预约演示

更新于：2025-06-01

Atomoxetine Hydrochloride

盐酸托莫西汀

更新于：2025-06-01

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 Australia Pty Ltd.

江苏正大丰海制药有限公司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)

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结构/序列

分子式C17H22ClNO

InChIKeyLUCXVPAZUDVVBT-UNTBIKODSA-N

CAS号82248-59-7

关联

229

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]

CTR20251274

/ RecruitingN/A

盐酸托莫西汀胶囊在健康受试者中随机、开放、两制剂、单次给药、双周期、双交叉空腹和餐后状态下的生物等效性试验

评价中国健康受试者在空腹和餐后条件下单剂量口服受试制剂盐酸托莫西汀胶囊40mg与参比制剂盐酸托莫西汀胶囊（strattera®）40mg的药代动力学参数，进行两制剂的生物等效性分析。观察盐酸托莫西汀胶囊受试制剂和参比制剂在健康人群中的安全性。

开始日期2025-05-07

申办/合作机构

山东达因海洋生物制药股份有限公司

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

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100 项与盐酸托莫西汀相关的转化医学

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100 项与盐酸托莫西汀相关的专利（医药）

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2,958

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 ; Modesti, Martina Nicole ; Pallottino, Simone ; 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.

2025-07-01·JOURNAL OF HAZARDOUS MATERIALS

Association between organic micropollutants in tap water and human exposure and birth outcomes: Implications for environmental health in northern Puerto Rico

Article

作者: Kaeli, David ; Padilla, Ingrid Y ; Rich, Stephanie L ; Manjourides, Justin ; Alshawabkeh, Akram N ; Gao, Griffith ; Feng, Yinmei ; Rosario-Pabón, Zaira ; Helbling, Damian E ; Li, Guangyu ; Gu, April Z ; Vega, Carmen Velez ; Meeker, John D

The presence of micropollutants in Puerto Rico's tap water, potentially linked to nearby Superfund sites, was hypothesized to contribute to the region's higher preterm birth rate than the US mainland. This study analyzed the presence of 175 micropollutants in tap water samples collected from participant households and evaluated their association with human exposure using 14 oxidative stress and inflammation biomarkers in urine samples collected from pregnant participants, and further with the subsequent birth outcome information. Notably, three out of four oxidative stress biomarkers consistently showed negative correlations with five micropollutant categories, highlighting the oxidative stress induced by these contaminants. For the ten selected inflammation-related biomarkers, two showed positive yet not significant correlations with the five categories of micropollutants and, only one biomarker (MMP1), an inflammation biomarker whose down-regulation was associated with pre-mature birth implications, showed significant negative correlation with industrial chemicals and pesticides. Interestingly, the detected urinary phthalate metabolites in pregnant women could not be linked with the two parent phthalates found in the tap water, suggesting that the two phthalates in tap water may not be the primary source of phthalate exposure to human body. Furthermore, hormones in tap water showed significant moderate-to-strong negative correlations with birth outcomes, raising specific health concerns for pregnant women in northern Puerto Rico. This is the first study to investigate the association among a wider spectrum of tap water micropollutants with pregnancy exposure and birth outcome in Puerto Rico and provide insights into water quality and associated human health impacts.

2025-06-01·CLINICAL PHARMACOLOGY & THERAPEUTICS

A Comprehensive CYP2D6 Drug–Drug–Gene Interaction Network for Application in Precision Dosing and Drug Development

Article

作者: Solodenko, Juri ; Schwab, Matthias ; Teutonico, Donato ; Fuhr, Laura Maria ; Rüdesheim, Simeon ; Marok, Fatima Zahra ; Lehr, Thorsten ; Loer, Helena Leonie Hanae ; Selzer, Dominik ; Moes, Dirk Jan A. R. ; Frechen, Sebastian ; Schneider, Annika R. P. ; van der Lee, Maaike ; Feick, Denise ; Swen, Jesse J.

