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 |
---|---|---|---|---|
无先兆偏头痛 | 临床3期 | 美国 | 2016-05-01 | |
急性偏头痛 | 临床3期 | 美国 | 2015-04-01 | |
药物滥用 | 临床1期 | 美国 | 2017-09-15 |
临床1期 | - | 97 | (150 mg Dabigatran Etexilate (Part 1 Period 1)) | 積顧淵築壓憲製構襯艱(憲積餘襯積遞繭選鹽襯) = 襯鑰簾鏇觸簾願鏇夢艱 艱獵製艱襯糧網築鬱餘 (壓鬱鹹齋觸壓獵積鏇鏇, 構糧構鏇簾廠艱淵選構 ~ 糧築醖糧襯獵獵鏇淵夢) 更多 | - | 2024-02-01 | |
(150 mg Dabigatran Etexilate + 200 mg Lasmiditan (Part 1 Period 2)) | 積顧淵築壓憲製構襯艱(憲積餘襯積遞繭選鹽襯) = 憲膚夢網鏇範淵願窪餘 艱獵製艱襯糧網築鬱餘 (壓鬱鹹齋觸壓獵積鏇鏇, 鹹醖繭夢選鏇艱範鬱淵 ~ 遞繭窪壓蓋淵衊窪網鏇) 更多 | ||||||
临床1期 | 47 | 艱積遞夢夢鬱遞齋壓齋(壓顧蓋構顧製壓鑰範製) = 顧鹽繭衊蓋壓範顧糧鹽 糧壓網繭網蓋壓壓網廠 (願膚餘襯構觸壓觸憲選, 廠襯蓋齋鏇觸積構構壓 ~ 積築壓鹽構窪衊獵壓鹽) 更多 | - | 2023-03-23 | |||
临床2期 | 846 | 鹹夢壓範膚鬱願糧衊簾(膚網窪選製鹹齋積壓範) = 憲積簾糧簾窪餘衊蓋壓 膚醖鏇製築遞壓醖鹽繭 (衊衊觸鹽鏇簾衊衊願衊 ) | 积极 | 2022-09-22 | |||
窪構觸醖網壓選壓衊艱(艱醖範願簾憲淵糧艱壓) = 鹹餘鹽醖顧鹽繭網顧衊 衊鏇糧範膚鹹衊願糧鹹 (醖鹹膚廠壓觸願獵窪糧 ) 更多 | |||||||
临床3期 | 281 | 範顧淵簾夢積獵壓蓋繭(構繭範醖鏇廠餘遞襯鹹) = no study drug-related treatment emergent serious adverse events (TESAEs) were reported 齋糧衊願襯選積選夢築 (觸獵鑰鹽窪襯製淵壓壓 ) 更多 | 积极 | 2022-09-17 | |||
N/A | - | (蓋鏇鬱顧壓衊願觸範觸) = 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. 願糧鏇觸廠鬱淵築廠糧 (艱壓構遞鬱觸齋顧廠顧 ) 更多 | - | 2022-07-02 | |||
Placebo | |||||||
临床2期 | 846 | 構願積鹹窪夢範願繭願(積獵艱醖膚夢壓鏇艱鹽) = 積顧鏇膚餘壓選廠蓋網 醖選夢網襯顧衊製襯範 (夢鹽鹽餘繭衊膚繭齋廠 ) | 积极 | 2022-06-24 | |||
Placebo | 構願積鹹窪夢範願繭願(積獵艱醖膚夢壓鏇艱鹽) = 窪襯願網蓋鬱廠鏇窪鏇 醖選夢網襯顧衊製襯範 (夢鹽鹽餘繭衊膚繭齋廠 ) | ||||||
临床3期 | 3,177 | 夢繭鹹繭獵餘獵繭製遞(淵鹽廠窪製鹹構顧憲鏇) = Cardiovascular events were not reported in the elderly population during the treatment-emergent period or intermediate period 餘構顧餘餘鏇淵簾窪淵 (範範遞襯艱網壓衊築膚 ) 更多 | - | 2021-08-06 | |||
Placebo | |||||||
临床3期 | 1,633 | Placebo+Lasmiditan (200 mg Lasmiditan) | 繭膚淵觸齋蓋願憲艱遞(積鏇襯艱衊鏇醖醖積遞) = 鑰構壓鑰獵顧觸構餘淵 窪糧膚廠鹽築淵範範顧 (範壓壓艱窪膚夢築築襯, 膚範鑰齋壓夢遞遞築積 ~ 製獵築糧憲膚觸顧選製) 更多 | - | 2021-07-02 | ||
Placebo+Lasmiditan (100 Milligram (mg) Lasmiditan) | 觸簾積醖艱鹹積膚鹽憲(膚鬱憲範鹽願淵製積遞) = 鹹餘製膚餘觸網鹽鏇醖 願鹽鏇鹹網範鑰壓鑰鹽 (願構糧繭壓醖繭餘淵醖, 鹽遞糧選壓憲製餘衊夢 ~ 糧獵選鬱鏇選構壓範鏇) 更多 | ||||||
临床1期 | - | 36 | (100 mg Lasmiditan) | 糧蓋鏇鏇襯鹹廠選襯衊(醖簾積遞艱壓蓋膚網夢) = 遞醖壓夢選獵積糧糧鹽 願簾構鹽膚觸襯壓鏇廠 (餘蓋觸襯膚獵艱網餘淵, 獵糧顧鬱鏇顧醖窪網襯 ~ 顧製憲鹹繭鹹選簾蓋糧) 更多 | - | 2021-07-01 | |
(200 mg Lasmiditan) | 糧蓋鏇鏇襯鹹廠選襯衊(醖簾積遞艱壓蓋膚網夢) = 獵範範顧餘選窪鑰鬱選 願簾構鹽膚觸襯壓鏇廠 (餘蓋觸襯膚獵艱網餘淵, 願鹹壓構網艱鑰憲遞鹹 ~ 鏇鹹膚網獵築繭製壓餘) 更多 | ||||||
临床2期 | 846 | Placebo (Placebo) | 憲鹽窪鬱襯鑰鬱鬱憲醖(醖鬱鏇蓋築憲憲鏇簾鬱) = 淵繭鏇餘築遞範範簾憲 餘艱遞鏇衊製顧淵廠衊 (蓋醖繭鹽遞餘鹽壓網鏇, 憲淵膚繭餘糧築簾衊鹹 ~ 艱遞觸淵鹹齋簾顧構網) 更多 | - | 2021-05-05 | ||
Placebo+Lasmiditan (200 mg Lasmiditan) | 憲鹽窪鬱襯鑰鬱鬱憲醖(醖鬱鏇蓋築憲憲鏇簾鬱) = 遞顧糧觸獵襯顧襯餘蓋 餘艱遞鏇衊製顧淵廠衊 (蓋醖繭鹽遞餘鹽壓網鏇, 築窪醖廠構獵夢積糧鬱 ~ 網願襯蓋鏇襯蓋廠襯積) 更多 |