更新于：2024-12-14
Bilastine
比拉斯汀
更新于：2024-12-14
概要
基本信息
原研机构 |
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- |
登录后查看时间轴
结构
分子式C28H37N3O3 |
InChIKeyACCMWZWAEFYUGZ-UHFFFAOYSA-N |
CAS号202189-78-4 |
关联
119
项与 比拉斯汀 相关的临床试验评估受试制剂比拉斯汀片（规格：20mg）与参比制剂比拉斯汀片（规格：20mg）在健康成年受试者空腹状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性研究。
珠海市汇通达医药有限公司研制的比拉斯汀口腔崩解片（10 mg）与原研参比制剂（10 mg）在中国健康受试者中进行的单中心、随机、开放、单剂量、两周期、双交叉空腹状态下的人体生物等效性研究
江苏联环药业股份有限公司研制的比拉斯汀片（20 mg）与FAES FARMA, S.A.为持证商的比拉斯汀片（20 mg）在中国健康受试者中进行的随机、开放、单剂量、两序列、两周期、空腹状态下的生物等效性研究
100 项与 比拉斯汀 相关的临床结果
登录后查看更多信息
100 项与 比拉斯汀 相关的转化医学
登录后查看更多信息
100 项与 比拉斯汀 相关的专利（医药）
登录后查看更多信息
227
项与 比拉斯汀 相关的文献（医药）2024-12-09Journal of investigational allergology & clinical immunology
english
Article
作者: Arranz, P ; Gonzalo, A ; Gomes, P J ; Hernández, G ; Fernández, N ; Ciolino, J B
Background: Allergic conjunctivitis is the most common type of ocular allergy.
Objective: The objective of this study was to evaluate the efficacy of a new once-daily, preservative-free, bilastine 0.6% eye drop formulation for the treatment of allergic conjunctivitis.
Methods: Two double-masked, vehicle-controlled, clinical studies (a phase 2 dose-ranging study and a phase 3 efficacy study) were conducted to assess the efficacy of bilastine ophthalmic solution for treatment of the signs and symptoms of allergic conjunctivitis. Both studies used the Ora-CAC® Conjunctival Allergen Challenge (CAC) model to enable observation of allergic responses under controlled conditions. Each study was analyzed separately and then combined to create an integrated data set.
Results: Efficacy was achieved for the primary efficacy endpoint of ocular itching with 3 bilastine concentrations (0.2%, 0.4%, and 0.6%) at 15 minutes and 8 hours after instillation. Bilastine 0.6% ophthalmic solution was also efficacious at 16 hours after instillation. Bilastine 0.6% ophthalmic solution demonstrated noninferiority to ketotifen 0.025% at the onset of action. According to the integrated data set, differences between vehicle and bilastine 0.6% after instillation were significant at all time points both at onset (15 minutes) and after a prolonged duration (16 hours).
Conclusion: This multitrial assessment suggests that bilastine 0.6% ophthalmic solution is efficacious for the treatment of the signs and symptoms of allergic conjunctivitis, with a rapid onset and prolonged duration of action, and has a favorable safety profile. The added convenience of once-daily dosing may contribute to adherence and improve quality of life.
2024-12-01EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES
Comparative inhibition by oral bilastine, parenteral dexchlorpheniramine, and a new bilastine parenteral (i.v. and i.m.) formulation of histamine-induced wheal and flare response: A randomised phase I trial
Article
作者: Coimbra, Jimena ; Sánchez, Carlos ; Gilaberte, Inmaculada ; Puntes, Montserrat ; Arranz, Paula ; Gich, Ignasi ; Antonijoan, Rosa ; Molina, Pol
BACKGROUND:
Bilastine is a well-known non-sedating second-generation antihistamine authorised worldwide for the symptomatic treatment of allergic rhinoconjunctivitis (seasonal and perennial) and urticaria with proven efficacy and good safety and tolerability profile. When the oral route is not suitable or a rapid onset of action is preferred, parenteral formulations represent an effective treatment option. However, the parenteral formulations currently available are sedating antihistamines. The objective of this research was to compare the peripheral anti-H1 activity of different bilastine formulations (i.v., i.m. and oral) and dexchlorpheniramine among them also versus placebo.
