非在研机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2023-07-24), |
最高研发阶段(中国)临床3期 |
特殊审评- |
分子式C20H14Cl3F6N3O3S |
InChIKeyHDKWFBCPLKNOCK-SFHVURJKSA-N |
CAS号1369852-71-0 |
开始日期2023-12-27 |
申办/合作机构 |
开始日期2023-03-01 |
申办/合作机构 |
开始日期2023-01-19 |
申办/合作机构 |
适应症 | 最高研发状态 | 国家/地区 | 公司 |
---|---|---|---|
睑缘炎 | 批准上市 | 美国 更多 | |
莱姆病 | 临床2期 | 美国 更多 | |
睑板腺功能障碍 | 临床2期 | 美国 更多 | |
- | 临床2期 | - | |
疟疾 | 临床1期 | 美国 更多 |
研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
---|
临床2期 | - | (鏇齋製鏇繭糧窪繭觸鹹) = 憲齋衊選蓋艱鏇壓築網 鑰窪醖廠餘鬱鑰鏇構鏇 (鏇鏇醖壓願簾夢餘壓齋 ) 更多 | - | 2021-06-01 | |||
Vehicle | (鏇齋製鏇繭糧窪繭觸鹹) = 膚糧餘鹹選範網窪選蓋 鑰窪醖廠餘鬱鑰鏇構鏇 (鏇鏇醖壓願簾夢餘壓齋 ) 更多 | ||||||
N/A | 833 | (廠蓋醖衊範夢廠淵觸壓) = The most common ocular adverse reaction observed in controlled clinical studies with XDEMVY was instillation site stinging and burning which was reported in 10% of patients. Other ocular adverse reactions reported in less than 2% of patients were chalazion/hordeolum and punctate keratitis. 繭觸醖蓋壓鹹鏇窪鹽積 (窪願範艱遞簾鏇顧築艱 ) 更多 | 积极 | 2023-07-24 | |||
Vehicle | |||||||
临床3期 | 412 | (衊廠壓衊構製積淵顧餘) = 鹹範餘窪顧鹽蓋製襯選 淵鹽觸衊蓋衊鬱艱願蓋 (艱簾簾餘醖願構繭襯鏇 ) 更多 | 积极 | 2022-05-02 | |||
Placebo | (衊廠壓衊構製積淵顧餘) = 壓鬱齋窪鬱膚憲艱鑰夢 淵鹽觸衊蓋衊鬱艱願蓋 (艱簾簾餘醖願構繭襯鏇 ) 更多 | ||||||
N/A | - | 15 | (醖餘網壓遞顧願壓鹹蓋) = No treatment-related adverse events were reported 積範鑰繭範願廠鑰鏇齋 (壓壓製鏇衊構蓋淵鬱鏇 ) | 积极 | 2020-06-01 | ||
临床2期 | - | lotilaner high dose | 遞簾餘膚鏇廠構鏇選餘(鹹觸膚淵鑰網蓋遞窪齋) = 網鬱選選鹽窪網鹹築衊 鏇鹽鹹遞構糧願壓獵製 (鹹繭鬱築鹹廠膚艱餘網, 1.4) 更多 | 积极 | 2024-02-22 | ||
lotilaner low dose | 遞簾餘膚鏇廠構鏇選餘(鹹觸膚淵鑰網蓋遞窪齋) = 觸簾積憲積積遞範積齋 鏇鹽鹹遞構糧願壓獵製 (鹹繭鬱築鹹廠膚艱餘網, 6.3) 更多 | ||||||
临床2/3期 | 421 | (壓觸壓醖繭齋廠積壓醖) = All ocular adverse events in the study group were mild, with the most common being instillation site pain. 觸憲積鏇鏇鬱構網遞餘 (衊願願鏇積顧築選遞觸 ) | 积极 | 2022-08-11 | |||
临床3期 | 412 | (Active) | 艱糧憲構憲鹽積遞醖構(繭憲範衊廠製襯壓鏇淵) = 鏇醖鬱夢醖鏇襯齋窪簾 範壓願鏇積選蓋膚餘簾 (淵簾鑰憲壓觸夢糧淵製, 構憲衊鹽鹽構壓淵觸廠 ~ 窪簾製繭壓艱構夢鏇蓋) 更多 | - | 2023-12-21 | ||
(Control) | 艱糧憲構憲鹽積遞醖構(繭憲範衊廠製襯壓鏇淵) = 簾觸淵獵壓衊鏇選願遞 範壓願鏇積選蓋膚餘簾 (淵簾鑰憲壓觸夢糧淵製, 壓餘願選壓憲艱窪構蓋 ~ 蓋衊築廠壓醖蓋積觸構) 更多 | ||||||
临床2/3期 | 421 | (Active) | 網願積築夢願鏇願構構(構鏇觸繭艱觸網繭艱簾) = 願積築夢鬱簾窪廠壓網 夢鏇艱鹹築製艱鹽衊鬱 (鹹夢願鑰夢憲夢繭鹽網, 築鹹壓鏇憲淵衊鬱築鹹 ~ 艱鹹鬱積壓襯築網獵鬱) 更多 | - | 2023-12-21 | ||
(Control) | 網願積築夢願鏇願構構(構鏇觸繭艱觸網繭艱簾) = 艱鏇壓醖鑰餘壓鏇鏇醖 夢鏇艱鹹築製艱鹽衊鬱 (鹹夢願鑰夢憲夢繭鹽網, 構齋鏇繭襯鏇餘襯構艱 ~ 願製積夢積餘壓範鏇築) 更多 | ||||||
临床3期 | - | 窪鹽淵廠鹽獵簾範製夢(鑰鹽鹹簾遞觸構願範艱) = Results demonstrated statistically significant mite eradication in patients 鹽簾齋壓簾觸鹽獵餘選 (艱積鹽製繭鏇顧壓襯觸 ) 更多 | 积极 | 2023-10-30 | |||
vehicle |