阿普唑仑(Alprazolam) - 药物靶点：DOCK5 x GABAA receptor_在研适应症：睡眠异常，紧张症，抑郁症_专利_临床

概要

基本信息

简介阿普唑仑是一种小分子药物，可作为 GABAA 受体的激动剂，GABAA 受体是一种对抑制性神经递质γ-氨基丁酸 (GABA) 有反应的神经递质受体。通过增强 GABA 在大脑中的作用，阿普唑仑具有抗焦虑、镇静和抗惊厥的特性。这种药物主要用于治疗焦虑症和恐慌症。然而，它也被发现对某些癫痫和哮喘相关焦虑症有效。阿普唑仑于1981年10月16日首次获得FDA批准，由日本制药公司武田制药公司研制。阿普唑仑有多种形式，包括速释片和缓释片，以及口服溶液。应谨慎使用，因为它可能会导致依赖性和戒断症状。

药物类型

小分子化药

别名

8-Chloro-1-methyl-6-phenyl-4H-s-triazolo(4,3-a)(1,4)benzodiazepine、Alprazolcem、AP-1002

+ [19]

靶点

DOCK5 x GABAA receptor

作用方式

抑制剂、激动剂

作用机制

DOCK5抑制剂(dedicator of cytokinesis 5 inhibitors)、GABAA receptor激动剂(γ-氨基丁酸 A 受体激动剂)

治疗领域

神经系统疾病其他疾病

在研适应症

睡眠异常紧张症抑郁症+ [7]

非在研适应症

药物滥用Dravet综合征轻度哮喘+ [1]

原研机构

Takeda Pharmaceutical Co., Ltd.Upjohn Pharmaceuticals Ltd.

在研机构

优时比贸易（上海）有限公司Upjohn US 2 LLCUCB Pharma SA

+ [6]

非在研机构

Viatris, Inc.

Engage Therapeutics, Inc.

Sandoz Group AG

+ [4]

权益机构

Alexza Pharmaceuticals, Inc.

李氏大药厂控股有限公司

Engage Therapeutics, Inc.

+ [1]

最高研发阶段批准上市

首次获批日期

美国 (1981-10-16),

焦虑症惊恐障碍

最高研发阶段(中国)批准上市

特殊审评突破性疗法 (中国)

登录后查看时间轴

结构/序列

分子式C17H13ClN4

InChIKeyVREFGVBLTWBCJP-UHFFFAOYSA-N

CAS号28981-97-7

关联

132

项与阿普唑仑相关的临床试验

NCT07275710

/ Not yet recruitingN/AIIT

Role of Alprazolam in Management of Post Endodontic Pain After Single Visit Root Canal Treatment

To compare mean pain score between two group of participants undergoing post operative pain management after single visit root canal treatment: one group receiving NSAIDs alone and the other receiving a combination of NSAIDs and an anxiolytic medication i.e alprazolam.

开始日期2026-02-01

申办/合作机构-

NCT07154147

/ Recruiting临床4期IIT

Cataract Oral vs IV Sedation Pilot RCT: A Non-inferiority Assessment of Perioperative Safety and Cognitive Recovery in Older Adults

The goal of this clinical trial is to find out if taking a pill (oral sedation) works just as well as getting medicine through a vein (IV sedation) to help older adults feel relaxed during cataract surgery. We are also studying how these two methods affect recovery, especially thinking and memory after surgery, and how satisfied people are with their care. Participants in this study will be randomly assigned to receive either oral sedation (+ IV placebo) or IV sedation (+ oral placebo) before their cataract surgery. They will complete short surveys about their thinking and recovery before and after surgery, and will be contacted by phone after surgery to check on their recovery. The results of this study will help doctors understand if a simple pill can be a safe and effective alternative to IV sedation for cataract surgery.

开始日期2025-08-12

申办/合作机构

The University of California, San Francisco

NCT07020988

/ Completed临床1期

An Open Label, Single Dose, Randomized, Active Comparator, Quantitative Electroencephalogram Crossover Study to Assess the Time to Onset of Action of Staccato Alprazolam Versus Intravenous Midazolam and of Staccato Alprazolam Versus Nasal Diazepam in Healthy Study Participants

The purpose of this study is to estimate the difference in the time to onset of action between Staccato alprazolam and intravenous (iv) midazolam using changes in power in the combined spindle and β1 frequency bands in the qEEG (quantitative electroencephalogram).

