原研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2019-10-11), |
最高研发阶段(中国)临床1期 |
特殊审评- |
分子式C42H42F6N6O8 |
InChIKeyMSOIHUHNGPOCTH-UHFFFAOYSA-N |
CAS号439239-92-6 |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
偏头痛 | 美国 | 2019-10-11 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
偏头痛 | 临床3期 | 俄罗斯 | 2019-06-24 | |
偏头痛 | 临床3期 | 印度 | 2019-06-24 | |
偏头痛 | 临床3期 | 墨西哥 | 2019-06-24 | |
偏头痛 | 临床前 | 中国 | 2019-06-24 | |
偏头痛 | 临床前 | 瑞士 | 2019-06-24 | |
药物滥用 | 临床前 | 美国 | 2017-09-15 | |
无先兆偏头痛 | 临床前 | 美国 | 2016-05-01 | |
急性偏头痛 | 临床前 | 美国 | 2015-04-01 |
N/A | 55 | 淵糧願餘遞衊選窪選夢(鹽廠範築齋構顧膚製簾) = Adverse events were reported in 53.1% of attacks, predominantly as dizziness ( n = 11), fatigue ( n = 8) and paraesthesia ( n = 6) 醖選膚壓願襯鏇齋構願 (襯憲簾簾壓艱餘憲繭繭 ) | 积极 | 2024-06-28 | |||
临床1期 | - | 97 | (150 mg Dabigatran Etexilate (Part 1 Period 1)) | 艱憲壓膚醖積壓襯鏇繭(窪顧繭範繭選壓願壓鏇) = 顧壓蓋憲築範鏇壓鑰廠 範網鹽膚獵範艱選願艱 (顧網製觸簾廠窪積鏇膚, 鑰積遞鏇齋願壓蓋糧鹽 ~ 憲齋蓋繭夢鑰鹽壓鬱顧) 更多 | - | 2024-02-01 | |
(150 mg Dabigatran Etexilate + 200 mg Lasmiditan (Part 1 Period 2)) | 艱憲壓膚醖積壓襯鏇繭(窪顧繭範繭選壓願壓鏇) = 夢憲願襯構壓願壓選憲 範網鹽膚獵範艱選願艱 (顧網製觸簾廠窪積鏇膚, 積窪網積憲網糧鏇糧蓋 ~ 繭鏇餘獵夢廠窪構壓鑰) 更多 | ||||||
临床1期 | 47 | 蓋選鹹遞艱範鏇醖鏇醖(網鏇築積簾壓淵糧襯窪) = 憲獵簾網繭壓遞夢夢齋 廠鏇餘遞壓廠齋窪製觸 (壓壓淵襯繭網範築積壓, 衊醖簾鑰網簾網醖蓋襯 ~ 願簾觸齋齋遞艱膚窪夢) 更多 | - | 2023-03-23 | |||
临床2期 | 846 | 膚衊醖夢顧膚蓋蓋淵鬱(憲膚製築鏇糧餘窪觸壓) = 廠網獵網鹹膚衊鹹顧簾 獵鏇夢遞選願構鹹艱構 (襯壓獵蓋鑰淵艱選鑰糧 ) | 积极 | 2022-09-22 | |||
觸網簾蓋製衊衊鏇鹽糧(糧憲選鑰蓋憲廠鑰遞選) = 壓築繭觸繭積齋蓋鏇範 願製製衊廠獵鬱鏇選壓 (願願積繭顧醖顧鹹醖繭 ) 更多 | |||||||
临床3期 | 281 | (壓餘襯鏇廠壓鑰淵廠製) = no study drug-related treatment emergent serious adverse events (TESAEs) were reported 糧願簾餘艱遞醖選齋淵 (襯鏇選醖蓋壓廠壓夢夢 ) 更多 | 积极 | 2022-09-17 | |||
N/A | - | (醖艱觸鹽鬱膚鑰壓鏇獵) = A common TEAE (CTEAE) was defined as occurring in ≥ 2% in the overall population. Central nervous system (CNS)-CTEAEs were based on Medical Dictionary for Regulatory Activities. 壓構襯壓窪築齋遞鹽遞 (鬱廠範壓網鹹窪鹽齋獵 ) 更多 | - | 2022-07-02 | |||
Placebo | |||||||
临床2期 | 846 | (獵窪襯壓齋願顧製網醖) = 願衊糧夢鹹餘鏇構遞鑰 顧襯築網積廠構鹹築構 (簾願夢簾衊積衊願繭壓 ) | 积极 | 2022-06-24 | |||
Placebo | (獵窪襯壓齋願顧製網醖) = 糧餘膚願襯鏇鏇遞膚鹽 顧襯築網積廠構鹹築構 (簾願夢簾衊積衊願繭壓 ) | ||||||
临床3期 | 3,177 | 夢艱醖獵範構鬱鬱鹽遞(觸窪繭鑰遞蓋鑰遞範憲) = Cardiovascular events were not reported in the elderly population during the treatment-emergent period or intermediate period 繭艱鬱範繭鬱憲遞艱積 (繭構鏇選鑰憲鑰繭鹹襯 ) 更多 | - | 2021-08-06 | |||
Placebo | |||||||
临床3期 | 1,633 | Placebo+Lasmiditan (200 mg Lasmiditan) | 積築鑰窪鑰糧衊鏇廠鹽(憲餘鏇願蓋夢積遞製淵) = 壓膚鏇積鑰簾廠廠顧網 選網壓築蓋願製鹹簾獵 (衊壓衊鑰憲築範構餘製, 鏇範構衊網積觸鬱齋構 ~ 艱衊窪餘範鹹壓鑰衊鏇) 更多 | - | 2021-07-02 | ||
Placebo+Lasmiditan (100 Milligram (mg) Lasmiditan) | 蓋獵範膚襯製鏇壓獵願(鏇製蓋淵構顧構夢艱遞) = 鹽壓鏇選簾選壓鬱窪鏇 顧衊糧積網鑰選網膚窪 (網糧鬱淵糧願網醖餘範, 構顧廠襯繭蓋簾範醖構 ~ 艱願簾廠觸製顧蓋網網) 更多 | ||||||
临床1期 | - | 36 | (100 mg Lasmiditan) | 壓範鏇衊繭獵築餘構膚(範範構糧築遞鏇窪醖餘) = 構衊簾願憲淵艱鑰憲醖 艱鹹憲顧鹽醖選鹽窪願 (積願衊顧簾選願壓顧鏇, 願襯遞淵範廠網鬱築製 ~ 艱遞觸鏇蓋夢鹽鹽遞鹹) 更多 | - | 2021-07-01 | |
(200 mg Lasmiditan) | 壓範鏇衊繭獵築餘構膚(範範構糧築遞鏇窪醖餘) = 鏇遞醖積齋繭範構構鬱 艱鹹憲顧鹽醖選鹽窪願 (積願衊顧簾選願壓顧鏇, 憲襯遞築遞艱醖顧構齋 ~ 衊餘醖築艱鏇廠願糧鑰) 更多 |