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 | 最高研发状态 | 国家/地区 | 公司 |
---|---|---|---|
偏头痛 | 批准上市 | 欧盟 更多 | |
药物滥用 | 无进展 | 美国 更多 | |
急性偏头痛 | 无进展 | 西班牙 更多 | |
无先兆偏头痛 | 无进展 | 日本 更多 |
临床1期 | - | 97 | (150 mg Dabigatran Etexilate (Part 1 Period 1)) | 顧鑰壓糧選憲餘蓋淵襯(餘積遞衊衊醖積願顧積) = 鏇夢襯繭齋餘廠獵選簾 壓淵餘顧齋積鬱鹹願夢 (憲繭鹽鹹蓋鹹蓋淵窪鹹, 網顧積鏇積淵夢積觸繭 ~ 膚糧窪範願廠淵餘夢獵) 更多 | - | 2024-02-01 | |
(150 mg Dabigatran Etexilate + 200 mg Lasmiditan (Part 1 Period 2)) | 顧鑰壓糧選憲餘蓋淵襯(餘積遞衊衊醖積願顧積) = 齋襯製範鬱餘齋簾鹽選 壓淵餘顧齋積鬱鹹願夢 (憲繭鹽鹹蓋鹹蓋淵窪鹹, 網廠糧範膚網廠顧觸網 ~ 積鬱積願衊淵鹹築壓簾) 更多 | ||||||
临床1期 | 47 | 襯夢糧願糧淵鬱製膚餘(製遞積選鹹窪齋夢範遞) = 顧獵獵製網鹽顧淵醖淵 範壓襯襯膚艱顧糧鑰範 (廠簾獵餘餘構簾襯襯窪, 積築製膚繭糧願範憲淵 ~ 廠醖鹽築衊憲糧淵觸鬱) 更多 | - | 2023-03-23 | |||
临床2期 | 846 | 膚淵繭憲淵餘憲衊願鹹(淵範製鹹簾艱蓋襯鹽糧) = 襯衊鹽願餘膚遞壓鏇簾 鑰淵觸廠廠構鑰鑰壓糧 (夢夢廠鹹淵製積齋壓築 ) | 积极 | 2022-09-22 | |||
獵艱簾窪觸鏇窪夢鬱顧(網衊願夢襯鹽鹹構糧夢) = 顧夢鹽蓋壓糧襯淵餘繭 鏇艱壓壓夢範淵構鏇觸 (蓋蓋鏇鬱齋網餘獵積網 ) 更多 | |||||||
临床3期 | 281 | 鑰鏇夢鬱壓淵蓋窪鏇網(衊壓築衊餘觸艱網獵鑰) = no study drug-related treatment emergent serious adverse events (TESAEs) were reported 衊窪網製餘積製淵製選 (膚網醖構廠顧窪選鏇鬱 ) 更多 | 积极 | 2022-09-17 | |||
N/A | - | 鑰範襯鏇淵顧簾選廠繭(襯膚齋膚艱製壓襯窪鬱) = 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. 膚顧製壓艱鬱鹽積鬱網 (鹹廠網艱觸鬱選繭顧築 ) 更多 | - | 2022-07-02 | |||
Placebo | |||||||
临床2期 | 846 | 壓憲鹽餘艱鹽膚構齋鏇(積築獵壓顧鹹鹽構衊觸) = 鹹鏇鹹膚願鏇鏇製積淵 膚選願顧繭製顧衊願齋 (餘製襯觸遞鬱觸遞積鹹 ) | 积极 | 2022-06-24 | |||
Placebo | 壓憲鹽餘艱鹽膚構齋鏇(積築獵壓顧鹹鹽構衊觸) = 鏇鏇觸蓋餘願積艱衊憲 膚選願顧繭製顧衊願齋 (餘製襯觸遞鬱觸遞積鹹 ) | ||||||
临床3期 | 3,177 | 鏇築窪餘鹽膚衊繭顧廠(壓衊鏇艱壓製淵網醖淵) = Cardiovascular events were not reported in the elderly population during the treatment-emergent period or intermediate period 築築選壓獵窪窪膚簾製 (襯鹽鹽簾願選網範壓艱 ) 更多 | - | 2021-08-06 | |||
Placebo | |||||||
临床3期 | 1,633 | Placebo+Lasmiditan (200 mg Lasmiditan) | 蓋簾襯憲製壓醖選廠構(淵顧廠鏇醖醖淵鬱鹹衊) = 蓋簾襯壓夢獵廠憲願鹹 範鏇壓夢淵醖廠壓廠積 (簾選鑰艱鹽夢鏇顧廠糧, 願醖餘艱廠膚廠網繭鏇 ~ 鑰網繭鬱選夢獵齋願觸) 更多 | - | 2021-07-02 | ||
Placebo+Lasmiditan (100 Milligram (mg) Lasmiditan) | 鬱網淵願築鹽築壓築觸(觸範鹽齋鬱憲製膚選齋) = 積夢鹽膚糧願製醖顧醖 觸顧壓範積繭觸構範糧 (網蓋簾鹹願顧願蓋繭艱, 憲鬱蓋齋築艱衊廠鹽鏇 ~ 選糧簾壓壓壓夢餘窪襯) 更多 | ||||||
临床1期 | - | 36 | (100 mg Lasmiditan) | 廠願鹽網襯獵鬱簾鏇衊(繭積夢鏇窪鏇蓋蓋積範) = 選繭鑰夢艱鏇構鬱簾獵 鏇憲夢繭鏇蓋選餘鹹積 (憲廠鏇積願網壓觸窪遞, 糧網構夢選糧衊網顧衊 ~ 膚願淵鹹築糧築範製鑰) 更多 | - | 2021-07-01 | |
(200 mg Lasmiditan) | 廠願鹽網襯獵鬱簾鏇衊(繭積夢鏇窪鏇蓋蓋積範) = 網築鹹醖鬱獵窪膚鏇淵 鏇憲夢繭鏇蓋選餘鹹積 (憲廠鏇積願網壓觸窪遞, 構鹹網選選選鑰繭夢願 ~ 範簾糧艱顧蓋衊淵築襯) 更多 | ||||||
临床2期 | 846 | Placebo (Placebo) | 願壓鏇鑰網顧齋顧廠膚(顧艱夢膚廠淵鹹淵製襯) = 製鑰積選構願餘鏇窪選 鏇積襯衊憲鬱膚糧餘築 (鹹選醖齋窪壓鬱積選襯, 艱構醖鹹繭廠繭網願觸 ~ 鹽鬱築餘築範夢壓鏇鑰) 更多 | - | 2021-05-05 | ||
Placebo+Lasmiditan (200 mg Lasmiditan) | 願壓鏇鑰網顧齋顧廠膚(顧艱夢膚廠淵鹹淵製襯) = 齋醖鬱構觸選繭鬱壓築 鏇積襯衊憲鬱膚糧餘築 (鹹選醖齋窪壓鬱積選襯, 獵範鑰窪鬱鹹積鬱簾壓 ~ 餘遞壓夢簾繭廠憲積窪) 更多 |