开始日期2025-06-12

申办/合作机构

UCB Biopharma SRL

100 项与阿普唑仑相关的临床结果

登录后查看更多信息

100 项与阿普唑仑相关的转化医学

登录后查看更多信息

100 项与阿普唑仑相关的专利（医药）

登录后查看更多信息

4,608

项与阿普唑仑相关的文献（医药）

2026-08-01·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Isolation and identification of the designer benzodiazepine cyclopropylflualprazolam in pressed candies marketed for sleep improvement

Article

作者: Liu, Xiaopu ; Xiang, Xinhua ; Ge, Xiaowei ; Zhao, Lihong ; Dong, Peizhi

A novel alprazolam analog was detected as an illegal additive in pressed candies marketed for sleep improvement using high-performance liquid chromatography (HPLC)-diode array detection (DAD). The compound was further isolated and purified via semi-preparative liquid chromatography, and its chemical structure was elucidated through high-resolution mass spectrometry (HRMS) and nuclear magnetic resonance (NMR) spectroscopy. The compound was identified as cyclopropylflualprazolam. Since alprazolam is a psychotropic controlled substance, this finding has garnered significant attention from regulatory authorities. It is recommended that cyclopropylflualprazolam be included in the screening list of prohibited substances in functional foods.

2026-04-01·PHYSIOLOGY & BEHAVIOR

Kratom (Mitragyna speciosa) alkaloids influence on cardiopulmonary measures and high-fat diet-induced weight gain in mice

Article

作者: Elango, Arul ; Bello, Nicholas T ; Sweeney, Adrianna M ; Bernstein, Emma ; Vasilatis, Ariane ; Simon, James E ; Fields, Spencer E ; Akgun, Elif Ece ; Wu, Qingli ; Carry, Eileen

Kratom (Mitragyna speciosa) has been marketed and used for a variety of health-promoting applications. Kratom contains an expansive bioactive alkaloid profile with mitragynine (MTG) as the most abundant. Individual responses to kratom have been reported, but the role of obesity as a factor influencing the effects of kratom has not been studied. First, we used a standardized kratom extract (KE) to determine the cardiopulmonary differences with KE (290, 500 mg/kg) and matched MTG (18 mg/kg) in high-fat diet (HFD; 45% Fat) induced obese male C57Bl/6 J mice. As measured by whole-body plethysmography, acute oral dosing revealed an approximate 15% reduction in the respiratory rate with all doses of KE and MTG. Unlike a well-known respiratory depressant, alprazolam, KE and MTG did not reduce minute ventilation (MvB; ml/min). As measured by volume-pressure recordings, KE 500 mg/kg produced an approximate 12% reduction in heart rate in normal weight mice. Second, we determined whether daily oral dosing KE (50, 150 mg/kg) prevented HFD-induced weight gain. Daily 150 mg/kg resulted in an increase in body weight gain (∼1 g) in the last week after 21 days of dosing. After 4 days following kratom cessation, there was reduced distance traveled in the KE 150 mg/kg compared with the KE 50 mg/kg group in an elevated plus maze test. These findings demonstrate a dose-dependent-increase in weight gain with KE, suggesting further investigation is needed to delineate kratom alkaloid effects on metabolism and body weight control.

2026-04-01·JOURNAL OF ANXIETY DISORDERS

Efficacy and safety of etifoxine versus alprazolam in generalized anxiety disorders with somatic symptoms: A randomized, double-blind, comparative study

Article

作者: Kumar, Ashutosh ; Dutta, Mithun ; Neeli, Uma Jyothi ; Mohide, Ashish ; Dalaya, Nitin ; Mehta, Suyog ; Joglekar, Sadhna ; Thaker, Spandan ; Chaudhari, Dhananjay ; Ganesan, Gopalakrishnan ; Mukhopadhyay, Asish ; Prabhakar, Kalmegh ; Shaikh, Raisa ; Behera, Sapan ; Saha, Shruti ; Patil, Dipak ; Pandit, Sucheta ; Devkare, Prashant ; Sonowal, Supriya ; Rajendra, Rajagopal ; Ghadge, Pravin ; Patil, Bharati ; Lakhwani, Lalit

