布瑞哌唑(Brexpiprazole) - 药物靶点：5-HT1A receptor x 5-HT2A receptor x D2 receptor_在研适应症：抑郁症，痴呆引起的激越，躁动_专利_临床

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]

靶点

5-HT1A receptor x 5-HT2A receptor x D2 receptor

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)

治疗领域

其他疾病神经系统疾病

在研适应症

抑郁症痴呆引起的激越躁动+ [6]

非在研适应症

焦虑症注意缺陷和破坏性行为障碍注意缺陷障碍伴多动+ [12]

原研机构

Otsuka Pharmaceutical Co., Ltd.

在研机构

Otsuka Holdings Co., Ltd.Lundbeck Australia Pty Ltd.

Sharp Corp.

+ [28]

非在研机构

大冢制药研发（北京）有限公司

权益机构

H. Lundbeck A/S

Otsuka Holdings Co., Ltd.

最高研发阶段批准上市

首次获批日期

美国 (2015-07-10),

重度抑郁症精神分裂症

最高研发阶段(中国)批准上市

特殊审评快速通道 (美国)、优先审评 (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

项与布瑞哌唑相关的临床试验

CTR20252502

/ RecruitingN/A

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

以山东信谊制药有限公司研制的布瑞哌唑片（规格：2 mg）为受试制剂，Otsuka Pharmaceutical Co.，Ltd.持证的布瑞哌唑片（商品名：Rexulti®，规格：2 mg）为参比制剂，考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度，评价两制剂是否具有生物等效性。同时评价两种制剂在健康人体中的安全性和耐受性

开始日期2025-07-16

申办/合作机构

山东信谊制药有限公司

CTR20251906

/ Active, not recruitingN/A

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。

主要研究目的：研究餐后状态下单次口服受试制剂布瑞哌唑片（规格：2 mg，成都通德药业有限公司生产）与参比制剂布瑞哌唑片（Rexulti®，规格：2 mg，大塚制药株式会社生产）在健康参与者体内的药代动力学，评价餐后状态下口服两种制剂的生物等效性。次要研究目的：评估受试制剂布瑞哌唑片（规格：2 mg）和参比制剂布瑞哌唑片（Rexulti®，规格：2 mg）在健康参与者中的安全性。

开始日期2025-06-14

申办/合作机构

成都通德药业有限公司

CTR20251094

/ RecruitingN/A

布瑞哌唑口服溶液空腹及餐后人体生物等效性研究

以鲁南贝特制药有限公司生产的布瑞哌唑口服溶液（规格：120mL：30mg）为受试制剂，大冢制药株式会社持证的布瑞哌唑片（REXULTI®，规格：2mg）为参比制剂，考察两制剂在空腹及餐后状态下单次给药吸收速度和程度的差异，评价两制剂是否具有生物等效性

开始日期2025-06-11

申办/合作机构

鲁南贝特制药有限公司

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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569

项与布瑞哌唑相关的文献（医药）

2025-11-01·JOURNAL 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.

2025-11-01·JOURNAL 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.

2025-08-12·NEUROLOGY

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.

348

项与布瑞哌唑相关的新闻（医药）

2025-08-15

·FiercePharma

Lundbeck dials up migraine drug's US peak sales estimate, stays positive on Rexulti's PTSD use

