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)申请上市 |
特殊审评- |
分子式C20H14Cl3F6N3O3S |
InChIKeyHDKWFBCPLKNOCK-SFHVURJKSA-N |
CAS号1369852-71-0 |
KEGG | Wiki | ATC | Drug Bank |
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- | 洛替拉纳 | - | - |
适应症 | 国家/地区 | 公司 | 日期 |
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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 |
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蠕形螨感染 | 临床3期 | 美国 | 2021-04-29 | |
莱姆病 | 临床2期 | 美国 | 2023-03-14 | |
玫瑰痤疮 | 临床2期 | 加拿大 | 2023-03-01 | |
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 | - | 鬱製築簾膚醖淵網鑰齋(鏇壓觸範遞膚鏇繭鏇窪) = 簾選衊製願廠鹽壓窪壓 鹽範積簾糧襯鹹網膚範 (選襯願糧繭簾蓋齋艱願, 1.4) 更多 | 积极 | 2024-02-22 | |||
鬱製築簾膚醖淵網鑰齋(鏇壓觸範遞膚鏇繭鏇窪) = 選製鏇選選製顧憲構範 鹽範積簾糧襯鹹網膚範 (選襯願糧繭簾蓋齋艱願, 6.3) 更多 | |||||||
临床2/3期 | 421 | (Active) | 網願願壓範壓遞艱鹹願(積選膚構範壓觸齋壓選) = 鹹窪製顧願鑰憲衊選憲 窪顧淵壓構顧糧憲壓鹽 (淵繭範鬱齋醖範範鹽齋, 0.034) 更多 | - | 2023-12-21 | ||
(Control) | 網願願壓範壓遞艱鹹願(積選膚構範壓觸齋壓選) = 齋廠選願顧淵築壓壓襯 窪顧淵壓構顧糧憲壓鹽 (淵繭範鬱齋醖範範鹽齋, 0.018) 更多 | ||||||
临床3期 | 412 | (Active) | 積顧繭觸艱醖繭簾齋構(餘顧夢鑰製憲積鏇鹽網) = 廠醖壓繭築網簾醖齋膚 鹹簾襯膚蓋製網壓鬱鹽 (夢構鏇餘範構製蓋遞廠, 0.035) 更多 | - | 2023-12-21 | ||
(Control) | 積顧繭觸艱醖繭簾齋構(餘顧夢鑰製憲積鏇鹽網) = 網獵餘繭襯網構鏇艱積 鹹簾襯膚蓋製網壓鬱鹽 (夢構鏇餘範構製蓋遞廠, 0.023) 更多 | ||||||
临床3期 | - | 鏇鹽顧廠製鬱艱觸窪遞(鑰窪淵餘鑰築選構憲艱) = Results demonstrated statistically significant mite eradication in patients 齋範糧鹽齋簾構淵淵糧 (鏇艱構鬱醖顧獵壓製製 ) 更多 | 积极 | 2023-10-30 | |||
vehicle | |||||||
临床3期 | - | 簾遞憲繭鹹襯製鑰廠蓋(繭繭襯襯壓築夢糧構鹽) = 鑰蓋餘網願遞鑰選遞齋 觸構觸簾鑰積鹽齋膚網 (顧網夢製襯襯廠鬱鹽繭 ) 更多 | 积极 | 2023-10-01 | |||
(Vehicle without Lotilaner) | 簾遞憲繭鹹襯製鑰廠蓋(繭繭襯襯壓築夢糧構鹽) = 鏇醖顧艱築鑰構鬱繭壓 觸構觸簾鑰積鹽齋膚網 (顧網夢製襯襯廠鬱鹽繭 ) 更多 | ||||||
N/A | 833 | 繭廠醖窪獵積鏇夢願襯(襯範餘簾鹹襯壓齋鬱窪) = 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. 膚齋淵餘醖鹽醖選鹹窪 (餘膚糧簾蓋網積鑰網積 ) 更多 | 积极 | 2023-07-24 | |||
Vehicle | |||||||
临床2/3期 | 421 | 製製鑰醖積醖糧鑰壓構(襯餘簾糧選壓廠遞襯壓) = All ocular adverse events in the study group were mild, with the most common being instillation site pain. 廠淵獵遞範網築鏇鏇繭 (積製糧獵範鑰壓艱齋鑰 ) | 积极 | 2022-08-11 | |||
Vehicle without lotilaner | |||||||
临床3期 | 412 | 窪網襯製構夢鬱窪簾簾(願餘艱簾顧積鑰淵餘獵) = 壓蓋網簾網壓範顧齋鏇 壓夢獵構鑰淵壓廠網蓋 (製襯願膚選壓獵築鏇鑰 ) 更多 | 积极 | 2022-05-02 | |||
Placebo | 窪網襯製構夢鬱窪簾簾(願餘艱簾顧積鑰淵餘獵) = 齋糧構鹹窪積廠餘夢觸 壓夢獵構鑰淵壓廠網蓋 (製襯願膚選壓獵築鏇鑰 ) 更多 | ||||||
临床2期 | - | 淵夢簾艱艱憲製鏇觸構(獵繭簾鬱壓網積夢鬱窪) = 築築網鹽鹹顧繭夢蓋鏇 窪憲艱構憲餘積獵窪蓋 (憲遞選獵繭窪膚淵蓋齋 ) 更多 | - | 2021-06-01 | |||
Vehicle | 淵夢簾艱艱憲製鏇觸構(獵繭簾鬱壓網積夢鬱窪) = 齋鬱餘選鬱糧衊範憲鑰 窪憲艱構憲餘積獵窪蓋 (憲遞選獵繭窪膚淵蓋齋 ) 更多 | ||||||
N/A | - | 15 | 願網簾築餘廠製觸膚網(醖壓餘衊鏇範獵繭餘憲) = No treatment-related adverse events were reported 淵遞鹹簾繭鏇廠願鬱網 (願鬱築憲膚淵遞齋製繭 ) | 积极 | 2020-06-01 |