METHODS:
This was a single-dose, randomized, crossover, double-blind, placebo-controlled, phase I clinical study performed on 25 adult healthy volunteers that compared the peripheral antihistaminic activity of a single dose of bilastine 12 mg i.v., bilastine 12 mg i.m., bilastine 20 mg oral tablets and dexchlorpheniramine 5 mg i.m. among them and versus placebo by inhibiting the histamine-induced wheal and flare (W&F) response. Pharmacokinetics, safety, and tolerability were also evaluated.
RESULTS:
All bilastine formulations showed a rapid onset of action (15 min for parenteral and 30 min for the oral formulation), and the maximum effect in both wheal (i.v. 74.44 %; i.m.:74.29 %; oral 70,27 %) and flare area reduction (i.v. and i.m. 80.63 %; oral 77.67 %), was significantly larger compared to dexchlorpheniramine i.m. (25.85 % for wheal and 28.65 % for flare) and placebo (1.35 % for wheal and 4.02 % for flare). A more pronounced reduction in itching score was reached for bilastine oral, followed by i.m. and i.v. formulations. No serious adverse events (SAEs) were reported during the study, and 8 treatment-emergent adverse events (TEAEs) were reported by 5 subjects, all resolved without sequelae. For psychomotor assessments, dexchlorpheniramine i.m. showed a fast onset of drowsiness, as well as decreased attention and coordination when compared to all bilastine formulations and placebo.
CONCLUSIONS:
All bilastine formulations showed a peripheral H1-blocking effect inducing a significantly greater inhibition of the wheal and flare response as compared to dexchlorpheniramine i.m. or placebo and provided a greater reduction of the itching sensation score. This study reconfirmed that bilastine has no sedative effect, even in a parenteral formulation. These results suggest that new bilastine parenteral formulation (i.v. or i.m.) may represent a suitable alternative for patients requiring immediate treatment of histamine-mediated type I hypersensitivity reactions, such as acute urticaria, or in those cases where oral administration is not possible.
2024-12-01Indian Journal of Otolaryngology and Head & Neck Surgery
Correction to: Comparison of the Efficacy and Safety of Bilastine 20 mg versus Fexofenadine 180 mg for Treatment of Perennial Allergic Rhinitis: Randomized Controlled Study
作者: Mahmood, Tariq ; Matreja, Pritpal Singh ; Agrawal, Pooja ; Chatterji, Probal ; Singhal, Aditya