Lundbeck is undergoing a sweeping capital reallocation initiative to channel resources to strategic brands such as Vyepti and Rexulti, plus key R&D projects. After a 54% year-over-year sales increase for CGRP migraine drug Vyepti in the U.S., Lundbeck has raised its peak sales projection for the therapy in the key market.The Danish company now expects the CGRP blocker to reach more than $1.1 billion in sales at peak in the U.S., a $100 million increase from its previous guidance. In the second quarter, Vyepti’s sales were 1.83 billion Danish kroner ($287 million) in the States, representing 87% of the drug's global total.Vyepti is the only infused CGRP med in a drug class filled with oral pills and under-the-skin injectables. Approved by the FDA in 2020 to prevent migraine episodes, Vyepti was the fastest-growing anti-CGRP agent in the U.S. as of June, with its demand growth of 50% year over year versus 20% for the overall market, according to Lundbeck.To fuel Vyepti’s growth, Lundbeck has invested in healthcare provider engagement, patient activation and patient support services, Tom Gibbs, head of Lundbeck’s U.S. operations, said in an investor call Thursday.“We continue to see accelerating demand by driving depth and breadth of prescribing of Vyepti and continued positive momentum in new patient starts supported by a high written-to-infusion conversion ratio and best-in-class patient persistency,” Gibbs said.Vyepti’s rollout has benefited from a sweeping capital reallocation initiative launched after Lundbeck’s current CEO Charl van Zyl joined in 2023. The goal is to channel resources to strategic brands such as Vyepti and the antipsychotic Rexulti, plus key R&D projects. Toward that end, Lundbeck last year transferred U.S. rights and promotion responsibility around the depression drug Trintellix to its partner Takeda.The company now expects to redeploy about 1.3 billion Danish kroner to 1.5 billion kroner by 2027, an increase from a previous range between 1 billion kroner to 1.3 billion kroner, thanks in part to changes in Lundbeck’s commercial model as a result of the Trintellix divestiture, CFO Joerg Hornstein said on the call. Besides Vyepti, Otsuka-partnered Rexulti also delivered strong sales growth for Lundbeck, at 28% worldwide, to reach revenue of 3 billion kroner in the second quarter. The increase has been driven by demand for the treatment of Alzheimer’s disease agitation.But Rexulti recently suffered a setback as an FDA advisory committee cast an overwhelmingly negative vote, saying that the efficacy of the drug’s proposed use alongside sertraline in post-traumatic stress disorder (PTSD) has not been established by existing clinical data.The problem stemmed from one of two phase 3 trials of Rexulti in the indication missing statistical significance. Still, the near-unanimous thumbs-down came as a bit of a surprise given that several panel members suggested that combo may be effective. Lundbeck’s R&D chief, Johan Luthman, apparently picked up on the positive sentiment despite the negative vote.“I think this is an interesting sentiment because we have good data, but not what you regularly like to see for an approval in this space,” he said, referring to the FDA’s typical requirement to have two positive phase 3 trials to grant an antipsychotic approval.There’s a high medical need in PTSD as the last FDA approval in the field was 23 years ago, Luthman noted on Thursday’s call.Several advisory committee members suggested that they would be willing to use the Rexulti regimen off-label in patients who do not respond to sertraline, one analyst recalled on the Lundbeck conference call.Gibbs noted that Rexulti enjoys very good payer access on both the commercial side and on Medicare, and that payer management of utilization doesn’t really get to the indication level. In addition to Alzheimer’s agitation, the drug is currently also approved for major depressive disorder and schizophrenia.Thanks to strong performance from Vyepti and Rexulti, Lundbeck again raised its full-year growth expectations to a range between 11% to 13% at constant currencies, versus the prior projection of 8% to 11% growth. For the first half of the year, Lundbeck’s total revenue jumped 14% to 12.3 billion kroner ($1.9 billion).

