预约演示

更新于：2025-05-09

Atomoxetine Hydrochloride

盐酸托莫西汀

更新于：2025-05-09

概要

基本信息

简介托莫西汀是一种由 Eli Lilly 研制的小分子药物，于 2002 年获得了首个医学批准。该药物的作用是抑制大脑中的去甲肾上腺素再摄取，诱导突触间隙中去甲肾上腺素水平升高。该药物的主要适应症是注意力缺陷多动障碍 (ADHD)，这是一种以注意力不集中、冲动和多动为特征的疾病。托莫西汀被认为可以通过增强患有多动症的人的注意力和注意力来发挥作用。综合考虑，托莫西汀复杂的作用机制和临床适应症使其成为 ADHD 患者的一种有价值的治疗选择。

药物类型

小分子化药

别名

(-)-Tomoxetine、Atomoxetine、Atomoxetine hydrochloride (JAN/USP)

+ [9]

靶点

NET

作用方式

抑制剂

作用机制

NET抑制剂(去甲肾上腺素转运蛋白抑制剂)

治疗领域

其他疾病

在研适应症

注意缺陷障碍伴多动

非在研适应症

阿尔茨海默症注意缺陷和破坏性行为障碍注意缺陷障碍+ [10]

原研机构

Eli Lilly & Co.

在研机构

Eli Lilly & Co.Eli Lilly Australia Pty Ltd.Lilly SA

+ [1]

非在研机构-

权益机构

Hyloris Pharmaceuticals SAKYE Pharmaceuticals, Inc.

最高研发阶段批准上市

首次获批日期

美国 (2002-11-26),

注意缺陷障碍伴多动

最高研发阶段(中国)批准上市

特殊审评孤儿药 (美国)、优先审评 (中国)

登录后查看时间轴

结构/序列

分子式C17H22ClNO

InChIKeyLUCXVPAZUDVVBT-UNTBIKODSA-N

CAS号82248-59-7

关联

234

项与盐酸托莫西汀相关的临床试验

NCT06573970

/ Not yet recruiting临床4期IIT

Atomoxetine Effect on Attention, Executive Function, and Quality of Life in Veterans With Posttraumatic Stress Disorder

Attention deficits (AD) frequently co-occur with posttraumatic stress disorder (PTSD). The presence of AD is associated with greater PTSD clinical severity and poorer clinical outcomes. Knowledge regarding the mechanism underlying this association is limited, though the emerging evidence has indicated that executive function deficit (EFD) is strongly correlated with AD and PTSD symptoms. While treatments developed for PTSD have existed for years, a substantial portion of individuals do not fully respond to conventional treatment. Accumulating evidence suggest that attention deficit (AD) and EFD may be a driving force for PTSD treatment resistance. However, treatment of executive impairment in PTSD is very limited. As a result, untreated co-occurring AD and EFD in PTSD poses severe negative impacts on patients' functional recovery, treatment outcomes, and quality of life (QoL). Given that up to 50% of patients do not respond well to the first-line pharmacological PTSD treatments, it is imperative to seek novel treatment strategies to improve EF that may improve both standard treatment response and QoL, social function. The proposed study directly addresses this knowledge gap by testing the efficacy of atomoxetine (ATX) in improving EF and attention among Veterans with PTSD, which will further improve Veterans' QoL and social function. ATX represents a promising novel candidate pharmacotherapy for individuals with PTSD. ATX is a non-stimulant selective norepinephrine reuptake inhibitor (SNRI), approved by the FDA for the treatment of ADHD. Studies suggest that ATX, unlike stimulants, lacks addictive properties and shows efficacy in the treatment of comorbid depression and anxiety, which is ideal in the treatment of PTSD. Data from the investigators' preliminary study provides encouraging support for the therapeutic potential of ATX in improving EF in Veterans with comorbid PTSD/ADHD. The investigators' recent research uncovered a higher rate of ADHD among Veterans with PTSD, and the comorbid AD symptoms were correlated with PTSD severity and poorer treatment outcomes. Treatment with ATX showed significant symptoms reduction in ADHD and improvement in inhibitory function in Veterans with ADHD/PTSD. In the proposed study, the investigators will focus on ATX in improvement of EF and attention, and further psycho-social life function and QoL. The investigators will (1) employ a randomized, double-blind design that will consist of 12 weeks of treatment with ATX or placebo medication; (2) use standardized, repeated dependent measures to rigorously assess AD and EFD symptomatology; (3) measure impairment in associated mental and behavioral health problems (e.g., attention deficit, depression, anxiety, suicidality, QoL, family/social functioning); and (4) use response inhibition task GoNogo, working memory and attention tests Digit Span and Trail Making to investigate the underlying pathophysiology of PTSD and prognostic indicators of treatment outcome. To achieve these goals, the investigators have assembled a multidisciplinary team with expertise in PTSD, ADHD clinical trials, and human laboratory paradigms who have successfully collaborated in the past and are uniquely qualified to implement this type of investigation. The proposed project is directly responsive to the mission of the VA-RRD "to maximize Veterans' functional independence, quality of life and participation in their lives and community." Successful completion of this study will provide a platform for a large multi-center trial to further confirm the important role of EF in PTSD treatment outcomes. The findings from this study will provide critically needed evidence to help inform clinical practice guidelines on the treatment of PTSD. The outcome of the proposed research will be significant, because it provides a knowledge base to allow for development of new PTSD intervention strategies. More importantly, this clinical trial may immediately benefit Veterans by enhancing their cognitive function, reducing AD related disability, and further improving quality of life for Veterans who suffer from PTSD.

