National, Multicenter, Open, Single-arm, Phase III Clinical Trial to Evaluate the Safety and Efficacy of Zolpidem in the Long-Term Treatment of Insomnia.

The purpose of this study is to evaluate the safety and efficacy of sublingual zolpidem during the long-term treatment of insomnia.

开始日期2024-06-01

申办/合作机构

EMS Co. Ltd.

NCT06084130 / Not yet recruiting临床4期

The Effect of Zolpidem on CPAP Acclimatization in Patients With OSA: A Crossover, Randomized, Double-blinded, Placebo-controlled Trial

Obstructive sleep apnea (OSA) is a sleep disorder characterized by a cessation or significant decrease in airflow during sleep. CPAP is the preferred therapy and has high effectiveness at all levels of OSA severity. It acts as a pneumatic splint to maintain upper airway patency during sleep, preventing the soft tissues from collapsing. However, the patient's compliance continues to be an issue. One of the main contributors to CPAP therapy failure is difficulty falling asleep. To aid in the machine's adaptation, hypnotic medicine was administered.

开始日期2023-10-15

申办/合作机构

Siriraj Hospital

JPRN-jRCT2032230353 / Recruiting临床2期

A two-arm, randomized, open-label, multicenter exploratory study to evaluate the efficacy and safety of a cognitive behavioral therapy application (IIIP MED: Sleepy Med) for patients with insomnia, using zolpidem tartrate as a control.

开始日期2023-09-21

申办/合作机构-

100 项与酒石酸唑吡坦相关的临床结果

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100 项与酒石酸唑吡坦相关的转化医学

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100 项与酒石酸唑吡坦相关的专利（医药）

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项与酒石酸唑吡坦相关的文献（医药）

2024-12-01·Sleep Medicine: X

Transitioning insomnia patients from zolpidem to lemborexant: A multicenter, open-label study evaluating a next-dose transition approach to insomnia pharmacotherapy

Article

作者: Ahmad, Maha ; Kelly, James ; Moline, Margaret ; Amchin, Jess ; Kumar, Dinesh ; Malhotra, Manoj ; Perdomo, Carlos ; Montano, C Brendan

ObjectiveFew clinical studies have assessed real-world abrupt transitioning between insomnia medications. This study assessed strategies for directly transitioning patients from zolpidem tartrate (ZOL) immediate/extended release to the dual orexin receptor antagonist, lemborexant (LEM).MethodsThis randomized, open-label, multicenter study (Study 312; E2006-A001-312) enrolled 53 adults age ≥18 years with insomnia disorder and ≥1-month history of intermittent (3-4 nights/week) or frequent (≥5 nights/week) ZOL use. Subjects recorded their ZOL use in a 3-week Pretreatment Phase, followed by a 2-week Treatment Phase (TRT; Titration) during which ZOL was discontinued. Intermittent ZOL users transitioned to LEM 5 mg (LEM5), Cohort 1, and frequent ZOL users were randomized 1:1 to LEM5, Cohort 2A, or LEM 10 mg (LEM10), Cohort 2B. One dose adjustment was permitted during the TRT. Subjects completing the TRT could continue LEM in the 12-week Extension Phase (EXT). The primary outcome was proportion of subjects who successfully transitioned and remained on LEM at the end of the TRT.ResultsMost subjects (43 [81.1 %]) successfully transitioned to LEM (9 [90 %], 17 [81.0 %], and 17 [77.3 %] in Cohorts 1, 2A, and 2B, respectively). By the end of the EXT, 66.7 % in Cohort 1 and 60.0 % in Cohort 2A up-titrated to LEM10, whereas 41.2 % in Cohort 2B down-titrated to LEM5; 61.0 % were receiving LEM10 at study end. At the end of the TRT, more subjects taking LEM reported that it helped them return to sleep after waking, compared with those taking ZOL (71.7 % vs. 49.1 %). There were no important differences between treatments regarding how subjects reported feeling as they fell asleep. Most of the treatment-emergent adverse events with LEM were mild in severity.ConclusionsMost subjects transitioned successfully to LEM from ZOL (intermittent or frequent use). LEM was well tolerated.

