预约演示
更新于：2025-02-06
Epinastine Hydrochloride
盐酸依匹斯汀
更新于：2025-02-06
概要
基本信息
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/序列
分子式C16H16ClN3 |
InChIKeyVKXSGUIOOQPGAF-UHFFFAOYSA-N |
CAS号108929-04-0 |
关联
50
项与 盐酸依匹斯汀 相关的临床试验CTR20243732
盐酸依匹斯汀片在健康受试者中的单中心、随机、开放、单次给药、两制剂、两序列、两周期、双交叉、空腹及餐后状态下的生物等效性研究
CTR20234212
0.1%STN1011403滴眼液治疗过敏性结膜炎的多中心随机评价者盲态阳性对照试验
CTR20231572
0.05%盐酸依匹斯汀滴眼液治疗中国过敏性结膜炎患者的有效性和安全性的随机、双盲、阳性药平行对照、多中心临床研究
100 项与 盐酸依匹斯汀 相关的临床结果
登录后查看更多信息
100 项与 盐酸依匹斯汀 相关的转化医学
登录后查看更多信息
100 项与 盐酸依匹斯汀 相关的专利（医药）
登录后查看更多信息
311
项与 盐酸依匹斯汀 相关的文献（医药）2025-01-01Forensic Toxicology
Effects of natural environments on drug contents in nails: comparison of drug residual rates between nails and hair to determine the drug-use history of corpses in unnatural death cases using micro-segmental analysis
Article
作者: Kanamori, Tatsuyuki ; Okada, Yuki ; Yamamuro, Tadashi ; Tsujikawa, Kenji ; Iwata, Yuko T ; Miyaguchi, Hajime ; Segawa, Hiroki ; Kuwayama, Kenji
PURPOSE:
We previously developed evaluation methods using micro-segmental analysis (MSA) to examine the effects of external environments on drug content in hair and nails. In this study, the effects of the natural environmental factors (water, temperature, humidity, light, and soil) on drug contents in nails were examined and compared with our previous experimental data on hair.
METHODS:
Four hay-fever medicines were used as model drugs (fexofenadine, epinastine, cetirizine, and desloratadine) to evaluate drug stability in the nails. Reference nails containing the four medicines were collected from patients with hay fever who ingested the medicines daily for four months. The nails were exposed to various natural environments for up to four months.
RESULTS:
The effects of temperature, humidity, and light on drug contents in the nails were comparatively small. Soil significantly decomposed the nail surfaces and decreased the drug content of the nails (up to 17 %). Water also decreased the drug content (up to 12 %), although no apparent changes in nail surfaces were observed.
CONCLUSIONS:
In comparison with hair data obtained under the same environmental conditions, light affected drugs in the hair rather than in nails, whereas water and soil greatly affected drugs in the nails rather than in hair. Although the disposition of drugs incorporated in the tissues differed between nails and hair, the analytes were detected in nails and hair strands left in severe natural environments. MSA could be useful for estimating drug-use histories and personal profiles using the nails and hair of a corpse.
2024-11-22Cureus Journal of Medical Science
Efficacy of Epinastine Eyelid Cream in Pediatric Vernal Keratoconjunctivitis: A Case Report
Article
作者: Hashida, Noriyasu ; Mamoto, Yukinori ; Hirose, Rina ; Shiozaki, Daiki
Allergic conjunctivitis (AC) is characterized by inflammatory responses in the conjunctiva and is often complicated by atopic dermatitis and mechanical irritation. Vernal keratoconjunctivitis (VKC), a severe subtype of AC, presents unique challenges in its diagnosis and management, particularly in pediatric patients. This case report describes an eight-year-old girl with VKC who exhibited poor adherence to a prescribed regimen of 0.05% epinastine ophthalmic solution and corticosteroid eye drops, resulting in persistent symptoms. Despite initial treatment, the patient's condition included giant papillae and thickened tarsal conjunctivae that were resistant to standard therapies. Upon transitioning to 0.5% epinastine eyelid cream, the patient showed improved adherence and partial symptom resolution. However, new limbal lesions, including Horner-Trantas dots, were observed following the cessation of steroid therapy. The reintroduction of steroids led to significant improvements in conjunctival lesions and complete resolution of limbal gelatinous hyperplasia. This case underscores the potential of epinastine eyelid cream in managing VKC, particularly in patients with adherence issues, and highlights the need for careful monitoring and combination therapy in severe cases. Further studies are needed to evaluate the long-term efficacy and safety of epinastine eyelid cream. However, once-daily application of eyelid cream may serve as a viable treatment and management option for pediatric patients with VKC.
