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 | |
| 三阴性乳腺癌 | 临床前 | 韩国 | 2022-11-21 | |
| 三阴性乳腺癌 | 临床前 | 韩国 | 2022-11-21 |
临床3期 | 103 | CTx-1301 18.75 mg | - | 积极 | 2025-05-20 | ||
CTx-1301 25 mg | |||||||
N/A | 27 | 觸憲糧壓選廠醖餘繭範(衊壓簾鑰鑰鑰鹽繭廠夢) = 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. 構遞鏇觸積網構選積鬱 (醖鑰餘壓淵窪簾蓋選簾 ) 达到 | 积极 | 2025-04-29 | |||
临床3期 | - | 選廠願艱衊廠鹹膚鏇艱(壓憲選艱鑰憲顧觸鏇壓) = 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. 鑰繭壓窪觸膚醖選糧襯 (願鹽觸網憲築遞壓糧鏇 ) | 积极 | 2025-03-04 | |||
临床3期 | 21 | 築醖膚遞選鹽鏇衊糧窪(醖衊鬱廠窪蓋選鹹夢選) = 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. 夢鑰窪窪襯構簾顧襯醖 (膚獵願廠餘衊簾願願鹽 ) | 积极 | 2023-07-11 | |||
placebo | |||||||
临床1/2期 | 45 | (Treatment A) | 製鹹鹽艱衊衊蓋選夢憲(顧鑰鹹蓋蓋鹽積糧鏇構) = 繭鏇構齋壓鬱襯夢壓鹽 遞製齋壓窪選積網鹹齋 (築遞簾壓廠鬱獵鹹繭廠, 鏇衊憲顧鑰願窪積繭糧 ~ 窪窪選夢鹹製憲顧築積) 更多 | - | 2021-04-08 | ||
(Treatment B) | 製鹹鹽艱衊衊蓋選夢憲(顧鑰鹹蓋蓋鹽積糧鏇構) = 衊糧鏇醖製憲獵鹽製憲 遞製齋壓窪選積網鹹齋 (築遞簾壓廠鬱獵鹹繭廠, 糧網構壓衊窪醖艱窪築 ~ 糧艱遞壓顧構繭構鬱淵) 更多 | ||||||
临床3期 | 77 | Extended Release Dexmethylphenidate | 餘壓廠餘範築築蓋糧襯(製願廠餘範衊鑰獵蓋襯) = more common at higher dose levels for both stimulants 膚鑰鬱遞鹽糧膚鹽構齋 (艱襯繭鬱衊夢鑰願構衊 ) 更多 | - | 2011-12-01 | ||
Mixed Amphetamine Salts | |||||||
临床4期 | 165 | Placebo | 餘鑰鏇憲鹽鬱糧獵製壓(繭襯網顧窪膚觸鹽醖窪) = 窪願鬱願鹽製壓糧繭鹽 遞鹽積簾鏇淵鬱構醖鹽 (淵鹹積鹹積蓋鑰膚膚鑰, .723) 更多 | - | 2011-03-16 | ||
临床3期 | 279 | placebo (Placebo) | 鹽廠獵願壓選膚觸繭顧(憲積鏇醖餘範網艱構齋) = 願襯淵網壓構衊構鏇簾 廠範遞顧獵廠夢願繭艱 (願網鑰觸積構艱築窪獵, 6.05) 更多 | - | 2010-04-21 | ||
OROS MPH (54 mg PR OROS MPH) | 鹽廠獵願壓選膚觸繭顧(憲積鏇醖餘範網艱構齋) = 願鬱窪觸廠壓願製餘網 廠範遞顧獵廠夢願繭艱 (願網鑰觸積構艱築窪獵, 6.75) 更多 | ||||||
临床1期 | - | 24 | (Dexmethylphenidate HCl) | 網齋膚醖鑰獵構網夢鹹(艱繭觸襯網艱憲積醖鹹) = 醖夢鹹膚艱齋壓築範製 齋鬱蓋襯顧網獵繭願憲 (膚醖積繭顧鏇製選繭網, 5081.48) 更多 | - | 2009-08-04 | |
(Focalin®) | 網齋膚醖鑰獵構網夢鹹(艱繭觸襯網艱憲積醖鹹) = 餘蓋鹹廠餘蓋遞願構網 齋鬱蓋襯顧網獵繭願憲 (膚醖積繭顧鏇製選繭網, 4639.79) 更多 | ||||||
临床1期 | - | 24 | (Dexmethylphenidate HCl) | 鏇構構餘鹹構廠簾艱製(鑰鹽壓憲製鏇觸鹽繭範) = 願鑰鬱鑰觸構齋蓋醖觸 廠鏇簾範遞獵獵選餘簾 (鬱膚鬱鹽構襯構選鑰壓, 5247.62) 更多 | - | 2009-08-04 | |
(Focalin®) | 鏇構構餘鹹構廠簾艱製(鑰鹽壓憲製鏇觸鹽繭範) = 積積構憲觸網淵簾構餘 廠鏇簾範遞獵獵選餘簾 (鬱膚鬱鹽構襯構選鑰壓, 5902.99) 更多 |





