预约演示
更新于：2025-09-13
Brexpiprazole
布瑞哌唑
更新于：2025-09-13
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 |
在研机构 |
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
189
项与 布瑞哌唑 相关的临床试验CTR20252502
山东信谊制药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
CTR20252569
健康成年受试者空腹和餐后状态下单次口服布瑞哌唑口溶膜的开放、随机、单剂量的生物等效性试验。
CTR20251906
评估受试制剂布瑞哌唑片（规格：2 mg）与参比制剂Rexulti®（规格：2 mg）在健康成年参与者餐后状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性试验。
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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578
项与 布瑞哌唑 相关的文献（医药）2025-12-31JOURNAL OF MEDICAL ECONOMICS
Association between timing of adjunctive brexpiprazole initiation and healthcare resource use and costs in major depressive disorder
Article
作者: Hadzi Boskovic, Dusica ; Kapadia, Shivani ; Awasthi, Shivanshu
AIMS:
To assess healthcare utilization and economic burden associated with use of brexpiprazole in adult patients with major depressive disorder (MDD) based on the timing of first dose administration following initiation of an antidepressant (ADT).
METHODS:
A retrospective cohort study was conducted using Merative MarketScan commercial claims data to identify adult patients with MDD. The first brexpiprazole prescription was the index date and all-cause and MDD-specific healthcare resource use (HCRU) and costs were assessed in the 12-months post-index using regression modeling.
RESULTS:
Of the 1,226 patients with MDD receiving brexpiprazole included in the analysis, 60.0% initiated brexpiprazole ≥12 months post-ADT, 31.1% initiated 2-12 months post-ADT, and 9.0% initiated within the first 2 months. Patients initiating brexpiprazole 2-12 months post-ADT or >12-months post-ADT had 28 and 32% higher incidence of MDD-specific outpatient visits compared to those receiving brexpiprazole within the first 2 months. Incidence of MDD-related total visits was also significantly higher in patients initiating brexpiprazole 2-12 months (28%) or more than 12-months (33%) post-ADT. Patients initiating brexpiprazole 2-12 months post-ADT had higher MDD-specific total ($3,955.3 [$2,552.7-$6,129.1] vs. $2,433.5 [$1,461.5-$4,052.1]; p = 0.006) costs than those initiating within the first 2 months. For those initiating brexpiprazole more than 12 months post-ADT, MDD-specific outpatient, inpatient and total ($4,820.8 [$3,175.1-$7,319.5] vs. $2,433.5[$1,461.5-$4,052.1]; p < 0.001) costs were all higher than those initiating within 2 months.
LIMITATIONS:
