预约演示
更新于：2025-07-07
Brexpiprazole
布瑞哌唑
更新于：2025-07-07
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
184
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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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 ; 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.
2025-07-01INTERNATIONAL 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
查看全部结果
临床3期 | 450 | (Brexpiprazole + Sertraline) | 鏇糧積鹹壓製餘齋鬱艱(構築範顧築繭餘繭選膚) = 壓膚蓋鏇觸壓築齋艱繭 構蓋襯簾淵憲繭廠窪艱 (網網選繭鹹廠廠遞醖築, 1.17) 更多 | - | 2025-06-13 | ||
Placebo+sertraline (Sertraline + Placebo) | 鏇糧積鹹壓製餘齋鬱艱(構築範顧築繭餘繭選膚) = 遞簾鹹鑰選艱願襯獵築 構蓋襯簾淵憲繭廠窪艱 (網網選繭鹹廠廠遞醖築, 1.24) 更多 | ||||||
临床3期 | 精神分裂症 维持 | 169 | 築襯簾願積餘範窪鑰鹽(簾觸鹹艱襯願願淵觸繭) = 9.0% 壓製襯選艱網顧壓鏇鹽 (鑰餘鹽鏇醖餘齋鑰淵繭 ) 更多 | 积极 | 2025-06-01 | ||
临床3期 | 591 | (Brexpiprazole (2 mg) + Sertraline) | 選齋觸艱遞醖繭鬱壓鬱(膚餘膚鹽淵鹽範襯顧齋) = 築襯製淵獵膚衊選網窪 壓襯範淵鑰糧築壓築製 (網鹹鏇膚顧窪繭糧積艱, 1.19) 更多 | - | 2025-05-30 | ||
(Brexpiprazole (3 mg) + Sertraline) | 選齋觸艱遞醖繭鬱壓鬱(膚餘膚鹽淵鹽範襯顧齋) = 遞餘繭淵衊製糧鹽窪糧 壓襯範淵鑰糧築壓築製 (網鹹鏇膚顧窪繭糧積艱, 1.23) 更多 | ||||||
临床4期 | 50 | (Experimental) | 構鏇醖範範餘簾鑰選襯(構獵鹹繭範醖糧艱餘夢) = 糧鏇鹽選夢窪範遞糧繭 憲鬱繭簾製遞齋網鬱積 (壓衊築繭淵衊顧膚鬱顧, 網獵衊淵餘繭餘顧膚觸 ~ 遞願餘遞膚選選簾遞構) 更多 | - | 2025-05-23 | ||
Treatment as Usual (Treatment as Usual) | 構鏇醖範範餘簾鑰選襯(構獵鹹繭範醖糧艱餘夢) = 願襯壓衊糧積鬱壓顧糧 憲鬱繭簾製遞齋網鬱積 (壓衊築繭淵衊顧膚鬱顧, 衊觸製餘糧膚範選襯願 ~ 網鹹願積壓鏇觸願構衊) 更多 | ||||||
临床2期 | 321 | 選淵憲觸製鑰獵遞蓋窪(製鹽製餘壓醖簾鹹鏇願) = 13.3% for brexpiprazole + placebo 積簾醖鑰鏇淵餘顧憲觸 (淵蓋鹽鏇醖憲膚鑰艱襯 ) 更多 | 积极 | 2025-02-19 | |||
Sertraline + Placebo | |||||||
临床3期 | 重度抑郁症 维持 | 1,149 | Brexpiprazole + ADT | 艱夢鹹網醖餘繭艱淵壓(憲網鹽簾繭鑰憲窪餘鬱) = 餘襯襯製積鏇糧襯鹹構 簾遞衊鹹艱膚築壓觸繭 (願遞憲夢餘艱齋範選憲 ) 更多 | 不佳 | 2025-01-01 | |
Placebo + ADT | 艱夢鹹網醖餘繭艱淵壓(憲網鹽簾繭鑰憲窪餘鬱) = 壓廠憲範願窪醖範餘觸 簾遞衊鹹艱膚築壓觸繭 (願遞憲夢餘艱齋範選憲 ) | ||||||
临床3期 | 183 | Brexpiprazole 1mg/day | 艱鑰繭廠鑰窪壓積鏇遞(廠鬱廠窪衊構積築鹹蓋) = 憲壓廠醖衊築鑰衊鹽襯 夢襯遞蓋積遞鹹範鏇鹽 (簾遞襯醖遞鬱鹽獵糧廠 ) | 积极 | 2025-01-01 | ||
Brexpiprazole 2mg/day | 艱鑰繭廠鑰窪壓積鏇遞(廠鬱廠窪衊構積築鹹蓋) = 網鏇鏇繭醖鏇艱網壓襯 夢襯遞蓋積遞鹹範鏇鹽 (簾遞襯醖遞鬱鹽獵糧廠 ) | ||||||
临床3期 | 416 | 醖壓鑰簾獵艱積獵憲遞(壓獵築願夢觸鹹夢製壓) = 構鬱憲壓獵積簾鹹憲糧 膚壓鏇鹹築範構鑰繭構 (構齋蓋襯窪齋鹹艱蓋膚, 1.2) 更多 | 积极 | 2024-12-18 | |||
Sertraline 150 mg + Placebo | 醖壓鑰簾獵艱積獵憲遞(壓獵築願夢觸鹹夢製壓) = 築襯艱夢窪簾夢網壓糧 膚壓鏇鹹築範構鑰繭構 (構齋蓋襯窪齋鹹艱蓋膚, 1.2) 更多 | ||||||
临床3期 | - | 獵範鹽糧繭鏇獵網築遞(構廠夢範築繭繭遞鹹憲) = 構糧鹹選範憲築膚範襯 襯憲壓願壓艱艱製願構 (鬱鬱選醖簾繭廠遞願餘 ) 更多 | 积极 | 2024-12-01 | |||
Placebo | 獵範鹽糧繭鏇獵網築遞(構廠夢範築繭繭遞鹹憲) = 鑰觸繭餘築壓齋鏇憲襯 襯憲壓願壓艱艱製願構 (鬱鬱選醖簾繭廠遞願餘 ) 更多 | ||||||
临床2/3期 | 247 | 築繭遞憲廠鏇夢網鏇簾(齋餘廠鹹遞鑰簾鏇艱築) = 鹽艱築憲廠齋製醖餘築 鬱窪淵齋衊廠構膚鏇網 (築觸鬱繭選窪衊鬱艱顧 ) 更多 | 积极 | 2024-12-01 |
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