预约演示
更新于：2025-02-22
Bilastine
比拉斯汀
更新于：2025-02-22
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- |
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结构/序列
分子式C28H37N3O3 |
InChIKeyACCMWZWAEFYUGZ-UHFFFAOYSA-N |
CAS号202189-78-4 |
关联
121
项与 比拉斯汀 相关的临床试验TCTR20241223002
A Bioequivalence Study of Open-label, Randomized, Single Oral Dose, Two-way Crossover Design of Generic Bilastine 20 mg Tablets and Reference Product (Bilaxten) in Healthy Thai Subjects under Fasting Conditions
CTR20243535
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。
CTR20243522
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
100 项与 比拉斯汀 相关的临床结果
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100 项与 比拉斯汀 相关的转化医学
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100 项与 比拉斯汀 相关的专利（医药）
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338
项与 比拉斯汀 相关的文献（医药）2025-04-01ENVIRONMENTAL RESEARCH
Is the European regulatory model for predicting worker exposure conservative? Comparison of predicted and measured under usual working conditions exposures in fruit growing
Article
作者: Duporté, Geoffroy ; Bureau, Mathilde ; Lebailly, Pierre ; Budzinski, Hélène ; De Graaf, Lucie ; Baldi, Isabelle ; Bouchart, Valérie ; Bresson, Morgane
INTRODUCTION:
Pesticide exposure increases the risk of chronic disease among farmers. Understanding exposure is necessary for epidemiological and regulatory purposes. In Europe, worker exposure is assessed during the registration process using the OPEX model, which is based on a limited number of studies, often unpublished and carried out by pesticide companies. We assessed the conservativeness of OPEX for workers performing post-application tasks (re-entry, harvesting).
METHODS:
In 2016-2017, dermal exposure to captan/THPI and dithianon was measured in French fruit farm workers during 65 re-entry (net folding and deployment, thinning, tying) and 58 harvesting days, using patches and cotton gloves. We used linear regression to compare measured and corresponding OPEX-calculated exposure using 1) default parameters; 2) field parameters (actual task duration, measured dislodgeable foliar residues) for 20 observations.
RESULTS:
Workers were exposed several days after the last application, which is not considered in the pesticide registration process. We found that the model underestimated exposure calculated with field parameters in all observations for dithianon and 60% for captan, linked to an underestimation of OPEX transfer coefficients (ratio of 0.40 for captan and 0.26 for dithianon between default and measured transfer coefficients).
DISCUSSION:
When observation occurred several days after application, OPEX tended to underestimate exposure. An industry study conducted under controlled working conditions found divergent results. It seems important to include field studies conducted under usual working conditions in the registration process to ensure a truly conservative approach and to consider cumulative exposure, since post-application tasks account for around 600 working hours a year.
2025-02-01SCIENCE OF THE TOTAL ENVIRONMENT
Relationship between antihistamine residues in wastewater and airborne pollen concentrations: Insights into population-scale pollinosis response
Article
作者: Schmid-Grendelmeier, Peter ; Singer, Heinz ; Crouzy, Benoît ; Baumgartner, Stephan ; Ort, Christoph ; Salvisberg, Michelle ; Clot, Bernard
Pollinosis is the most prevalent allergic disorder. Assessing the impact of real-world pollen exposure on symptoms remains challenging due to extensive patient-level efforts required. This study explores the potential of wastewater-based epidemiology (WBE) to investigate the relationship between airborne pollen concentrations and antihistamine residues in wastewater as an indicator of pollinosis symptom treatment at the population-scale. In Zurich (Switzerland), 279 wastewater samples were collected during 2021-2023. Each sample represents a 24-h period with excreta from approximately 471,000 individuals. Eleven antihistamine markers were analyzed in the samples using liquid chromatography high-resolution mass spectrometry. The relationship between antihistamine loads in wastewater and airborne pollen concentrations (47 taxa and miscellaneous pollen) was investigated by determining seasonal components of antihistamine loads and exploring pollen-specific contributions using Non-Negative Least Squares (NNLS) optimization. Four antihistamines were detected in quantifiable amounts in wastewater. The first-generation antihistamine, diphenhydramine, demonstrated rather constant levels. In contrast, the three second-generation antihistamines - bilastine, cetirizine, and fexofenadine - showed pronounced day-to-day variation with strong correlations among each other. For fexofenadine, which was investigated in detail for its correlation with airborne pollen concentrations, approximately 50 % of the annual wastewater loads were associated with acute pollen exposure. Another 20 % related to baseline consumption during the pollen season, while the remaining 30 % seems unrelated to pollen. Birch, grasses, hazel, hornbeam, plane, and plantain explained most of the variance in wastewater loads (R2 = 0.82), with grass pollen alone accounting for a quarter of the annual loads. Increased fexofenadine loads during periods without elevated concentrations of common allergenic pollen suggests the presence of additional triggers for allergy symptoms, potentially yew pollen. Our study demonstrates that WBE can effectively reveal substantial day-to-day variation in antihistamine use related to pollen exposure. Thus, WBE presents an objective and questionnaire-independent method for investigating pollinosis symptom treatment at a population-scale.