Conducting clinical studies on drug–drug‐gene interactions (DDGIs) and extrapolating the findings into clinical dose recommendations is challenging due to the high complexity of these interactions. Here, physiologically‐based pharmacokinetic (PBPK) modeling networks present a new avenue for exploring such complex scenarios, potentially informing clinical guidelines and handling patient‐specific DDGIs at the bedside. Moreover, they provide an established framework for drug–drug interaction (DDI) submissions to regulatory agencies. The cytochrome P450 (CYP) 2D6 enzyme is particularly prone to DDGIs due to the high prevalence of genetic variation and common use of CYP2D6 inhibiting drugs. In this study, we present a comprehensive PBPK network covering CYP2D6 drug–gene interactions (DGIs), DDIs, and DDGIs. The network covers sensitive and moderate sensitive substrates, and strong and weak inhibitors of CYP2D6 according to the United States Food and Drug Administration (FDA) guidance. For the analyzed CYP2D6 substrates and inhibitors, DD(G)Is mediated by CYP3A4 and P‐glycoprotein were included. Overall, the network comprises 23 compounds and was developed based on 30 DGI, 45 DDI, and seven DDGI studies, covering 32 unique drug combinations. Good predictive performance was demonstrated for all interaction types, as reflected in mean geometric mean fold errors of 1.40, 1.38, and 1.56 for the DD(G)I area under the curve ratios as well as 1.29, 1.43, and 1.60 for DD(G)I maximum plasma concentration ratios. Finally, the presented network was utilized to calculate dose adaptations for CYP2D6 substrates atomoxetine (sensitive) and metoprolol (moderate sensitive) for clinically untested DDGI scenarios, showcasing a potential clinical application of DDGI model networks in the field of model‐informed precision dosing.

213

项与盐酸托莫西汀相关的新闻（医药）

2025-05-31

·医学新视点

全球约10亿人受影响！只需每晚一片减少打呼噜，口服疗法或为患者带来新选择

Apnimed公司近期宣布，其潜在“first-in-class”口服候选药物AD109在关键性3期临床试验SynAIRgy中获得积极结果。该试验评估了AD109在轻度、中度和重度阻塞性睡眠呼吸暂停（OSA）成人患者中（涵盖所有体重类别）的疗效与安全性。SynAIRgy试验达到主要终点：与安慰剂相比，AD109在治疗26周后显著改善呼吸暂停低通气指数（AHI），平均变化具有统计学显著性（p=0.001）。打呼虽然常见，但有时可能是严重疾病的征兆。医学上看，经常打呼可能意味着患有OSA。这是由于患者在睡眠时上呼吸道扩张肌放松，导致呼吸道阻塞。全球约10亿人受到OSA的影响，患者在一个夜晚可能经历数百次呼吸暂停事件，反复缺氧会损害正常细胞功能，显著增加心血管疾病、神经认知障碍、代谢紊乱和早期死亡等严重长期健康风险。过去40年以来，常见治疗手段为在睡眠时佩戴特定装置来给气管“通气”，但治疗效果有限，很多患者也难以忍受佩戴装置带来的不适。若能有口服疗法问世，将为患者提供更便利的治疗选择。3期临床试验数据显示：在治疗26周后，AD109使AHI从基线平均下降55.6%，并显著改善血氧饱和度与疾病严重程度。51.2%的AD109治疗组受试者，其OSA严重程度降低至少一个等级。22.3%的AD109治疗组受试者AHI降至＜5次/小时，达到病情获得完全控制的标准。SynAIRgy试验的完整研究数据将在今年晚些时候于医学会议上公布。同时，另一项AD109的关键性3期研究LunAIRo正在进行中，预计将在2025年第三季度公布主要结果。该研究是一项为期一年的长期疗效与安全性评估。Apnimed计划在2026年初向美国FDA提交AD109的新药上市申请（NDA）。▲AD109的作用机制（图片来源：参考资料[2]）AD109是一种潜在“first-in-class”抗睡眠呼吸暂停神经肌肉调节剂。它是一种由选择性去甲肾上腺素再摄取抑制剂托莫西汀（atomoxetine）与抗毒蕈碱药物aroxybutynin构成的组合配方。AD109靶向OSA关键的神经通路，通过激活上呼吸道扩张肌，使得患者在睡眠时仍可维持呼吸道的畅通。该药物为每日一次、睡前口服剂型，有望简化治疗流程，帮助更多患者实现高质量、恢复性的睡眠。近年来，OSA治疗领域不断取得突破。礼来（Eli Lilly and Company）公司开发的重磅疗法替尔泊肽（tirzepatide）在去年获得美国FDA批准，用于改善OSA肥胖患者的睡眠呼吸异常情况。替尔泊肽是首个获批用于治疗中重度OSA肥胖患者的处方药物。期待口服OSA药物研发进展顺利，给更多患者带来便捷有效的治疗手段。推荐阅读打一针管3个流行季？保护效力约63%！《柳叶刀》子刊：新型疫苗有效预防呼吸道感染改善呼吸道症状竟如此简单？《柳叶刀》子刊：用鼻喷剂、多运动、缓解压力都可以每20人中就有1个！顶级医学期刊：有这4个呼吸道症状，早诊早治！参考资料：[1] Apnimed Announces Positive Topline Results in the First Landmark Phase 3 Clinical Trial of AD109, an Investigational Once-Daily Oral Pill for Obstructive Sleep Apnea. Retrieved May 19, 2025, from https://apnimed.com/article/ad109phase3toplineresults/[2] Apnimed- Drug therapy for obstructive sleep apnea. Retrieved May 19, 2025 from https://apnimed.com/wp-content/uploads/2022/06/Apnimed_Jefferies_June2022.pdf免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，传递医学新知