Etifoxine, a non-benzodiazepine anxiolytic, is useful for managing anxiety symptoms. However, its role in managing somatic symptoms in generalized anxiety disorder (GAD) remains unclear. Hence, we aimed to compare the efficacy and safety of Etifoxine with Alprazolam in adults with GAD with somatic symptoms. This phase 3, randomized, double-blind, double-dummy study included 260 patients aged 18-65 years with GAD with somatic symptoms who received either Etifoxine 50 mg TID or Alprazolam 0.5 mg TID (1:1) for 4 weeks. The primary outcome was the change from baseline to day 28 in the Hamilton Anxiety Rating Scale (HAM-A) total score. Secondary efficacy outcomes included changes from baseline to days 7 and 14 in HAM-A total score, changes from baseline to days 7, 14, and 28 in HAM-A psychic and somatic sub-scores, clinical global impression-severity score, and percentage of patients with clinical and patient global impression-improvement scale responses. Our study results indicated that both Etifoxine and Alprazolam demonstrated significant improvements in mean change in HAM-A total scores at day 28 from baseline [mean (SD): -13.5 (4.21) and -13.4 (4.64), respectively; p < 0.0001 for both]. The adjusted mean difference (95% CI) was -0.18 (-1.08, 0.72), indicating non-inferiority of Etifoxine. Changes in secondary efficacy parameters were also comparable between groups. Treatment-emergent AEs were mild and observed in 10% and 7.7% of patients in the Etifoxine and Alprazolam groups, respectively. Etifoxine was non-inferior to Alprazolam in reducing anxiety symptoms in GAD, was well-tolerated, and can be a promising alternative for anxiety management without drug dependence risk.

174

项与阿普唑仑相关的新闻（医药）

2026-04-20

·BioSpace

Viatris recalls extended-release Xanax over dissolution test failure

Matt Molloy/Getty Images/iStockphoto Viatris, which Pfizer created in 2020, voluntarily withdrew extended-release products made at a plant in Ireland after an analysis revealed an issue that could affect bioavailability. Viatris has recalled one batch of the anti-anxiety medicine Xanax XR in the U.S. because it failed a test of the rate and extent of drug release. The company voluntarily initiated the recall after a batch of bottles containing 60 3-mg tablets of the drug failed dissolution specifications. Drugmakers run dissolution tests to assess the conversion of oral dosage forms into solutions. That conversion determines the bioavailability of the active ingredient and thereby affects the efficacy of the drug product. Viatris found that the dissolution of a batch of extended-release Xanax manufactured in Ireland diverged from the specifications, triggering the Class II recall. The news comes four years after Viatris pulled 110 bottles of Xanax XR from the U.S. market because of out-of-specification results for dissolution. Pfizer, which used to own the drug, recalled 36,000 bottles of immediate-release Xanax in 2012 over dissolution test results. The FDA approved Xanax XR in 2003, months before Pfizer acquired the asset as part of its $60 billion takeover of Pharmacia. An immediate-release formulation of the active ingredient, the benzodiazepine alprazolam, was already available. However, the older product needed to be taken three to four times a day. Xanax XR is taken once daily. Alprazolam was off patent and facing generic competition when the FDA approved Xanax XR. Supported by the extended-release formulation, Pfizer grew sales of its Xanax franchise to $350 million in 2008. By then, generic extended-release alprazolam products were competing for market share. Actavis launched a generic copy of the drug in 2007. Impax Laboratories, which is now part of Amneal Pharmaceuticals, entered the market months after Actavis. Aurobindo Pharma’s generic won FDA approval in 2011. Xanax XR was part of Pfizer until the drugmaker merged its Upjohn business with Mylan to form Viatris in 2020. Viatris reported $139.9 million in Xanax sales last year. Sales have slipped in recent years, falling from $154.8 million in 2023 to $145 million in 2024. FDA FDA mulls compounding for peptides previously flagged over safety risks With Health Secretary Robert F. Kennedy Jr. declaring himself “a big fan of peptides,” the FDA has arranged an advisory committee to discuss allowing compounders to make molecules despite earlier safety concerns. April 16, 2026 · 1 min read · Nick Paul Taylor Read more Viatris’ Xanax XR withdrawal was one of 30 drug recalls in the FDA’s latest weekly enforcement report , which also included five recalls by Teva Pharmaceuticals. The company withdrew about 30,000 packages of the acne medicine isotretinoin across two recalls because they were superpotent or subpotent. Teva recalled isotretinoin in January, but the FDA only classified the action this month. Teva’s three other recalls stemmed from the use of an unapproved raw material. The FDA listed Actavis Laboratories as the manufacturer of the recalled batches of Teva’s clonidine transdermal system.