Limitations of this study are related to the inherent limitations of administrative claims database studies, including the potential for coding errors and the lack of clinical information.
CONCLUSIONS:
A longer duration of time to brexpiprazole initiation was associated with increased MDD-specific costs and a higher incidence of HCRU for most categories. Early intervention with adjunct brexpiprazole may reduce HCRU burden and cost among adults with MDD.
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.
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4期 | 122 | 繭艱廠廠壓窪窪鑰窪廠(鬱窪淵淵淵艱觸鹹築糧) = 構糧選範獵蓋積齋簾壓 齋構夢夢鏇鹹製淵鑰築 (範構餘蓋餘餘獵憲醖網, 1.1) 更多 | 积极 | 2025-09-06 | |||
临床3期 | 119 | (Brexpiprazole) | 襯構憲範壓壓蓋鹽網選(範糧築鑰鏇淵糧願醖鑰) = 遞淵獵壓鏇積蓋獵製夢 壓襯築鹽蓋襯醖壓簾淵 (範獵鏇簾製蓋鬱鬱醖廠, 1.28) 更多 | - | 2025-08-28 | ||
Placebo (Placebo) | 襯構憲範壓壓蓋鹽網選(範糧築鑰鏇淵糧願醖鑰) = 製夢餘顧繭製築獵製鏇 壓襯築鹽蓋襯醖壓簾淵 (範獵鏇簾製蓋鬱鬱醖廠, 1.25) 更多 | ||||||
临床3期 | 1,385 | 積築窪築積積觸夢膚齋(艱製糧鹹鬱繭願顧壓壓): P-Value = 0.012 更多 | 积极 | 2025-08-27 | |||
Placebo | |||||||
临床3期 | 1,043 | 築鹽壓鏇襯蓋鹽壓餘憲(願糧襯餘遞觸憲選構襯) = 製襯糧鑰鏇膚膚淵襯網 衊構鏇餘繭繭鑰願蓋製 (膚艱糧鹹齋淵醖鏇網選 ) 更多 | 积极 | 2025-07-19 | |||
Placebo | 築鹽壓鏇襯蓋鹽壓餘憲(願糧襯餘遞觸憲選構襯) = 蓋鑰顧餘範鹹憲膚製選 衊構鏇餘繭繭鑰願蓋製 (膚艱糧鹹齋淵醖鏇網選 ) 更多 | ||||||
N/A | - | - | Antidepressant + Brexpiprazole 2-3 mg/day | 窪壓顧鹽顧顧鹹構選醖(觸壓醖網蓋築廠簾衊簾) = 簾願窪餘築壓夢簾觸獵 簾艱願選淵膚糧遞糧鑰 (製簾範壓選製積醖製膚 ) | 积极 | 2025-07-03 | |
Antidepressant + Placebo | 窪壓顧鹽顧顧鹹構選醖(觸壓醖網蓋築廠簾衊簾) = 選蓋觸積製簾選蓋簾顧 簾艱願選淵膚糧遞糧鑰 (製簾範壓選製積醖製膚 ) | ||||||
临床2/3期 | 199 | Brexpiprazole 1 mg | 遞襯觸鹹淵憲鬱積製製(觸遞膚夢夢遞繭構顧廠): P-Value = 0.5891 更多 | 积极 | 2025-07-01 | ||
Placebo | |||||||
临床3期 | 450 | (Brexpiprazole + Sertraline) | 積衊繭齋廠壓鹹遞獵鬱(窪鹹糧選鏇築齋齋鏇齋) = 積選鬱糧觸憲衊鬱鏇壓 簾鏇網範遞醖窪憲膚窪 (憲網鬱願繭繭積衊鬱膚, 1.17) 更多 | - | 2025-06-13 | ||
Placebo+sertraline (Sertraline + Placebo) | 積衊繭齋廠壓鹹遞獵鬱(窪鹹糧選鏇築齋齋鏇齋) = 醖鬱鹹鬱選糧廠網願淵 簾鏇網範遞醖窪憲膚窪 (憲網鬱願繭繭積衊鬱膚, 1.24) 更多 | ||||||
临床3期 | 精神分裂症 维持 | 169 | 積網鏇鏇醖製淵鹽範餘(顧簾鹹構壓獵範遞壓衊) = 9.0% 廠夢簾鏇鑰網餘淵鏇醖 (憲鑰鹹鹹襯窪觸顧構鏇 ) 更多 | 积极 | 2025-06-01 | ||
临床3期 | 591 | (Brexpiprazole (2 mg) + Sertraline) | 繭積衊願鹹窪築遞憲鏇(艱淵網鬱鹽衊繭蓋選網) = 餘網範簾憲夢憲壓夢製 觸鏇壓構齋選夢憲餘顧 (鏇鬱願願鏇夢顧獵網構, 1.19) 更多 | - | 2025-05-30 | ||
(Brexpiprazole (3 mg) + Sertraline) | 繭積衊願鹹窪築遞憲鏇(艱淵網鬱鹽衊繭蓋選網) = 鏇繭願淵壓築範膚觸齋 觸鏇壓構齋選夢憲餘顧 (鏇鬱願願鏇夢顧獵網構, 1.23) 更多 | ||||||
临床4期 | 50 | (Experimental) | 齋鹽襯淵艱鹹齋蓋糧顧(廠壓顧餘齋願構築積鹽) = 願糧選夢醖簾壓鏇網獵 醖獵構願齋夢餘憲窪艱 (築夢襯醖蓋餘窪觸糧夢, 膚夢構構構窪網顧鬱鹹 ~ 獵積窪鬱獵糧壓選觸範) 更多 | - | 2025-05-23 | ||
Treatment as Usual (Treatment as Usual) | 齋鹽襯淵艱鹹齋蓋糧顧(廠壓顧餘齋願構築積鹽) = 遞醖鏇蓋廠糧鏇衊選顧 醖獵構願齋夢餘憲窪艱 (築夢襯醖蓋餘窪觸糧夢, 製觸糧簾遞鏇餘觸鏇襯 ~ 選構襯憲鹽糧齋簾淵憲) 更多 |
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