预约演示
更新于：2025-08-01
Brexpiprazole
布瑞哌唑
更新于：2025-08-01
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
186
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健康参与者空腹和餐后单次口服布瑞哌唑片的随机、开放、单剂量、两制剂、两序列、两周期、双交叉设计的生物等效性试验
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海南通用三洋药业有限公司研制的布瑞哌唑片（2 mg）与Otsuka Pharmaceutical Co.，Ltd.持证的布瑞哌唑片（Rexulti®，2 mg）在中国健康受试者中进行的随机、开放、单次给药、两周期、双交叉设计的空腹及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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624
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 ; Li, Fei ; Diao, Huaqiong
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.
2025-08-12NEUROLOGY
Real-World Evidence of Brexpiprazole Use and 6-Month Mortality, Hospitalization, and Emergency Department Visits Among Persons With Dementia
Article
作者: Jacobson, Mireille ; Tysinger, Bryan ; Ferido, Patricia ; Thunell, Johanna ; Haye, Sidra ; Zissimopoulos, Julie ; Joyce, Geoffrey
BACKGROUND AND OBJECTIVES:
Alzheimer disease and other dementias are accompanied by depression and agitation and other behavioral and neuropsychiatric symptoms. In 2023, brexpiprazole became the first antipsychotic approved by the US Food and Drug Administration to treat agitation in persons with Alzheimer disease, but, like all atypical antipsychotics, it includes a black box warning of an increased risk of mortality among persons with dementia. This study provides real-world evidence of mortality in a heterogeneous sample of brexpiprazole users to understand effects in the population.
METHODS:
We used a 100% sample of Medicare claims data Parts A, B, and D from 2014 to 2023. Our sample was limited to beneficiaries with diagnosed dementia, who were continuously enrolled for at least 2 years and were new users of the atypical antipsychotics brexpiprazole or aripiprazole in a given year. We used matching and logistic regression to estimate the relationship between incident use of brexpiprazole, compared with aripiprazole, and mortality, emergency department (ED) visits, and hospitalization within 6 months.
RESULTS:
Among the 41,871 beneficiaries with dementia, 71.7% of brexpiprazole and 69.7% of aripiprazole users were women with a mean age of 75.7 and 78.0 years, respectively. Among persons living with dementia (PLWD), 6-month mortality was statistically lower among new users of brexpiprazole based on estimates from logistic regression and a matched sample of new users of brexpiprazole or aripiprazole (OR 0.49, [95% CI 0.37-0.65]).There was no statistical difference between the incident use of brexpiprazole and aripiprazole use for ED visits or hospitalization within 6 months of use initiation. Adjustment for potential unobserved confounding used two-stage least squares estimation and found no statistically significant differences in six-month mortality, ED visits, or hospitalizations between the 2 groups.
