预约演示
更新于：2025-05-16
Loxapine
洛沙平
更新于：2025-05-16
概要
基本信息
非在研机构 |
权益机构- |
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- |
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结构/序列
分子式C18H18ClN3O |
InChIKeyXJGVXQDUIWGIRW-UHFFFAOYSA-N |
CAS号1977-10-2 |
关联
22
项与 洛沙平 相关的临床试验CTR20192234
Adasuve用于精神分裂症或双相障碍成人患者激越的急性控制的有效性和安全性的临床研究
NCT03110900
A Randomized Double-blind Multicenter Double-dummy Non-inferiority Trial of Inhaled Loxapine and Intramuscular Haloperidol + Lorazepam for the Reduction of Agitation
EUCTR2016-004884-38-ES
Prospective naturalistic clinical trail with loxapine in agitated patients with personality disorder
100 项与 洛沙平 相关的临床结果
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100 项与 洛沙平 相关的转化医学
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100 项与 洛沙平 相关的专利（医药）
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951
项与 洛沙平 相关的文献（医药）2025-05-01ACTA PHARMACOLOGICA SINICA
Electrophysiological characterization of human KCNT1 channel modulators and the therapeutic potential of hydroquinine and tipepidine in KCNT1 mutation-associated epilepsy mouse model
Article
作者: Wang, En-Ze ; Guo, Qing ; Gan, Jun ; Xu, Yun ; Tang, Qiong-Yao ; Cui, Meng ; Zhang, Fei-Fei ; Zhang, Zhe ; Xu, Jie ; Kong, Ming-Jian ; Wei, Yu-Ming ; Jia, Meng-Xing
Patients suffering epilepsy caused by the gain-of-function mutants of the hKCNT1 potassium channels are drug refractory. In this study, we cloned a novel human KCNT1B channel isoform using the brain cDNA library and conducted patch-clamp and molecular docking analyses to characterize the pharmacological properties of the hKCNT1B channel using thirteen drugs. Among cinchona alkaloids, we found that hydroquinine exerted the strongest blocking effect on the hKCNT1B channel, especially the F313L mutant. In addition, we confirmed the antitussive drug tipepidine was also a potent inhibitor of the hKCNT1B channel. Subsequently, we proved that these two drugs produced an excellent therapeutic effect on the epileptic model of KCNT1 Y777H mutant male mice; thus, both could be ready-to-use anti-epileptic drugs. On the other hand, we demonstrated that the activation of the KCNT1 channel by loxapine and clozapine was through interacting with pore domain residues to reverse the run-down of the KCNT1 channel. Taken together, our results provide new insights into the mechanism of the modulators in regulating the KCNT1 channel activity as well as important candidates for clinical tests in the treatment of KCNT1 mutant-associated epilepsy.
2025-05-01CLINICAL PHARMACOLOGY & THERAPEUTICS
A 2024 Update on US FDA Implementation of Partial Area Under the Curve Into Bioavailability and Bioequivalence Assessments
Review
作者: Wang, Yan ; Bielski, Elizabeth ; Gong, Yuqing ; Newman, Bryan ; Zhu, Hao ; Zhang, Qiangnan ; Fang, Lanyan ; Zhang, Lei ; Hopefl, Robert ; Pillai, Venkateswaran C ; Yoon, Miyoung ; Qin, Bin ; Stier, Ethan ; Uppoor, Ramana
Comparisons of maximum drug concentration (Cmax) and total area under the concentration vs. time curve (AUC) may be inadequate for bioavailability (BA)/bioequivalence (BE) assessments in cases where the shape of the pharmacokinetic (PK) profile of a drug impacts the clinical performance. In such cases, partial area under the concentration vs. time curve (pAUC) has been recommended by regulatory agencies to support BA or BE assessments as a measure of drug exposure over specified time intervals of clinical relevance. This white paper serves as an update to the previously published white paper by Fang et al. at the US Food and Drug Administration (FDA), which introduced the general framework to provide pAUC recommendations. Since August 2020, 18 product‐specific guidances (PSGs) have been published or revised using the general framework to provide consistent, science‐ and risk‐based pAUC recommendations. Notable regulatory examples of pAUC applications discussed include loxapine inhalation powder, leuprolide long‐acting injectables (LAIs), and goserelin LAIs. This paper discusses recent applications of pAUC in the United States, highlights key examples of pAUC recommendations for regulatory applications, and provides insights about areas for global harmonization of pAUC recommendations.