上市批准临床3期生物类似药临床结果财报

2025-08-10

·信狐药迅

新药上市申请3个品规、仿制药上市申请30个品规被发通知件| 新获批(8.4-8.10）

每周药品注册获批数据，分门别类呈现，一目了然。(8.4-8.10）新药上市申请药品名称企业注册分类受理号磷酸奥司他韦口腔崩解片北京星昊医药股份有限公司2.2CXHS2400027磷酸奥司他韦口腔崩解片北京星昊医药股份有限公司2.2CXHS2400026马来酸噻吗洛尔凝胶上海奥全生物医药科技有限公司2.4;2.2CXHS2400111 新药临床申请药品名称企业注册分类受理号HRS-6093片江苏恒瑞医药股份有限公司1CXHL2500550HRS-6093片江苏恒瑞医药股份有限公司1CXHL2500549HRS-4508片江苏恒瑞医药股份有限公司1CXHL2500541HRS-4508片江苏恒瑞医药股份有限公司1CXHL2500540QL-H118片南京芩领医药科技有限公司1CXHL2500538SZ2001片苏中药业集团股份有限公司1CXHL2500524SZ2001片苏中药业集团股份有限公司1CXHL2500523HSK47388片海思科医药集团股份有限公司1CXHL2500521HSK47388片海思科医药集团股份有限公司1CXHL2500522BGB-16673片百济神州(苏州)生物科技有限公司1CXHL2500526BGB-16673片百济神州(苏州)生物科技有限公司1CXHL2500525RO7840734罗氏(中国)投资有限公司1CXHL2500519RO7840734罗氏(中国)投资有限公司1CXHL2500518SYN818片杭州圣域生物医药科技有限公司1CXHL2500511SYN818片杭州圣域生物医药科技有限公司1CXHL2500510HW241045片武汉人福创新药物研发中心有限公司1CXHL2500498HW241045片武汉人福创新药物研发中心有限公司1CXHL2500497DC411151胶囊杭州民生药业股份有限公司1CXHL2500487DC411151胶囊杭州民生药业股份有限公司1CXHL2500486HEC20002胶囊广东东阳光药业股份有限公司2.2CXHL2500527KEM2417缓释干混悬剂深圳珐玛易药品科技有限公司2.2CXHL2500515KEM2417缓释干混悬剂深圳珐玛易药品科技有限公司2.2CXHL2500514盐酸奥洛他定口服液海南万玮制药有限公司2.2CXHL2500504MZ-01吸入溶液成都米子生物医药科技有限公司2.2;2.4CXHL2500513注射用多西他赛(白蛋白结合型)石药集团中奇制药技术(石家庄)有限公司2.4CXHL2500537氟[18F]阿洛夫定注射液江苏华益科技有限公司2.4CXHL2500485重组带状疱疹疫苗(CHO细胞)桓科(河北)生物技术有限公司1.3CXSL2500371注射用LM-24C5礼新医药科技(上海)有限公司1CXSL2500457注射用SHR-A1811苏州盛迪亚生物医药有限公司1CXSL2500455SIBP-A10注射液上海生物制品研究所有限责任公司1CXSL2500449注射用YL201苏州宜联生物医药有限公司1CXSL2500441注射用BAT8008百奥泰生物制药股份有限公司1CXSL2500440BAT1308注射液百奥泰生物制药股份有限公司1CXSL2500438注射用YL202苏州宜联生物医药有限公司1CXSL2500437注射用YL201苏州宜联生物医药有限公司1CXSL2500436注射用BL-B01D1成都百利多特生物药业有限责任公司1CXSL2500424注射用IMD303亲合力(成都)药业有限公司1CXSL2500422SHR-7782注射液苏州盛迪亚生物医药有限公司1CXSL2500416注射用TJ101一线医药(杭州)有限公司1CXSL2500413注射用LB4330上海健信生物医药科技有限公司1CXSL2500407注射用重组抗PD1/TIM3人源化双特异抗体上海健信生物医药科技有限公司1CXSL2500404注射用MHB042C明慧医药(杭州)有限公司1CXSL2500409注射用BC3195无锡智康弘义生物科技有限公司1CXSL2500398CM512注射液康诺亚生物医药科技(成都)有限公司1CXSL2500391ABO2102注射剂苏州艾博生物科技有限公司1CXSL2500388NW-101C注射液新景智源生物科技(苏州)有限公司1CXSL2500386NW-101C注射液新景智源生物科技(苏州)有限公司1CXSL2500385SENL103自体T细胞注射液河北森朗生物科技有限公司1CXSL2500382SYS6026注射液石药集团巨石生物制药有限公司1CXSL2500376EXG202注射液杭州嘉因生物科技有限公司1CXSL2500375自体天然肿瘤浸润淋巴细胞注射液上海君赛生物药业有限公司1CXSL2500374人脐带间充质干细胞注射液天津华域药业有限公司1CXSL2500373替雷利珠单抗注射液广州百济神州生物制药有限公司2.1CXSL2500447贝伐珠单抗注射液苏州盛迪亚生物医药有限公司2.2CXSL2500450阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2500448BAT4706注射液百奥泰生物制药股份有限公司2.4CXSL2500439 