临床结果临床3期临床成功

2025-05-31

·丁香园

全球首款！10 亿患者，将迎来唯一口服新药

本文作者：原野这种慢性病，推测全球有 9.36 亿患者，我国有 1.76 亿。长期以来，该病不仅诊断率仅约 1%，还无法吃药治疗——想治，只能日复一日戴着通气面罩睡觉。这就是大名鼎鼎的阻塞性睡眠呼吸暂停（obstructive sleep apnoea，OSA）。而就在本月，OSA 界的希望之星，Apnimed 公司的口服药 AD109，终于交出了积极的 Ⅲ 期临床结果。全球首款 OSA 口服药，终于要来了。药企官网截图确诊往往已是重症，很多人还不知道自己病了要想讲清楚这款药的意义，就要先讲清楚 OSA。（点击查看丁香园往期内容：《确诊往往已是重症，近 2 亿中国人还不知道自己病了》）OSA 的首发表现，通常就是睡觉打鼾。患者睡觉时每个小时至少发生 5 次以上呼吸暂停，重度患者则可能每小时暂停几十甚至上百次。但区别于普通鼾症，「呼吸暂停」是 OSA 真正的定时炸弹。与普通的打鼾不同，OSA 带来的慢性缺氧，长期频繁的呼吸暂停，会损害正常细胞功能，引起广泛并发症，包括高血压、冠心病、心律失常、脑血管病、认知功能障碍、2 型糖尿病等，最终患者卒中率是普通人的 4.33 倍，病死率是 1.98 倍。未经治疗的重度 OSA 患者，病死率更高出普通人群 3.8 倍。[1]柳叶刀子刊的一项全球患病率研究显示，在 30～69 岁的人群中，全球估计有 9.36 亿人患有轻度至重度 OSA，4.25 亿人患有中度至重度 OSA。[2]而就是如此高发、后果严重的疾病，长期以来不仅诊断率仅约 1%，还一直没有专门的药物——过去几十年，对付 OSA，一线治疗方案是在睡觉时佩戴特定的装置（NPPV，即通过睡眠时佩戴正压通气面罩，气体正压可以有效增加肺泡通气）。但先不论疗效，日复一日戴着东西睡觉，很多人都难以忍受，临床应用中患者依从性一直不佳。图源：资料 1睡前吃一次，口服药终于要来了本次传来最新消息的 AD109 靶向针对的是 OSA 关键神经通路，是潜在「first-in-class」抗睡眠呼吸暂停神经肌肉调节剂。该药由选择性去甲肾上腺素再摄取抑制剂托莫西汀（atomoxetine）和抗毒蕈碱药物（aroxybutynin）复方，通过增加睡眠期间的上气道肌肉张力，来解决导致 OSA 的根本问题。AD109 作用机制示意（图源：资料 8）而且，它只需要每天睡前口服一次。研发这款药物的公司 Apnimed 成立于 2017 年，致力于开发用于治疗阻塞性睡眠呼吸暂停（OSA）和其他睡眠相关呼吸疾病的创新口服药物。2022 年 6 月，Apnimed 宣布 AD109 获得 FDA 快速通道资格。近几年，Apnimed 已经进行了超过 15 项 1 期和 2 期临床试验，积累了 AD109 的疗效、安全性和耐受性数据。在关键的 MARIPOSA 2b 期临床试验中，与安慰剂相比，两种测试剂量的 AD109 都达成了显著的 AHI 降低。图源：资料 9本月 19 日，AD109 的 Ⅲ 期临床结果终于公布。根据其 Ⅲ 期临床试验 SynAIRgy 结果，与安慰剂相比，AD109 在治疗 26 周后显著改善呼吸暂停低通气指数（AHI），平均变化具有统计学显著性（p=0.001）。虽然完整数据尚未公布，但据目前已公开的信息，治疗 26 周后试验组患者 AHI 从基线平均下降 55.6%，血氧饱和度和疾病严重程度都有显著改善试验组患者中 51.2% OSA 严重程度降低至少一级，22.3% AHI 降至＜5 次/小时，达到完全控制标准。该药另一项关键性 Ⅲ 期研究 LunAIRo 还在进行，预计将在今年第三季度公布一年长期疗效和安全性评估结果。图源：资料 10明星药入局，替尔泊肽已获批当然，OSA 这个赛道上，不止 Apnimed。与 OSA 联系最紧密的关键词，就是肥胖。虽然各相关研究数据差异较大，但已足以说明 OSA 和肥胖不分家的现象。研究普遍显示，OSA 患者肥胖率大约在 50～70％，而 40～90％的肥胖人群患 OSA，且患病率和严重程度均与 BMI 呈正相关 [3]替尔泊肽是一种葡萄糖依赖性促胰岛素多肽（GIP）/胰高糖素样肽-1（GLP-1）受体激动剂，可结合并激活 GIP 受体和 GLP-1 受体，通过调节食欲来减少食物摄入、降低体重和减少脂肪量。