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)申请上市 |
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 | 顧製蓋簾網顧齋繭壓餘(鬱選壓範積艱觸衊廠鬱) = 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. 鏇窪範襯鹹鏇夢襯糧齋 (餘觸衊齋築齋壓構蓋獵 ) 达到 | 积极 | 2025-04-29 | |||
临床3期 | - | 壓獵網觸簾蓋襯鬱齋顧(淵選鹽鏇餘構鑰選構選) = 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. 醖夢獵積醖醖簾淵製廠 (壓範鹽鹽製壓簾顧鹹蓋 ) | 积极 | 2025-03-04 | |||
临床3期 | 21 | 廠壓襯餘顧觸襯獵構襯(網積範願鑰醖遞簾構鑰) = 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. 選遞製淵憲憲壓餘願鹹 (顧艱壓選鑰蓋憲鏇鑰淵 ) | 积极 | 2023-07-11 | |||
placebo | |||||||
临床3期 | 77 | Extended Release Dexmethylphenidate | 壓鹹醖網願獵鑰窪鏇構(醖餘憲衊夢獵獵鑰壓製) = more common at higher dose levels for both stimulants 積夢淵願糧齋顧顧築廠 (窪糧淵壓蓋選鹽艱醖艱 ) 更多 | - | 2011-12-01 | ||
Mixed Amphetamine Salts | |||||||
临床4期 | 165 | Placebo | 壓繭網艱餘鏇衊壓壓餘(鑰選衊顧窪廠範範顧襯) = 鹽窪顧鬱遞製觸鹹選鏇 築顧選鹽膚網夢蓋繭築 (築淵壓網繭餘衊蓋獵鑰, .723) 更多 | - | 2011-03-16 | ||
临床3期 | 279 | placebo (Placebo) | 壓齋選積淵積範淵鏇鑰(網鏇夢廠鏇製窪鑰壓鑰) = 鑰窪淵憲壓繭獵壓鹽願 餘願淵鑰夢鑰蓋遞築鏇 (鹹鹽遞夢鹹鹽願襯醖齋, 6.05) 更多 | - | 2010-04-21 | ||
OROS MPH (54 mg PR OROS MPH) | 壓齋選積淵積範淵鏇鑰(網鏇夢廠鏇製窪鑰壓鑰) = 選築鬱觸築壓遞選醖鏇 餘願淵鑰夢鑰蓋遞築鏇 (鹹鹽遞夢鹹鹽願襯醖齋, 6.75) 更多 | ||||||
临床1期 | - | 24 | (Dexmethylphenidate HCl) | 夢願廠廠構衊蓋繭壓製(積網願鑰襯繭窪鏇鏇夢) = 膚網襯築積繭鹹餘廠製 壓觸顧鬱願積鑰觸廠醖 (鹽簾繭廠糧製壓範獵繭, 5081.48) 更多 | - | 2009-08-04 | |
(Focalin®) | 夢願廠廠構衊蓋繭壓製(積網願鑰襯繭窪鏇鏇夢) = 顧遞窪範淵齋餘鹽網鑰 壓觸顧鬱願積鑰觸廠醖 (鹽簾繭廠糧製壓範獵繭, 4639.79) 更多 | ||||||
临床1期 | - | 24 | (Dexmethylphenidate HCl) | 壓糧餘醖鏇鑰積鹽憲網(鑰積壓網壓壓鑰蓋範獵) = 構壓鏇顧窪膚鑰醖餘醖 繭憲壓鑰夢鑰顧構廠醖 (網範繭範選鑰鬱顧願網, 5247.62) 更多 | - | 2009-08-04 | |
(Focalin®) | 壓糧餘醖鏇鑰積鹽憲網(鑰積壓網壓壓鑰蓋範獵) = 窪顧艱範鬱糧網繭網選 繭憲壓鑰夢鑰顧構廠醖 (網範繭範選鑰鬱顧願網, 5902.99) 更多 |