仿制药申请药品名称企业注册分类受理号西格列汀二甲双胍缓释片杭州和泽坤元药业有限公司3CYHS2403955盐酸纳美芬注射液广州市联瑞制药有限公司3CYHS2403434阿糖胞苷注射液吉斯美(武汉)制药有限公司3CYHS2403402阿糖胞苷注射液吉斯美(武汉)制药有限公司3CYHS2403404盐酸纳美芬注射液成都明德至远医药科技有限公司3CYHS2403300注射用乳糖酸红霉素广东金城金素制药有限公司3CYHS2403305盐酸纳美芬注射液江苏安必生制药有限公司3CYHS2403223氯化钙注射液海南倍特药业有限公司3CYHS2403093布瑞哌唑口腔崩解片成都康弘药业集团股份有限公司3CYHS2402954小儿复方氨基酸注射液(19AA-I)湖北民康药业集团有限公司3CYHS2400829奥贝胆酸片正大天晴药业集团股份有限公司3CYHS2400425奥贝胆酸片正大天晴药业集团股份有限公司3CYHS2400424度拉糖肽注射液山东博安生物技术股份有限公司3.3CXSS2400054度拉糖肽注射液山东博安生物技术股份有限公司3.3CXSS2400053度拉糖肽注射液山东博安生物技术股份有限公司3.3CXSS2400052度拉糖肽注射液山东博安生物技术股份有限公司3.3CXSS2400051阿达木单抗注射液武汉生物制品研究所有限责任公司3.3CXSS2300100乙酰半胱氨酸注射液嘉实(湖南)医药科技有限公司4CYHS2502336硫酸艾沙康唑胶囊福安药业集团庆余堂制药有限公司4CYHS2502230溴芬酸钠滴眼液盈科瑞(珠海金湾)制药有限公司4CYHS2502224磷酸芦可替尼片齐鲁制药有限公司4CYHS2501525磷酸芦可替尼片齐鲁制药有限公司4CYHS2501524磷酸芦可替尼片齐鲁制药有限公司4CYHS2501523噻托溴铵吸入喷雾剂天津信达制药有限公司4CYHS2404343洛索洛芬钠凝胶贴膏广东恒健制药有限公司4CYHS2403666地屈孕酮片浙江美迪深生物医药有限公司4CYHS2403641右旋糖酐羟丙甲纤维素滴眼液宏越科技(湖州)有限公司4CYHS2403233多巴丝肼片上海理想制药有限公司4CYHS2403254富马酸贝达喹啉片中诺凯琳健康产业(海南)有限公司4CYHS2403134熊去氧胆酸口服混悬液海南斯达制药有限公司4CYHS2402608丙酸氯倍他索搽剂江苏知原药业股份有限公司4CYHS2401668盐酸氨溴索注射液多多药业有限公司4CYHS2401261丙戊酸钠口服溶液浙江赛默制药有限公司4CYHS2400631盐酸特比萘芬喷雾剂浙江赛默制药有限公司4CYHS2303349培哚普利氨氯地平片(III)宁波科尔康美诺华药业有限公司4CYHS2303149培哚普利氨氯地平片(I)宁波科尔康美诺华药业有限公司4CYHS2303148培哚普利氨氯地平片(I)宁波科尔康美诺华药业有限公司4CYHS2303147吸入用复方异丙托溴铵溶液深圳大佛药业股份有限公司4CYHS2200587国;CYHS2200587苯磺顺阿曲库铵润都制药(荆门)有限公司CYHS2460216维生素D口服溶液厦门紫旭医药科技有限公司3CYHL2500105氨苯砜凝胶深圳珐玛易药品科技有限公司3CYHL2500101艾考糊精腹膜透析液仁合益康集团有限公司4CYHL2500093注射用SIM0692山东先声生物制药有限公司3.3CXSL2500417 进口申请药品名称企业注册分类受理号埃万妥单抗注射液Janssen-Cilag International NV2.2JXSS2400004GIREDESTRANTGenentech, Inc.1JXHL2500122CHF1535-IICHIESI FARMACEUTICI SPA2.2JXHL2500110TAR-210Janssen Research & Development, LLC2.2;2.4JXHL2500125匹妥布替尼片Eli Lilly and Company2.4JXHL2500113PF-08046047Pfizer Inc.1JXSL2500085Depemokimab注射液GlaxoSmithKline Research & Development Limited1JXSL2500080SAR402663注射液Sanofi-Aventis Recherche & Developpement1JXSL2500074Mosunetuzumab Injection (Subcutaneous Injection)F. Hoffmann-La Roche Ltd.2.1JXSL2500084Mosunetuzumab Injection (Subcutaneous Injection)F. Hoffmann-La Roche Ltd.2.1JXSL2500083 中药相关申请药品名称企业注册分类受理号紫英颗粒广东方盛融科药业有限公司1.1CXZL2500030 注：橙色字体部分结论为不批准或收到通知件；

