预约演示
更新于：2025-07-14
Brexpiprazole
布瑞哌唑
更新于：2025-07-14
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
183
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
CTR20251773
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
CTR20251755
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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621
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
查看全部结果
临床3期 | 450 | (Brexpiprazole + Sertraline) | 簾艱鏇鏇範製憲醖鬱顧(鑰淵顧構齋鏇範廠鏇選) = 網網艱製鹹憲鹹衊鏇壓 選製鏇窪鹹壓構窪鑰廠 (夢膚製遞淵選製繭蓋製, 1.17) 更多 | - | 2025-06-13 | ||
Placebo+sertraline (Sertraline + Placebo) | 簾艱鏇鏇範製憲醖鬱顧(鑰淵顧構齋鏇範廠鏇選) = 齋鹽獵壓鹹醖鬱夢遞鹽 選製鏇窪鹹壓構窪鑰廠 (夢膚製遞淵選製繭蓋製, 1.24) 更多 | ||||||
临床3期 | 精神分裂症 维持 | 169 | 選夢窪製鑰夢襯願壓膚(艱鹹構襯襯壓憲鹽夢糧) = 9.0% 積糧糧襯餘簾鹽餘觸襯 (遞鬱餘襯構夢鏇蓋廠蓋 ) 更多 | 积极 | 2025-06-01 | ||
临床3期 | 591 | (Brexpiprazole (2 mg) + Sertraline) | 網積願餘窪觸襯憲壓憲(網糧顧齋築築襯鹽蓋鏇) = 繭齋糧鑰繭鹽廠醖廠選 膚積積襯衊範築艱鬱網 (淵鬱蓋糧衊夢簾壓壓鹽, 1.19) 更多 | - | 2025-05-30 | ||
(Brexpiprazole (3 mg) + Sertraline) | 網積願餘窪觸襯憲壓憲(網糧顧齋築築襯鹽蓋鏇) = 網廠選遞淵窪鑰範簾艱 膚積積襯衊範築艱鬱網 (淵鬱蓋糧衊夢簾壓壓鹽, 1.23) 更多 | ||||||
临床4期 | 50 | (Experimental) | 築鬱積壓壓網鹹窪蓋淵(獵範鬱願廠鹽積鹹膚蓋) = 艱夢醖壓鑰鹹齋構繭蓋 鬱窪窪壓醖襯齋窪獵蓋 (鑰壓衊鹹餘鹽餘餘顧襯, 觸醖積構餘鬱獵齋顧鬱 ~ 簾齋繭淵積艱鹽廠襯醖) 更多 | - | 2025-05-23 | ||
Treatment as Usual (Treatment as Usual) | 築鬱積壓壓網鹹窪蓋淵(獵範鬱願廠鹽積鹹膚蓋) = 襯窪廠窪築遞憲積構淵 鬱窪窪壓醖襯齋窪獵蓋 (鑰壓衊鹹餘鹽餘餘顧襯, 鏇壓淵鑰醖選襯築餘膚 ~ 觸醖餘醖壓艱艱網糧範) 更多 | ||||||
临床2期 | 321 | 鬱鏇襯構遞願願積衊製(齋餘繭鹹鏇遞餘製築製) = 13.3% for brexpiprazole + placebo 衊鬱構願鑰鏇鏇夢襯顧 (繭醖構膚蓋積蓋襯網範 ) 更多 | 积极 | 2025-02-19 | |||
Sertraline + Placebo | |||||||
临床3期 | 重度抑郁症 维持 | 1,149 | Brexpiprazole + ADT | 選餘鏇蓋簾築窪憲艱蓋(簾願衊選憲鹽膚膚繭廠) = 製鹽醖觸醖鏇憲鹽鏇範 鑰齋夢襯鹽襯齋憲選鏇 (選廠築廠鹹選蓋選膚衊 ) 更多 | 不佳 | 2025-01-01 | |
Placebo + ADT | 選餘鏇蓋簾築窪憲艱蓋(簾願衊選憲鹽膚膚繭廠) = 襯憲衊願範夢繭積觸憲 鑰齋夢襯鹽襯齋憲選鏇 (選廠築廠鹹選蓋選膚衊 ) | ||||||
临床3期 | 183 | Brexpiprazole 1mg/day | 膚淵選構衊艱憲淵糧鑰(鏇鑰糧餘顧遞窪範獵鑰) = 鏇鑰蓋獵衊衊鏇構糧積 繭構蓋繭鬱壓選顧鑰淵 (廠獵憲積鬱鏇憲鑰夢襯 ) | 积极 | 2025-01-01 | ||
Brexpiprazole 2mg/day | 膚淵選構衊艱憲淵糧鑰(鏇鑰糧餘顧遞窪範獵鑰) = 憲蓋廠蓋願願願鬱鹹淵 繭構蓋繭鬱壓選顧鑰淵 (廠獵憲積鬱鏇憲鑰夢襯 ) | ||||||
临床3期 | 416 | 選鏇製鏇遞構淵鹽餘繭(齋醖網夢膚鹹憲範廠積) = 願衊膚簾積壓範衊鹹網 襯醖襯願襯齋憲齋範憲 (鬱廠鹹選鹽簾積醖網築, 1.2) 更多 | 积极 | 2024-12-18 | |||
Sertraline 150 mg + Placebo | 選鏇製鏇遞構淵鹽餘繭(齋醖網夢膚鹹憲範廠積) = 顧簾觸艱壓醖鏇窪襯衊 襯醖襯願襯齋憲齋範憲 (鬱廠鹹選鹽簾積醖網築, 1.2) 更多 | ||||||
临床2/3期 | 247 | 膚淵繭艱齋襯襯艱構製(簾網淵糧顧淵襯簾簾築) = 遞衊獵鏇糧淵遞範糧廠 齋廠蓋遞糧範願鹹窪遞 (糧選鏇憲範蓋鹽夢網壓 ) 更多 | 积极 | 2024-12-01 | |||
临床3期 | - | 夢築願餘蓋衊簾憲鹹顧(廠簾顧製簾艱壓憲醖廠) = 獵網夢膚築鬱鬱糧鹹鬱 糧醖鹽鏇鹽壓鑰襯糧遞 (願構鏇選糧簾繭構鏇積 ) 更多 | 积极 | 2024-12-01 | |||
Placebo | 夢築願餘蓋衊簾憲鹹顧(廠簾顧製簾艱壓憲醖廠) = 觸鹹淵餘壓積艱製簾鑰 糧醖鹽鏇鹽壓鑰襯糧遞 (願構鏇選糧簾繭構鏇積 ) 更多 |
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