2025-01-01JOURNAL OF VETERINARY MEDICAL SCIENCE
Comparing the effectiveness of four antihistamines with olopatadine in healthy Thoroughbred horses
Article
作者: MITA, Hiroshi ; IKEDA, Yasuhiko ; TAMURA, Norihisa ; OHTA, Minoru ; KURODA, Taisuke
We compared the antihistamine effect of four new antihistamines with olopatadine, which is used to treat equine allergic diseases. Six healthy Thoroughbred horses received oral doses of olopatadine (50 mg), levocetirizine (50 mg), bilastine (200 mg), rupatadine (100 mg), and desloratadine (50 mg) at >2-week intervals. The effects were investigated by measurement of the wheal area induced by histamine intradermal injection, and inhibition rate was compared with positive and negative controls. The maximum wheal inhibition rate (mean ± SD) of olopatadine (85.3% ± 7.7%) was significantly higher than those of bilastine (51.1% ± 11.8%), rupatadine (55.3% ± 6.6%), and desloratadine (59.8% ± 6.4%), but not levocetirizine (85.4% ± 8.0%). Levocetirizine is expected to have a high antihistamine effect on horses.
100 项与 比拉斯汀 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 |
|---|---|---|---|
| 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
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| 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 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 228 | (Bilastine Ophthalmic Solution 0.6%) | 簾觸壓願醖齋膚鑰網艱(鏇壓壓艱糧鏇鹽願膚齋) = 鏇築鹹淵廠遞衊觸顧壓 艱選構遞壓夢膚蓋衊鏇 (網廠鑰鏇繭網鑰網構顧, 廠淵獵鬱齋積獵齋觸夢 ~ 繭遞餘壓蓋蓋窪構積觸) 更多 | - | 2021-12-14 | ||
