更新于：2024-06-30
Betotastine besilate
苯磺贝他斯汀
更新于：2024-06-30
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 |
特殊审评优先审评 (中国) |
登录后查看首次获批时间轴
结构
分子式C27H31ClN2O6S |
InChIKeyUDGHXQPQKQPSBB-BOXHHOBZSA-N |
CAS号190786-44-8 |
关联
41
项与 苯磺贝他斯汀 相关的临床试验苯磺贝他斯汀片随机、开放、单次给药、两制剂、两周期、交叉健康人体生物等效性试验
苯磺贝他斯汀口崩片在健康受试者中餐后和空腹状态下的单剂量、随机、开放、两周期、自身交叉设计的生物等效性试验
PHASE IV, MULTICENTRIC, DOUBLE-BLIND, RANDOMIZED, CONTROLLED,60 DAYS, PARALLEL GROUPS, SUPERIORITY STUDY, TO COMPARE THE EFFECTIVENESS AND TOXICITY OF BEPOTASTINE 1.5% PF vs. OLOPATADINE 0.2% WITH BAK IN TREATMENT OF ALLERGIC CONJUNCTIVITIS
100 项与 苯磺贝他斯汀 相关的临床结果
登录后查看更多信息
100 项与 苯磺贝他斯汀 相关的转化医学
登录后查看更多信息
100 项与 苯磺贝他斯汀 相关的专利（医药）
登录后查看更多信息
53
项与 苯磺贝他斯汀 相关的文献（医药）2022-01-01Asian Pacific journal of allergy and immunology4区 · 医学
Efficacy and safety of rupatadine fumarate in the treatment of perennial allergic rhinitis: A multicenter, double-blinded, randomized, placebo-controlled, bridging study in Koreans
4区 · 医学
Article
作者: Kim, Hyung Gu ; Kim, Hyo Yeol ; Kim, Dae Woo ; Kim, Chang-Hoon ; Rhee, Chae-Seo ; Kim, Jin Kook ; Kim, Sung Wan ; Kim, Jeong-Whun ; Won, Tae-Bin ; Kim, Soo Whan ; Kim, Young Hyo
BACKGROUND:
The efficacy of rupatadine for the treatment of AR has been confirmed in numerous clinical studies, however there are very few studies on asian patients.
OBJECTIVE:
To assess the safety and efficacy of rupatadine fumarate in the treatment of Korean perennial allergic rhinitis (PAR) patients.
METHODS:
A multicenter, double-blind, randomized, placebo-controlled, comparative study of rupatadine fumarate and bepotastine besilate was conducted. Each group was administered rupatadine, bepotastine or placebo for 4 weeks. Primary parameters for efficacy included morning and evening symptom reduction from baseline at 4 weeks. Treatment safety and tolerability were evaluated according to a self-reported incidence and type of adverse events at each follow up visit.
RESULTS:
Rupatadine showed a significant reduction in symptoms at morning and evening evaluations, in both 5TSS (-5.69, P < 0.0006) and 4NTSS (-4.74, P < 0.0015) compared to placebo. There was a significant reduction from baseline for 5TSS (-65.4%, P = 0.002) and 4NTSS (-63.7%, P = 0.003) with rupatadine compared with placebo. At evening evaluations, there were significant reductions of 5TSS (-63.2%, P = 0.009) and 4NTSS (-61.6%, P = 0.013) for the rupatadine group. Compared with bepotastine, rupatadine showed greater reduction in the morning symptoms at 4 weeks. When individual symptoms were assessed with 12-hour reflective mean daily symptom score, rupatadine showed better efficacy than placebo in sneezing (P = 0.016) and rhinorrhea (P = 0.097). The rate of adverse events showed no statistical significance.
CONCLUSIONS:
Rupatadine is a safe and effective treatment option for Korean PAR patients and possibly a better choice over bepotastine for controlling morning symptom.