开始日期2025-06-01

申办/合作机构

VA Office of Research and Development

[+1]

KCT0010317

/ Not yet recruitingN/AIIT

An exploratory clinical trial to evaluate the efficacy and safety of combined administration of atomoxetine and oxybutynin in patients with obstructive sleep apnea

开始日期2025-04-01

申办/合作机构

Chonnam National University Hospital

NCT06899178

/ Not yet recruiting临床2期IIT

A Phase 2, Double Blind, Randomized, Placebo-controlled Crossover Trial to Evaluate the Efficacy and Safety of Atomoxetine in Adults with Melanocortin Obesity Syndrome

This is a phase 2 randomized placebo-controlled crossover trial to determine the safety and efficacy of atomoxetine for treating obesity caused by loss-of-function variants in the melanocortin-4 receptor (MC4R), the most common cause of genetic obesity disorders. Atomoxetine was selected for this pilot trial because it has been shown to increase brain-derived neurotrophic factor (BDNF) within the central nervous system and in peripheral circulation. Targeting BDNF is a specific strategy for treating MC4R abnormalities because BDNF functions as a downstream mediator of MC4R signaling.

开始日期2025-04-01

申办/合作机构

Icahn School of Medicine at Mount Sinai

[+1]

100 项与盐酸托莫西汀相关的临床结果

登录后查看更多信息

100 项与盐酸托莫西汀相关的转化医学

登录后查看更多信息

100 项与盐酸托莫西汀相关的专利（医药）

登录后查看更多信息

2,951

项与盐酸托莫西汀相关的文献（医药）

2025-07-01·INTERNATIONAL JOURNAL OF LAW AND PSYCHIATRY

ADHD in adults and criminal behavior: The role of psychiatric comorbidities and clinical and sociodemographic factors in a clinical sample

Article

作者: Gubbini, Silvia ; Del Casale, Antonio ; Ferracuti, Stefano ; De Rossi, Pietro ; Adriani, Barbara ; Nicolò, Giuseppe ; Parmigiani, Giovanna ; Pallottino, Simone ; Modesti, Martina Nicole ; Guariglia, Cecilia ; Manzi, Agostino

INTRODUCTION:

ADHD is a neurodevelopmental disorder associated with functional, behavioral, and relational difficulties. Its onset is in childhood, before the age of 12, and it often persists into adulthood. This study investigates the link between ADHD in adulthood, psychiatric comorbidities, and the risk of criminal behavior, analyzing the impact of clinical and sociodemographic variables.

METHODS:

This cross-sectional study included a sample of 308 patients diagnosed with ADHD, treated at the ADHD Outpatient Clinic of SS Gonfalone Hospital in Monterotondo between 2019 and 2024. Diagnoses and comorbidities were assessed through structured interviews and standardized diagnostic tools (ASRS, DIVA-5). Information on legal status and types of crimes was collected through individual interviews. Statistical analysis was performed using t-tests, chi-square tests, and stepwise logistic regression models.

RESULTS:

In the sample, 8.1 % of patients with ADHD had committed crimes, with a male prevalence (92 %). Significant predictors of criminal behavior included male gender (OR = 1.899, p = 0.004) and alcohol use disorder (OR = 4.59, p = 0.002). Additionally, oppositional defiant disorder, ADHD diagnosis before the age of 18, and unemployment showed a potential association with risky criminal behavior. Lifetime prescription of antipsychotics (61.4 %) and antiepileptics (48.7 %) was more frequent among participants who committed crimes, while no significant differences were found in the use of atomoxetine and methylphenidate.

CONCLUSIONS:

Adult ADHD, particularly in males, with combined presentation and in the presence of comorbidities such as oppositional defiant disorder and alcohol use disorder, is associated with an increased risk of criminal behavior. The findings highlight the need for personalized and multimodal interventions to mitigate these risks. Future studies should adopt longitudinal designs to explore causal dynamics and evaluate the effectiveness of therapeutic strategies in forensic contexts.

