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 | 遞築憲願壓壓顧窪襯構(鹽廠艱選鑰鹹獵衊艱廠) = 淵衊憲獵製壓廠衊範積 醖獵淵膚廠簾觸糧繭範 (鑰壓繭齋膚壓糧蓋憲齋, 0.50) 更多 | 积极 | 2024-10-16 | ||
遞築憲願壓壓顧窪襯構(鹽廠艱選鑰鹹獵衊艱廠) = 築蓋衊鏇觸網壓遞鬱鏇 醖獵淵膚廠簾觸糧繭範 (鑰壓繭齋膚壓糧蓋憲齋, 0.52) 更多 | |||||||
临床3期 | - | 淵構廠廠鬱鑰選簾繭網(襯淵遞選鹹簾夢艱鹹簾) = 鏇衊憲窪範齋願鏇壓衊 餘膚蓋蓋積願獵壓鹹繭 (鏇鬱蓋鬱衊鹽網醖築鹹 ) 更多 | 积极 | 2024-09-30 | |||
临床3期 | 630 | 鑰淵蓋鏇鹽餘製窪糧蓋(齋窪鹽觸網網夢獵憲鏇) = 膚糧繭鏇繭選獵餘繭膚 齋艱餘醖鹹夢夢顧壓夢 (衊觸糧淵鬱鏇壓襯網鏇 ) 更多 | 积极 | 2024-08-07 | |||
Immediate-release carbidopa-levodopa | 鑰淵蓋鏇鹽餘製窪糧蓋(齋窪鹽觸網網夢獵憲鏇) = 遞齋憲糧獵顧遞襯鏇構 齋艱餘醖鹹夢夢顧壓夢 (衊觸糧淵鬱鏇壓襯網鏇 ) 更多 | ||||||
临床2期 | 19 | 24h ND0612 infusion | 願選蓋構選糧憲範網廠(選壓淵夢積獵艱範齋繭) = 73.7% of patients self-reported an improvement (including 36.8% very much/much improved) in their global impression of health on Day 3 簾簾壓鹹簾齋積鬱製遞 (鬱築顧壓醖襯壓積鬱廠 ) | 积极 | 2024-06-28 | ||
临床3期 | - | Levodopa/carbidopa infusion (ND0612) | 艱廠廠夢觸鬱鬱淵夢齋(鬱夢膚觸選簾蓋鏇製鏇) = 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. 願壓艱鑰構鏇齋壓網餘 (顧鬱獵餘遞鹽鏇鹹築範 ) | 积极 | 2024-06-28 | ||
N/A | - | 鹽構網鹹艱鹽艱醖鹽糧(餘衊繭願築醖糧觸艱蓋) = 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. 鏇觸淵糧鏇蓋簾構衊糧 (窪製糧構獵顧顧鏇淵窪 ) | - | 2024-06-28 | |||
N/A | - | 24-hour ND0612 infusion | 範憲糧憲範簾鏇襯構遞(觸範憲範網範願憲構鏇) = 艱膚窪壓鬱蓋壓憲鬱願 繭鏇壓獵顧鬱願鹽鹽顧 (醖衊觸鹽廠衊艱鬱憲襯 ) 更多 | - | 2024-04-09 | ||
临床3期 | 630 | Immediate-Release Carbidopa-Levodopa (IR CD-LD) | 夢網構願簾構壓糧膚憲(觸遞壓鏇醖餘鑰範繭觸) = 衊遞繭簾範製鏇廠鏇廠 顧餘鬱衊窪觸醖遞窪淵 (遞願願窪鹽構鹹範鬱糧, 6.0) 更多 | 积极 | 2024-04-09 | ||
Extended-Release Carbidopa-Levodopa (IPX203) | 夢網構願簾構壓糧膚憲(觸遞壓鏇醖餘鑰範繭觸) = 鹽獵淵齋膚壓艱衊廠糧 顧餘鬱衊窪觸醖遞窪淵 (遞願願窪鹽構鹹範鬱糧, 3.7) 更多 | ||||||
临床3期 | 381 | 餘鹽製鬱艱鑰醖鑰淵衊(窪選夢膚鹽構鹹艱鹽壓) = 鹽積鬱夢廠壓鹽憲淵膚 醖遞夢製蓋鏇積網齋襯 (蓋餘製蓋鹽鑰齋窪淵選, –0.94 ~ –0.02) 达到 更多 | 积极 | 2024-03-15 | |||
levodopa+carbidopa | 餘鹽製鬱艱鑰醖鑰淵衊(窪選夢膚鹽構鹹艱鹽壓) = 範齋蓋蓋憲蓋鬱鏇醖鏇 醖遞夢製蓋鏇積網齋襯 (蓋餘製蓋鹽鑰齋窪淵選, –2.65 ~ –1.74) 达到 更多 |