上市批准并购

2026-04-18

·GoodGood123

第⑧篇人类CNS疾病治疗药物开发进展

(接续前面第⑦篇介绍泌尿生殖系统治疗药物)本第⑧篇接着介绍中枢神经系统(CNS)疾病治疗药物的开发进展。说起中枢神经系统药物的研发早有渊源，在东汉时期华佗就曾用曼陀罗配制“头风散”，试图为曹操治疗头风顽疾。可惜那段佳话终成遗憾，华佗入狱后，其毕生心血《青囊书》因狱卒不敢承接而随葬焚毁，大量珍贵药方与医术就此失传。但后人从未停止对中枢神经系统治疗领域的继续探索，针对头痛的方剂历代不断积累和完善，从华佗的古法麻沸散，到欧美用笑气、乙醚实施手术麻醉，再到巴比妥类安眠药的问世，人类一直在与神经系统的病痛博弈。从最初的天然草药，到近代的麻醉剂，再到镇静催眠药、抗精神病与抗抑郁药，最后进化到现代靶向药与生物制剂，与其说这是一部药物史，不如说是人类试图解开“头痛脑热”背后谜题的进化史。很多疾病的根源，都在于神经指挥系统的失调。中医常说“痛则不通，通则不痛”，放在这里也同样贴切：神经一旦失调，身体就会发出痛的信号；当药物帮助神经恢复秩序时，痛感自然随之消散……简单的说中枢神经系统药物开发脉路，从古代天然药物 → 近代麻醉药 → 镇静催眠药 → 抗精神病/抗抑郁 → 现代靶向药生物药的方向推进。1.古代用天然植物经验用药，无现代药理概念不懂受体、神经递质，药物以镇痛、安神、麻醉为主。东汉末年华佗用曼陀罗花、草乌、麻醉草等配成麻沸散，做腹腔手术麻醉，是世界最早有记载的外科全身麻醉。用酸枣仁、朱砂、茯神等制成头风散治疗头风、头痛、眩晕(这些症状在今天可能是偏头痛、高血压头痛、神经痛)，靠植物生物碱镇静镇痛，用于安神、助眠、癫狂、惊悸，对应今天失眠、焦虑、精神躁动症状治疗。 2. 西方古代用罂粟(鸦片)、古柯叶、颠茄、曼德拉草等用于止痛、麻醉、镇静，但成瘾、剧毒、不安全，没有标准化。3.近代18世纪末-19世纪，化学麻醉药的诞生，才是真正意义上现代中枢神经系统(CNS)药物的起点，从手术麻醉开始。1772年英国人普利斯特里发现一氧化二氮(俗称笑气) 有麻醉作用，1844年美国人霍勒斯·威尔斯用于拔牙麻醉手术。1846年美国牙医莫顿公开演示乙醚麻醉下无痛手术，这是人类第一次真正可靠、可控的全身麻醉外科手术的开始。1847年发现氯仿比乙醚麻醉更强、更快，但有心脏毒性、呼吸抑制、致死风险高，后来逐渐被淘汰。1903—1960年代麻醉药成功后，人类开始追求让人睡觉、平静、抗焦虑。诞生了第一代镇静催眠药巴比妥类时代。1863年合成巴比妥(Barbital)，1903年后上市巴比妥、苯巴比妥、异戊巴比妥、司可巴比妥等，作用于镇静、催眠、抗惊厥、麻醉，这类药缺点是治疗剂量和中毒剂量很接近，容易过量致死，严重成瘾依赖性。同时期开发的溴化物有简单镇静低效果毒性大。植物提纯药吗啡可待因有强效镇痛止咳作用，但成瘾性极强。1960s—至今天还在广泛使用的药物，是开发革命性替代药物彻底替代巴比妥类的苯二氮䓬类药物，这是CNS药物史上最重要飞跃之一。1955年合成氯氮䓬(利眠宁)1960年上市。1963年合成上市地西泮(安定)，之后是阿普唑仑、劳拉西泮、艾司唑仑、咪达唑仑等。优点安全范围大，不容易一下子吃死，有抗焦虑、催眠、抗惊厥、肌肉松弛作用，广泛用于焦虑、失眠、癫痫、麻醉辅助。缺点依然有依赖性成瘾性、戒断困难，长期用记忆力下降、反应慢。1950s后抗癫痫、抗帕金森症药物逐步成熟。早期抗癫痫药是苯巴比妥、苯妥英钠。现代用卡马西平、丙戊酸钠、拉莫三嗪、左乙拉西坦等药物更安全、广谱、副作用小。1960s抗帕金森病药物左旋多巴上市，用于补充多巴胺。之后多巴胺受体激动剂、COMT抑制剂、MAO-B抑制剂等药物相继上市。1950s开始诞生抗精神病药用于治疗精神分裂症。1952年用氯丙嗪做抗组胺药，偶然发现其能镇静、控制幻觉妄想，是人类第一个抗精神病药。后来搞清楚氯丙嗪机制是阻断多巴胺受体，之后开发上市氟哌啶醇、奋乃静等第一代抗精神病药。1980s后开发诞生第二代抗精神病药：氯氮平、利培酮、奥氮平、喹硫平、阿立哌唑等上市。优点不会僵硬手抖锥体外系副作用小，对冷漠退缩阴性症状效果更好。