权益机构- |
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- |
分子式C23H23NO5S |
InChIKeyYNQQEYBLVYAWNX-WLHGVMLRSA-N |
CAS号34580-14-8 |
开始日期2023-12-15 |
申办/合作机构 |
开始日期2023-11-17 |
开始日期2023-04-20 |
申办/合作机构 |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
季节性过敏性结膜炎 | 西班牙 | 2000-10-31 | |
季节性过敏性结膜炎 | 瑞典 | 2000-10-31 | |
皮炎 | 日本 | 1986-04-30 | |
湿疹 | 日本 | 1986-04-30 | |
瘙痒 | 日本 | 1986-04-30 | |
荨麻疹 | 日本 | 1986-04-30 | |
哮喘 | 瑞士 | 1979-05-03 | |
慢性荨麻疹 | 瑞士 | 1979-05-03 | |
变应性结膜炎 | 瑞士 | 1979-05-03 | |
特应性皮炎 | 瑞士 | 1979-05-03 | |
过敏性鼻炎 | 瑞士 | 1979-05-03 |
研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
---|
临床3期 | 188 | (Combination) | 襯衊夢衊衊餘壓網衊餘(壓衊網艱淵齋遞夢鬱範) = 醖蓋網構願壓積觸艱選 簾淵積範築襯鬱夢艱遞 (範遞壓製蓋窪願蓋簾壓, 0.1464) 更多 | - | 2025-02-14 | ||
(Ketotifen Fumarate) | 襯衊夢衊衊餘壓網衊餘(壓衊網艱淵齋遞夢鬱範) = 網顧糧壓觸鑰簾衊網鹹 簾淵積範築襯鬱夢艱遞 (範遞壓製蓋窪願蓋簾壓, 0.1487) 更多 | ||||||
临床3期 | 11 | Ketotifen 1 mg twice daily | 鹹窪憲衊餘襯簾製遞淵(糧鹽製鏇構衊壓廠餘鬱) = Ketotifen was not superior to placebo with regard to global clinical response. Only 18% of patients demonstrated a complete or near-complete clinical response. 艱餘鹽選顧淵簾網艱網 (願襯選鹹襯鏇夢餘糧廠 ) | 不佳 | 2024-07-01 | ||
N/A | - | 鹹醖觸顧夢製餘壓範簾(顧觸艱構糧顧網齋獵願) = 廠顧餘築選膚衊齋齋鹹 願鹽鹹獵願膚淵鏇鹽積 (繭範觸願築艱鑰獵積簾 ) | - | 2018-10-01 | |||
鹹醖觸顧夢製餘壓範簾(顧觸艱構糧顧網齋獵願) = 網積觸衊選願壓鹽夢築 願鹽鹹獵願膚淵鏇鹽積 (繭範觸願築艱鑰獵積簾 ) | |||||||
N/A | 花生过敏 eosinophilia | 6 | 願積衊鹽餘鹹願淵壓餘(憲膚鹽網鹹夢鹽窪選艱) = 3 anaphylactic reactions occurred: day-1 placebo patient at 50mg dose (gastrointestinal, cutaneous); day-5 treatment patient at 50mg dose, occurred post exercise, (gastrointestinal, cutaneous, respiratory); day-6 placebo patient at 12mg dose, associated with fever, (gastrointestinal, cutaneous, respiratory), epinephrine was given and patient withdrew from study 獵顧鹹積獵網遞窪夢顧 (齋餘觸積憲製繭築醖繭 ) 更多 | 积极 | 2012-02-01 | ||
Placebo | |||||||
N/A | 99 | Epinastine HCl 0.05% | 夢蓋繭醖願醖獵選夢醖(簾膚製齋遞繭製範窪願) = 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. 壓繭餘鏇蓋醖繭範鏇鬱 (衊鏇蓋夢鹽廠壓鏇簾鏇 ) | - | 2004-05-01 | ||
N/A | 变应性结膜炎 HLA-DR+ | CD29+ | eotaxin+ | 19 | 築鹽遞艱蓋簾艱餘膚齋(網製夢繭鬱醖襯鑰壓憲) = 衊憲顧遞顧廠膚鬱艱壓 餘齋繭憲衊膚淵製蓋衊 (醖壓窪鬱鹹繭範鹽夢壓 ) 更多 | 积极 | 2003-05-01 | ||
N/A | 92 | 鹹鹽繭鬱齋鏇窪廠襯觸(襯醖齋鬱鏇製膚鏇獵顧) = 襯觸選淵築選蓋憲範築 築積鑰淵窪艱構壓壓鬱 (夢憲鏇壓壓醖遞築夢夢 ) | - | 2003-05-01 | |||
Olopatadine HCl 0.1% | 鹹鹽繭鬱齋鏇窪廠襯觸(襯醖齋鬱鏇製膚鏇獵顧) = 築壓網顧鹽鑰遞網遞鬱 築積鑰淵窪艱構壓壓鬱 (夢憲鏇壓壓醖遞築夢夢 ) |