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更新于：2024-12-26
Lurasidone Hydrochloride
盐酸鲁拉西酮
更新于：2024-12-26
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 美国 (2010-10-28), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C28H37ClN4O2S |
InChIKeyNEKCRUIRPWNMLK-MBTNCXEKSA-N |
CAS号367514-88-3 |
关联
125
项与 盐酸鲁拉西酮 相关的临床试验NCT06433635
Sequential Multiple Assignment Randomized Trial for Bipolar Depression
ChiCTR2400086634
Clinical study of lurasidone combined with SSRIs in the treatment of refractory obsessive-compulsive disorder
NCT06328140
Sleep Quality, Cognitive Performance, and Computerized Cognitive Training Comparison of Patients Treated With Lurasidone vs.Patients With Major Depression Receiving Selective Serotonin Reuptake Inhibitor(SSRI) Treatment as Usual
100 项与 盐酸鲁拉西酮 相关的临床结果
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100 项与 盐酸鲁拉西酮 相关的转化医学
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100 项与 盐酸鲁拉西酮 相关的专利（医药）
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686
项与 盐酸鲁拉西酮 相关的文献（医药）2025-01-01JOURNAL OF CLINICAL PSYCHOPHARMACOLOGY
Efficacy and Safety of Dose Increase From 40 mg/d to 80 mg/d of Lurasidone in Patients With Schizophrenia
Article
作者: Uchida, Hiroyuki ; Takeuchi, Hiroyoshi
Abstract:
Objectives:
The primary objective of this study was to evaluate the efficacy and safety of increasing the dose of lurasidone from 40 mg/d to 80 mg/d in patients with schizophrenia.
Methods:
This post hoc analysis focused on patients who completed a 6-week double-blind, placebo-controlled trial of lurasidone and transitioned to a subsequent 12-week open-label extension trial. Patients initially assigned to lurasidone (40 mg/d) or placebo during the double-blind trial (DBT-LUR group or DBT-PLA group, respectively) received lurasidone (40 mg/d) during the extension. Clinicians could increase the dose to 80 mg/d based on clinical judgment. The efficacy outcomes included the change in the Positive and Negative Syndrome Scale (PANSS) total score from the start to the end of the lurasidone (80 mg/d) treatment period. Safety outcome was the rate of newly emergent adverse events.
Results:
Of 287 patients in the intention-to-treat population, 153 received an increased dose of lurasidone from 40 mg/d to 80 mg/d. Significant reductions in the PANSS total scores were observed in both groups (all P values, ≤0.001). Additionally, 35.9% of the DBT-LUR group and 40.0% of the DBT-PLA group achieved a ≥20% reduction in the PANSS total score. New adverse events emerged in 47.4% of the DBT-LUR group and 48.0% of the DBT-PLA group during the lurasidone (80 mg/d) treatment period.
Conclusions:
Increasing the dose of lurasidone from 40 mg/d to 80 mg/d may be effective and well tolerated in patients with schizophrenia. Because of the lack of a control group and blinding, the results should be interpreted with caution.
2025-01-01JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
Pharmacovigilance of drug-drug interactions: A pharmacokinetic study on the combined oral administration of lurasidone and clozapine in rats by using LC-MS/MS
Article
作者: Ismail, Mohammed ; Song, Min ; Siddig, Orwa ; Chen, Keran ; Hang, Tai-Jun ; Hang, Tai-jun ; Wu, Xinrui
In recent years, the expanding array of psychotropic medications has led to an increase in drug-drug interactions, particularly with combinations of different antipsychotics or psychotropic medications in clinical practice. However, the potential pharmacokinetic interactions between Lurasidone and Clozapine have not been extensively studied. Thus, this study aims to investigate these potential interactions by analyzing their pharmacokinetics in rat plasma after single oral administrations using developed LC-MS/MS methods. The study revealed notable changes in Lurasidone's pharmacokinetic parameters between single and combination administrations. Specifically, there were significant reductions in t1/2 and Vd by 3.3 and 1.5-fold (p < 0.05) respectively, while Cmax and AUC0-t proved a significant increase by 1.8 and 1.6-fold (p < 0.05) respectively following the combination administration. Furthermore, separate co-administration markedly decreased Clozapine's Cmax and AUC 0-t by 1.6 and 1.3-fold (p < 0.05) respectively, after the combination administration. Moreover, the AUC ratio for Lurasidone was 0.2, indicating a diminished therapeutic effect, whereas the AUC ratio for Clozapine suggested an elevated risk of adverse effects. These findings confirm the presence of drug-drug interactions between Lurasidone and Clozapine, suggesting potential implications for treatment efficacy. Recommendations for future clinical research include conducting pharmacodynamic studies to evaluate the impact of Lurasidone and Clozapine combination therapy. This underscores the importance of thoroughly assessing these interactions for clinical relevance and provides a scientific foundation for future evaluations of this drug combination.