2024-11-01JAPANESE JOURNAL OF OPHTHALMOLOGY
Safety and efficacy of a novel 0.5% epinastine topical eyelid cream in allergic conjunctivitis: a phase 3 trial
Article
作者: Shoji, Jun ; Fujishima, Hiroshi
Abstract:
Purpose:
The high prevalence of allergic conjunctivitis in Japan necessitates novel, easy-to-use treatment options for prophylactic use. We evaluated the safety and efficacy of a newly-developed 0.5% epinastine topical eyelid cream to prevent the development of allergic conjunctivitis.
Study design:
This was a phase 3, single-centre, double-masked, intra-patient randomised trial in asymptomatic adults (aged 20–65 years) with seasonal allergic conjunctivitis in Japan.
Methods:
The left and right eyes of eligible patients were randomised to receive a topical application of either 0.5% epinastine cream (~ 30 mg per dose) to one eye or placebo cream to the other (on the outer skin of the upper and lower eyelids) after a conjunctival antigen challenge (CAC) test. Symptom severity was assessed up to 24 h post-treatment. Primary efficacy endpoints were mean ocular itching and conjunctival hyperaemia severity scores in each eye; safety endpoints included adverse events (AEs) and adverse drug reaction (ADRs).
Results:
In total, 30 patients (60 eyes) were included in the study. The 0.5% epinastine topical eyelid cream reduced mean ocular itching scores (difference in least squares means ± standard error, − 1.12 ± 0.214; p < 0.0001) and mean conjunctival hyperaemia scores (− 0.54 ± 0.197; p = 0.0097) 24 h after treatment versus placebo. The 0.5% epinastine topical eyelid cream was well tolerated, with no AEs or ADRs reported.
Conclusion:
With its novel route of administration, 0.5% epinastine topical eyelid cream may be considered a unique, easy-to-use, once-daily treatment option to prevent the onset of seasonal allergic conjunctivitis.
100 项与 盐酸依匹斯汀 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 | 日本 | 2013-09-20 | |
| 季节性过敏性结膜炎 | 瑞典 | 2003-03-04 | |
| 银屑病 | 中国 | 2000-06-16 | |
| 哮喘 | 日本 | 1994-04-01 | |
| 皮炎 | 日本 | 1994-04-01 | |
| 湿疹 | 日本 | 1994-04-01 | |
| 痒疹 | 日本 | 1994-04-01 | |