[This corrects the article DOI: 10.1007/s12070-024-04770-0.].
100 项与 比拉斯汀 相关的药物交易
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 慢性荨麻疹 | 加拿大 | 2016-12-02 | |
| 皮炎 | 日本 | 2016-09-28 | |
| 湿疹 | 日本 | 2016-09-28 | |
| 瘙痒 | 日本 | 2016-09-28 | |
| 瘙痒 | 日本 | 2016-09-28 | |
| 过敏性鼻炎 | 日本 | 2016-09-28 | |
| 过敏性鼻炎 | 日本 | 2016-09-28 | |
| 季节性过敏性鼻炎 | 加拿大 | 2016-04-21 | |
| 过敏性鼻结膜炎 | 德国 | 2010-09-08 | |
| 荨麻疹 | 德国 | 2010-09-08 |
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 变应性结膜炎 | 临床3期 | 美国 | 2018-04-07 | |
| 常年性变应性鼻炎 | 临床3期 | - | 2004-05-01 | |
| 季节性过敏性结膜炎 | 临床2期 | 美国 | 2007-12-01 | |
| 鼻结膜炎 | 临床2期 | 加拿大 | 2007-10-01 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 228 | (Bilastine Ophthalmic Solution 0.6%) | 窪膚窪鏇選積衊網鑰襯(鹽獵夢範廠齋製鬱醖鏇) = 壓膚範鏇糧築網繭醖淵 繭窪夢願繭鏇襯積顧膚 (淵願觸糧淵築網淵鬱構, 艱鹹顧鹹獵簾窪遞艱鹽 ~ 網鬱膚憲選積襯襯膚淵) 更多 | - | 2021-12-14 | ||
(Ketotifen Ophthalmic Solution 0.025% (Zaditen)) | 窪膚窪鏇選積衊網鑰襯(鹽獵夢範廠齋製鬱醖鏇) = 獵繭構壓鑰築選蓋鑰憲 繭窪夢願繭鏇襯積顧膚 (淵願觸糧淵築網淵鬱構, 蓋鬱襯鏇遞鏇網醖齋蓋 ~ 醖膚齋鬱廠鏇鏇窪繭膚) 更多 | ||||||
临床2期 | 121 | (Bilastine 0.2%) | 夢鑰製膚網遞範簾鬱壓(齋鏇觸鏇簾齋淵觸願鹽) = 遞鬱鹽餘夢選願醖蓋簾 願鏇餘鑰遞餘積選齋簾 (選製鹹憲網顧憲廠襯餘, 夢壓醖廠糧襯簾齋積鹽 ~ 製網襯餘鏇鬱壓網遞製) 更多 | - | 2021-11-24 | ||
(Bilastine 0.4%) | 夢鑰製膚網遞範簾鬱壓(齋鏇觸鏇簾齋淵觸願鹽) = 淵鑰鹹築築築觸鹹顧窪 願鏇餘鑰遞餘積選齋簾 (選製鹹憲網顧憲廠襯餘, 憲築鹹衊簾築壓鹽廠選 ~ 製鏇觸鏇顧遞遞積壓艱) 更多 | ||||||
临床1期 | 一线 | 12 | 築壓廠網簾膚廠鑰窪繭(願鬱積鑰網願蓋醖願願) = 襯醖顧網襯網鑰鏇顧膚 網範齋夢遞膚夢憲衊憲 (遞鬱艱齋築淵膚積顧窪 ) 更多 | - | 2020-06-01 | ||
临床4期 | 454 | (Bilastine+Montelukast) | 鑰衊積膚醖選願廠網壓(築鹹艱衊餘艱製壓獵衊) = 積鹽範簾鹽壓衊衊膚衊 築顧鏇蓋觸壓艱願鹽築 (構壓衊觸襯獵繭顧壓選, 顧遞齋鬱顧網鹽顧襯鹹 ~ 選範憲顧衊襯齋網齋築) 更多 | - | 2019-07-12 | ||
Placebo Montelukast 10mg+Bilastine 20mg (Bilastine+Placebo Montelukast) | 網蓋壓範簾廠鹽顧衊築(餘齋鏇壓願餘鬱蓋衊餘) = 憲壓醖範壓選醖鑰艱夢 繭壓選齋獵觸蓋壓築鹹 (鹽遞獵範網襯構簾衊憲, 壓憲蓋鹽顧襯齋獵餘蓋 ~ 簾壓衊鏇齋範窪鏇繭淵) 更多 | ||||||
临床4期 | 19 | Placebo+Bilastine | 壓壓觸願壓構窪鹹鏇餘(鬱觸繭網鹹憲選窪選醖) = 壓鹹夢簾顧艱獵壓築積 鬱鏇鏇窪艱鹹窪獵鑰糧 (醖鏇鏇蓋鹽壓鬱鏇艱淵, 襯積蓋襯觸衊淵壓構窪 ~ 窪齋憲製夢齋窪齋壓鹽) 更多 | - | 2017-01-16 | ||
临床1期 | - | 12 | 20-mg oral tablet | 構蓋鏇齋網鏇願齋願製(壓廠膚衊選廠積觸製齋) = 鬱襯鬱遞鹽簾襯壓膚鏇 憲壓遞壓衊繭積選觸糧 (網窪憲選醖淵憲觸顧選, 53.79 ~ 67.56) | - | 2013-05-01 | |
临床1期 | - | 30 | Bilastine at therapeutic dose (20 mg once daily) | 膚鹹鏇襯觸鬱鹹夢餘顧(廠醖製鏇鹹鹹顧鹽積繭) = 範繭壓蓋醖糧鏇淵糧觸 鹽網壓觸窪獵獵鬱觸襯 (糧鑰積願齋夢鹽製觸繭 ) | - | 2012-06-01 | |
Bilastine at supratherapeutic dose (100 mg once daily) | 膚鹹鏇襯觸鬱鹹夢餘顧(廠醖製鏇鹹鹹顧鹽積繭) = 鹽獵憲衊鹽鑰艱襯夢壓 鹽網壓觸窪獵獵鬱觸襯 (糧鑰積願齋夢鹽製觸繭 ) |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
来和芽仔聊天吧
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用