2024-05-01·EXPLORE

Intervention effect of electroacupuncture therapy on drug reducing and discontinuation of insomnia patients with long-term excessive use of zolpidem

Article

作者: Zhang, Haixiao ; Lin, Zhichuan ; Rong, Haiqing ; Xiong, Sangsang ; Chen, Xilong

OBJECTIVETo explore therapeutic interventions after drug withdrawal reduction for insomnia patients who used zolpidem excessively for a long time.METHODSA total of 86 patients with simple insomnia were randomly rolled into treatment (Tre) group (electroacupuncture therapy under low-dose zolpidem+relaxation treatment intervention, n=40) and control (Ctrl) group (low-dose zolpidem+relaxation treatment intervention, n=40), all of which received treatment and intervention for four weeks.RESULTSAs a result, after the dosage of zolpidem was gradually reduced, the deep sleep time of patients in the two groups was reduced in the first stage. However, with the prolongation of treatment time, the reduction trend of the two groups was gradually alleviated, but no great difference was found between groups (P>0.05). In the second stage of treatment, the deep sleep time of patients in the two groups gradually recovered and increased, and that in Tre group was greater than that in Ctrl group, and the upward trend was significant but differed slightly between groups (P>0.05). After treatment, the insomnia severity index (ISI) scores of the two groups gradually decreased, and that in Tre group was drastically inferior to those of Ctrl group on days 14 and 28 after treatment (both Ps<0.05).CONCLUSIONSIn summary, electroacupuncture therapy can effectively alleviate the effect of zolpidem on sleep quality in patients with insomnia after drug discontinuation and promote the recovery of deep sleep time in patients, thereby alleviating the side effects and drug dependence of patients.

2024-05-01·Journal of the Neurological Sciences

Successful treatment of cranial dystonia using a Zolpidem+Melatonin combination: A video case-series

Article

作者: Barad, Narendrakumar H ; Mulroy, Eoin

INTRODUCTIONCranial dystonias (CrD) are challenging to treat. Oral pharmacotherapy is often sub-optimal, while delicate anatomy and limited availability of skilled botulinum toxin injectors makes this approach risky, and often difficult to access; neurosurgical options e.g. deep brain stimulation, are high-risk in the elderly populations most affected. We observed significant improvement in CrD in 2 patients prescribed Zolpidem+Melatonin combination treatment for insomnia, and therefore trialled this treatment in a further 4 patients with CrD.METHODSSix patients were treated with Zolpidem+Melatonin. Pre- and post-treatment videotaped clinical examinations were blindly rated by an independent assessor (EM) and scored using the 'Facial and Oral Movements' section of the abnormal involuntary movements scale (AIMS), as well as the Jankovic rating scale for blepharospasm.RESULTSDystonic features, as measured by the abnormal involuntary movements scale (AIMS) improved by an average of 75% after treatment (6.5±3.1 before treatment to 1.7 +/- 0.8 after treatment). Improvements were also observed in blepharospasm severity scores, and in cervical dystonic features.CONCLUSIONZolpidem+Melatonin combination treatment represents a safe and effective treatment for CrD. Low cost and wide availability makes it an attractive option, particularly in resource-constrained healthcare settings, or in patients who have failed, or lack access to alternatives.

项与酒石酸唑吡坦相关的新闻（医药）

2024-04-10

·Science Daily

Research uncovers differences between men and women in sleep, circadian rhythms and metabolism