1950s后抗抑郁药物的发展，早期抗抑郁药物用单胺氧化酶抑制剂(MAOI)效果不错，但饮食禁忌多、危险，现在已很少使用。之后上市阿米替林、丙米嗪等三环类抗抑郁药(TCA)有效，但口干、便秘、心慌、心脏毒性，副作用大。1980s后上市有划时代的SSRI选择性5-羟色胺再摄取抑制剂药物：氟西汀(百忧解)、帕罗西汀、舍曲林、氟伏沙明、西酞普兰、艾司西酞普兰等，优点是安全性大幅提高，至今仍是主流一线抗抑郁药。2000s后开发上市快速起效抗抑郁艾司氯胺酮（鼻喷剂）作用于谷氨酸系统，几小时起效。 2000s—至今天，治疗CNS疾病思路完全变了，对最难突破的神经退行性疾病治疗也取得了进展。精准靶向、生物药、基因疗法 → 试图延缓逆转疾病，而不只是缓解症状。从“抑制神经”转向“调节修复神经”，不再只是让人睡觉、镇静、神经麻木，从“对症”走向“精准、疾病修饰”神经，调节神经介质5-羟色胺、多巴胺、谷氨酸、GABA、组胺、腺苷等。相继上市非苯二氮䓬类新一代失眠药物：唑吡坦、佐匹克隆、右佐匹克隆、扎来普隆等，优点入睡快、依赖性更低、第二天更清醒。①阿尔茨海默病的治疗，早年用多奈哌齐、美金刚药物只缓解症状不治疗疾病。近年用仑卡奈单抗、多奈单抗等抗淀粉样蛋白抗体，首次能延缓病程。阿尔茨海默病(AD)治疗已上市新药-2024.1月卫材的仑卡奈单抗：靶向β淀粉样蛋白，显著减缓认知衰退。2024.12月礼来的多奈单抗：III期显示减缓衰退35%，适用于早期患者。2026年在研突破药物，口服Valiltramiprosate不增加脑水肿风险，为不耐受抗体患者提供新选择。司美格鲁肽药物调节神经炎症，降低tau蛋白，非淀粉样蛋白路径。CAR-T细胞疗法，工程化T细胞清除淀粉样斑块，动物实验成功。 ②帕金森症近年在研究基因治疗、细胞治疗有所进展。帕金森病(PD)治疗-基因疗法BIIB094靶向LRRK2，I期使蛋白水平降低59%，安全性良好。口服小分子ABBV-951、Tava podium 改善运动波动与异动症。AAV基因治疗修复多巴胺能神经元，进入II期。③精神分裂症治疗-2024年获批KarXT药物，是70多年来首个非靶点多巴胺的原创机制新药，新型机制的毒蕈碱受体激动剂，无传统抗精神病药副作用。M4受体正向变构调节剂NMRA-898，I期临床试验改善阳性/阴性症状。④抑郁症治疗-2024年绿叶制药的托鲁地文拉法辛药物长效缓释，一周一次。此外5-MeO-DMT、MM120等迷幻药疗法也在治疗抑郁症等疾病中展现出巨大潜力。艾司氯胺酮鼻喷剂、别孕烷醇酮，快速抗抑郁数小时起效。⑤采用新技术治疗中枢神经系统疾病，有血脑屏障穿透技术、基因治疗、AAV载体、干细胞、CAR-T、AI药物设计、靶向受体、多肽、核酸药物等等新方法新思维治疗方案。⑥修复与再生疗法：NVG-291在慢性脊髓损伤中取得前所未有效果；中国研发的全球首个异体通用型iPSC衍生神经细胞药已获批临床。2026年将迎来包括帕金森病药物tavapadon的NDA审查，以及针对SCN2A/8A癫痫的relutrigine等新药上市申请。⑦技术赋能破局：跨越血脑屏障(BBB)的新一代"脑内穿梭机"技术(转铁蛋白受体等)能有效携带大分子药物入脑，trontinemab仅需传统剂量1/5便达3倍疗效。AI与递送技术加速研发，AI驱动药物研发，英矽智能等公司利用AI平台成功设计出具良好脑部暴露的候选分子，并达成多项重磅合作，标志着AI正从概念走向现实。⑧CNS药物开发面临挑战：整体成功率仅6% 左右，远低于其他领域。主要挑战是中枢神经系统疾病机制复杂，存在多基因、多通路、神经炎症、免疫紊乱交织，精神疾病尤其缺乏有效生物标志物，动物模型难以模拟人类神经疾病病理，导致临床前评估困难。血脑屏障仅400-600Da脂溶性分子易穿透，中枢神经系统疾病治疗存在神经毒性、免疫反应、脱靶效应等安全性问题。虽然前景光明，但高悬的失败率与瓶颈，使FDA正推动使用类器官、器官芯片、AI模型等"新方法学"替代部分动物实验，这有望从根本上革新研发与审评路径。 ……（下一篇待续）#基因治疗新时代 #精准医疗进展 #生物制药工厂探秘 #实验室里的科技力量 #基因测序技术解析 #基因细胞治疗 #生物大分子药物 #药物研发历程