2025-05-01·The Lancet Psychiatry

Comparative cardiovascular safety of medications for attention-deficit hyperactivity disorder in children, adolescents, and adults: a systematic review and network meta-analysis

Review

作者: Farhat, Luis C ; Cipriani, Andrea ; Garcia-Argibay, Miguel ; Fava, Cristiano ; Tomlison, Anneka ; Ostinelli, Edoardo G ; Del Giovane, Cinzia ; Revet, Alexis ; Cortese, Samuele ; Montastruc, François ; Larsson, Henrik ; Chang, Zheng ; Parlatini, Valeria ; Lannes, Alice

BACKGROUND:

Concerns about the cardiovascular safety of medications used for the treatment of attention-deficit hyperactivity disorder (ADHD) remain. We aimed to compare the effects of pharmacological treatments for ADHD on haemodynamic values and electrocardiogram (ECG) parameters in children, adolescents, and adults.

METHODS:

For this systematic review and network meta-analysis, we searched 12 electronic databases, including Cochrane CENTRAL, Embase, PubMed, and the WHO International Clinical Trials Registry Platform, from database inception to Jan 18, 2024, for published and unpublished randomised controlled trials comparing amphetamines, atomoxetine, bupropion, clonidine, guanfacine, lisdexamfetamine, methylphenidate, modafinil, or viloxazine against each other or placebo. Primary outcomes were change in systolic blood pressure (SBP) and diastolic blood pressure (DBP), measured in mm Hg, and pulse, measured in beats per minute, at timepoints closest to 12 weeks, 26 weeks, and 52 weeks. Summary data were extracted and pooled in random-effects network meta-analyses. Certainty of evidence was assessed with the Confidence in Network Meta-Analysis (CINeMA) framework. This study was registered with PROSPERO, CRD42021295352. Before study initiation, we contacted representatives of a UK-based charity of people with lived experience of ADHD-the ADHD Foundation-regarding the relevance of the topic and the appropriateness of the outcomes chosen.

FINDINGS:

102 randomised controlled trials with short-term follow-up (median 7 weeks [IQR 5-9]) were included, encompassing 13 315 children and adolescents (aged ≥5 years and <18 years; mean age 11 years [SD 3]; of available data, 9635 [73%] were male and 3646 [27%] were female; of available data, 289 [2%] were Asian, 1719 [15%] were Black, and 8303 [71%] were White) and 9387 adults (≥18 years, mean age 35 years [11]; of available data, 5064 [57%] were male and 3809 [43%] were female; of available data, 488 [6%] were Asian, 457 [6%] were Black, and 6372 [79%] were White). Amphetamines, atomoxetine, lisdexamfetamine, methylphenidate, and viloxazine led to increments in haemodynamic values in children and adolescents, adults, or both. In children and adolescents, mean increase against placebo ranged from 1·07 (95% CI 0·36-1·79; moderate CINeMA confidence) with atomoxetine to 1·81 (1·05-2·57; moderate) with methylphenidate for SBP; from 1·93 (0·74-3·11; high) with amphetamines to 2·42 (1·69-3·15; low) with methylphenidate for DBP; and from 2·79 (1·05-4·53; moderate) with viloxazine to 5·58 (4·67-6·49; high) with atomoxetine for pulse. In adults, mean increase against placebo ranged from 1·66 (95% CI 0·38-2·93; very low) with methylphenidate to 2·3 (0·66-3·94; very low) with amphetamines for SBP; from 1·60 (0·29-2·91; very low) with methylphenidate to 3·07 (0·69-5·45; very low) with lisdexamfetamine for DBP; and from 4·37 (3·16-5·59; very low) with methylphenidate to 5·8 (2·3-9·3; very low) with viloxazine for pulse. Amphetamines, lisdexamfetamine, or methylphenidate were not associated with larger increments in haemodynamic values compared with atomoxetine or viloxazine in either children and adolescents or adults. Guanfacine was associated with decrements in haemodynamic values in children and adolescents (mean decrease against placebo of -2·83 [95% CI -3·8 to -1·85; low CINeMA confidence] in SBP, -2·08 [-3 to -1·17; low] in DBP, and -4·06 [-5·45 -2·68; moderate] in pulse) and adults (mean decrease against placebo of -10·1 [-13·76 to -6·44; very low] in SBP, -7·73 [-11·88 to -3·58; very low] in DBP, and -6·83 [-10·85 to -2·81; very low] in pulse). Only four RCTs informed on effects in the medium term and none on the long term.

INTERPRETATION:

Practitioners should monitor blood pressure and pulse in patients with ADHD treated with any pharmacological intervention, and not stimulants only. Given the short duration of available randomised controlled trials, new research providing insights on the causal effects of ADHD medications on cardiovascular parameters in the longer term should be funded.

FUNDING:

National Institute for Health and Care Research.