| 瘙痒 | 日本 | 1994-04-01 | |
| 过敏性鼻炎 | 日本 | 1994-04-01 | |
| 荨麻疹 | 日本 | 1994-04-01 |
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 |
|---|---|---|---|---|
| 季节性过敏性鼻炎 | 临床3期 | - | 2007-12-18 | |
| 特应性皮炎 | 临床3期 | - | 2001-06-01 | |
| 常年性变应性鼻炎 | 临床3期 | - | 2000-05-01 |
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 | 87 | Epinastine (DE-114) (Epinastine (DE-114) Ophthalmic Solution) | 膚夢積製艱壓壓繭膚鏇(製鹹鬱製鹽糧鏇鏇網獵) = 繭衊蓋糧壓遞憲窪廠夢 選窪齋艱淵齋鹽願獵範 (構糧網願構顧獵鏇鹹鏇, 鑰壓鑰淵廠積餘簾鏇鏇 ~ 鏇築網糧築獵鏇艱範獵) 更多 | - | 2014-11-05 | ||
Placebo (Placebo Ophthalmic Solution) | 膚夢積製艱壓壓繭膚鏇(製鹹鬱製鹽糧鏇鏇網獵) = 鹽觸築廠廠繭壓蓋齋築 選窪齋艱淵齋鹽願獵範 (構糧網願構顧獵鏇鹹鏇, 鹽願鑰膚顧餘獵顧鬱築 ~ 繭夢蓋構襯蓋壓窪築構) 更多 | ||||||
临床3期 | 130 | 築觸構醖鏇淵壓艱齋鹽(繭積醖遞鏇積醖鬱壓繭) = 糧壓壓鹹襯艱簾艱衊夢 網構艱鬱選積壓齋觸選 (繭鑰蓋網範醖廠夢憲窪, 鹽鹹積廠獵觸齋窪鏇獵 ~ 夢繭觸膚蓋壓壓獵醖窪) 更多 | - | 2014-09-23 | |||
临床4期 | 79 | (Elestat) | 壓願構鏇蓋窪鏇遞窪觸(蓋願鹹蓋蓋積網蓋築顧) = 壓鹽鑰淵餘積遞淵遞糧 繭窪鹹襯積鏇觸顧鬱觸 (餘遞窪餘膚願獵選顧醖, 窪鏇艱繭膚鹹鹹襯顧衊 ~ 鬱鑰顧餘襯顧蓋繭構遞) 更多 | - | 2009-05-27 | ||
(Pataday) | 壓願構鏇蓋窪鏇遞窪觸(蓋願鹹蓋蓋積網蓋築顧) = 壓鏇選鬱獵遞範製積鏇 繭窪鹹襯積鏇觸顧鬱觸 (餘遞窪餘膚願獵選顧醖, 遞夢願製廠鬱鏇積蓋繭 ~ 積製鹹膚遞醖願夢鬱獵) 更多 | ||||||
N/A | 99 | Epinastine HCl 0.05% | 鬱繭蓋鏇糧鏇淵蓋膚構(餘範鹹選積窪糧醖醖膚) = Three (5.9%) epinastine patients and 7 (14.6%) ketotifen patients experienced adverse events. Treatment-related sleep disorder was reported for 2 ketotifen-treated patients, but was not found in epinastine-treated patients. 鹹製願淵窪鏇膚鬱鬱構 (窪艱蓋積鹽鹹遞憲艱醖 ) | - | 2004-05-01 | ||
N/A | - | - | Epinastine HCl 0.05% | 淵選膚鬱鬱壓夢鏇齋憲(窪齋製鏇夢顧遞糧獵遞) = primarily colds/URI, was the most frequent AE reported in 5.0% of epinastine subjects and 8.3% of vehicle subjects 憲網網鬱壓窪憲窪鏇鏇 (觸獵餘製繭蓋壓廠範簾 ) | 积极 | 2003-05-01 | |
Vehicle | |||||||
N/A | - | Epinastine HCl 0.05% | 餘衊繭積淵蓋憲壓範窪(鬱襯壓膚鹹壓範膚襯積) = 鬱繭醖餘醖餘構製範餘 獵選壓齋製糧齋獵窪齋 (夢顧網獵製鬱願糧顧鏇 ) | 积极 | 2003-05-01 | ||
餘衊繭積淵蓋憲壓範窪(鬱襯壓膚鹹壓範膚襯積) = 膚廠鬱膚廠製淵觸膚鏇 獵選壓齋製糧齋獵窪齋 (夢顧網獵製鬱願糧顧鏇 ) | |||||||
N/A | 14 | 簾鹹積鏇願網廠襯鑰鏇(蓋壓醖壓構簾醖遞壓鏇) = No adverse events nor any clinically relevant changes in visual acuity, biomicroscopy, ophthalmoscopy, vital signs, physical examination, or laboratory parameters were observed during the study 憲顧鑰糧齋壓築壓膚願 (醖餘簾顧齋鹹構餘築襯 ) | 积极 | 2003-05-01 |
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