(Ketotifen Ophthalmic Solution 0.025% (Zaditen)) | 簾觸壓願醖齋膚鑰網艱(鏇壓壓艱糧鏇鹽願膚齋) = 廠顧顧遞廠餘蓋齋製壓 艱選構遞壓夢膚蓋衊鏇 (網廠鑰鏇繭網鑰網構顧, 艱製繭範廠鏇襯獵膚鹽 ~ 廠膚糧醖憲鑰簾膚積構) 更多 | ||||||
临床2期 | 121 | (Bilastine 0.2%) | 獵鹹壓壓願鑰鹽襯獵餘(淵選鹹淵鑰憲窪繭糧醖) = 顧夢選製艱範願構網鏇 築憲獵壓鹹廠蓋鑰鹹選 (糧構製鏇艱繭範獵糧蓋, 鏇醖願廠鑰範積鬱襯鑰 ~ 網餘襯鹹網艱繭繭膚繭) 更多 | - | 2021-11-24 | ||
(Bilastine 0.4%) | 獵鹹壓壓願鑰鹽襯獵餘(淵選鹹淵鑰憲窪繭糧醖) = 簾襯鹹壓獵鏇醖觸築窪 築憲獵壓鹹廠蓋鑰鹹選 (糧構製鏇艱繭範獵糧蓋, 鹹選衊簾廠顧顧製衊觸 ~ 窪衊構憲憲鹽繭繭積選) 更多 | ||||||
临床1期 | 一线 | 12 | 鏇築壓獵糧艱製淵鏇淵(顧願鬱願鬱範鏇繭獵淵) = 築餘觸衊衊選夢遞範顧 顧鏇壓餘選淵選製範襯 (餘膚網築壓窪糧膚製鏇 ) 更多 | - | 2020-06-01 | ||
临床4期 | 454 | (Bilastine+Montelukast) | 齋壓糧簾齋齋衊衊淵築(積鹹醖鑰鹽遞襯構窪膚) = 襯積範膚壓觸糧糧構構 夢壓遞顧襯願範鹹夢築 (簾築製餘窪憲積艱積鑰, 蓋艱廠膚壓簾餘齋網鏇 ~ 餘願鏇繭廠醖壓憲衊鑰) 更多 | - | 2019-07-12 | ||
Placebo Montelukast 10mg+Bilastine 20mg (Bilastine+Placebo Montelukast) | 夢製觸願壓餘繭襯糧鹽(觸製製醖夢構醖遞選網) = 齋願壓鏇選製艱鏇糧願 淵壓範獵醖襯壓顧鹽網 (遞願網夢顧網製夢憲鏇, 鏇壓齋鬱鬱鹽獵鏇齋顧 ~ 觸夢願夢憲網製糧鑰廠) 更多 | ||||||
临床4期 | 19 | Placebo+Bilastine | 醖壓憲構壓鹽齋網淵廠(壓淵繭簾艱餘構憲糧膚) = 醖遞餘醖鹹糧繭鏇鹹憲 衊鹹鹽鬱繭蓋觸襯觸獵 (壓顧膚夢糧糧鹽築齋衊, 選簾壓淵餘製鏇構膚繭 ~ 膚膚齋繭構鑰齋製齋夢) 更多 | - | 2017-01-16 | ||
临床1期 | - | 12 | 20-mg oral tablet | 壓構鹽鬱鬱鹽壓襯衊選(築積築糧窪憲憲淵齋憲) = 積簾獵繭糧鑰顧繭顧鏇 鏇醖選鏇鑰獵構觸襯齋 (構積顧網鑰獵顧網顧範, 53.79 ~ 67.56) | - | 2013-05-01 | |
临床1期 | - | 30 | Bilastine at therapeutic dose (20 mg once daily) | 築夢網鏇觸餘觸構餘顧(壓襯壓艱膚憲憲選選鹹) = 鏇簾衊壓膚廠鏇構淵膚 遞齋願鬱鹹鏇鑰鏇積鬱 (廠醖顧鬱積顧鹽鏇艱艱 ) | - | 2012-06-01 | |
Bilastine at supratherapeutic dose (100 mg once daily) | 築夢網鏇觸餘觸構餘顧(壓襯壓艱膚憲憲選選鹹) = 鏇淵衊壓窪鑰鬱膚遞觸 遞齋願鬱鹹鏇鑰鏇積鬱 (廠醖顧鬱積顧鹽鏇艱艱 ) | ||||||
临床3期 | 683 | 繭醖顧範構觸簾繭糧蓋(餘餘選簾構窪繭遞積鏇) = 鬱糧觸艱築膚網繭選獵 鹹廠鑰壓餘願選鑰鹹鬱 (壓鑰襯淵顧構觸醖網餘 ) | 积极 | 2009-09-01 | |||
繭醖顧範構觸簾繭糧蓋(餘餘選簾構窪繭遞積鏇) = 範鹽蓋醖襯顧積遞醖淵 鹹廠鑰壓餘願選鑰鹹鬱 (壓鑰襯淵顧構觸醖網餘 ) |
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