A new review of research evidence has explored the key differences in how women and men sleep, variations in their body clocks, and how this affects their metabolism. A new review of research evidence has explored the key differences in how women and men sleep, variations in their body clocks, and how this affects their metabolism. Published in Sleep Medicine Reviews, the paper highlights the crucial role sex plays in understanding these factors and suggests a person's biological sex should be considered when treating sleep, circadian rhythm and metabolic disorders. Differences in sleep The review found women rate their sleep quality lower than men's and report more fluctuations in their quality of sleep, corresponding to changes throughout the menstrual cycle. "Lower sleep quality is associated with anxiety and depressive disorders, which are twice as common in women as in men," says Dr Sarah L. Chellappa from the University of Southampton and senior author of the paper. "Women are also more likely than men to be diagnosed with insomnia, although the reasons are not entirely clear. Recognising and comprehending sex differences in sleep and circadian rhythms is essential for tailoring approaches and treatment strategies for sleep disorders and associated mental health conditions." The paper's authors also found women have a 25 to 50 per cent higher likelihood of developing restless legs syndrome and are up to four times as likely to develop sleep-related eating disorder, where people eat repeatedly during the night. Meanwhile, men are three times more likely to be diagnosed with obstructive sleep apnoea (OSA). OSA manifests differently in women and men, which might explain this disparity. OSA is associated with a heightened risk of heart failure in women, but not men. Sleep lab studies found women sleep more than men, spending around 8 minutes longer in non-REM (Rapid Eye Movement) sleep, where brain activity slows down. While the time we spend in NREM declines with age, this decline is more substantial in older men. Women also entered REM sleep, characterised by high levels of brain activity and vivid dreaming, earlier than men. Variations in body clocks The team of all women researchers from the University of Southampton in the UK, and Stanford University and Harvard University in the United States, found differences between the sexes are also present in our circadian rhythms. They found melatonin, a hormone that helps with the timing of circadian rhythms and sleep, is secreted earlier in women than men. Core body temperature, which is at its highest before sleep and its lowest a few hours before waking, follows a similar pattern, reaching its peak earlier in women than in men. Corresponding to these findings, other studies suggest women's intrinsic circadian periods are shorter than men's by around six minutes. Dr Renske Lok from Stanford University, who led the review, says: "While this difference may be small, it is significant. The misalignment between the central body clock and the sleep/wake cycle is approximately five times larger in women than in men. Imagine if someone's watch was consistently running six minutes faster or slower. Over the course of days, weeks, and months, this difference can lead to a noticeable misalignment between the internal clock and external cues, such as light and darkness. "Disruptions in circadian rhythms have been linked to various health problems, including sleep disorders, mood disorders and impaired cognitive function. Even minor differences in circadian periods can have significant implications for overall health and well-being." Men tend to be later chronotypes, preferring to go to bed and wake up later than women. This may lead to social jet lag, where their circadian rhythm doesn't align with social demands, like work. They also have less consistent rest-activity schedules than women on a day-to-day basis. Impact on metabolism The research team also investigated if the global increase in obesity might be partially related to people not getting enough sleep -- with 30 per cent of 30- to 64-year-olds sleeping less than six hours a night in the United States, with similar numbers in Europe. There were big differences between how women's and men's brains responded to pictures of food after sleep deprivation. Brain networks associated with cognitive (decision making) and affective (emotional) processes were twice as active in women than in men. Another study found women had a 1.5 times higher activation in the limbic region (involved in emotion processing, memory formation, and behavioural regulation) in response to images of sweet food compared to men. Despite this difference in brain activity, men tend to overeat more than women in response to sleep loss. Another study found more fragmented sleep, taking longer to get to sleep, and spending more time in bed trying to get to sleep were only associated with more hunger in men. Both women and men nightshift workers are more likely to develop type 2 diabetes, but this risk is higher in men. Sixty-six per cent of women nightshift workers experienced emotional eating and another study suggests they are around 1.5 times more likely to be overweight or obese compared to women working day shifts. The researchers also found emerging evidence on how women and men respond differently to treatments for sleep and circadian disorders. For example, weight loss was more successful in treating women with OSA than men, while women prescribed zolpidem (an insomnia medication) may require a lower dosage than men to avoid lingering sleepiness the next morning. Dr Chellappa added: "Most of sleep and circadian interventions are a newly emerging field with limited research on sex differences. As we understand more about how women and men sleep, differences in their circadian rhythms and how these affect their metabolism, we can move towards more precise and personalised healthcare which enhances the likelihood of positive outcomes." The research was funded by the Alexander Von Humboldt Foundation, the US Department of Defense and the National Institute of Health.

