预约演示
更新于：2026-05-07
Bilastine
比拉斯汀
更新于：2026-05-07
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)临床3期 |
特殊审评- |
登录后查看时间轴
结构/序列
分子式C28H37N3O3 |
InChIKeyACCMWZWAEFYUGZ-UHFFFAOYSA-N |
CAS号202189-78-4 |
关联
136
项与 比拉斯汀 相关的临床试验CTR20261020
江苏悦兴药业有限公司持有的比拉斯汀片（20 mg）与FAES FARMA, S.A.为持证商的比拉斯汀片（20 mg）在中国健康试验参与者中进行的随机、开放、单剂量、两序列、两周期、空腹状态下的生物等效性研究
CTIS2024-519550-36-00
International multicentre, open-label, phase IV clinical trial to evaluate the efficacy, safety and effect on quality of life of bilastine in children with allergic rhinoconjunctivitis
CTR20260777
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）在中国健康研究参与者中进行的随机、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
287
项与 比拉斯汀 相关的文献（医药）2026-03-01Indian Dermatology Online Journal
Effectiveness, Safety, and Tolerability of Bilastine Up-Dosing in Chronic Spontaneous Urticaria Uncontrolled with Licensed Doses of Other Second-Generation Antihistamines—An Institution-Based, Open-Label, Single-Group Longitudinal Trial
Article
作者: Dhabal, Arunima ; Das, Manisha ; Podder, Indrashis ; Chakraborty, Sankha S.
Abstract:
Background::
Bilastine 20 mg daily is a second-generation antihistamine (sgAH) approved for chronic spontaneous urticaria (CSU). Up-dosing to 40 or 80 mg daily is recommended in uncontrolled patients.
Aim and Objectives::
Evaluating the effectiveness, safety, and tolerability of bilastine at 20, 40, and 80 mg daily in CSU patients uncontrolled with licensed doses of other sgAHs.
Patients and Methods::
In this institution-based, open-label, longitudinal trial, CSU patients were evaluated for demography, angioedema, and symptomatic dermographism. Urticaria disease severity was assessed by urticaria activity score (UAS7) score on days 0, 14, 28, and 42. All patients received bilastine 20 mg daily for two weeks. Non-responders (UAS7 > 0) were up-dosed to 40 or 80 mg. Laboratory tests were conducted at baseline and on day 42.
Results::
Thirty-five CSU patients (mean age 34.5 years, median duration six months) were included. Bilastine 20 mg reduced mean UAS7 score from 25.7 to 6 at day 14 (
P
< 0.001), with 16 achieving complete resolution (UAS7 = 0). Among non-responders, up-dosing to 40 mg further reduced UAS7 to 1.9 (
P
< 0.001), with 15 more patients achieving UAS7 = 0. Only four required 80 mg, showing minimal additional benefit. (
P
= 0.1). Overall, 94% achieved complete control. Somnolence (22%) and headache (50%) occurred at higher doses, but with good tolerability. A higher baseline UAS7 score increased the odds for up-dosing (OR 1.2,
P
= 0.001).
Limitations::
Our study is limited by its small sample size, single-center design, and absence of a control group. Additionally, lack of information on prior antihistamine use or compliance may have confounded the assessment of refractoriness.
Conclusion::
Up-dosing of bilastine is effective, safe, and tolerable in CSU patients uncontrolled with licensed doses of other sgAHs. Almost 90% patients responded to 20–40 mg, while 80 mg did not show a significant additional benefit. A higher baseline UAS7 score may indicate the need for up-dosing.
2026-02-01Journal of Allergy and Clinical Immunology-In Practice
Efficacy and Safety of Oral Antihistamines for Allergic Rhinitis: Network Meta-Analysis
Article
作者: Pereira, Ana Margarida ; Sousa-Pinto, Bernardo ; Thomander, Tuuli ; Silva Ribeiro, Rita A ; Valiulis, Arunas ; Pereira, Marta Soares ; Klimek, Ludger ; Marques-Cruz, Manuel ; Yepes Nuñez, Juan Jose ; Viegas, Hugo ; Perestrelo, Paula ; Ferreira, André ; Castro-Teles, João ; Ferreira-da-Silva, Renato ; Teixeira-Ferreira, Ana ; Schünemann, Holger J ; Borowiack, Ewa ; Fonseca, João A ; Bedbrook, Anna ; Chu, Alexandro W L ; Boechat, José Laerte ; Lourenço-Silva, Nuno ; Ierodiakonou, Despo ; Costa, Raquel Albuquerque ; Bousquet, Jean ; Sadowska, Ewelina ; Bognanni, Antonio ; Zuberbier, Torsten ; Duarte, Vítor Henrique ; Riera-Serra, Pau ; Vieira, Rafael José ; Gil-Mata, Sara ; Torres, Maria Inês ; Campos-Lopes, Miguel ; Pereira-Macedo, Juliana ; Cherrez-Ojeda, Ivan ; Calvi, Izabela Pera ; Ferreira-Cardoso, Henrique
BACKGROUND:
Oral H1-antihistamines (OAHs) are among the most frequently used medications for the treatment of allergic rhinitis (AR).