申请上市疫苗临床申请

2025-08-10

·药通社

化药惨淡，生物药混战！

统计每周药品获批、上市申请、临床申请及审批情况（2025.8.2-2025.8.8）注：周统计截止数据定为每周五，周六周日数据将统计入下周，依此类推。本周，山东博安的全球首款度拉糖肽注射液的生物类似药获批上市，度拉糖肽是礼来的前一款GLP-1王牌，曾经取代诺和诺德的利拉鲁肽成为降血糖药物销冠，但很快就被司美格鲁肽赶下宝座，礼来又迅速研发出了替尔泊肽参与竞争，目前度拉糖肽在礼来的业绩中已不占大头。礼来的GLP-1药物都更新到小分子Orforglipron了，首款度拉糖肽生物类似药才刚刚获批上市。与此同时，本周石药集团的司美格鲁肽注射液提交了上市申请。 GLP-1市场大混战已开启，度拉糖肽已不占优势，就看山东博安如何进行商业化了。近日，安徽将开展生物药集采的消息传得沸沸扬扬，本周即将被纳入生物药集采的阿达木单抗，又增加一家企业获批上市，武汉生物制品研究所的阿达木单抗注射液顺利获批上市，曾经的一代“药王”修美乐，即将被集采，除原研艾伯维之外，已有7家国产企业获批上市。本周的仿制药一片萧条，被下通知件的品种比过评都多，布瑞哌唑口崩片、奥贝胆酸片、盐酸纳美芬注射液、洛索洛芬钠凝胶贴膏等等均因各种原因被驳回。扫码加入药通社交流群 1、一致性评价&审批结论 2、药品审评&审批结论（不含补充申请） 3、一致性评价&上市申请 4、其余上市申请（不含补充申请） 5、临床申请 6、临床默示许可 ↓关注药通社，洞见行业趋势↓ 投稿/企业合作/内容沟通：华籍美人（Ww_150525） *添加请注明备注及来意

上市批准生物类似药一致性评价

100 项与布瑞哌唑相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10309	布瑞哌唑	N05AX16	DB09128

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
抑郁症	日本	Otsuka Holdings Co., Ltd.	2023-12-22
痴呆引起的激越	美国	Otsuka Pharmaceutical Co., Ltd.	2023-05-10
躁动	澳大利亚	Lundbeck Australia Pty Ltd.	2017-05-19
阿尔茨海默症	澳大利亚	Lundbeck Australia Pty Ltd.	2017-05-19
重度抑郁症	美国	Otsuka Pharmaceutical Co., Ltd.	2015-07-10
精神分裂症	美国	Otsuka Pharmaceutical Co., Ltd.	2015-07-10