2025-05-01·ENVIRONMENTAL RESEARCH

Occurrence and risk assessment of different cyanotoxins and their relationship with environmental factors in six typical eutrophic lakes of China

Article

作者: Chen, Wei ; Yao, Yujia ; Yang, Huiting ; Gu, Xiaohong ; Chen, Huihui ; Zeng, Qingfei ; Xiang, Tao ; Mao, Zhigang

Cyanobacterial blooms can generate various toxic metabolites in freshwater, and pose serious threats to drinking water safety and human health. Although microcystins (MCs) have been detected in many freshwater ecosystems in China, little is known about the other cyanotoxins. An investigation of six eutrophic lakes (i.e. Hulun Lake, Wuliangsuhai Lake, Chaohu Lake, Taihu Lake, Xingyun Lake, and Dianchi Lake) in different geographical locations of China was performed during the summer of 2022 to determine the occurrence of various cyanotoxins (i.e. anatoxin-a (ATX), cylindrospermopsin (CYN), and MCs) in water column and their possible risks, and to evaluate the related environmental factors. MCs levels in sediment of these lakes were also investigated. MCs were the primary cyanotoxins in the water column of investigated lakes. The mean MCs contents in water column of Hulun Lake, Wuliangsuhai Lake, Chaohu Lake, Taihu Lake, Xingyun Lake, and Dianchi Lake were 3.61, 0.13, 3.60, 2.18, 0.57, and 2.56 μg/L, respectively. The total MCs levels in water column exceeded 1 μg/L in some areas of these lakes except Wuliangsuhai Lake. Replete nitrogen and/or phosphorus levels seemed to be related to MCs production. ATX can be detected in these lakes except Xingyun Lake at ng/L levels. CYN can be detected in all lakes at ng/L levels. However, the levels of ATX and CYN appear to be not significantly associated with environmental factors. MCs and CYN can pose a high or moderate risk for humans and aquatic organisms in some areas of these lakes, while ATX can pose a low or no risk for humans and aquatic organisms in most areas of these lakes. MCs can also be detected in sediment of all lakes at ng/g levels. This research emphasizes the necessity for long-term monitoring of different cyanotoxins in eutrophic lakes, and the implementation of nutrient control and management strategies.

207

项与盐酸托莫西汀相关的新闻（医药）

2025-05-06

·PRNewswire

Apnimed Announces Multiple Presentations at the American Thoracic Society (ATS) International Conference 2025 Highlighting Novel Techniques and Unmet Medical Needs in Sleep Medicine

CAMBRIDGE, Mass., May 6, 2025 /PRNewswire/ -- Apnimed, Inc., a pharmaceutical company building the industry-leading portfolio of first-in-class oral drugs that address the root causes of obstructive sleep apnea (OSA) and other sleep-related breathing diseases, today announced multiple upcoming presentations at the American Thoracic Society International Conference (ATS), which will take place May 16-21, 2025, in San Francisco, CA. The presentations will include additional details on Apnimed's ongoing Phase 3 program evaluating AD109 in OSA. Other presentations relate to novel applications of technology to enable digital medicine in sleep medicine, findings on the real-world prevalence and characteristics of patients with obesity hypoventilation syndrome, a condition defined by a combination of sleep-disordered breathing, obesity, and daytime hypercapnia (high levels of arterial carbon dioxide). Apnimed ATS 2025 Presentation Details: Oral Presentation: A20, Abstract 9127 Sensor-Based Digital Health Technology Enables Digital Medicine for Sleep-Related Breathing Diseases Time: Sunday, May 18, 2025, 10:03 AM-10:15 AM PT Location: Moscone Center, South Building Room 303 Poster: B58, Poster Board #P91 Real-World Prevalence and Characteristics of Patients With Obesity Hypoventilation Syndrome: A Retrospective Cohort Analysis of Medicare Fee-For-Service Claims Data Time: Monday, May 19, 2025, 11:30 AM-1:15 PM PT Location: Moscone Center, North Building Area A, Hall F Poster: C78, Poster Board # P1343 Aroxybutynin and Atomoxetine (AD109) in Obstructive Sleep Apnea: Participant Demographics and Baseline Disease Characteristics of the LunAIRo Phase 3 Trial Time: Tuesday, May 20, 2025, 11:30 AM – 1:15 PM PT Location: Moscone Center, North Building Area K, Hall F Poster: C78, Poster Board # P1345 Rationale and Design of a Phase 3 Open-label Extension Study of Fixed Dose Combination of Aroxybutynin and Atomoxetine (AD109) in Obstructive Sleep Apnea Time: Tuesday, May 20, 2025, 11:30 AM – 1:15 PM PT Location: Moscone Center, North Building Area K, Hall F For more information about the 2025 ATS International Conference, please visit the conference website, here. About AD109 AD109 is an investigational once-nightly oral pill that could become the first pharmacological treatment to improve oxygenation during sleep by directly targeting the underlying neuromuscular dysfunction that can cause the upper airway to collapse in people with obstructive sleep apnea (OSA). It is a first-in-class investigational combination of aroxybutynin, a novel antimuscarinic, and atomoxetine, a selective norepinephrine reuptake inhibitor. These compounds are designed to work synergistically to target the neuromuscular root cause of OSA. In a disease characterized by complex and invasive treatment options, AD109 may offer a simple solution to help improve oxygenation and overall health and quality of life for people living with OSA. The AD109 Phase 3 clinical trial program is fully enrolled with topline results expected Q2 and Q3 2025. About Obstructive Sleep Apnea Obstructive sleep apnea (OSA) is a serious, chronic sleep-related breathing disease in which the upper airway repeatedly collapses during sleep, leading to intermittent oxygen deprivation. It is caused by two overlapping mechanisms: neuromuscular dysfunction during sleep and predisposing anatomic abnormalities. It has been demonstrated that OSA affects people of all weight classes, ages and genders —there is no single "face" of the disease. An estimated 80 million people in the United States and 1 billion people worldwide suffer from OSA. An individual with OSA can experience hundreds of sleep apnea events in a single night, each one reducing the blood oxygen levels and negatively impacting cellular functions vital to normal health and function. Failure to effectively treat OSA increases the risk of serious long-term health consequences, such as high blood pressure, cardiovascular disease and type 2 diabetes, along with impacts on quality of life, including daytime fatigue and cognitive function. The majority of those diagnosed with OSA refuse, abandon, or underutilize current treatment options. Currently, no available pharmacological treatments directly address the underlying neuromuscular dysfunction that is present in all people with OSA. About Apnimed Apnimed is a privately held clinical-stage pharmaceutical company dedicated to transforming the treatment landscape for sleep-related breathing diseases. We believe the introduction of simple, once-nightly oral drugs has the potential to dramatically expand diagnosis and the reach of treatment for people with OSA. OSA, like other common chronic diseases such as diabetes or hypertension, would benefit from having multiple drugs with differing mechanisms to more fully address the heterogeneity of disease pathophysiology. Apnimed envisions a new era where novel oral therapies simplify intervention, expand the reach of diagnosis and treatment, and help more people get the oxygen and restorative sleep needed to thrive. Based in Cambridge, Mass., Apnimed is advancing a robust pipeline of oral pharmaceutical product candidates designed to improve oxygenation in individuals living with OSA and other sleep-related breathing disorders. Our lead candidate, AD109, could become the catalyst for a new oral treatment paradigm for OSA that has been historically limited to cumbersome devices or invasive surgeries. AD109 is currently in Phase 3 clinical trials for the treatment of mild, moderate and severe OSA. Apnimed is also developing several therapies as part of its joint venture with Shionogi & Co., Ltd., Shionogi-Apnimed Sleep Science. Learn more at apnimed.com or follow us on X and LinkedIn. Media Contact: [email protected] Investor Contact: Ramzi Benamar [email protected] SOURCE Apnimed, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床3期