2024-03-23

·药融圈

【药融咨询】掘金中国失眠创新药蓝海，谁领风骚？

▲5月30-31日第八届广州生物医药创新者峰会扫码立即报名注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。3月21日是世界睡眠日，人的生命约有1/3是在睡眠中度过的，睡眠与健康密切相关。睡眠障碍已经成为影响全球人类健康的一个突出问题，失眠症是最常见的睡眠障碍，流行病学研究显示，中国有45.4%的被调查者在过去1个月中曾经历过不同程度的失眠。长期失眠影响个体的正常生活和工作，增加罹患各种健康问题的风险。严重的睡眠缺失将降低患者的工作效率和警觉水平，甚至有可能引发恶性意外事故，造成巨大损失。目前催眠镇静剂市场规模超48亿，临床仍有较大的未满足需求失眠的治疗方法主要包括心理治疗和药物治疗。心理治疗是首选的治疗方法，但因难以获得和成本高昂等原因应用不广。药物治疗主要包括苯二氮卓类受体激动剂（benzodiazepine receptor agonists，BZRAs）、褪黑素受体激动剂、食欲素受体拮抗剂和具有催眠效应的抗抑郁药物。据药融云数据显示，2022年失眠化药在全国院内市场销售额超48亿元。目前国内失眠化药多为老品种(地达西尼上市前我国失眠行业近16年没有新药获批)，多家仿制药上市，价格偏低，导致国内市场规模始终保持较低水平。2018-2023年全国院内镇静催眠药物市场规模（数据截至2023Q3）截图来源：药融云全国院内销售数据库BZRAs：分为苯二氮卓类药物和非苯二氮卓类药物。BZDs于20世纪60年代开始使用，可非选择性激动γ-氨基丁酸受体A上不同的α1亚基，具有镇静、催眠、抗焦虑、肌肉松弛和抗惊厥的药理作用。20世纪80年代以来，以唑吡坦（zolpidem）和右佐匹克隆（eszopiclone）为代表的non-BZDs先后应用于失眠的临床治疗，它们对γ-氨基丁酸受体A上的α1亚基选择性激动，主要发挥催眠作用，不良反应较BZDs轻，已经逐步成为治疗失眠的临床常用药物。褪黑素和褪黑素受体激动剂：褪黑素参与调节睡眠觉醒周期，可以改善时差变化所致睡眠觉醒障碍、睡眠觉醒时相延迟障碍等昼夜节律失调性睡眠觉醒障碍，但使用普通褪黑素治疗失眠尚无一致性结论，故不推荐将普通褪黑素作为催眠药物使用。食欲素受体激动剂：食欲素又称下丘脑分泌素，具有促醒作用。针对食欲素双受体发挥抑制作用的拮抗剂苏沃雷生（suvorexant），已获得美国食品药品监督管理局批准用于治疗成人失眠（入睡困难和睡眠维持障碍）。其发挥催眠作用的靶点不同于其他催眠药，现有研究数据显示其具有较好的临床疗效和耐受性。抗抑郁药物：部分抗抑郁药具有镇静作用，在失眠伴随抑郁、焦虑心境时应用较为有效。临床上常用具有镇静催眠作用的药物中国失眠创新药一片蓝海，空间巨大自2007年江苏天士力帝益药业的右佐匹克隆上市以来，中国创新失眠药领域一直面临长期空白，直到2023年浙江京新药业的地达西尼上市后，才打破国内16年来没有治疗失眠障碍创新药上市的局面。2010年以来中国上市失眠创新药Dimdazenil（地达西尼）地达西尼是治疗失眠的1类小分子新药，为为γ-氨基丁酸A型（GABAA）受体的部分正向别构调节剂，通过部分激活GABAA受体，产生促进睡眠的作用。与传统失眠药物相比具有GABAA受体部分激动，避免过度抑制，日间损害和不良反应更小；1h达峰，快速诱导睡眠；半衰期4h，有效维持生理睡眠；主要通过FMO代谢，显著降低药物相互作用风险的特点。截图来源：药融云全球药物研发数据库地达西尼最早由Roche研发，随后德国公司Evotec获得全球独占权并将其开发用于治疗失眠症，于2008年在国外完成I、II期临床。2010年京新药业与Evotec签署协议，获得地达西尼在中国的独家专利许可和开发权。地达西尼在中国的获批上市是基于JX202001-EVT201-III一项评价EVT201胶囊对比安慰剂在失眠障碍患者中疗效和安全性的多中心、随机、双盲III期临床试验。