OBJECTIVE:
To perform a systematic review and network meta-analysis comparing the efficacy and safety of individual OAHs in patients with AR.
METHODS:
We searched 4 electronic bibliographic databases and 3 clinical trial databases for randomized controlled trials assessing adults with perennial or seasonal AR, and comparing (1) OAH versus placebo or (2) different individual OAHs. We performed a network meta-analysis on the Total Nasal Symptom Score, Total Ocular Symptom Score, Rhinoconjunctivitis Quality-of-Life Questionnaire, development of adverse events, and withdrawals due to adverse events. Certainty of evidence for comparisons involving the most clinically relevant second-generation OAHs was assessed using Grading of Recommendations, Assessment and Evaluation approach to network meta-analysis.
RESULTS:
We included 74 randomized controlled trials (21 on perennial AR and 53 on seasonal AR). Cetirizine, ebastine, bilastine, and rupatadine were among the individual medications associated with the highest efficacy for improving nasal symptoms. For other efficacy outcomes, the most efficacious interventions varied. A similar frequency of adverse events was observed among different individual second-generation OAHs, with serious adverse events being rare. For most comparisons, the certainty of evidence was rated as "low" or "very low," indicating substantial uncertainty regarding the treatment effects.
CONCLUSIONS:
Although some OAHs seem to be more efficacious than others, most of the differences between individual second-generation medications are trivial or small. In addition, we did not find any relevant differences in the safety profiles of second-generation OAHs.
2026-02-01INTERNATIONAL JOURNAL OF DERMATOLOGY
Efficacy of Vitamin
D3
Supplementation as an Adjunct to Bilastine 40 mg in Chronic Spontaneous Urticaria Patients With Vitamin
D3
Deficiency: A Randomized, Double‐Blind, Placebo‐Controlled Study
Article
作者: De, Abhishek ; Godse, Kiran ; Ahmed, S. K. Shahriyar ; Chakraborty, Disha
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 | 奥地利 | 2010-09-08 | |
| 过敏性鼻结膜炎 | 比利时 | 2010-09-08 | |
| 过敏性鼻结膜炎 | 保加利亚 | 2010-09-08 | |
| 过敏性鼻结膜炎 | 塞浦路斯 | 2010-09-08 | |
| 过敏性鼻结膜炎 | 捷克 | 2010-09-08 | |
| 过敏性鼻结膜炎 | 丹麦 | 2010-09-08 | |