2025-04-24

·FiercePharma

Lupin recalls nearly 3,000 bottles of OCD medication in the US after subpar stability testing results

Lupin is no stranger to recalls, and has at times even had to suspend production of U.S.-bound drugs at its plants. Mumbai's Lupin has issued a voluntary recall of 2,724 bottles of the tricyclic antidepressant clomiPRAMINE hydrochloride, which is used to treat obsessive-compulsive disorder (OCD) by boosting serotonin activity in the brain.Lupin’s product pull covers 25-mg capsules of the drug in 100-count bottles. The suspect batch, which was distributed across the U.S., was set to expire at the end of June, according to a recent FDA enforcement report. The manufacturer formally kicked off the recall on April 10.According to the FDA’s report, Lupin said the drug—manufactured at the company’s Baltimore, Maryland, production site—failed to meet impurities and degradation specifications during an 18-month stability study.The recall ranks as Class II, which means the FDA figures there is a low chance the issue could cause serious injuries or death. Lupin is no stranger to recalls, and has at times even had to suspend production of U.S.-bound drugs at its plants.In late November, Lupin recalled more than 600,000 bottles of the high blood pressure and heart failure drug ramipril due to the presence of an active pharmaceutical ingredient (API) that came from an unapproved vendor.Before that, the company in 2023 pulled two lots of birth control pills from U.S. shelves. The recall, which covered Tydemy tablets, also stemmed from out-of-specification stability testing results that led Lupin to fear the drugs might not be effective in preventing pregnancy.As for the manufacturing suspension at its troubled Tarapur facility in the Indian state of Maharashtra, the FDA in 2022 asked Lupin to alert it before resuming operations there with the intent to produce for the U.S. market. The restriction followed the receipt of a warning letter at that facility.Elsewhere, multiple other drugmakers have initiated recalls of their own in 2025.Glenmark pulled roughly 1.48 million bottles of the generic attention-deficit/hyperactivity disorder (ADHD) drug atomoxetine in early March, citing unacceptable levels of the possible carcinogen N-nitroso atomoxetine. Prior to that, ICU Medical in February recalled two lots of potassium chloride intravenous bags over labeling issues that could increase the chances of an accidental overdose. Potassium chloride solution is used to rapidly restore potassium levels in patients with hypokalemia.Meanwhile, Alvogen, Astellas Pharma and Endo have triggered 2025 recalls on pain meds, immunosuppressants and vasoconstrictors, respectively.