此前，替尔泊肽已成功在包括我国在内的许多国家和地区获批，用于控制成人 2 型糖尿病和肥胖症。[4]去年 12 月，美国 FDA 批准其用于治疗成年肥胖患者的中度至重度 OSA，与低热量饮食和增加体力活动结合使用。（点击查看丁香园往期文章：《全球首款！上亿患者，迎来唯一治疗药物》）这也让替尔泊肽成为全球首款、也是目前唯一一款，获批用于治疗 OSA 的药物。[5]图源：FDA根据其 2 项 Ⅲ 期临床试验，替尔泊肽均能显著减少呼吸中断次数，同时伴有体重大幅减轻。礼来美国总裁 Patrik Jonsson 表示，「替尔泊肽是第一种能显著改善中度至重度 OSA 的药物，这标志着在减轻 OSA 疾病负担方面迈出了关键一步。」[6,7]不过，目前替尔泊肽仅限于肥胖合并 OSA 的患者使用。同时，作为一种临床难点聚焦在患者依从性的慢性疾病，人们总是对口服药抱有更大的期待。在这样的背景下，直击 OSA、仅需口服的 AD109 可谓万众瞩目。公告中，Apnimed 宣布计划在 2026 年初向美国 FDA 提交 AD109 的新药上市申请。首款口服 OSA 药，可能很快就要来了。策划：z_popeye | 监制：islay题图来源：视觉中国参考文献：[1] 中国医师协会睡眠医学专业委员会. 成人阻塞性睡眠呼吸暂停多学科诊疗指南 [J] . 中华医学杂志, 2018, 98(24) : 1902-1914.[2] Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Benjafield, Adam V et al. The Lancet Respiratory Medicine, Volume 7, Issue 8, 687 - 698[3] 丁钐,郭立新. 肥胖与阻塞性睡眠呼吸暂停综合征的研究进展[J]. 临床内科杂志, 2020, 37(9): 616-619.[4] https://www.lilly.com/our-medicines/current-medicines [5] https://www.fda.gov/news-events/press-announcements/fda-approves-first-medication-obstructive-sleep-apnea [6] N Engl J Med 2024;391:1193-205. DOI: 10.1056/NEJMoa2404881[7] https://investor.lilly.com/news-releases/news-release-details/fda-approves-zepboundr-tirzepatide-first-and-only-prescription [8] https://apnimed.com/ad109/ [9] Schweitzer, Paula K et al. “The Combination of Aroxybutynin and Atomoxetine in the Treatment of Obstructive Sleep Apnea (MARIPOSA): A Randomized Controlled Trial.” American journal of respiratory and critical care medicine vol. 208,12 (2023): 1316-1327. doi:10.1164/rccm.202306-1036OC[10]https://apnimed.com/article/ad109phase3toplineresults/ 丁香园招聘新媒体运营（丁香园公众号）点击直接投递也可将简历投至邮箱 niyj@dxy.cn邮件标题：新媒体运营 - 姓名，请将既往作品附在邮件中丁香园社区运营（点击直接投递）也可将简历投至邮箱 niyj@dxy.cn邮件标题：社区运营 - 姓名，请将既往作品附在邮件中丁香园是面向医疗从业者的专业平台，以「助力中国医生」为己任。在丁香园，可以和同行讨论病例，在线学习公开课，使用用药助手等临床决策工具，在丁香人才找可靠医疗岗位。

