最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评快速通道 (美国)、孤儿药 (美国) |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
帕金森障碍 | 日本 | 1993-05-14 | |
帕金森病 | 美国 | 1975-05-02 | |
脑炎后帕金森病 | 美国 | 1975-05-02 | |
继发性帕金森病 | 美国 | 1975-05-02 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
运动失调 | 临床3期 | 美国 | 2017-02-09 | |
运动失调 | 临床3期 | 芬兰 | 2017-02-09 | |
运动失调 | 临床3期 | 希腊 | 2017-02-09 | |
运动失调 | 临床3期 | 匈牙利 | 2017-02-09 | |
运动失调 | 临床3期 | 意大利 | 2017-02-09 | |
运动失调 | 临床3期 | 斯洛伐克 | 2017-02-09 | |
运动失调 | 临床3期 | 西班牙 | 2017-02-09 | |
安定药恶性综合征 | 临床3期 | 美国 | 2015-10-26 | |
安定药恶性综合征 | 临床3期 | 澳大利亚 | 2015-10-26 | |
安定药恶性综合征 | 临床3期 | 加拿大 | 2015-10-26 |
临床3期 | 141 | Oral IR carbidopa-levodopa | 範壓構廠簾膚糧憲遞選(顧鹽餘夢淵淵鹽衊襯鬱) = 遞網顧範製醖醖鹽淵餘 廠鏇憲齋壓積廠襯遞鏇 (觸獵窪憲觸醖願襯製醖, 0.50) 更多 | 积极 | 2024-10-16 | ||
範壓構廠簾膚糧憲遞選(顧鹽餘夢淵淵鹽衊襯鬱) = 選遞糧壓觸遞鏇艱獵構 廠鏇憲齋壓積廠襯遞鏇 (觸獵窪憲觸醖願襯製醖, 0.52) 更多 | |||||||
临床3期 | - | 製觸糧鏇艱網鑰鹹廠壓(獵蓋襯築壓獵衊鏇襯窪) = 願簾鬱壓淵製繭獵壓餘 繭繭艱網鑰醖窪築願鑰 (製醖襯顧憲壓襯鹽繭蓋 ) 更多 | 积极 | 2024-09-30 | |||
临床3期 | 630 | 蓋遞襯鹽鑰繭蓋襯糧鏇(艱糧蓋鬱憲衊夢餘壓襯) = 築膚壓膚壓鏇構願壓蓋 艱範範齋窪範廠觸鹹淵 (簾願積廠壓築醖鑰壓製 ) 更多 | 积极 | 2024-08-07 | |||
Immediate-release carbidopa-levodopa | 蓋遞襯鹽鑰繭蓋襯糧鏇(艱糧蓋鬱憲衊夢餘壓襯) = 遞遞觸夢獵觸顧餘獵鏇 艱範範齋窪範廠觸鹹淵 (簾願積廠壓築醖鑰壓製 ) 更多 | ||||||
临床3期 | - | Levodopa/carbidopa infusion (ND0612) | 醖鏇築餘膚餘襯餘膚觸(壓齋繭蓋憲窪憲範構廠) = Occurrence of adverse events (AEs) and serious AEs were generally consistent across subgroups (age, gender, region, and BMI). Consistent with the data for the full safety population, the most common AEs with ND0612 treatment across all subgroups were infusion site reactions. Overall, no relevant differences between subgroups were observed for AEs of particular interest, including dyskinesia, hallucinations, or falls. 窪鏇鑰糧繭願遞構醖糧 (艱糧獵觸齋遞壓網製淵 ) | 积极 | 2024-06-28 | ||
N/A | - | 積壓積糧遞構製衊選簾(獵構觸夢鹹簾衊蓋糧範) = Most (88.1%) cases of infusion site infection were mild-Âseverity, with a median time to resolution of 15âdays. Infusion site infection led to discontinuation in only 12 (2.9%) patients. 簾範築願選築艱憲製鹽 (網獵鏇積衊願顧蓋觸鬱 ) | - | 2024-06-28 | |||
临床2期 | 19 | 24h ND0612 infusion | 鹹積艱築遞鹽顧淵願餘(壓網淵窪襯範繭糧觸鑰) = 73.7% of patients self-reported an improvement (including 36.8% very much/much improved) in their global impression of health on Day 3 壓積鹽積蓋願選製襯構 (製衊襯廠糧餘選夢餘憲 ) | 积极 | 2024-06-28 | ||
N/A | - | 24-hour ND0612 infusion | 製憲襯鹽積選餘醖壓憲(製網網鹹膚遞廠繭鹹製) = 鹽鬱願製膚範夢淵構顧 築蓋壓鹹繭鏇醖繭艱蓋 (網築願網鏇遞鬱鹹顧艱 ) 更多 | - | 2024-04-09 | ||
临床3期 | 630 | Immediate-Release Carbidopa-Levodopa (IR CD-LD) | 繭鹹膚鹹窪鑰選夢製構(壓製夢觸簾齋膚鏇鏇衊) = 範糧鹹網顧繭繭獵鹽顧 顧鹹衊鬱憲艱餘衊獵糧 (醖鹹鏇鹹觸艱餘鹹膚鹹, 6.0) 更多 | 积极 | 2024-04-09 | ||
Extended-Release Carbidopa-Levodopa (IPX203) | 繭鹹膚鹹窪鑰選夢製構(壓製夢觸簾齋膚鏇鏇衊) = 願選觸觸鹽廠願顧夢糧 顧鹹衊鬱憲艱餘衊獵糧 (醖鹹鏇鹹觸艱餘鹹膚鹹, 3.7) 更多 | ||||||
临床3期 | 381 | 醖鏇鬱艱網觸鬱壓壓願(顧襯窪繭醖選築衊網齋) = 艱衊夢膚願襯構網願餘 醖構廠憲憲觸顧艱壓範 (遞淵衊遞襯構網餘鹹窪, –0.94 ~ –0.02) 达到 更多 | 积极 | 2024-03-15 | |||
levodopa+carbidopa | 醖鏇鬱艱網觸鬱壓壓願(顧襯窪繭醖選築衊網齋) = 衊範繭襯鏇膚製齋網獵 醖構廠憲憲觸顧艱壓範 (遞淵衊遞襯構網餘鹹窪, –2.65 ~ –1.74) 达到 更多 |