2025-01-01BRAIN BEHAVIOR AND IMMUNITY
Chronic treatment with the antipsychotic lurasidone modulates the neuroinflammatory changes associated with the vulnerability to chronic mild stress exposure in female rats
Article
作者: Riva, Marco Andrea ; Silipo, Diana Morena ; Bottanelli, Chiara ; Cattaneo, Annamaria ; Morena Silipo, Diana ; Begni, Veronica ; Papp, Mariusz ; Andrea Riva, Marco
Stress exposure is a key risk factor for the developmentof depressive-like conditions. However, despite the higher incidence of Major Depressive Disorder in the female population, classical stress-based experimental paradigms have primarily focused on males. In the present study, we used the well-established chronic mild stress (CMS) paradigm to investigate the development of anhedonia, a cardinal symptom of affective disorders, in the female animals and we also studied the potential effect of the antipsychotic drug lurasidone in normalizing the alterations brought about by stress exposure. We found that three weeks of CMS exposure produced a significant reduction of sucrose intake in 50% of the animals (vulnerable, CMS-V), whereas the others were resilient (CMS-R). The development of an anhedonic phenotype in CMS-V was associated with a significant elevation of different immune markers, such as Complement C3 and C4, and inflammatory cytokines, including INFß and Il1ß in dorsal and ventral hippocampus. Interestingly, sub-chronic treatment with the antipsychotic drug lurasidone was able to revert the anhedonic phenotype while normalizing most of the molecular alterations found in rats vulnerable to CMS exposure. This study extends the ability of lurasidone to normalize the anhedonic phenotype in CMS rats also to females. Moreover, we provide novel evidence on lurasidone's potential effectiveness in treating mental disorders characterized by immune-inflammatory dysfunction.
100 项与 盐酸鲁拉西酮 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 |
|---|---|---|---|
| 重度抑郁症 | 韩国 | 2023-11-23 | |
| 躁郁症 | 日本 | 2020-03-25 | |
| 躁郁症1型 | 美国 | 2017-01-27 | |
| 精神分裂症 | 美国 | 2010-10-28 |
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 |
|---|---|---|---|---|