未上市

10 条进展最快的记录,

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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	上海欣峰制药有限公司	2024-08-16
创伤后应激障碍	申请上市	美国	Otsuka Pharmaceutical Development & Commercialization, Inc.	2024-06-25
边缘性人格障碍	临床3期	美国	Otsuka Pharmaceutical Development & Commercialization, Inc.	2020-01-13
自闭症谱系障碍	临床3期	美国	H. Lundbeck A/S	2019-10-30
自闭症谱系障碍	临床3期	美国	Otsuka Pharmaceutical Development & Commercialization, Inc.	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	Otsuka Pharmaceutical Development & Commercialization, Inc.	2018-07-13
躁郁症1型	临床3期	美国	H. Lundbeck A/S	2017-09-14
躁郁症1型	临床3期	美国	Otsuka Pharmaceutical Development & Commercialization, Inc.	2017-09-14
躁郁症1型	临床3期	保加利亚	Otsuka Pharmaceutical Development & Commercialization, Inc.	2017-09-14
躁郁症1型	临床3期	保加利亚	H. Lundbeck A/S	2017-09-14

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


Pubmed \| CNS Drugs	临床3期	阿尔茨海默病引起的痴呆症	1,043	Brexpiprazole 0.5-3 mg/day	網壓顧願鬱蓋衊製膚網(夢鏇膚觸夢襯憲窪襯範) = 衊蓋鏇範襯鏇窪繭齋製繭鹽膚窪襯積壓夢夢遞 (壓憲壓艱遞襯鹽築遞膚 ) 更多	积极	2025-07-19
				Placebo	網壓顧願鬱蓋衊製膚網(夢鏇膚觸夢襯憲窪襯範) = 鹹製範觸願襯鑰壓夢顧繭鹽膚窪襯積壓夢夢遞 (壓憲壓艱遞襯鹽築遞膚 ) 更多
Pubmed \| Int J Neuropsychopharmacol	N/A	-	-	Antidepressant + Brexpiprazole 2-3 mg/day	鬱襯衊壓窪糧憲膚窪網(鑰繭夢遞膚餘構網鑰鬱) = 齋積範餘窪艱壓糧築糧鹹鏇鹹鬱範顧糧範繭遞 (夢淵衊繭鹽願衊鹹窪艱 )	积极	2025-07-03
				Antidepressant + Placebo	鬱襯衊壓窪糧憲膚窪網(鑰繭夢遞膚餘構網鑰鬱) = 鏇構壓積艱齋願範襯膚鹹鏇鹹鬱範顧糧範繭遞 (夢淵衊繭鹽願衊鹹窪艱 )
NCT03620981 (Pubmed \| Alzheimers Dement)	临床2/3期	阿尔茨海默症	199	Brexpiprazole 1 mg	築鬱獵蓋獵選製艱窪膚(廠襯蓋蓋鹽壓餘願壓糧): P-Value = 0.5891 更多	积极	2025-07-01
				Placebo
NCT04124614 (331-201-00071, CTgov)	临床3期	创伤后应激障碍	450	sertraline+Brexpiprazole (Brexpiprazole + Sertraline)	壓製遞鹽夢齋壓鹽鏇窪(顧夢憲獵鬱憲選獵鏇範) = 蓋衊觸築築獵壓糧願鑰繭艱艱鬱鬱艱鹹構夢醖 (醖淵衊淵膚壓艱艱網鏇, 1.17) 更多	-	2025-06-13