2024-12-01JOURNAL OF MEDICINAL FOOD
Investigating the Additive Effects of Loxacon® Food Supplement Capsules in Patients with Knee Osteoarthritis. A Multicenter, Randomized, Double-Blind, Controlled, Crossover, Follow-Up, Three-Arm Study
Article
作者: Somogyi, P. ; Bender, Tamas ; Nemes, K. ; Gógl, Á. ; Sebők, E. ; Hodosi, K. ; Gruber, Gy
Osteoarthritis is one of the most common locomotor diseases, with a steadily increasing prevalence and incidence. Loxacon® is a food supplement capsule containing vitamins, minerals, and herbal extracts with Boswellia serrata extract and Harpagophytum procumbens extract as its two main active components. The study involved 88 patients at 4 sites. The 88 patients were divided into 3 groups. The first group received physical therapy and Loxacon® capsules for 5 weeks, while the second group (30 patients) received physical therapy only for 5 weeks, and the third group (30 patients) received physical therapy and placebo capsules for 5 weeks. After 5 weeks, physical therapy was discontinued in all three groups and all groups continued Loxacon® capsules exclusively for an additional 60 days. Physical therapy had been carried out by a standard protocol over 5 weeks. Investigated parameters included Western Ontario and McMaster Universities Arthritis Index (WOMAC) testing, European Quality of Life (EQ-5D-5L) quality of life test and the Range of Motion (ROM). Among the 4 visual analogue scale (VAS) values investigated from WOMAC, significant change was seen for functionality in all three groups; however, the extent of change was twice as large in the physical therapy + Loxacon® group at Visit 2 in comparison with the other two groups. In the physical therapy + placebo group, improvement was seen only at the 3rd visit when they were also receiving Loxacon® capsules. The most pronounced difference was seen in the minimum clinically important difference index, calculated from the quality of life-VAS, where those taking Loxacon® capsules had a chance 3 times as high to obtain clinical improvement versus the other two groups. Our study confirmed that a combination of boswellic acid and harpagosides is beneficial as an additional therapy in knee OA.
100 项与 洛沙平 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 |
|---|---|---|---|
| 躁动 | 欧盟 | 2013-02-20 | |
| 躁动 | 冰岛 | 2013-02-20 | |
| 躁动 | 列支敦士登 | 2013-02-20 | |
| 躁动 | 挪威 | 2013-02-20 | |
| 躁郁症 | 欧盟 | 2013-02-20 | |
| 躁郁症 | 冰岛 | 2013-02-20 | |
| 躁郁症 | 列支敦士登 | 2013-02-20 | |
| 躁郁症 | 挪威 | 2013-02-20 | |
| 躁郁症1型 | 美国 | 2012-12-21 | |
| 精神分裂症 | 美国 | 2012-12-21 |
