更新于：2024-12-17
Blonanserin
布南色林
更新于：2024-12-17
概要
基本信息
药物类型 小分子化药 |
别名 Blonanserin (JAN/INN)、LONASEN Tape、AD 5423 + [6] |
作用机制 5-HT2A receptor拮抗剂(5-羟色胺2A受体拮抗剂)、D2 receptor拮抗剂(多巴胺D2受体拮抗剂) |
治疗领域 |
在研适应症 |
非在研适应症- |
最高研发阶段批准上市 |
首次获批日期 日本 (2008-01-25), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国) |
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结构
分子式C23H30FN3 |
InChIKeyXVGOZDAJGBALKS-UHFFFAOYSA-N |
CAS号132810-10-7 |
关联
56
项与 布南色林 相关的临床试验浙江金华康恩贝生物制药有限公司生产的布南色林片与持证商为Sumitomo Dainippon Pharma Co.，Ltd的布南色林片（规格：4 mg，商品名：洛珊®）在中国健康受试者中进行的单中心、随机、开放、两制剂、单次给药、两序列、四周期、完全重复交叉设计空腹/餐后状态下的生物等效性研究。
Comparative effectiveness and tolerability of Amisulpride versus Blonanserin augmentation to Clozapine in Treatment Resistant Schizophrenia - nil
布南色林片（规格：4mg）在中国健康受试者中餐后给药条件下随机、开放、单剂量、两序列、交叉生物等效性试验
100 项与 布南色林 相关的临床结果
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100 项与 布南色林 相关的转化医学
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100 项与 布南色林 相关的专利（医药）
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188
项与 布南色林 相关的文献（医药）2024-12-01Neuropsychopharmacology reports
Association between treatment response and dose of blonanserin transdermal patch in patients with acute schizophrenia: A post hoc cluster analysis based on baseline psychiatric symptoms
Article
作者: Takekita, Yoshiteru ; Matsumoto, Yuji ; Masuda, Takahiro ; Yoshida, Kazumasa ; Koshikawa, Yosuke ; Kato, Masaki
Abstract:
Aim:
To explore the optimal dose of blonanserin transdermal patch (BNS‐P) based on baseline psychiatric symptomatic characteristics during acute schizophrenia.
Methods:
A post hoc cluster analysis was conducted using data from a 6‐week randomized, double‐blind, placebo‐controlled study of BNS‐P (40 or 80 mg/day) in acute schizophrenia. We classified patients into three clusters based on baseline psychiatric symptoms. Efficacy was assessed using the change from baseline to week 6 in the PANSS total score. Safety was assessed by the incidence of adverse events.
Results:
Among 577 patients, three clusters were identified, characterized by severe psychiatric (Cluster‐S; n = 122), predominant negative (Cluster‐N; n = 191), and predominant positive (Cluster‐P; n = 264) symptoms. In Cluster‐P, both BNS‐P 40 and 80 mg/day reduced PANSS total score significantly more than placebo (p = 0.036, effect size = 0.342; p < 0.001, effect size = 0.687, respectively). In Cluster‐S and ‐N, only BNS‐P 80 mg/day reduced PANSS total score significantly more than placebo (p = 0.045, effect size = 0.497; p = 0.034, effect size = 0.393, respectively). The effect size was greater at 80 mg/day than at 40 mg/day across all clusters. The most common treatment‐emergent adverse events were akathisia and skin‐related adverse events in all clusters.
Conclusion:
BNS‐P exhibited a dose‐dependent antipsychotic effect in all clusters, particularly highlighting its efficacy in patients with predominant positive symptoms, even at lower doses. These findings provide novel and valuable insights for determining BNS‐P dose tailoring to individual symptomatic characteristics in real‐world practice.
2024-12-01SCHIZOPHRENIA RESEARCH
Efficacy and tolerability of blonanserin in schizophrenia: A systematic review and meta-analysis of randomized controlled trials
Review
作者: Dong, Shimeng ; Schneider-Thoma, Johannes ; Wu, Hui ; Yanagimoto, Hiroko ; Lin, Xiao ; Tian, Jing ; Leucht, Stefan ; Nomura, Nobuyuki ; Qin, Mengchang ; Siafis, Spyridon
BACKGROUND:
Blonanserin is approved for treating schizophrenia in Japan, South Korea, India, and China. We aimed to synthesize the efficacy and tolerability of blonanserin compared to other antipsychotics.
METHODS:
A systematic review and pairwise meta-analysis were conducted using the Cochrane Schizophrenia Group's study-based trial register until January 24, 2024. We included open and blinded randomized controlled trials (RCTs) involving schizophrenia patients, with studies lasting at least 3 weeks. Primary outcomes focused on overall schizophrenia symptoms using rating scales and relapse rates. Secondary outcomes included symptom subtypes, treatment response, dropout rates, quality of life, and side effects, analyzed using standardized mean difference (SMD), mean difference (MD), and risk ratio (RR) with 95 % confidence intervals (CIs). The review protocol was published in Open Science Framework (https://osf.io/e7jfa/).