2026-04-16

·FiercePharma

Viatris, Teva kick off separate recalls over dissolution, raw material issues

Both recalls were graded Class II, suggesting that use of the suspect meds could lead to temporary or reversible negative health effects. Viatris and Teva Pharmaceutical Industries recently launched separate recalls in the U.S. related to dissolution problems for a common anxiety medication and concerns around an unapproved raw material in a high blood pressure patch, respectively.Both recalls were graded Class II, suggesting that use of the suspect meds could lead to temporary or reversible negative health effects. In both instances, the FDA determined that the probability of serious health risks to patients was remote.In the case of Viatris, the drugmaker is pulling (PDF) one lot of extended release Xanax tablets, citing failed dissolution specifications, which concerns (PDF) how drugs are broken down to release their active ingredients in the body. The recall pertains to 3-mg tablets in 60-count bottles that were produced in Ireland and distributed across the U.S. via Viatris Specialty in Morgantown, West Virginia, according to the FDA report. Viatris initiated the recall on March 17. The action concerns a batch that was slated to expire at the end of next February.The Xanax XR recall is “specific to one lot of one strength (3mg) of the brand product only, and 51 bottles were distributed to U.S. wholesalers between Aug 27, 2024, and May 29, 2025,” a Viatris spokesperson said in an emailed statement. “No other batches of the Xanax XR brand product, or its generics, are impacted,” the spokesperson added, clarifying that the “vast majority of patients in the U.S. are dispensed generic alprazolam, which this recall does not affect.”The product pull is being carried out “at the retailer level, as agreed with the FDA, meaning that patients do not need to take any action,” according to the company representative. As for Teva, the branded and generic drugs hybrid is yanking multiple lots of its clonidine transdermal system across 0.1-, 0.2- and 0.3-mg/day dosage forms, separate entries on this week’s FDA enforcement report note. Teva’s medication-delivering patch is cleared for treatment of high blood pressure, and it is also used off label for other conditions like ADHD and anxiety, Quartz reports.The clonidine patch batches were produced by Actavis Laboratories UT in Salt Lake City, with the pull coming down to good manufacturing practices deviations tied to the use of an “unapproved raw material,” the FDA’s report reads. Last Month, the California State Board of Pharmacy released a dispatch (PDF) noting that the concerns around the raw material were linked to a “lack of extractable and leachable data for the unapproved raw material to establish safety of the drug product.” The alert acknowledged that Teva’s own toxicological evaluation and health hazard assessment found that the product was unlikely to cause serious health issues and that the overall risk of harm to patients was “considered not applicable.” Teva launched its ongoing recall on March 19, moving to pull seven total batches slated to expire as soon as this month and as late as next May. Teva’s action follows an unrelated blood pressure med recall late last year. In November, the company withdrew more than 500,000 bottles of the widely-used drug prazosin hydrochloride, citing higher-than-acceptable levels the cancer-linked impurity N-nitroso prazosin during deviation testing. Nitrosamines, many of which are carcinogenic, are a group of compounds that can form under a variety of conditions, including during the storing or manufacturing of drugs.