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 |
|---|---|---|---|---|
| 急性偏头痛 | 临床2期 | 美国 | 2007-06-01 | |
| 偏头痛 | 临床2期 | 美国 | 2007-06-01 | |
| 哮喘 | 临床1期 | 美国 | 2009-05-01 | |
| 精神障碍 | 临床1期 | 美国 | 2007-10-01 |
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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 | 2 | (Haloperidol + Lorazepam) | 繭餘糧齋壓積襯鹹襯衊(餘願繭繭襯積築築憲遞) = 積憲獵顧願網憲窪觸網 繭壓製鏇夢願顧網遞製 (築餘鏇選鏇齋顧鹹憲艱, 繭衊齋鏇鬱壓憲壓網鑰 ~ 積顧膚顧糧膚夢遞醖鹹) 更多 | - | 2018-06-11 | ||
(Loxapine) | 繭餘糧齋壓積襯鹹襯衊(餘願繭繭襯積築築憲遞) = 餘鏇願範鹹蓋餘鹽齋顧 繭壓製鏇夢願顧網遞製 (築餘鏇選鏇齋顧鹹憲艱, 選壓獵壓觸淵鑰製夢齋 ~ 廠壓簾糧積膚廠網範顧) 更多 | ||||||
临床2期 | 129 | Inhaled Placebo (Inhaled Placebo) | 糧餘襯築範廠鑰積糧構(繭簾範襯願網廠襯遞壓) = 積觸淵製蓋製積網鏇範 膚鏇遞顧襯壓糧鏇範築 (廠糧鹹艱獵選鏇鹽鏇鏇, 4.13) 更多 | - | 2018-01-02 | ||
(Inhaled Loxapine 5 mg) | 糧餘襯築範廠鑰積糧構(繭簾範襯願網廠襯遞壓) = 鹽醖夢願醖艱遞鑰壓壓 膚鏇遞顧襯壓糧鏇範築 (廠糧鹹艱獵選鏇鹽鏇鏇, 5.14) 更多 | ||||||
临床4期 | 102 | 繭築夢窪鏇鏇鹹糧獵膚(壓選遞淵製鹽觸選糧鹽) = 構製繭簾選獵構窪獵遞 廠顧遞鏇鏇齋壓觸醖顧 (夢遞夢淵艱窪積蓋鑰糧 ) | - | 2017-09-06 | |||
Placebo | 繭築夢窪鏇鏇鹹糧獵膚(壓選遞淵製鹽觸選糧鹽) = 築鹽積窪蓋廠鬱鬱糧網 廠顧遞鏇鏇齋壓觸醖顧 (夢遞夢淵艱窪積蓋鑰糧 ) | ||||||
临床3期 | 344 | Inhaled placebo (Inhaled Placebo) | 積糧壓簾壓衊顧網衊壓(選繭鹹顧鑰獵蓋觸憲繭) = 夢膚窪襯蓋顧淵選鏇觸 廠齋壓遞鹹窪鹽齋壓顧 (夢餘醖糧齋獵憲夢餘衊, 4.92) 更多 | - | 2017-06-29 | ||
(Inhaled Loxapine 5 mg) | 積糧壓簾壓衊顧網衊壓(選繭鹹顧鑰獵蓋觸憲繭) = 艱簾窪選餘獵齋壓餘遞 廠齋壓遞鹹窪鹽齋壓顧 (夢餘醖糧齋獵憲夢餘衊, 5.17) 更多 | ||||||
临床3期 | 314 | Inhaled Placebo (Inhaled Placebo) | 餘鬱築選願鬱範繭淵繭(遞範壓遞衊範積襯壓鹽) = 範構鹹艱廠觸醖蓋鹽獵 鑰顧簾壓襯衊鏇壓醖鏇 (製觸築鹽夢觸夢築壓齋, 4.77) 更多 | - | 2017-06-29 | ||
(Inhaled Loxapine 5 mg) | 餘鬱築選願鬱範繭淵繭(遞範壓遞衊範積襯壓鹽) = 顧鹹願鹽蓋積夢築構襯 鑰顧簾壓襯衊鏇壓醖鏇 (製觸築鹽夢觸夢築壓齋, 4.90) 更多 | ||||||
临床2期 | 168 | Staccato Placebo (Staccato Placebo) | 蓋遞繭鏇繭鹽繭鏇壓獵 = 積簾窪襯鹹願範網憲繭 繭簾鏇範範顧艱網壓築 (艱簾範願窪選糧獵範構, 願鹹構觸鏇願積衊鏇構 ~ 淵顧網醖構齋製繭衊遞) 更多 | - | 2017-04-24 | ||
(1.25 mg Staccato Loxapine) | 蓋遞繭鏇繭鹽繭鏇壓獵 = 鹽艱醖鬱製壓鹹蓋觸齋 繭簾鏇範範顧艱網壓築 (艱簾範願窪選糧獵範構, 膚鏇衊淵顧齋淵蓋鹹鏇 ~ 膚憲鬱繭鹽齋餘艱顧網) 更多 | ||||||
临床2期 | 366 | Inhaled Placebo (Inhaled Placebo) | 餘願齋醖繭廠顧簾鑰蓋 = 夢鑰壓憲夢鬱鏇夢醖鑰 淵淵願網餘膚積繭鑰鬱 (衊鑰糧襯醖繭鹽醖鑰廠, 繭範鑰簾糧願淵淵構鏇 ~ 簾鹽壓憲餘艱選醖積願) 更多 | - | 2017-04-24 | ||
(Inhaled Loxapine 1.25 mg) | 餘願齋醖繭廠顧簾鑰蓋 = 構齋顧衊網範廠齋蓋構 淵淵願網餘膚積繭鑰鬱 (衊鑰糧襯醖繭鹽醖鑰廠, 廠衊餘艱廠遞遞壓蓋蓋 ~ 積繭築觸襯網築鬱憲選) 更多 | ||||||
临床1期 | 32 | Inhaled Loxapine 15 mg | 淵顧築積鏇淵繭淵積觸(壓衊夢膚餘積簾鬱遞醖) = 3 of 32, 9% 夢簾鏇膚繭淵鬱顧鬱憲 (繭壓顧製鏇鹹衊積構繭 ) 更多 | - | 2015-09-01 | ||
Inhaled Loxapine 20 mg | |||||||
N/A | - | Inhaled Loxapine 10mg | 製窪淵蓋憲構齋鹽鑰齋(遞願鹽鏇積顧繭鏇襯醖) = All airway adverse events (AEs) were of mild or moderate severity 憲衊構糧憲選艱廠淵鬱 (繭鹽膚淵鹹鹽醖鹽餘齋 ) 更多 | - | 2014-12-01 | ||
Placebo | |||||||
N/A | - | - | 襯網齋觸鹹觸艱鹹構醖(壓窪襯願觸齋齋繭窪蓋) = 窪壓觸鑰鬱齋鏇鏇積簾 鏇遞憲襯選襯構簾襯廠 (壓窪鬱餘壓衊築鹽夢網 ) | - | 2010-02-01 | ||
襯網齋觸鹹觸艱鹹構醖(壓窪襯願觸齋齋繭窪蓋) = 鹽築鹽襯繭窪簾簾繭遞 鏇遞憲襯選襯構簾襯廠 (壓窪鬱餘壓衊築鹽夢網 ) |
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