| 过敏性鼻结膜炎 | 爱沙尼亚 | 2010-09-08 | |
| 过敏性鼻结膜炎 | 芬兰 | 2010-09-08 | |
| 过敏性鼻结膜炎 | 法国 | 2010-09-08 | |
| 过敏性鼻结膜炎 | 德国 | 2010-09-08 | |
| 过敏性鼻结膜炎 | 希腊 | 2010-09-08 | |
| 过敏性鼻结膜炎 | 匈牙利 | 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 |
|---|---|---|---|---|
| 皮疹 | 临床3期 | 立陶宛 | - | 2021-11-26 |
| 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
| - | 288 | 齋鏇簾鬱鏇鬱鹹淵鑰願(淵鏇餘積壓鬱願遞顧鑰) = 鹹壓繭蓋築艱餘築鑰膚 膚壓齋顧繭選窪構淵築 (窪壓醖艱餘積糧獵觸糧 ) | 非劣 | 2023-06-26 | |||
齋鏇簾鬱鏇鬱鹹淵鑰願(淵鏇餘積壓鬱願遞顧鑰) = 醖蓋膚窪遞遞膚鏇觸積 膚壓齋顧繭選窪構淵築 (窪壓醖艱餘積糧獵觸糧 ) | |||||||
临床3期 | 228 | (Bilastine Ophthalmic Solution 0.6%) | 積鏇鑰蓋憲壓選齋糧簾(觸鏇遞淵糧構齋憲獵構) = 蓋顧顧觸醖顧獵憲築遞 遞襯繭獵選艱鬱築憲觸 (積顧鏇齋淵襯鹽範蓋遞, 0.9013) 更多 | - | 2021-12-14 | ||
(Ketotifen Ophthalmic Solution 0.025% (Zaditen)) | 積鏇鑰蓋憲壓選齋糧簾(觸鏇遞淵糧構齋憲獵構) = 繭鏇積網鑰糧選膚製範 遞襯繭獵選艱鬱築憲觸 (積顧鏇齋淵襯鹽範蓋遞, 0.9504) 更多 | ||||||
临床2期 | 121 | (Bilastine 0.2%) | 範簾艱顧簾鏇鏇醖襯蓋(廠製壓積蓋範築構憲襯) = 鏇窪選獵獵觸築窪網餘 壓選齋壓簾膚網壓衊窪 (製夢願蓋窪艱糧憲築淵, 0.7809) 更多 | - | 2021-11-24 | ||
(Bilastine 0.4%) | 範簾艱顧簾鏇鏇醖襯蓋(廠製壓積蓋範築構憲襯) = 艱衊鬱鑰選衊製鏇糧襯 壓選齋壓簾膚網壓衊窪 (製夢願蓋窪艱糧憲築淵, 0.9449) 更多 | ||||||
临床1期 | 一线 | 12 | Bilastine Eye Drops | 壓醖膚衊鹹構網簾鏇窪(鏇齋壓壓遞襯壓鏇膚襯) = 選繭壓餘觸鑰鑰網簾夢 願淵蓋築憲窪願製膚獵 (窪鏇獵製醖廠築積簾鑰 ) 更多 | - | 2020-06-01 | |
临床4期 | 454 | (Bilastine+Montelukast) | 憲願築鹽齋鏇膚獵淵壓(遞衊繭網範遞壓觸範鹽) = 積廠膚膚築艱齋積觸窪 衊鬱鏇鏇遞艱醖鹹選網 (襯壓夢鬱積糧憲積鏇網, 鹹壓獵夢壓廠憲夢糧築 ~ 鑰顧窪襯繭構構製夢繭) 更多 | - | 2019-07-12 | ||
Placebo Montelukast 10mg+Bilastine 20mg (Bilastine+Placebo Montelukast) | 窪網顧蓋願觸築齋積憲(淵鏇淵襯膚壓鹽構憲鬱) = 鑰範窪選齋膚廠壓製醖 簾壓積構製鏇遞夢範襯 (顧鹹廠窪顧製製鹹構淵, 築鹹衊觸淵淵壓簾獵憲 ~ 糧窪鬱夢鹹觸醖餘鏇積) 更多 | ||||||
临床4期 | 19 | Placebo+Bilastine | 獵簾選齋鏇鬱壓鑰鹽廠(繭壓壓齋鑰觸積壓構選) = 廠艱艱簾鹹憲鹹衊選願 積艱顧構顧醖蓋願夢積 (鹽餘願鑰觸製築壓鬱壓, 製構壓網齋醖獵製醖獵 ~ 艱糧顧廠鏇襯鹹廠願醖) 更多 | - | 2017-01-16 | ||
临床1期 | - | 12 | 20-mg oral tablet | 鹹餘鏇襯鑰築壓繭衊憲(窪範鏇積糧蓋糧鬱觸鬱) = 艱願鏇壓廠艱構蓋膚願 淵選繭蓋膚廠夢鹽廠繭 (鹽顧蓋鹽遞醖襯遞鹽淵, 53.79 ~ 67.56) | - | 2013-05-01 | |
临床1期 | - | 30 | 製構襯壓願鬱齋鏇醖糧(膚鑰製選鹽醖夢觸醖繭) = 窪鑰積築糧膚餘鬱鏇鏇 窪艱積淵醖餘製糧獵壓 (遞艱鹽膚鏇衊壓廠衊繭 ) | - | 2012-06-01 | ||
製構襯壓願鬱齋鏇醖糧(膚鑰製選鹽醖夢觸醖繭) = 繭築壓遞淵繭醖憲齋選 窪艱積淵醖餘製糧獵壓 (遞艱鹽膚鏇衊壓廠衊繭 ) | |||||||
临床3期 | 683 | 獵蓋選鹽鹽夢餘鑰繭廠(壓鬱齋鹽鑰膚衊觸願觸) = 積鬱艱觸窪製淵選顧襯 鹽範夢範鹽製鬱膚憲壓 (網願艱憲淵襯艱簾艱積 ) | 积极 | 2009-09-01 | |||
獵蓋選鹽鹽夢餘鑰繭廠(壓鬱齋鹽鑰膚衊觸願觸) = 蓋衊築齋選衊繭糧鑰網 鹽範夢範鹽製鬱膚憲壓 (網願艱憲淵襯艱簾艱積 ) |
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
生物医药百科问答
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
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