基于统计分析模型，以第13/14晚PSG监测的平均TST值为反应变量，基线TST、年龄为协变量，组别为自变量计算，EVT201胶囊组相对于安慰剂组的优效性成立，EVT201胶囊可快速起效、提高睡眠效率，同时改善次日嗜睡等残留效应。食欲素是一种由下丘脑自然产生的神经肽，食欲素和其受体共同构成的食欲素系统能够刺激唤醒中枢神经系统的目标神经元，然后释放几种促进清醒的化学物质。近年来食欲素及其拮抗剂的研究越来越受到重视，已发现食欲素拮抗剂对失眠具有治疗作用。目前中国在研失眠新药中就是主要以食欲素受体（OX1R、OX2R）为主。中国在研失眠创新药Lemborexant（莱博雷生）Lemborexant是卫材研发的一款双重食欲素拮抗小分子药物，通过竞争性结合OX1R、OX2R，抑制食欲素神经传递，调节睡眠-觉醒节律。双食欲素神经肽信号系统在觉醒中有重要作用，作为一种竞争性拮抗剂，莱博雷生对OX2R具有更强的抑制作用，可抑制REM和非REM睡眠驱动，从而为患者提供更快的睡眠开始、更好的睡眠维持。截图来源：药融云全球药物研发数据库一项为期12个月的全球多中心、随机双盲、平行组的III期临床实验结果显示，莱博雷生与安慰剂相比，对于所有睡眠参数都观察到了显著的益处。与唑吡坦相比，莱博雷生疗法显著改善了睡眠的维持时间，并缩短了下半夜的觉醒时间。同时，相比苯二氮卓类药物的戒断反应，莱博雷生没有出现相关的戒断反应，这表明服药达一年不会产生躯体依赖。Fazamorexant（YZJ-1139）Fazamorexant是扬子江药业子公司上海海雁医药的一款双重食欲素抗体拮抗药物，通过抑制食欲素受体从而改善睡眠，包括加快睡眠速度和延长睡眠时间。同时，fazamorexant拥有吸收快速和半衰期适中的优势，可以达到快速起效和次日残留效应低的效果。截图来源：药融云全球药物研发数据库2021年5月举办的亚洲睡眠医学会第三届睡眠大会（ASSM 2021）公布的该药的Ⅱ期临床试验结果显示，YZJ-1139可剂量相关地改善睡眠效率，各剂量组均可以改善受试者睡眠效率至健康水平。同时，与安慰剂组相比，YZJ-1139未出现明显的中枢神经系统副作用，第二日残留效应低。YZJ-1139 Ⅱ期临床试验的积极结果，为Ⅲ期临床试验提供了有力依据。Daridorexant hydrochloride（达利雷生）Daridorexant是由Idorsia研发的双重食欲素拮抗药。Daridorexant是通过阻断食欲素受体与促觉醒神经肽食欲素的结合，抑制过度活跃的不眠状态。2022年11月先声药业与Idorsia签订独家授权协议，先声药业获得大中华地区开发和商业化独家权益。截图来源：药融云全球药物研发数据库发表于《柳叶刀神经病学》的海外III期临床数据显示，在接受1个月、3个月治疗后，达利雷生较安慰剂显著改善了患者入睡、睡眠维持及自我报告的总睡眠时间，不改变睡眠结构，且未发现依赖性、反跳性失眠、戒断症状和药物滥用证据，显著区分于传统镇静催眠药苯二氮卓类药物。版权声明：本文转自药融云，如不希望被转载的媒体或个人可与我们联系，我们将立即删除活动推荐 8月 • 第六届CMC-China博览会关键词：生物药、小分子创新药、药学CMC&创新&CXO、原辅包（点击下方图片查看详情）▼【关于药融圈】药融圈PRHub旨在帮助生物医药科技型企业进行品牌推广及商务拓展服务，针对客户的真实需求制定系统化解决方案，通过“翻译-降维-场景化”将客户的品牌信息以直白易懂的方式被公众知悉，同时在流量渠道覆盖100万+垂直用户基础上实现合作目的，帮助合作伙伴完成从品牌开始到商务为终的闭环营销服务。我们已经完成了数十场线下1000人规模的生物医药研发类会议，涵盖小分子新药，大分子新药，改良型新药，BD跨境交易等多个领域，服务了百余家上市/独角兽/生物技术/制药企业。