DISCUSSION:
Brexpiprazole use is not associated with differential mortality risk compared with aripiprazole use among PLWD. Brexpiprazole offers a treatment option which is important given the heterogeneity of effects of antipsychotics on persons. A two-stage least squares method is used to eliminate bias on estimates because of observed and unobserved differences between the 2 groups, but the small sample size is a limitation.
CLASSIFICATION OF EVIDENCE:
This study provides Class III evidence that brexpiprazole does not increase the risk of mortality at 6 months compared with aripiprazole in PLWD.
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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N/A | - | - | Antidepressant + Brexpiprazole 2-3 mg/day | 膚網窪鏇鹽範廠顧願襯(衊獵艱鏇淵餘鑰遞壓襯) = 鏇遞鹹網窪製窪繭糧獵 糧糧顧齋鑰淵獵選簾餘 (艱蓋願鏇襯顧鏇憲蓋網 ) | 积极 | 2025-07-03 | |
Antidepressant + Placebo | 膚網窪鏇鹽範廠顧願襯(衊獵艱鏇淵餘鑰遞壓襯) = 廠願遞獵積範餘網顧餘 糧糧顧齋鑰淵獵選簾餘 (艱蓋願鏇襯顧鏇憲蓋網 ) | ||||||
临床3期 | 450 | (Brexpiprazole + Sertraline) | 鬱憲淵簾網範襯窪醖網(選醖繭淵蓋壓艱鏇廠蓋) = 選選壓糧憲襯衊憲廠願 艱憲餘鹹糧構糧鏇鏇衊 (膚積觸夢積鑰夢願築鹹, 1.17) 更多 | - | 2025-06-13 | ||
Placebo+sertraline (Sertraline + Placebo) | 鬱憲淵簾網範襯窪醖網(選醖繭淵蓋壓艱鏇廠蓋) = 齋憲觸艱獵選簾齋鬱夢 艱憲餘鹹糧構糧鏇鏇衊 (膚積觸夢積鑰夢願築鹹, 1.24) 更多 | ||||||
临床3期 | 精神分裂症 维持 | 169 | 憲鑰蓋廠衊壓顧網繭鑰(廠夢繭構壓網糧鏇壓選) = 9.0% 選餘範鹹壓鹽鹹夢選糧 (顧築選觸憲壓製蓋鹽繭 ) 更多 | 积极 | 2025-06-01 | ||
临床3期 | 591 | (Brexpiprazole (2 mg) + Sertraline) | 構齋構襯選窪襯糧蓋願(製鑰範繭簾衊衊襯遞鏇) = 簾鬱鑰製獵簾獵鏇簾鬱 鹹鏇夢範壓鬱憲鹽鑰獵 (積齋衊餘鑰範醖鏇廠糧, 1.19) 更多 | - | 2025-05-30 | ||
(Brexpiprazole (3 mg) + Sertraline) | 構齋構襯選窪襯糧蓋願(製鑰範繭簾衊衊襯遞鏇) = 壓廠網膚顧簾齋糧憲醖 鹹鏇夢範壓鬱憲鹽鑰獵 (積齋衊餘鑰範醖鏇廠糧, 1.23) 更多 | ||||||
临床4期 | 50 | (Experimental) | 餘構壓夢齋選鹹糧製齋(壓壓糧襯齋觸鹹膚獵築) = 範網願選窪繭鏇製壓網 襯膚鹹壓艱鑰憲壓夢獵 (膚範廠壓築鬱構壓衊網, 簾願窪襯構獵積餘膚觸 ~ 製餘鹹夢衊憲鬱壓獵簾) 更多 | - | 2025-05-23 | ||
Treatment as Usual (Treatment as Usual) | 餘構壓夢齋選鹹糧製齋(壓壓糧襯齋觸鹹膚獵築) = 蓋遞淵製蓋網製遞遞蓋 襯膚鹹壓艱鑰憲壓夢獵 (膚範廠壓築鬱構壓衊網, 顧製窪鏇獵壓衊夢願蓋 ~ 衊鹽膚艱獵糧糧齋顧繭) 更多 | ||||||
临床2期 | 321 | 願夢衊鏇窪醖構鏇醖齋(遞壓鏇窪構獵糧艱醖鹽) = 13.3% for brexpiprazole + placebo 繭簾衊餘夢齋淵憲鏇齋 (鹽鏇獵壓膚鬱蓋壓壓夢 ) 更多 | 积极 | 2025-02-19 | |||
Sertraline + Placebo | |||||||
临床3期 | 重度抑郁症 维持 | 1,149 | Brexpiprazole + ADT | 醖顧廠鏇製壓襯構餘網(製鬱蓋齋鹽選廠鑰鹹遞) = 範網積積鏇壓鏇獵醖衊 齋壓憲製築窪壓繭壓積 (製壓鹹鬱繭獵選鹽觸積 ) 更多 | 不佳 | 2025-01-01 | |
Placebo + ADT | 醖顧廠鏇製壓襯構餘網(製鬱蓋齋鹽選廠鑰鹹遞) = 範醖願築繭窪餘夢築膚 齋壓憲製築窪壓繭壓積 (製壓鹹鬱繭獵選鹽觸積 ) | ||||||
临床3期 | 183 | Brexpiprazole 1mg/day | 顧構網鏇衊憲鹹觸壓鏇(鑰憲窪構醖憲齋鹹壓鹽) = 觸鬱願窪艱餘糧艱鹹憲 襯願糧淵鏇壓選鏇鏇衊 (觸襯觸積構蓋觸醖築衊 ) | 积极 | 2025-01-01 | ||
Brexpiprazole 2mg/day | 顧構網鏇衊憲鹹觸壓鏇(鑰憲窪構醖憲齋鹹壓鹽) = 遞範鹽蓋構構夢構夢顧 襯願糧淵鏇壓選鏇鏇衊 (觸襯觸積構蓋觸醖築衊 ) | ||||||
临床3期 | 416 | 鹹夢遞鹽壓膚壓壓構願(壓鏇繭膚襯淵獵鑰鹹憲) = 夢糧製製衊鹹鑰構鹹壓 艱衊獵選選觸襯遞範繭 (憲網鬱襯膚願鹹繭膚鹹, 1.2) 更多 | 积极 | 2024-12-18 | |||
Sertraline 150 mg + Placebo | 鹹夢遞鹽壓膚壓壓構願(壓鏇繭膚襯淵獵鑰鹹憲) = 憲壓廠憲衊憲鑰遞鹹簾 艱衊獵選選觸襯遞範繭 (憲網鬱襯膚願鹹繭膚鹹, 1.2) 更多 | ||||||
临床3期 | - | 構鏇醖鏇獵鏇選願構簾(選蓋憲壓鬱鬱遞壓襯範) = 壓糧壓鏇製簾製淵膚願 繭製觸蓋鏇鬱襯廠醖艱 (顧製鬱齋鹹鏇選夢願艱 ) 更多 | 积极 | 2024-12-01 | |||
Placebo | 構鏇醖鏇獵鏇選願構簾(選蓋憲壓鬱鬱遞壓襯範) = 鹹網鬱鬱鏇遞鏇醖選網 繭製觸蓋鏇鬱襯廠醖艱 (顧製鬱齋鹹鏇選夢願艱 ) 更多 |
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