2025-04-17

·CPHI制药在线

中药新药大爆发，宝仁堂药业进军“鼾症”市场

关注并星标CPHI制药在线4月9日，CDE官网显示，宝仁堂药业自主研发的1.1类创新中药“三贝苎鼾胶囊”的上市申请获受理。三贝苎鼾胶囊是宝仁堂药业依据祖传治疗“鼾症”的配方进行自主研发的中药，用于治疗阻塞性睡眠呼吸暂停（OSA）。2024年12月，该药治疗阻塞性睡眠呼吸暂停低通气综合征（痰瘀互结证）的多中心、随机、双盲、安慰剂平行对照3期临床试验总结会成功召开。结果显示：三贝苎鼾胶囊治疗OSA疗效显著，可明显降低呼吸暂停低通气指数（AHI），提高应答率，且药物安全性良好。OSA指患者在睡眠过程中反复出现呼吸暂停和低通气，临床表现为打鼾，鼾声大且不规律，夜间窒息感或憋醒，睡眠紊乱，白天出现嗜睡，记忆力下降，严重者出现认知功能下降，行为异常。据美国睡眠医学会估计，2025年全球OSA患病人数将增加到11.6亿。我国的OSA患者人数居全球首位，其次是美国、巴西和印度。目前，OSA的治疗手段主要包括危险因素控制（如饮食控制、加强锻炼）、体位治疗（无创气道正压通气治疗）、口腔矫治和外科手术治疗。2024年12月，FDA批准首款OSA直接治疗药物Zepbound（tirzepatide）。该药是全球首款获批上市的GLP-1/GIP双重受体激动剂，被FDA批准用于治疗中重度OSA合并肥胖症成人患者，且还被批准用于降糖和减重。此外，目前全球还有多款在研OSA新药，如AD109（Apnimed，3期临床）、IHL-42X（Incannex，2/3期临床）、THX-110（SciSparc，2期临床）、BIOS-0618（百诚医药，获批临床）。AD109是一种包含具选择性的去甲肾上腺素再摄取抑制剂托莫西汀与抗毒蕈碱aroxybutynin的组合配方，通过靶向OSA关键的神经通路，活化上呼吸道扩张肌，使得患者在睡眠时仍可维持呼吸道的畅通。AD109治疗OSA的2b期临床试验MARIPOSA结果显示：与安慰剂相比，AD109组患者的呼吸暂停低通气指数（AHI4，呼吸不足定义为4%饱和度降低）降低45%，达到主要研究终点。而且，2.5/75 mg AD109组患者在PROMIS疲劳量表（该量表测量日间疲劳程度及OSA对日常活动的影响）上表现出统计学显著改善。AD109使用方便，每天仅需睡前口服一次，曾被FDA授予快速通道资格。IHL-42X是屈大麻酚和乙酰唑胺的组合，已完成2期概念验证临床试验结果显示：与基线相比，使用低剂量 IHL-42X，患者AHI减少50.7%。此外，IHL-42X还能够改善患者的睡眠质量。THX-110是基于大麻素的创新药物之一，由屈大麻酚和大麻素棕榈酰乙醇酰胺组合而成。人的大脑和免疫系统中存在有大麻素受体，THX-110旨在刺激中枢神经系统的大麻素受体，抑制内源性大麻素的代谢降解，提高四氢大麻酚的吸收。中药新药大爆发2025第一季度批准8款在国家大力发展中医药创新的背景下，我国中药市场持续向好，中药创新也进一步加速。据悉2024年NMPA共批准12个中药新药，其中包括3个1.1类中药复方制剂（即儿茶上清丸、九味止咳口服液和秦威颗粒），8个3.1类按古代经典名方目录管理的中药复方制剂（即芍药甘草颗粒、苓桂术甘颗粒、温经汤颗粒、当归补血汤颗粒、二冬汤颗粒、一贯煎颗粒、枇杷清肺颗粒）和1个3.2类其他来源于古代经典名方的中药复方制剂（即温阳解毒颗粒）。2025年中药新药获批数量有望再攀新高。据悉，2025年第一季度NMPA已批准8款中药新药（详见下表），其中包括2款1.1类中药复方制剂。此外，截至2025年4月10日，据CDE官网，已有17款中药新药申请上市（详见下图），其中包括4款1.1类新药，即宝仁堂药业的三贝苎鼾胶囊（治疗阻塞性睡眠呼吸暂停）、以岭药业的芪桂络痹通片（治疗类风湿关节炎）、康缘药业的六味地黄苷糖片（治疗更年期综合征）和天士力的安神滴丸（治疗失眠症）。仅从2025年第一季度批准以及报产的中药新药来看，我国中药新药进入收获期，且覆盖的适应症愈发广泛。期待在利好政策的加持下，我国中药新药在人类抗击疾病的历史上更佳灿烂辉煌。END2025金笔奖征文即将截止，速来投稿！领取CPHI & PMEC China 2025展会门票智药研习社课程预告来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

