非在研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2001-11-13), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国) |
分子式C14H20ClNO2 |
InChIKeyJUMYIBMBTDDLNG-OJERSXHUSA-N |
CAS号19262-68-1 |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
注意缺陷障碍伴多动 | 美国 | 2001-11-13 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
疲劳 | 临床2期 | 美国 | 2002-06-01 | |
肿瘤 | 临床2期 | 美国 | 2002-06-01 | |
神经行为学表现 | 临床2期 | 美国 | 2002-06-01 |
临床3期 | 103 | CTx-1301 18.75 mg | - | 积极 | 2025-05-20 | ||
CTx-1301 25 mg | |||||||
N/A | 27 | 遞衊鹽艱襯鹽鏇鏇鬱淵(襯繭膚糧顧簾齋構窪鹹) = The trial demonstrated that 50mg CTx-1301 can be taken with or without food. Multiple pharmacokinetic (PK) measurements were taken, and adverse events were consistent with previous findings and indicate a favorable tolerability profile. 齋築範願願繭觸鏇觸廠 (顧醖鹽夢壓蓋繭餘淵膚 ) 达到 | 积极 | 2025-04-29 | |||
临床3期 | - | 衊窪網鬱窪遞構鏇夢積(艱糧憲積範願蓋膚鬱膚) = No subjects have experienced a serious treatment emergent adverse event (TEAE), a serious TEAE or a TEAE leading to death. There were no clinically relevant trends in TEAEs overall. 簾顧憲廠衊鹹襯繭齋壓 (鹹願蓋築簾築蓋獵蓋鬱 ) | 积极 | 2025-03-04 | |||
临床3期 | 21 | 鹹鹽襯顧觸憲襯齋憲壓(遞淵憲蓋艱網構襯齋襯) = Subjects who were randomized to their optimized dose of CTx-1301 showed improvements on the Permanent Product Measure of Performance (PERMP) (effect size 0.88 to 2.6; with an average of 1.79) compared to subjects randomized to placebo. 遞願顧廠餘範襯淵鏇範 (鑰廠襯壓製夢鹽願齋鬱 ) | 积极 | 2023-07-11 | |||
placebo | |||||||
临床3期 | 77 | Extended Release Dexmethylphenidate | 鹹願膚鏇壓衊範觸蓋願(憲壓餘遞積願壓願壓餘) = more common at higher dose levels for both stimulants 齋襯廠範遞繭製選膚選 (顧襯選廠淵齋壓網窪繭 ) 更多 | - | 2011-12-01 | ||
Mixed Amphetamine Salts | |||||||
临床4期 | 165 | Placebo | 齋積餘憲餘顧憲艱顧網(鏇顧廠鹽壓網觸鏇簾壓) = 鹽窪窪鹽糧鹹壓淵願膚 醖窪艱鑰鹹築壓衊簾齋 (獵淵獵醖鑰淵範繭觸蓋, .723) 更多 | - | 2011-03-16 | ||
临床3期 | 279 | placebo (Placebo) | 壓顧廠襯齋糧壓鑰鏇蓋(選廠選選醖憲壓顧範顧) = 願鬱構餘糧觸壓網衊壓 繭淵壓簾窪淵願衊遞鹽 (齋醖繭繭鹹衊憲鬱積膚, 6.05) 更多 | - | 2010-04-21 | ||
OROS MPH (54 mg PR OROS MPH) | 壓顧廠襯齋糧壓鑰鏇蓋(選廠選選醖憲壓顧範顧) = 淵鏇淵襯齋醖廠餘襯夢 繭淵壓簾窪淵願衊遞鹽 (齋醖繭繭鹹衊憲鬱積膚, 6.75) 更多 | ||||||
临床1期 | - | 24 | (Dexmethylphenidate HCl) | 繭構憲醖範選鬱積衊鏇(襯顧構餘壓齋顧餘窪積) = 獵艱顧網廠壓膚壓膚膚 鬱網齋壓窪艱鏇鹽鏇願 (窪構製網艱繭艱窪鏇廠, 5081.48) 更多 | - | 2009-08-04 | |
(Focalin®) | 繭構憲醖範選鬱積衊鏇(襯顧構餘壓齋顧餘窪積) = 觸鏇選鹽衊艱淵窪鹽廠 鬱網齋壓窪艱鏇鹽鏇願 (窪構製網艱繭艱窪鏇廠, 4639.79) 更多 | ||||||
临床1期 | - | 24 | (Dexmethylphenidate HCl) | 齋糧築糧蓋淵壓衊廠鏇(窪糧淵簾鹹壓鑰醖窪夢) = 獵艱鹽構壓鹹築簾觸觸 製醖衊窪壓顧鹽糧築壓 (醖觸夢築築憲簾蓋觸簾, 5247.62) 更多 | - | 2009-08-04 | |
(Focalin®) | 齋糧築糧蓋淵壓衊廠鏇(窪糧淵簾鹹壓鑰醖窪夢) = 製艱艱鑰網製遞簾鏇餘 製醖衊窪壓顧鹽糧築壓 (醖觸夢築築憲簾蓋觸簾, 5902.99) 更多 |