上市批准

2024-03-21

·PRNewswire

MIRA Pharmaceuticals Welcomes Dr. Itzchak Angel, former Head of Pharmacology at Synthelabo, as Chief Scientific Advisor

A seasoned pharmaceutical industry executive with over 40 years at the forefront of innovation, including at Synthelabo (acquired by Sanofi-Aventis), Dr. Angel aims to propel MIRA Pharmaceuticals' mission to tackle unmet needs in neurologic and neuropsychiatric disorders MIAMI, March 21, 2024 /PRNewswire/ -- MIRA Pharmaceuticals Inc. (NASDAQ: MIRA) ("MIRA" or the "Company"), an innovative pre-clinical-stage pharmaceutical company focused on the development of novel treatments for neurologic and neuropsychiatric disorders, proudly announces the appointment of distinguished pharmaceutical executive Dr. Itzchak Angel as its new Chief Scientific Advisor. Dr. Angel brings over 40 years of preclinical, clinical and regulatory acumen to MIRA. He has significantly contributed to the research, development and regulatory approval of groundbreaking medications over his remarkable career. Notably, at Synthelabo (later acquired by Sanofi-Aventis), Dr. Angel played a pivotal role in advancing several drugs, including Litoxetine for depression and Deriglidole for Type-II diabetes, from conception to Investigational New Drug (IND) applications and clinical trials. Additionally, his activities contributed to the development and marketing of Mizollen (mizolastine), Xatral (alfuzosin) and Ambien (zolpidem). Beyond his tenure at Synthelabo, Dr. Angel has made significant advancements in the pharmaceutical industry, including impactful work at several companies, such as Teva, where he was an external consultant in strategic drug development and innovation. He has also founded and served as an officer and director of several pharma start-ups. He was Vice President for Research and Development at D-Pharm Biopharmaceuticals, where he advanced DP-VPA into the human trials for epilepsy and bi-polar disorders (later licensed to Shire Pharmaceuticals) and the chelator DP-b99 for stroke (which advanced to phase-III clinical trials). Dr Angel also served as President and Chief Executive Officer of stem-cell company Accellta; Vice President for Research and Development at Proteologics Ltd and at Galmed Pharmaceuticals (where he advanced Aramchol through an IND to phase-II clinical trials); Head of Discovery and Research and Development Concenter Biopharma (where he advanced Zygosid-50 towards clinical trials) and others. His experience extends through various therapeutic areas and has led to the successful research and development of several drugs, highlighting his vast expertise and ability to bring critical treatments through the regulatory process and ultimately to market. Dr. Angel's extensive background in drug development, from preclinical research through clinical trials and market introduction, positions him well to contribute to MIRA's scientific endeavors. His leadership is expected to accelerate MIRA's research and development pipeline, particularly in advancing its flagship compounds, including the innovative Ketamir-2 for treatment-resistant depression. "We are truly honored to have Dr. Angel on our team," stated Erez Aminov, Chairman & CEO of MIRA. "His distinguished career across the pharmaceutical industry, from start-ups to big pharma, his exceptional scientific skills and his dedication to pharmaceutical innovation will help propel our promising pre-clinical drug candidates forward. His expertise will be invaluable as we move our product candidates towards INDs and through the clinical trial and regulatory approval process and also as we seek to expand our product candidate portfolio." Dr. Angel stated, "I am thrilled to contribute to MIRA's pioneering efforts in addressing the challenges in neurologic and neuropsychiatric disorders. I look forward to applying my experience and insights to help advance MIRA." About MIRA Pharmaceuticals, Inc. MIRA Pharmaceuticals, Inc. (Nasdaq: MIRA) is a pre-clinical-stage pharmaceutical development company with two neuroscience programs targeting a broad range of neurologic and neuropsychiatric disorders. The Company's novel oral pharmaceutical marijuana, MIRA-55, is currently under investigation for treating adult patients suffering from anxiety and cognitive decline, often associated with early-stage dementia. MIRA-55, if approved by the FDA, could mark a significant advancement in addressing various neuropsychiatric, inflammatory, and neurologic diseases and disorders. MIRA also holds the exclusive U.S., Canadian and Mexican rights for Ketamir-2, a novel, patent pending novel oral ketamine analog under investigation to potentially deliver ultra-rapid antidepressant effects, providing hope for individuals battling treatment-resistant depression, major depressive disorder with suicidal ideation and post-traumatic stress disorder. The U.S. Drug Enforcement Administration's scientific review of Ketamir-2 concluded that it would not be considered a controlled substance or listed chemical under the Controlled Substances Act and its governing regulations. Additional information about the Company is available at: . Cautionary Note Regarding Forward-Looking Statements This press release and the statements of the Company's management related thereto contains "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as "Aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. These forward-looking statements include, without limitation, statements regarding Ketamir-2's potential in treating certain mental health conditions. Any forward-looking statements in this press release are based on the Company's current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond the Company's control) that could cause actual results (including the anticipated benefits Dr. Angel's services to the Company) to differ materially and adversely from those set forth in or implied by such forward-looking statements. These and other risks concerning the Company's programs and operations are described in additional detail in its registration statement on Form S-1 and other SEC filings, which are on file with the SEC at and the Company's website at . The Company explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. SOURCE MIRA Pharmaceuticals, Inc.