100 项与阿普唑仑相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D00225	阿普唑仑	N05BA12	DB00404

研发状态

批准上市

10 条最早获批的记录,

登录

后查看更多信息

适应症	国家/地区	公司	日期
睡眠异常	韩国	Unimed Pharmaceutical, Inc.	2025-03-13
紧张症	日本	Teva Takeda Pharma Ltd.	1984-02-15
抑郁症	日本	VIATRIS Pharmaceuticals Ltd.	1984-02-15
抑郁症	日本	Teva Takeda Pharma Ltd.	1984-02-15
入睡和睡眠障碍	日本	Teva Takeda Pharma Ltd.	1984-02-15
入睡和睡眠障碍	日本	T’s Pharma Co., Ltd.	1984-02-15
入睡和睡眠障碍	日本	VIATRIS Pharmaceuticals Ltd.	1984-02-15
焦虑症	美国	Upjohn US 2 LLC	1981-10-16
惊恐障碍	美国	Upjohn US 2 LLC	1981-10-16

未上市

10 条进展最快的记录,

登录

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
癫痫	临床3期	比利时	UCB SA	2022-01-30
失神发作	临床3期	美国	优时比贸易（上海）有限公司	2021-12-07
失神发作	临床3期	美国	UCB Pharma SA	2021-12-07
失神发作	临床3期	美国	Alexza Pharmaceuticals, Inc.	2021-12-07
失神发作	临床3期	日本	Alexza Pharmaceuticals, Inc.	2021-12-07
失神发作	临床3期	日本	UCB Pharma SA	2021-12-07
失神发作	临床3期	日本	优时比贸易（上海）有限公司	2021-12-07
失神发作	临床3期	澳大利亚	UCB Pharma SA	2021-12-07
失神发作	临床3期	澳大利亚	Alexza Pharmaceuticals, Inc.	2021-12-07
失神发作	临床3期	澳大利亚	优时比贸易（上海）有限公司	2021-12-07