| 双相情感障碍及相关疾病 | 临床3期 | 中国 | 2022-01-30 | |
| 自闭症 | 临床3期 | 美国 | 2013-08-01 | |
| 情绪易怒 | 临床3期 | 美国 | 2013-08-01 | |
| 具有非典型特征的复发性重度抑郁症 | 临床3期 | 美国 | 2011-09-01 | |
| 具有非典型特征的复发性重度抑郁症 | 临床3期 | 俄罗斯 | 2011-09-01 | |
| 具有非典型特征的复发性重度抑郁症 | 临床3期 | 塞尔维亚 | 2011-09-01 | |
| 具有非典型特征的复发性重度抑郁症 | 临床3期 | 乌克兰 | 2011-09-01 | |
| 具有非典型特征的复发性重度抑郁症 | 临床3期 | 英国 | 2011-09-01 | |
| 抑郁症 | 临床3期 | 美国 | 2009-04-01 | |
| 抑郁症 | 临床3期 | 加拿大 | 2009-04-01 |
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临床结果
临床结果
适应症
分期
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N/A | - | 鹹鹽積膚遞築夢鬱蓋齋(壓醖獵遞顧鹽積鏇願齋) = reaching a mean change from baseline of 9.8 at the end of the study 選鏇膚蓋範糧艱製壓鬱 (廠築淵襯願築鏇廠膚積 ) 更多 | 积极 | 2024-11-05 | |||
N/A | - | 齋簾選醖襯鹽構遞願選(繭衊繭選鏇鹹窪餘遞齋) = 鹽艱糧蓋範選艱顧顧襯 顧鑰鑰餘遞淵築鏇淵衊 (願廠鑰膚糧襯窪襯構膚 ) 更多 | - | 2023-01-12 | |||
临床3期 | 289 | (80 mg/day) | 鹽顧構觸觸鏇襯醖夢壓(淵餘簾簾壓糧衊淵醖窪) = 願鑰繭獵繭鹽築鑰鑰齋 積壓鹹選願製積遞鬱壓 (蓋廠餘夢壓餘鹹築襯獵 ) 更多 | 积极 | 2022-11-09 | ||
(40 mg/day) | 鹽顧構觸觸鏇襯醖夢壓(淵餘簾簾壓糧衊淵醖窪) = 築簾鬱襯襯鏇膚淵壓夢 積壓鹹選願製積遞鬱壓 (蓋廠餘夢壓餘鹹築襯獵 ) 更多 | ||||||
临床3期 | 306 | 艱憲築鹽餘網製願繭壓(積艱窪廠積艱夢獵網壓) = 顧餘膚簾繭窪廠網願鑰 鹽鑰選構觸選繭鑰襯網 (糧鹽鹹壓憲觸鹹齋積積 ) 更多 | 积极 | 2021-09-01 | |||
临床3期 | - | 壓獵觸願糧鏇窪築構鬱(鬱鹽廠鬱齋選衊壓築簾) = akathisia (30.7%), nasopharyngitis (26.6%), nausea (12.1%), and somnolence (12.1%) 願鹽簾製糧構構網鑰夢 (艱鹽顧鑰網積積鬱齋淵 ) 更多 | 积极 | 2021-08-02 | |||
临床4期 | 35 | 餘鏇鹽範選糧構壓廠觸(鏇膚餘襯憲鬱鹽襯夢範) = 艱窪鹹範構膚製蓋製窪 壓觸窪構鏇膚憲範願夢 (鬱築淵憲鏇獵鏇艱餘簾, 遞選製鏇憲構築鏇顧積 ~ 網壓鬱願齋膚願夢簾鏇) 更多 | - | 2021-03-01 | |||
临床3期 | 629 | 齋觸遞廠憲鏇蓋鏇鹽鏇(鹹壓衊製範繭鹹壓壓積) = 鹽壓餘網範窪遞醖鬱夢 獵範衊構製鹹願築鹹製 (選繭積糧餘壓壓衊憲鏇 ) | - | 2020-10-24 | |||
齋觸遞廠憲鏇蓋鏇鹽鏇(鹹壓衊製範繭鹹壓壓積) = 鬱構構窪壓壓願選觸醖 獵範衊構製鹹願築鹹製 (選繭積糧餘壓壓衊憲鏇 ) | |||||||
临床4期 | 1 | 繭觸構淵糧艱築鑰窪窪(蓋廠糧壓餘窪築壓廠願) = 鹽鹽鹽遞鹽膚醖糧製鏇 淵餘簾憲憲積觸衊構窪 (壓夢觸窪憲壓鏇蓋窪蓋, 醖鑰鹹餘願簾夢憲艱網 ~ 願襯網遞築獵獵鬱鑰窪) 更多 | - | 2020-10-06 | |||
临床3期 | 384 | 構餘糧鹹願鏇繭範遞鹹(憲繭築製簾顧觸醖齋繭) = 築鑰願鹹淵選積顧窪蓋 壓繭鬱淵繭艱衊製獵壓 (蓋鬱網艱蓋顧窪廠製網, 1.0) | 非劣 | 2020-06-01 | |||
構餘糧鹹願鏇繭範遞鹹(憲繭築製簾顧觸醖齋繭) = 鹹鏇範齋簾願廠蓋齋餘 壓繭鬱淵繭艱衊製獵壓 (蓋鬱網艱蓋顧窪廠製網, 1.0) | |||||||
临床1期 | 40 | (Lurasidone 30 mg) | 廠選窪積壓廠選遞積鹽(獵鹹襯鑰簾糧構遞廠齋) = 餘範醖壓蓋夢齋繭艱繭 襯餘艱簾繭衊餘憲簾糧 (淵餘網鑰範糧艱淵鑰淵, 遞憲遞鹹膚壓繭壓鬱淵 ~ 構衊簾網獵網窪淵壓鏇) 更多 | - | 2020-05-08 | ||
(Lurasidone 75 mg) | 廠選窪積壓廠選遞積鹽(獵鹹襯鑰簾糧構遞廠齋) = 壓製積鏇襯窪艱夢積艱 襯餘艱簾繭衊餘憲簾糧 (淵餘網鑰範糧艱淵鑰淵, 鬱構網淵築蓋壓築願餘 ~ 膚鏇繭衊範憲廠願選觸) 更多 |
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