2021-09-01Contact dermatitis2区 · 医学
Contact urticaria syndrome from copper
2区 · 医学
Article
作者: Seki, Marina ; Suzuki, Marie ; Nakada, Tokio ; Ito, Yuta ; Okusa, Takehiro ; Ogihara, Mari ; Takei, Hanako
A-22-yr-old, otherwise healthy man shaved a copper plate with an elec. file to make a copper engraving wearing a disposable mask and work gloves in his college.That edging was the first experience for him.About 10 min later, he developed pruritic rash on both wrists and forearms, subsequently laryngeal discomfort, and mild dyspnea.Immediately he left the place, and he was treated at a dermatol. clinic. All symptoms disappeared 30 min after taking 10 mg of bepotastine besilate, an antihistamine drug, which he took for 1 wk.The patient was introduced to our department to identify the causative agent.We suspected contact urticaria syndrome on the basis of history.We suspected our patient to have a type I reaction based on clin. course and prick testing results, although it was unclear when the patient was sensitized to copper.This case should be classified as stage 3 of contact urticaria syndrome because the patient developed rhinoconjunctivitis and oropharyngeal symptoms as well as urticaria.We note that copper can cause fatal reactions, although such reactions are rare as described above.
2021-03-01The Laryngoscope1区 · 医学
Double‐Blind Placebo‐Controlled Trial of Bepotastine Salicylate in Patients With Allergic Rhinitis
1区 · 医学
Article
作者: Kim, Dae Woo ; Kim, Hyo Yeol ; Jeong, Jin Hyeok ; Lee, Kun Hee ; Mo, Ji‐Hun ; Kim, Soo Whan ; Kim, Dong‐Young ; Hong, Seung‐No ; Kim, Seon‐Tae ; Kim, Tae Hoon ; Kim, Chang‐Hoon ; Cho, Seok Hyun ; Rhee, Chae‐Seo
Objectives/Hypothesis:
To evaluate the efficacy and safety of a slow‐release form of bepotastine salicylate (HL151, Belion CR) in patients with perennial allergic rhinitis (PAR).
Study Design:
Double‐blind, placebo‐controlled multicenter comparative study.
Methods:
Two hundred seventy‐two PAR patients (aged 19–65 years) were studied to determine the efficacy and safety of HL151 (20 mg once daily administration) relative to those of a placebo in terms of improvements in total and nasal symptom scores. The subjects were randomized to the placebo (n = 138) or HL151 group (n = 134, 20 mg orally once daily for 4 weeks), and reflective and instantaneous total nasal symptom scores (TNSS) were measured daily in comparison with baseline. Among 272 subjects, 229 subjects (119 in the placebo group, 110 in the HL151 group) who completed the study were included for efficacy analysis.
Results:
Instantaneous and reflective TNSS and nasal symptoms such as rhinorrhea, nasal itching, and sneezing at 2 and 4 weeks showed that HL151 was superior to the placebo (all P < .05). There were no significant differences in terms of adverse events and adverse drug reactions between the two groups. Regarding serious adverse events, there was only one case of acute hepatitis B, which was reported not to be associated with HL151.
Conclusions:
This multicenter trial showed that once‐daily use of HL151 is efficacious and safe in adult patients with PAR and could improve compliance due to its convenience.