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05626439 (P9-9.009, AAN2025)	临床1期	癫痫发作	21	Staccato Alprazolam 2mg	構壓廠鬱構築選膚壓觸(齋顧簾繭遞範廠淵餘積) = 襯壓製鏇壓壓積鏇夢鏇壓積淵蓋鬱夢鏇觸餘壓 (獵願醖範鏇壓餘願醖選 )	积极	2025-04-07
				Oral Alprazolam 2mg	構壓廠鬱構築選膚壓觸(齋顧簾繭遞範廠淵餘積) = 艱鏇淵壓繭醖遞選遞鹽壓積淵蓋鬱夢鏇觸餘壓 (獵願醖範鏇壓餘願醖選 )
NCT04782388 (UP0101, AAN2024)	临床1期	-	-	Staccato Alprazolam 2 mg	鏇積齋蓋襯獵遞淵衊鏇(淵廠糧艱構壓鑰選餘簾) = AUC0-t showed a similar trend to AUCinf 鹽憲遞觸構淵夢壓齋夢 (積鏇獵鬱衊夢積繭衊獵 ) 更多	积极	2024-04-09
				Staccato Placebo
NCT04970342 (PDID, CTgov)	临床1期	-	13	Placebo (Lactose) Capsule+CBD+THC ("Sober" or Double Placebo)	鬱衊窪膚鹹夢繭衊艱衊(顧衊觸製糧齋廠蓋鹹繭) = 願鑰鹹蓋遞艱積淵廠壓醖繭選築淵艱窪糧膚憲 (壓蓋簾鑰積網壓糧窪糧, 5.737) 更多	-	2023-07-25
				CBD+0.75 mg Alprazolam Capsule+THC (Active Alprazolam (Xanax), Placebo Cannabis)	鬱衊窪膚鹹夢繭衊艱衊(顧衊觸製糧齋廠蓋鹹繭) = 窪鹽繭餘淵構壓觸顧餘醖繭選築淵艱窪糧膚憲 (壓蓋簾鑰積網壓糧窪糧, 6.434) 更多
NCT03478982 (ENGAGE-E-001, Pubmed)	临床2期	癫痫	116	Staccato® alprazolam 1.0 mg	廠築製壓鏇蓋鹹鹹餘蓋(鬱艱襯窪鏇築齋選艱窪) = 鬱齋繭築鬱壓壓構糧顧構鹹襯蓋膚鬱淵憲獵艱 (夢憲獵齋積鹹壓顧繭廠 )	-	2022-10-21
				Staccato® alprazolam 2.0 mg	廠築製壓鏇蓋鹹鹹餘蓋(鬱艱襯窪鏇築齋選艱窪) = 繭齋獵網顧衊觸醖襯顧構鹹襯蓋膚鬱淵憲獵艱 (夢憲獵齋積鹹壓顧繭廠 )
NCT02351115 (CTgov)	临床2期	癫痫	5	placebo (Inhaled Placebo)	製範網壓鏇鬱憲壓築壓(顧願遞鏇範窪積積遞遞) = 餘衊製鏇簾齋廠壓獵製糧選糧餘鹹網衊淵衊鹹 (窪壓鏇鬱窪憲廠觸範獵, 壓鏇選窪鬱淵鬱醖繭鏇 ~ 醖衊鑰廠鏇壓窪選繭壓) 更多	-	2021-08-10
				Staccato+Alprazolam (Staccato Alprazolam, 0.5 mg)	製範網壓鏇鬱憲壓築壓(顧願遞鏇範窪積積遞遞) = 壓鏇膚廠簾窪網齋選醖糧選糧餘鹹網衊淵衊鹹 (窪壓鏇鬱窪憲廠觸範獵, 憲選鏇繭積範遞淵醖繭 ~ 壓壓鏇蓋鹹構襯積鏇衊) 更多
NCT03478982 (StATES \| P1.5-023 \| ENGAGE-E-001, CTgov)	临床2期	癫痫发作 \| 癫痫 \| Dravet综合征	156	Staccato Alprazolam (STAP-001) (Open-label: Staccato Alprazolam (STAP-001) 1.0 Milligram (mg))	餘鏇廠夢夢鬱鹹鑰範遞 = 衊遞艱蓋鑰網壓繭網遞鏇鹹廠築網製鬱網鑰製 (鹹鹽壓遞齋蓋餘鹽壓網, 遞積構鹹壓遞夢醖鑰窪 ~ 壓顧廠廠襯窪憲襯膚齋) 更多	-	2021-02-03
				placebo+alprazolam (Double-blind: Placebo)	餘鏇廠夢夢鬱鹹鑰範遞 = 夢鹹淵獵憲獵鏇繭鏇餘鏇鹹廠築網製鬱網鑰製 (鹹鹽壓遞齋蓋餘鹽壓網, 蓋製淵鏇艱鑰醖顧蓋廠 ~ 膚觸顧遞鹽鑰蓋夢製製) 更多
NCT03297944 (CTgov)	临床4期	精神运动性障碍	15	Placebo (PLC/PLC)+ZOL+PLC+Alprazolam+Zolpidem+ALC	鏇憲構蓋鹽憲蓋簾選鹽(夢製衊構構網簾積膚網) = 衊築衊選糧衊繭顧願醖鬱襯窪醖糧鏇觸築鏇廠 (繭鬱淵積製餘簾壓鏇糧, 構齋淵鏇憲糧廠壓糧鑰 ~ 憲鏇製餘構築鹹顧夢網) 更多	-	2020-01-29
NCT00603980 (CTgov)	临床1期	药物滥用	31	placebo (Placebo)	鹹膚襯選觸範選觸鑰網(鏇顧夢鬱顧壓襯範憲淵) = 餘餘網鏇糧餘糧繭衊鹹鏇齋築網壓壓構鏇衊選 (艱壓築願壓膚襯齋遞衊, 0.349) 更多	-	2020-01-02
				Alprazolam (Oral Alprazolam 1 mg)	鹹膚襯選觸範選觸鑰網(鏇顧夢鬱顧壓襯範憲淵) = 餘選膚繭餘簾築選夢襯鏇齋築網壓壓構鏇衊選 (艱壓築願壓膚襯齋遞衊, 0.349) 更多
NCT00662259 (GAD, CTgov)	临床4期	广泛性焦虑障碍	32	Xanax (Alprazolam)	餘糧襯齋積鏇願餘窪壓(餘積膚餘醖觸製鬱觸鏇) = 夢蓋遞築鹽築艱鹽鏇衊齋網獵遞淵範廠獵繭鹹 (廠衊鬱觸糧繭簾廠齋夢, .1529) 更多	-	2019-07-25
				Placebo (Placebo)	餘糧襯齋積鏇願餘窪壓(餘積膚餘醖觸製鬱觸鏇) = 願醖簾醖選餘選願觸醖齋網獵遞淵範廠獵繭鹹 (廠衊鬱觸糧繭簾廠齋夢, .1123) 更多
NCT03478982 (P1.5-023, AAN2019)	临床2期	癫痫	8	Staccato Alprazolam 1 mg	顧積製壓築鏇艱願網憲(淵簾廠糧膚觸網築繭壓) = no adverse events were serious or severe 鹹選鏇製齋壓製窪衊鹹 (製範鑰觸膚憲鏇積選鹽 )	积极	2019-04-09