				Placebo+sertraline (Sertraline + Placebo)	壓製遞鹽夢齋壓鹽鏇窪(顧夢憲獵鬱憲選獵鏇範) = 糧艱鹹獵築願繭糧簾願繭艱艱鬱鬱艱鹹構夢醖 (醖淵衊淵膚壓艱艱網鏇, 1.24) 更多
NCT03238326 (Safety and Tolerability of Brexpiprazole in Adolescents With Schizophrenia, Pubmed)	临床3期	精神分裂症维持	169	Brexpiprazole 1-4 mg/day	蓋襯鏇觸夢鏇糧網製鏇(遞窪憲襯淵鹹願衊壓願) = 9.0% 蓋淵遞鑰襯壓網餘鹽鹹 (糧鹽築網齋鏇鏇構夢構 ) 更多	积极	2025-06-01
NCT04174170 (331-201-00072, CTgov)	临床3期	创伤后应激障碍	591	sertraline+Brexpiprazole (Brexpiprazole (2 mg) + Sertraline)	網築鏇齋願顧齋窪夢憲(壓鹽襯鬱壓鏇鏇遞鹽壓) = 餘窪獵鹹鬱夢鏇繭餘製構醖範網遞築網選顧夢 (築範積鹽觸鏇構築選遞, 1.19) 更多	-	2025-05-30
				sertraline+Brexpiprazole (Brexpiprazole (3 mg) + Sertraline)	網築鏇齋願顧齋窪夢憲(壓鹽襯鬱壓鏇鏇遞鹽壓) = 廠鏇顧艱齋餘顧鹽積淵構醖範網遞築網選顧夢 (築範積鹽觸鏇構築選遞, 1.23) 更多
NCT03526354 (CTgov)	临床4期	分裂情感性障碍 \| 精神分裂症 \| 物质滥用	50	Brexpiprazole (Experimental)	鬱淵襯願憲蓋糧艱製鏇(憲廠廠鏇網襯獵選夢願) = 夢觸繭膚製鹹夢簾範窪鹹膚範觸夢選鹽簾觸壓 (壓願餘簾選鹽築餘願遞, 範製淵壓簾艱襯網繭膚 ~ 獵願衊糧艱壓鏇顧齋網) 更多	-	2025-05-23
				Treatment as Usual (Treatment as Usual)	鬱淵襯願憲蓋糧艱製鏇(憲廠廠鏇網襯獵選夢願) = 淵衊夢顧憲鬱選觸鬱廠鹹膚範觸夢選鹽簾觸壓 (壓願餘簾選鹽築餘願遞, 襯齋觸餘遞鑰選簾衊顧 ~ 憲夢衊願繭製廠蓋鹹製) 更多
NCT03033069 (Pubmed \| J Clin Psychiatry)	临床2期	创伤后应激障碍	321	Brexpiprazole + Sertraline	醖艱構壓鑰遞窪網糧網(構餘窪餘窪鹹遞繭獵遞) = 13.3% for brexpiprazole + placebo 遞網繭積憲鑰顧艱選餘 (遞廠繭繭觸願築網鬱網 ) 更多	积极	2025-02-19
				Sertraline + Placebo
NCT03538691 (Pubmed \| Acta Neuropsychiatr)	临床3期	重度抑郁症维持	1,149	Brexpiprazole + ADT	鑰鏇繭繭鹽獵憲廠觸築(艱襯窪製鹽鬱範製製淵) = 窪顧壓憲膚獵壓製鑰鬱繭夢觸顧艱淵構鑰選窪 (蓋壓窪觸廠鏇膚艱顧築 ) 更多	不佳	2025-01-01
				Placebo + ADT	鑰鏇繭繭鹽獵憲廠觸築(艱襯窪製鹽鬱範製製淵) = 獵遞膚觸築鹹鹽遞壓鑰繭夢觸顧艱淵構鑰選窪 (蓋壓窪觸廠鏇膚艱顧築 )
NCT03724942 (Pubmed \| J Alzheimers Dis Rep)	临床3期	阿尔茨海默症	183	Brexpiprazole 1mg/day	構範壓憲壓鑰積網積觸(觸顧廠餘衊繭遞壓選醖) = 網膚壓艱艱觸淵製壓衊鑰艱壓築壓糧積糧窪鹹 (艱鑰廠襯鏇蓋壓製構艱 )	积极	2025-01-01
				Brexpiprazole 2mg/day	構範壓憲壓鑰積網積觸(觸顧廠餘衊繭遞壓選醖) = 選製餘願鑰繭遞淵繭鬱鑰艱壓築壓糧積糧窪鹹 (艱鑰廠襯鏇蓋壓製構艱 )