临床2期临床3期

2025-05-19

·药明康德

只需每晚一片减少打呼噜！潜在“first-in-class”口服疗法达3期临床主要终点

Apnimed公司今日宣布，其潜在“first-in-class”口服候选药物AD109在关键性3期临床试验SynAIRgy中获得积极结果。该试验评估了AD109在轻度、中度和重度阻塞性睡眠呼吸暂停（OSA）成人患者中（涵盖所有体重类别）的疗效与安全性。SynAIRgy试验达到主要终点：与安慰剂相比，AD109在治疗26周后显著改善呼吸暂停低通气指数（AHI），平均变化具有统计学显著性（p=0.001）。打呼虽然常见，但有时可能是严重疾病的征兆。医学上看，经常打呼可能意味着患有OSA。这是由于患者在睡眠时上呼吸道扩张肌放松，导致呼吸道阻塞。全球约10亿人受到OSA的影响，患者在一个夜晚可能经历数百次呼吸暂停事件，反复缺氧会损害正常细胞功能，显著增加心血管疾病、神经认知障碍、代谢紊乱和早期死亡等严重长期健康风险。过去40年以来，常见治疗手段为在睡眠时佩戴特定装置来给气管“通气”，但治疗效果有限，很多患者也难以忍受佩戴装置带来的不适。若能有口服疗法问世，将为患者提供更便利的治疗选择。3期临床试验数据显示：在治疗26周后，AD109使AHI从基线平均下降55.6%，并显著改善血氧饱和度与疾病严重程度。51.2%的AD109治疗组受试者，其OSA严重程度降低至少一个等级。22.3%的AD109治疗组受试者AHI降至＜5次/小时，达到病情获得完全控制的标准。SynAIRgy试验的完整研究数据将在今年晚些时候于医学会议上公布。同时，另一项AD109的关键性3期研究LunAIRo正在进行中，预计将在2025年第三季度公布主要结果。该研究是一项为期一年的长期疗效与安全性评估。Apnimed计划在2026年初向美国FDA提交AD109的新药上市申请（NDA）。▲AD109的作用机制（图片来源：参考资料[2]）AD109是一种潜在“first-in-class”抗睡眠呼吸暂停神经肌肉调节剂。它是一种由选择性去甲肾上腺素再摄取抑制剂托莫西汀（atomoxetine）与抗毒蕈碱药物aroxybutynin构成的组合配方。AD109靶向OSA关键的神经通路，通过激活上呼吸道扩张肌，使得患者在睡眠时仍可维持呼吸道的畅通。该药物为每日一次、睡前口服剂型，有望简化治疗流程，帮助更多患者实现高质量、恢复性的睡眠。近年来，OSA治疗领域不断取得突破。礼来（Eli Lilly and Company）公司开发的重磅疗法Zepbound（tirzepatide）在去年获得美国FDA批准，用于改善OSA肥胖患者的睡眠呼吸异常情况。Zepbound是首个获批用于治疗中重度OSA肥胖患者的处方药物。期待口服OSA药物研发进展顺利，给更多患者带来便捷有效的治疗手段。参考资料：[1] Apnimed Announces Positive Topline Results in the First Landmark Phase 3 Clinical Trial of AD109, an Investigational Once-Daily Oral Pill for Obstructive Sleep Apnea. Retrieved May 19, 2025, from https://apnimed.com/article/ad109phase3toplineresults/[2] Apnimed- Drug therapy for obstructive sleep apnea. Retrieved May 19, 2025 from https://apnimed.com/wp-content/uploads/2022/06/Apnimed_Jefferies_June2022.pdf免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。👇 分享，点赞，在看，聚焦全球生物医药健康创新

临床3期临床成功临床结果临床2期

100 项与盐酸托莫西汀相关的药物交易

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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,

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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

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临床结果

适应症

分期

评价

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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