快速通道临床3期临床2期临床结果上市批准

100 项与盐酸托莫西汀相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D02574	盐酸托莫西汀	N06BA09	DB00289

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
注意缺陷障碍伴多动	美国	Eli Lilly & Co.	2002-11-26

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
认知功能障碍	临床3期	美国	Eli Lilly & Co.	2005-11-01
广泛性焦虑障碍	临床3期	-	Eli Lilly & Co.	2005-11-01
肿瘤	临床3期	美国	Eli Lilly & Co.	2005-11-01
社交恐怖症	临床3期	-	Eli Lilly & Co.	2005-11-01
注意缺陷和破坏性行为障碍	临床3期	澳大利亚	Eli Lilly & Co.	2003-12-01
注意缺陷和破坏性行为障碍	临床3期	比利时	Eli Lilly & Co.	2003-12-01
注意缺陷和破坏性行为障碍	临床3期	丹麦	Eli Lilly & Co.	2003-12-01
注意缺陷和破坏性行为障碍	临床3期	芬兰	Eli Lilly & Co.	2003-12-01
注意缺陷和破坏性行为障碍	临床3期	德国	Eli Lilly & Co.	2003-12-01
注意缺陷和破坏性行为障碍	临床3期	荷兰	Eli Lilly & Co.	2003-12-01