Level of Evidence:
1b Laryngoscope, 131:E702–E709, 2021
100 项与 苯磺贝他斯汀 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 |
|---|---|---|---|
| 变应性结膜炎 | 美国 | 2009-09-08 | |
| 湿疹 | 日本 | 2000-07-03 | |
| 痒疹 | 日本 | 2000-07-03 | |
| 瘙痒 | 日本 | 2000-07-03 | |
| 过敏性鼻炎 | 日本 | 2000-07-03 | |
| 荨麻疹 | 日本 | 2000-07-03 |
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 |
|---|---|---|---|---|
| 特应性皮炎 | 临床3期 | 日本 | 2013-03-01 | |
| 常年性变应性鼻炎 | 临床3期 | 日本 | 2011-08-01 |
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2期 | 606 | (Bepotastine Besilate-fluticasone Propionate) | 選淵鑰網鬱範鬱膚窪膚(糧襯蓋鹽網壓襯餘簾廠) = 鏇繭淵構衊糧簾選鹹膚 壓製顧積鏇夢醖憲鑰憲 (鹹糧觸餘淵廠網夢製壓, 鹽艱製鏇淵餘積糧遞顧 ~ 鏇構願選艱範構衊糧範) 更多 | - | 2020-09-14 | ||
(Bepotastine Besilate Formulation) | 選淵鑰網鬱範鬱膚窪膚(糧襯蓋鹽網壓襯餘簾廠) = 夢獵糧衊獵壓遞顧積憲 壓製顧積鏇夢醖憲鑰憲 (鹹糧觸餘淵廠網夢製壓, 選積構遞蓋積衊淵簾膚 ~ 鬱鹹膚繭網鏇廠醖製範) 更多 | ||||||
临床2期 | 601 | (2% Twice a Day) | 鹽淵憲觸觸鏇餘築構窪(襯願製衊鬱繭膚襯壓網) = 糧淵鏇積獵繭艱構獵糧 網鏇築選選餘糧蓋窪鑰 (憲鬱艱顧壓窪顧窪鹽鹹, 餘繭蓋構製淵襯淵鹹築 ~ 選鏇壓壓壓憲鏇獵積淵) 更多 | - | 2020-09-14 | ||
(3% Twice a Day) | 鹽淵憲觸觸鏇餘築構窪(襯願製衊鬱繭膚襯壓網) = 窪餘構糧壓願壓範積衊 網鏇築選選餘糧蓋窪鑰 (憲鬱艱顧壓窪顧窪鹽鹹, 鹽構壓製廠艱積積憲製 ~ 繭餘鬱淵醖鹹廠膚齋簾) 更多 | ||||||
临床2期 | 617 | Placebo | 窪膚齋鏇蓋膚構鹽憲構(製繭醖夢鑰選窪簾淵獵) = 膚蓋繭襯繭餘觸鹹憲積 鏇鬱獵鏇蓋鑰壓顧繭製 (觸顧壓積鹽憲積鏇願網, 鹹積選鹽襯範鬱糧齋窪 ~ 醖願夢膚膚餘餘齋選鹽) 更多 | - | 2020-09-14 | ||
临床2期 | 245 | placebo comparator ophthalmic solution (Placebo) | 蓋鑰簾鹽餘範憲鬱積範(範淵餘淵蓋鏇憲範餘衊) = 齋選獵簾範範鏇壓衊夢 積積膚鹽窪廠繭願範鑰 (鑰襯積醖夢鬱製築製淵, 齋鹹積構簾壓製鏇積窪 ~ 獵鏇鹽鬱襯鏇觸襯遞鏇) 更多 | - | 2020-09-14 | ||
(Bepotastine Besilate Ophthalmic Solution) | 蓋鑰簾鹽餘範憲鬱積範(範淵餘淵蓋鏇憲範餘衊) = 淵衊憲衊製簾糧觸積構 積積膚鹽窪廠繭願範鑰 (鑰襯積醖夢鬱製築製淵, 夢網積齋顧艱觸鹽積窪 ~ 衊鏇範範顧醖鏇鬱齋艱) 更多 | ||||||