高管变更并购

100 项与酒石酸唑吡坦相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00706	酒石酸唑吡坦	N05CF02	DB00425

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
入睡和睡眠障碍	美国	Sanofi-Aventis U.S. LLC	1992-12-16

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
注意缺陷障碍伴多动	临床2期	美国	Sanofi	2006-04-01
躁郁症	临床2期	日本	Astellas Pharma, Inc.	2006-03-01
精神分裂症	临床2期	日本	Astellas Pharma, Inc.	2006-03-01
注意缺陷障碍伴多动	药物发现	加拿大	Sanofi	2006-04-01

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


WSC2023	N/A	入睡和睡眠障碍	-	Zolpidem 10 mg	(構範獵襯餘願齋淵糧積) = 糧獵築壓廠簾鏇衊範廠鏇襯積遞衊衊壓襯衊繭 (糧鹽襯醖襯獵糧廠鑰觸 )	-	2023-10-22
NCT04720547 (Pubmed \| Sleep Breath)	临床4期	睡眠-觉醒节律障碍 \| 中枢性睡眠呼吸暂停	14	Zolpidem 5 mg	(鹹積衊鏇繭遞醖糧製網) = 簾鑰蓋醖廠築獵築構淵壓鹽醖醖壓壓願鑰齋積 (積膚膚遞積製觸願艱艱, 4.4) 更多	积极	2022-03-14
				No medication	(鹹積衊鏇繭遞醖糧製網) = 遞觸蓋艱衊選觸鑰鹹齋壓鹽醖醖壓壓願鑰齋積 (積膚膚遞積製觸願艱艱, 7.7) 更多
NCT03056053;NCT03545191 (Pubmed)	临床3期	入睡和睡眠障碍	-	Zolpidem	(齋觸憲蓋糧餘範蓋鏇壓) = 繭齋製廠築願獵壓窪顧築遞觸積獵簾範襯觸鹹 (艱範廠鏇鑰窪簾淵繭壓 )	-	2024-02-01
				Daridorexant	(齋觸憲蓋糧餘範蓋鏇壓) = 憲觸齋遞壓積壓鏇繭鹽築遞觸積獵簾範襯觸鹹 (艱範廠鏇鑰窪簾淵繭壓 )
N4.001 (AAN2022)	N/A	意识障碍	75	Zolpidem 30 mg/day	(膚鏇網網願獵願淵鑰選) = 鏇醖憲膚醖獵糧壓鹽獵憲廠齋選艱膚築繭鏇製 (壓遞獵醖淵鏇觸齋遞範 ) 更多	-	2022-05-03