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


NCT04905979 (Pubmed \| Sleep Breath)	临床2期	阻塞性睡眠呼吸暂停综合征 \| 高血压	-	Atomoxetine 80 mg	餘觸鏇遞製繭餘築簾餘(鏇鏇艱夢觸積淵構顧構) = 構壓選廠製顧鏇鬱鑰選獵製鑰醖齋醖鑰鹽艱觸 (齋蓋膚鏇製選獵繭鏇餘, 18.8 ~ 28.5) 更多	积极	2024-12-01
				Atomoxetine 80 mg + Spironolactone 80/50 mg	餘觸鏇遞製繭餘築簾餘(鏇鏇艱夢觸積淵構顧構) = 鏇網製積鑰艱鹹鹽積積獵製鑰醖齋醖鑰鹽艱觸 (齋蓋膚鏇製選獵繭鏇餘, 5.7 ~ 14.1)
NCT04445688 (Pubmed \| Sleep Breath)	临床2期	阻塞性睡眠呼吸暂停综合征	62	AD036 (atomoxetine 80 mg and oxybutynin 5 mg)	蓋鏇鏇鹽廠願艱鹽齋範(夢顧選簾顧醖鑰齋範積) = 廠選襯齋衊醖築願壓艱醖範夢獵構壓選淵鏇鹽 (製網選鹽餘夢範鑰淵範, 2.8 ~ 13.6)	积极	2022-05-13
				Atomoxetine 80 mg alone	蓋鏇鏇鹽廠願艱鹽齋範(夢顧選簾顧醖鑰齋範積) = 範範襯艱選選衊選餘憲醖範夢獵構壓選淵鏇鹽 (製網選鹽餘夢範鑰淵範, 1.4 ~ 11.6)
WSC2022	临床2期	-	30	Atomoxetine 75 mg + Aroxybutynin 2.5 mg	鹹顧窪夢顧構築製淵壓(淵網艱獵衊獵觸廠窪鑰) = 範襯衊憲選構糧製顧醖鹹網顧繭願鏇夢願獵鬱 (簾觸醖醖範願鹹餘廠範 ) 更多	积极	2022-03-11
				Atomoxetine 37.5 mg + Aroxybutynin 2.5 mg	鹹顧窪夢顧構築製淵壓(淵網艱獵衊獵觸廠窪鑰) = 窪鑰鏇願築衊膚遞鏇餘鹹網顧繭願鏇夢願獵鬱 (簾觸醖醖範願鹹餘廠範 ) 更多
NCT00628394 (CTgov)	临床4期	精神分裂症	119	Atomoxetine (Atomox/CR)	觸廠蓋齋製齋獵壓壓膚(壓構憲築廠繭積觸簾醖) = 蓋範獵鹹膚鬱構艱廠餘簾鑰範淵壓廠鏇憲範願 (鏇壓艱鏇膚鹽糧憲壓蓋, 1.71) 更多	-	2020-09-25
				Atomoxetine (Atomox/Control)	觸廠蓋齋製齋獵壓壓膚(壓構憲築廠繭積觸簾醖) = 窪壓糧選鹽網鹽蓋醖夢簾鑰範淵壓廠鏇憲範願 (鏇壓艱鏇膚鹽糧憲壓蓋, 1.77) 更多
NCT01340885 (CTgov)	临床4期	认知功能障碍 \| 帕金森病	9	Strattera (Atomoxetine)	糧繭範繭遞選襯醖製餘(築獵網廠膚蓋構齋製繭) = 糧製蓋齋簾餘構夢獵選築範醖窪簾選壓齋鹽糧 (壓襯願鬱糧鹽衊積獵簾, 膚餘觸觸繭窪淵襯網餘 ~ 選餘範網糧鹽餘蓋憲網) 更多	-	2020-07-07
				Exelon (Rivastigimine)	糧繭範繭遞選襯醖製餘(築獵網廠膚蓋構齋製繭) = 衊醖襯窪糧鏇餘鹽範鹹築範醖窪簾選壓齋鹽糧 (壓襯願鬱糧鹽衊積獵簾, 構廠醖積觸築積憲願顧 ~ 艱窪窪淵憲選廠鏇夢鹹) 更多
NCT02500732 (POST6, CTgov)	临床2期	血管迷走神经性晕厥	57	Placebo (Placebo)	範獵鹽範糧醖製鬱齋構 = 構簾築淵夢網齋獵觸遞積淵積觸積窪積顧壓獵 (醖選醖糧構積壓願製積, 鏇鬱網選願艱艱糧願夢 ~ 鹽淵簾積衊築壓簾壓範) 更多	-	2020-04-21
				Atomoxetine (Atomoxetine)	範獵鹽範糧醖製鬱齋構 = 繭廠憲艱餘顧網襯糧壓積淵積觸積窪積顧壓獵 (醖選醖糧構積壓願製積, 壓憲糧製獵餘窪鏇鹹觸 ~ 艱蓋糧簾獵廠願遞蓋構) 更多
NCT00918567 (CTgov)	临床4期	注意缺陷障碍伴多动	56	Behavior Modification Therapy+atomoxetine (Combined Therapy)	遞鏇觸壓遞壓積憲醖襯(顧膚憲淵獵構觸廠夢鬱) = 獵簾廠鏇願夢築簾鏇獵餘獵鬱齋糧衊醖積襯鑰 (壓選繭夢製鑰膚鑰壓衊, 1.37) 更多	-	2020-04-07
				atomoxetine (Drug Therapy)	遞鏇觸壓遞壓積憲醖襯(顧膚憲淵獵構觸廠夢鬱) = 選襯觸醖願製夢鑰餘觸餘獵鬱齋糧衊醖積襯鑰 (壓選繭夢製鑰膚鑰壓衊, 1.36) 更多
NCT03091400 (CTgov)	临床2期	顺行性遗忘 \| 多发性硬化症	11	Atomoxetine (Atomoxetine)	積願淵淵積構夢獵簾繭(鏇膚獵網鹽製繭築淵願) = 鬱網構餘廠顧觸範築醖壓觸衊簾顧積餘鑰壓壓 (襯顧鏇網夢鑰衊膚膚範, 0.60) 更多	-	2020-03-13
				Placebo (Placebo)	積願淵淵積構夢獵簾繭(鏇膚獵網鹽製繭築淵願) = 簾鹽襯襯窪顧製糧鏇簾壓觸衊簾顧積餘鑰壓壓 (襯顧鏇網夢鑰衊膚膚範, 0.46) 更多
NCT01522404 (ATX-001, CTgov)	临床2期	轻度认知障碍	39	Placebo+Atomoxetine (Atomoxetine / Inactive Compound)	廠鏇築網願衊窪鹹選鏇(鹹膚艱襯艱積壓鹹窪網) = 願糧淵獵鏇鏇願餘夢積鬱壓衊糧鏇壓顧艱積鏇 (壓鏇遞夢壓淵製壓觸觸, 8.6) 更多	-	2018-12-05
				Placebo+Atomoxetine (Inactive Compound / Atomoxetine)	廠鏇築網願衊窪鹹選鏇(鹹膚艱襯艱積壓鹹窪網) = 壓窪壓糧選醖範糧窪選鬱壓衊糧鏇壓顧艱積鏇 (壓鏇遞夢壓淵製壓觸觸, 7.5) 更多
NCT01738191 (ATM-Cog, CTgov)	临床2期	认知功能障碍 \| 轻度认知障碍 \| 帕金森病	30	Atomoxetine (Atomoxetine)	壓壓憲觸蓋壓糧廠窪夢(築選願窪窪鏇願憲壓淵) = 鏇遞積選艱鬱淵鹹淵鏇顧繭襯襯憲艱醖簾構夢 (鏇膚選鹽膚鑰窪餘鏇壓, 繭獵鏇醖構醖簾衊膚積 ~ 膚範範廠憲築窪糧觸齋) 更多	-	2018-08-23
				Placebo (Placebo)	壓壓憲觸蓋壓糧廠窪夢(築選願窪窪鏇願憲壓淵) = 鑰糧鑰簾窪選築選鹽鏇顧繭襯襯憲艱醖簾構夢 (鏇膚選鹽膚鑰窪餘鏇壓, 網鬱憲夢餘顧構淵鹹鏇 ~ 醖襯觸鬱選淵壓鏇獵製) 更多