RESULTS:
Fourteen acute-phase studies with 2697 participants compared blonanserin to olanzapine, haloperidol, risperidone, paliperidone, aripiprazole, amisulpride, and placebo. Blonanserin showed greater efficacy than placebo (SMD = -0.47, 95 % CI: -0.66 to -0.27) and similar efficacy to other antipsychotics in reducing schizophrenia overall symptoms. No data on the number of participants who experienced relapse with blonanserin was available in the single maintenance-phase study. There were also no clear differences between antipsychotics in most secondary efficacy outcomes, but blonanserin produced less prolactin and weight increase but more akathisia and tremor than risperidone, and less prolactin increase, anticholinergic and extrapyramidal side-effects than haloperidol.
CONCLUSION:
Our study suggests that differences in efficacy between blonanserin and other antipsychotics are small and that blonanserin has a different tolerability profile than haloperidol and risperidone.
2024-12-01INTERNATIONAL JOURNAL OF PHARMACEUTICS
Preparation and release pattern study of long-term controlled release Blonanserin microspheres
Article
作者: Lin, Guimei ; Zhou, Jiamin ; Li, Lian ; Qiu, Shengnan ; Wan, Xiaoyu ; Liu, Yingying ; Li, Yaqi ; Zhang, Yankun ; Zang, Hengchang ; Li, Zengmei ; Shi, Yanbin ; Fu, Xianglei ; Chen, Xiangqin
To prepare a PLGA microsphere loaded with the antipsychotic Blonanserin without release leg period and released in a near-zero model for long time, in this study, 15 kDa and 75 kDa PLGA were chosen to be mixed with different ratios, and Blonanserin microspheres (Bn-MS) without significant differences in the particle size, drug loading capacity, and encapsulation rate were prepared by microfluidics. The release kinetic model was fitted to the release behavior by monitoring the changes in particle size and morphology during the Bn-MS release to investigate microspheres' in vitro release pattern. The results showed that the addition of appropriate ratios of mixed molecular weights to Bn-MS could eliminate the release hysteresis period. When the ratio of 15 kDa and 75 kDa was 1:9 (F3), the Bn-MS had a low burst release rate, moderate release rate, no release hysteresis period, a long release period of up to 35 days, and a stable release pattern close to the zero level. The results of the release mechanism study indicated that the hybrid PLGA improved the release behavior of the microspheres by adjusting the dissolution degradation rate of Bn-MS, which in turn affected the release mechanism of the microspheres.
100 项与 布南色林 相关的药物交易
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研发状态
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 |
|---|---|---|---|
| 精神分裂症 | 日本 | 2008-01-25 |
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临床结果
临床结果
适应症
分期
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临床3期 | 580 | DSP-5423P Placebo (DSP-5423P Placebo) | 窪糧夢淵製築選衊糧顧(選鏇齋選糧繭簾製選蓋) = 網範廠廠繭鏇簾遞選觸 範壓構醖顧繭鏇膚製鹹 (齋鑰願衊簾壓艱願構鹹, 範構築繭壓糧繭構齋齋 ~ 獵製觸餘醖觸範餘遞選) 更多 | - | 2020-12-23 | ||
(DSP-5423P 40mg) | 窪糧夢淵製築選衊糧顧(選鏇齋選糧繭簾製選蓋) = 製觸衊齋鬱繭襯構築蓋 範壓構醖顧繭鏇膚製鹹 (齋鑰願衊簾壓艱願構鹹, 製網襯簾鹹築鹹壓獵蓋 ~ 衊窪鬱衊糧繭遞襯築製) 更多 | ||||||
临床3期 | 200 | (DSP-5423P (Cohort 1)) | 鹹餘觸獵蓋願窪淵襯製(遞顧鑰廠簾獵餘繭膚窪) = 膚繭餘餘襯鏇蓋築廠積 餘鑰構鬱選願廠築鏇窪 (構遞襯網選蓋襯遞選築, 糧餘壓顧壓願衊壓顧淵 ~ 壓鏇糧顧糧網獵範鹹簾) 更多 | - | 2020-11-19 | ||
(DSP-5423P (Cohort 2)) | 鹹餘觸獵蓋願窪淵襯製(遞顧鑰廠簾獵餘繭膚窪) = 艱鹽網製繭積構顧繭窪 餘鑰構鬱選願廠築鏇窪 (構遞襯網選蓋襯遞選築, 獵範積夢遞顧壓積鏇壓 ~ 鬱積構齋窪繭鬱衊壓衊) 更多 | ||||||
临床3期 | 267 | (Blonanserin) | 壓餘製築淵觸衊鬱夢願(窪願鏇遞選鏇廠淵餘網) = 蓋糧築網簾獵窪襯簾膚 衊蓋鏇鬱憲餘窪淵夢餘 (獵遞顧顧積淵襯選鑰網, 艱夢糧齋鑰觸窪壓製齋 ~ 鹹艱鑰願積糧積範夢鑰) 更多 | - | 2018-11-26 | ||
(Risperidone) | 壓餘製築淵觸衊鬱夢願(窪願鏇遞選鏇廠淵餘網) = 簾襯鹹鏇鏇選壓窪構鏇 衊蓋鏇鬱憲餘窪淵夢餘 (獵遞顧顧積淵襯選鑰網, 齋簾夢築襯繭顧壓憲範 ~ 遞淵顧簾齋遞願顧襯顧) 更多 |
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