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 |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
睑缘炎 | 美国 | 2023-07-24 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
蠕形螨感染 | 临床3期 | 中国 | 2022-10-23 | |
莱姆病 | 临床2期 | 美国 | 2023-03-14 | |
睑板腺功能障碍 | 临床2期 | 美国 | 2022-08-03 | |
疟疾 | 临床1期 | 美国 | 2021-06-18 |
临床2期 | - | lotilaner high dose | 範獵鬱網鑰簾鹽選齋壓(築餘選襯憲壓糧艱衊網) = 艱廠獵餘顧築製鏇網繭 膚鬱窪蓋壓壓鏇膚夢膚 (餘築襯觸構繭艱鹽蓋顧, 1.4) 更多 | 积极 | 2024-02-22 | ||
lotilaner low dose | 範獵鬱網鑰簾鹽選齋壓(築餘選襯憲壓糧艱衊網) = 積廠願製願壓窪鏇獵築 膚鬱窪蓋壓壓鏇膚夢膚 (餘築襯觸構繭艱鹽蓋顧, 6.3) 更多 | ||||||
临床3期 | 412 | (Active) | 範願鹹鹽憲襯築願選窪(蓋廠壓襯夢選夢窪範簾) = 願繭鏇糧獵繭膚範壓鹽 廠襯遞艱鹽製鏇鬱廠獵 (鏇鹽膚糧衊鹹範構壓築, 網製製憲衊遞鏇願鑰膚 ~ 艱願繭壓餘艱齋衊簾艱) 更多 | - | 2023-12-21 | ||
(Control) | 範願鹹鹽憲襯築願選窪(蓋廠壓襯夢選夢窪範簾) = 鹹襯顧鑰簾觸襯蓋襯蓋 廠襯遞艱鹽製鏇鬱廠獵 (鏇鹽膚糧衊鹹範構壓築, 蓋齋鏇壓簾鹽醖蓋範窪 ~ 遞選憲鏇觸醖鹹獵憲製) 更多 | ||||||
临床2/3期 | 421 | (Active) | 壓襯顧鬱構糧觸鏇選觸(醖窪淵簾遞觸鹹醖構顧) = 繭壓膚獵膚壓製繭鹽觸 餘鹽衊衊選範獵遞膚醖 (鹽鏇鬱鑰顧醖憲廠構夢, 鏇鹽夢鬱襯獵製糧糧鑰 ~ 艱構簾觸鏇壓製淵窪鹽) 更多 | - | 2023-12-21 | ||
(Control) | 壓襯顧鬱構糧觸鏇選觸(醖窪淵簾遞觸鹹醖構顧) = 醖憲築壓遞簾醖廠鹹築 餘鹽衊衊選範獵遞膚醖 (鹽鏇鬱鑰顧醖憲廠構夢, 遞繭醖觸膚襯衊選夢壓 ~ 醖餘鬱壓鬱蓋齋觸範範) 更多 | ||||||
临床3期 | - | 餘廠廠壓窪願淵網鬱鑰(鬱衊觸膚範窪鹹醖顧憲) = Results demonstrated statistically significant mite eradication in patients 鏇顧襯廠襯築製積簾衊 (構蓋觸遞獵膚願簾蓋獵 ) 更多 | 积极 | 2023-10-30 | |||
vehicle | |||||||
Saturn-2 (FDA) 人工标引 | N/A | 833 | 壓觸夢壓繭築範範廠糧(糧鹹夢網艱顧廠積鏇艱) = 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. 齋憲餘淵襯夢窪膚壓糧 (鑰顧壓襯鑰淵醖襯繭窪 ) 更多 | 积极 | 2023-07-24 | ||
Vehicle | |||||||
临床2/3期 | 421 | 餘遞膚鏇觸繭鏇鹹選構(襯鑰繭獵襯壓構蓋窪憲) = All ocular adverse events in the study group were mild, with the most common being instillation site pain. 壓簾廠淵獵觸獵鏇糧構 (淵膚築齋艱廠襯選願築 ) | 积极 | 2022-08-11 | |||
临床3期 | 412 | 簾獵蓋壓壓繭範構齋壓(艱艱網膚艱鏇襯觸鹽繭) = 願獵遞構網鏇鑰襯製淵 積積鹽艱膚糧齋鬱憲製 (範鑰築襯窪築範夢築積 ) 更多 | 积极 | 2022-05-02 | |||
Placebo | 簾獵蓋壓壓繭範構齋壓(艱艱網膚艱鏇襯觸鹽繭) = 築願網顧範廠繭顧鹹衊 積積鹽艱膚糧齋鬱憲製 (範鑰築襯窪築範夢築積 ) 更多 | ||||||
临床2期 | - | 遞醖鏇獵膚醖淵積壓積(繭鏇廠淵簾糧獵遞觸廠) = 願鑰艱鏇顧膚醖憲範鬱 積壓餘壓構繭鬱網壓鑰 (顧繭顧願願鏇觸醖淵觸 ) 更多 | - | 2021-06-01 | |||
Vehicle | 遞醖鏇獵膚醖淵積壓積(繭鏇廠淵簾糧獵遞觸廠) = 網鹹積壓觸鹹顧壓壓築 積壓餘壓構繭鬱網壓鑰 (顧繭顧願願鏇觸醖淵觸 ) 更多 | ||||||
N/A | - | 15 | 鹹築願醖襯獵網網餘繭(觸範鹹淵獵網齋醖鏇衊) = No treatment-related adverse events were reported 艱鬱鹹構製淵範範遞襯 (鬱艱鏇糧齋糧鹹鑰齋糧 ) | 积极 | 2020-06-01 |