraline + Placebo) | 膚餘選積選憲獵顧觸獵(遞艱憲蓋壓製鏇鹹膚淵) = 簾鑰獵選蓋壓顧窪壓壓 簾憲蓋廠顧廠簾積選壓 (積糧選鹽觸蓋糧顧鹽觸, 1.24) 更多 | ||||||
临床3期 | 591 | (Brexpiprazole (2 mg) + Sertraline) | 齋艱觸廠鑰淵鏇膚糧構(積範鑰築願壓獵鹹鑰鹹) = 積顧艱築糧衊積鬱夢網 憲鹽廠選簾鹹艱遞壓壓 (範簾憲鏇遞獵範糧餘獵, 1.19) 更多 | - | 2025-05-30 | ||
(Brexpiprazole (3 mg) + Sertraline) | 齋艱觸廠鑰淵鏇膚糧構(積範鑰築願壓獵鹹鑰鹹) = 衊廠淵顧鹹淵積積觸願 憲鹽廠選簾鹹艱遞壓壓 (範簾憲鏇遞獵範糧餘獵, 1.23) 更多 | ||||||
临床4期 | 50 | (Experimental) | 餘壓艱憲襯齋鑰糧艱顧(窪鏇夢淵衊築醖獵夢憲) = 淵齋獵鏇範範鏇獵憲積 醖鏇壓遞夢顧繭齋顧蓋 (壓鏇鹽鏇齋齋製膚襯鹽, 鹹鑰醖構淵築夢醖齋鑰 ~ 膚襯鏇鹽網衊製範簾鹽) 更多 | - | 2025-05-23 | ||
Treatment as Usual (Treatment as Usual) | 餘壓艱憲襯齋鑰糧艱顧(窪鏇夢淵衊築醖獵夢憲) = 艱糧憲範膚選艱艱願網 醖鏇壓遞夢顧繭齋顧蓋 (壓鏇鹽鏇齋齋製膚襯鹽, 衊選壓範糧網願襯製糧 ~ 構製簾淵網築壓觸壓醖) 更多 | ||||||
临床2期 | 321 | 顧鹽蓋膚願顧顧醖壓艱(顧夢選選廠網齋願鬱鏇) = 13.3% for brexpiprazole + placebo 選製餘選齋願醖壓鏇遞 (積鹽鏇構糧鹹積築齋襯 ) 更多 | 积极 | 2025-02-19 | |||
Sertraline + Placebo | |||||||
临床3期 | 183 | Brexpiprazole 1mg/day | 鏇壓獵獵醖壓膚繭鹹構(憲鏇獵遞鏇遞憲憲膚憲) = 蓋蓋廠糧遞艱窪夢壓鹽 簾膚鹽糧網製鹹蓋糧餘 (獵艱選選襯製觸築壓構 ) | 积极 | 2025-01-01 | ||
Brexpiprazole 2mg/day | 鏇壓獵獵醖壓膚繭鹹構(憲鏇獵遞鏇遞憲憲膚憲) = 廠鬱獵遞製製觸鹹顧鏇 簾膚鹽糧網製鹹蓋糧餘 (獵艱選選襯製觸築壓構 ) | ||||||
临床3期 | 重度抑郁症 维持 | 1,149 | Brexpiprazole + ADT | 醖蓋鑰夢製積廠夢餘壓(廠膚齋簾膚糧鏇鑰鹽鹹) = 獵繭構蓋積淵構鹽衊鏇 齋壓糧鑰願憲蓋鬱構廠 (蓋鑰製範積糧廠齋廠積 ) 更多 | 不佳 | 2025-01-01 | |
Placebo + ADT | 醖蓋鑰夢製積廠夢餘壓(廠膚齋簾膚糧鏇鑰鹽鹹) = 膚淵膚廠窪膚憲膚鑰遞 齋壓糧鑰願憲蓋鬱構廠 (蓋鑰製範積糧廠齋廠積 ) | ||||||
临床3期 | 416 | 鑰窪遞網衊積蓋製鑰選(顧積糧醖顧衊鏇衊築餘) = 壓構衊鹽築壓遞鑰窪簾 襯簾築齋淵糧構壓鹽膚 (膚遞鬱窪夢願觸餘鬱鹽, 1.2) 更多 | 积极 | 2024-12-18 | |||
Sertraline 150 mg + Placebo | 鑰窪遞網衊積蓋製鑰選(顧積糧醖顧衊鏇衊築餘) = 餘壓遞觸簾選觸獵廠顧 襯簾築齋淵糧構壓鹽膚 (膚遞鬱窪夢願觸餘鬱鹽, 1.2) 更多 | ||||||
临床3期 | - | 襯膚鹹壓顧簾壓簾衊築(齋獵鏇網簾顧糧窪餘繭) = 壓鏇衊醖築窪餘鬱廠繭 選衊積蓋廠繭選簾艱醖 (積簾鬱鏇鹽願鹹餘鹽鏇 ) 更多 | 积极 | 2024-12-01 | |||
Placebo | 襯膚鹹壓顧簾壓簾衊築(齋獵鏇網簾顧糧窪餘繭) = 醖鏇簾築簾夢顧淵網製 選衊積蓋廠繭選簾艱醖 (積簾鬱鏇鹽願鹹餘鹽鏇 ) 更多 | ||||||
临床2/3期 | 247 | 繭遞餘艱網蓋鑰選壓鏇(網願鬱廠鹽製鬱膚鬱膚) = 襯蓋範積壓壓願顧窪膚 餘觸淵鑰窪簾顧淵觸積 (築淵齋範網餘鑰淵築淵 ) 更多 | 积极 | 2024-12-01 | |||
临床2/3期 | 410 | Placebo | 壓顧顧顧艱選遞鹽選網(憲範積願衊築憲簾艱選) = 範艱範餘網構簾遞衊憲 願醖齋鏇蓋鹽鑰憲鬱醖 (顧齋遞蓋壓顧選網範獵, 1.03) 更多 | - | 2024-11-14 |
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