ACTRN12612001004853 (Pubmed \| Clin Chest Med)	N/A	阻塞性睡眠呼吸暂停综合征	21	Temazepam 10mg	製願觸範壓願糧膚遞淵(憲廠鬱鏇夢構餘齋獵淵) = 願壓簾範醖築繭壓窪願膚範鏇蓋淵獵廠衊獵積 (願憲憲築築蓋窪顧鹹範 )	-	2017-12-01
				Zolpidem 10mg	製願觸範壓願糧膚遞淵(憲廠鬱鏇夢構餘齋獵淵) = 構窪鏇糧鹹襯願鏇觸襯膚範鏇蓋淵獵廠衊獵積 (願憲憲築築蓋窪顧鹹範 )
WSC2023	N/A	入睡和睡眠障碍	716	Lemborexant	遞選繭願醖壓夢艱顧窪(網襯糧鹹糧憲網憲蓋齋) = 獵網獵鏇憲顧艱淵餘膚繭築簾積壓選餘獵製窪 (範衊遞顧願餘願築窪築 )	积极	2023-10-23
				Trazodone	遞選繭願醖壓夢艱顧窪(網襯糧鹹糧憲網憲蓋齋) = 鬱觸窪遞淵膚獵夢範製繭築簾積壓選餘獵製窪 (範衊遞顧願餘願築窪築 )
WSC2023	N/A	发作性睡病	-	Sodium oxybate	襯選簾襯夢選糧餘鏇遞(範鑰觸蓋鏇獵夢繭齋醖) = 蓋觸鏇窪齋繭積醖膚襯鹽願網觸壓選窪夢壓淵 (窪遞鏇窪鹽鑰鏇繭範淵 ) 更多	-	2023-10-22
				Zolpidem	範積窪築壓繭網繭願淵(憲構膚齋顧鏇願齋構廠) = 鏇夢繭範製鏇網壓觸壓餘膚積鹹構選鏇鹽網繭 (憲淵鏇簾餘鬱積遞獵齋 )
NCT01896336 (Pubmed \| Braz J Psychiatry)	临床4期	入睡和睡眠障碍	85	Oral zolpidem 10 mg	(繭範簾糧顧廠淵淵蓋遞) = Mild-to-moderate adverse events were reported by 25% of the participants, including headache, sleepiness, and dizziness 膚簾齋糧鬱觸顧糧淵齋 (餘衊壓鬱構憲鑰簾鬱網 )	-	2020-04-01
				Sublingual zolpidem 5 mg
NCT01651442 (Pubmed \| JAMA Psychiatry)	N/A	入睡和睡眠障碍	211	Zolpidem	(艱積窪襯選鏇糧窪廠壓) = 網顧獵襯衊構願範淵製齋鬱糧鹹構醖遞壓鏇築 (壓範膚糧鏇顧鹽鹹夢簾, NA)	-	2020-11-01
ANA2022	N/A	-	-	Zolpidem 5 mg	網膚簾鹹繭夢遞範網鹹(齋獵鬱範蓋衊製製壓齋) = 範鬱艱繭顧艱淵鑰夢鹽顧廠憲壓齋齋淵夢糧積 (夢淵構膚構餘廠夢齋觸 )	-	2022-09-14