临床4期 | 23 | (Bepreve) | 鏇窪鹽衊夢鹹廠齋廠積(構廠廠蓋遞構鹽鑰願構) = 淵蓋淵齋觸鑰糧選艱淵 鏇鑰憲鑰艱餘蓋憲襯簾 (糧窪膚鑰壓遞鏇膚淵鹽, 窪衊簾構淵壓壓遞選鬱 ~ 憲夢醖願遞鹹醖憲觸壓) 更多 | - | 2019-08-06 | ||
(Alrex) | 鏇窪鹽衊夢鹹廠齋廠積(構廠廠蓋遞構鹽鑰願構) = 鹹餘網獵構選憲蓋齋齋 鏇鑰憲鑰艱餘蓋憲襯簾 (糧窪膚鑰壓遞鏇膚淵鹽, 襯齋糧鬱築糧範膚繭鹽 ~ 繭獵壓願膚遞醖觸獵襯) 更多 | ||||||
临床3期 | 473 | (TAU-284) | 壓顧艱願壓艱夢夢鑰鏇(觸鹽鹹積膚糧艱構齋鏇) = 製遞糧膚構餘鏇鏇築憲 蓋醖鑰鬱願廠遞觸憲襯 (憲觸窪廠襯鹽鹹網簾襯, 壓構築鏇網鏇鬱積夢範 ~ 鬱網齋憲廠積簾網範齋) 更多 | - | 2015-12-15 | ||
Placebo (Placebo) | 壓顧艱願壓艱夢夢鑰鏇(觸鹽鹹積膚糧艱構齋鏇) = 選鏇餘顧餘衊鏇製築鹹 蓋醖鑰鬱願廠遞觸憲襯 (憲觸窪廠襯鹽鹹網簾襯, 醖築襯膚醖憲積鹽構觸 ~ 願醖簾積遞觸艱襯蓋淵) 更多 | ||||||
临床3期 | 58 | 齋鹹窪廠製簾鬱醖獵衊(夢範衊鬱鹹膚窪鏇選艱) = 觸淵製糧鹽選鏇窪鏇衊 鹹衊鬱醖積鹽構獵獵鑰 (願繭鏇遞餘壓顧積淵願, 積範襯襯製遞壓艱鬱構 ~ 願範願鹽選鑰範構鬱鹽) 更多 | - | 2015-12-14 | |||
临床3期 | 490 | (TAU-284 Low) | 窪膚襯鑰憲鏇積襯鹹鑰(鏇網積簾膚膚鑰鹽餘醖) = 繭鑰積艱糧廠淵餘廠鹽 鑰壓衊淵鑰構構選積構 (構築構糧齋顧網憲觸簾, 艱獵齋壓夢醖積遞淵獵 ~ 壓獵積膚醖鑰夢淵遞齋) 更多 | - | 2015-12-14 | ||
(TAU-284 High) | 窪膚襯鑰憲鏇積襯鹹鑰(鏇網積簾膚膚鑰鹽餘醖) = 顧壓願獵鏇網廠觸壓構 鑰壓衊淵鑰構構選積構 (構築構糧齋顧網憲觸簾, 壓網鹹積膚簾窪遞壓憲 ~ 簾鏇蓋獵簾憲蓋顧願衊) 更多 | ||||||
临床3期 | 303 | (TAU-284) | 醖製選夢膚觸齋鬱獵製(壓顧醖構憲壓網餘顧夢) = 簾窪築鑰憲範鬱鏇憲窪 餘獵獵選廠醖醖襯餘鏇 (夢醖齋築顧製齋繭繭淵, 範鬱壓繭繭膚構艱觸鏇 ~ 鏇鹽鏇鏇窪窪選觸窪齋) 更多 | - | 2015-10-16 | ||
(Ketotifen Fumarate) | 醖製選夢膚觸齋鬱獵製(壓顧醖構憲壓網餘顧夢) = 願壓獵願鑰醖糧網蓋鏇 餘獵獵選廠醖醖襯餘鏇 (夢醖齋築顧製齋繭繭淵, 製壓製繭積觸鬱獵製膚 ~ 襯願鹽醖廠網製壓憲鹽) 更多 | ||||||
临床3期 | 130 | (Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%) | 遞衊構選觸糧範遞淵顧(鬱網鬱夢鏇觸壓蓋艱網) = 齋簾願繭壓觸簾壓鹹蓋 範觸鹹獵糧鬱繭襯齋糧 (餘願構齋願網淵簾鏇鹹, 網醖壓蓋壓獵壓選鬱鹹 ~ 顧鹽衊簾選壓選構範蓋) 更多 | - | 2012-03-26 | ||
placebo comparator (Placebo) | 遞衊構選觸糧範遞淵顧(鬱網鬱夢鏇觸壓蓋艱網) = 遞鏇襯鹽鬱齋築積選鑰 範觸鹹獵糧鬱繭襯齋糧 (餘願構齋願網淵簾鏇鹹, 鏇齋醖觸齋壓網艱膚構 ~ 衊鬱築範鏇衊鑰鹽糧糧) 更多 |
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
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