ATS2025	N/A	阻塞性睡眠呼吸暂停综合征	58	Atomoxetine Plus Oxybutynin (AtoOxy)	廠築襯艱窪鑰鑰積積艱(鏇繭獵糧壓艱範淵襯積): P-Value = 0.041 更多	积极	2025-05-16
				Placebo
NCT04565288 (CTgov)	临床2期	酒精使用障碍	42	Atomoxetine (Atomoxetine)	齋憲網範窪窪糧獵遞艱 = 觸糧觸艱願醖簾憲獵鹹糧艱廠蓋遞鹽繭遞夢衊 (鏇艱繭遞觸鑰網憲簾廠, 夢蓋鹽醖鬱襯鹹壓顧獵 ~ 範鹹蓋鹽糧淵鏇獵齋構) 更多	-	2025-05-09
				Placebo (Placebo)	齋憲網範窪窪糧獵遞艱 = 憲襯衊廠淵築壓範醖蓋糧艱廠蓋遞鹽繭遞夢衊 (鏇艱繭遞觸鑰網憲簾廠, 獵蓋遞願壓窪選餘製簾 ~ 觸鬱鏇願鬱醖窪膚淵積) 更多
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	鬱糧艱醖鏇廠膚憲膚淵(築窪築鏇遞鑰構壓醖範) = 獵壓醖淵膚夢憲鏇鏇夢鑰選廠壓廠鏇鹽醖構構 (餘壓鏇衊鏇餘夢製淵獵, 18.8 ~ 28.5) 更多	积极	2024-12-01
				Atomoxetine 80 mg + Spironolactone 80/50 mg	鬱糧艱醖鏇廠膚憲膚淵(築窪築鏇遞鑰構壓醖範) = 壓鑰鹹構蓋觸壓艱鬱襯鑰選廠壓廠鏇鹽醖構構 (餘壓鏇衊鏇餘夢製淵獵, 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)	築觸觸鬱淵繭選壓繭蓋(鹹獵簾夢範範鑰簾夢鬱) = 糧廠製夢網衊糧醖齋艱鹹鹽顧鏇範觸觸鬱窪觸 (餘衊繭顧選遞顧構憲網, 2.8 ~ 13.6)	积极	2022-05-13
				Atomoxetine 80 mg alone	築觸觸鬱淵繭選壓繭蓋(鹹獵簾夢範範鑰簾夢鬱) = 繭鬱鏇構衊膚製製淵顧鹹鹽顧鏇範觸觸鬱窪觸 (餘衊繭顧選遞顧構憲網, 1.4 ~ 11.6)
WSC2022	临床2期	-	30	Atomoxetine 75 mg + Aroxybutynin 2.5 mg	醖壓餘製襯鏇憲艱鏇鹹(鹹鹽膚襯獵獵製獵積觸) = 齋醖網鹹鑰廠憲夢壓網壓構夢鏇膚網獵遞膚鬱 (鹽襯鹹簾獵鬱鏇齋選鑰 ) 更多	积极	2022-03-11
				Atomoxetine 37.5 mg + Aroxybutynin 2.5 mg	醖壓餘製襯鏇憲艱鏇鹹(鹹鹽膚襯獵獵製獵積觸) = 簾襯廠衊製顧構憲簾鬱壓構夢鏇膚網獵遞膚鬱 (鹽襯鹹簾獵鬱鏇齋選鑰 ) 更多
NCT00628394 (CTgov)	临床4期	精神分裂症	119	Atomoxetine (Atomox/CR)	繭遞憲糧廠簾製蓋簾範(壓鹹獵鬱顧鑰窪鬱餘製) = 醖鹽顧衊蓋製鬱築鏇繭憲衊選餘遞製範壓壓壓 (選鬱夢鏇蓋觸觸範簾餘, 1.71) 更多	-	2020-09-25
				Atomoxetine (Atomox/Control)	繭遞憲糧廠簾製蓋簾範(壓鹹獵鬱顧鑰窪鬱餘製) = 糧餘範網簾築鹹構艱夢憲衊選餘遞製範壓壓壓 (選鬱夢鏇蓋觸觸範簾餘, 1.77) 更多
NCT01340885 (CTgov)	临床4期	认知功能障碍 \| 帕金森病	9	Strattera (Atomoxetine)	淵襯衊蓋襯糧遞願鏇築(憲齋餘製獵艱繭膚繭醖) = 膚繭襯願醖構窪獵製窪蓋壓淵醖夢鑰顧積窪齋 (壓鹽壓構齋獵蓋淵艱廠, 齋鬱膚積艱憲製繭憲蓋 ~ 鏇蓋齋範衊夢衊蓋鏇艱) 更多	-	2020-07-07
				Exelon (Rivastigimine)	淵襯衊蓋襯糧遞願鏇築(憲齋餘製獵艱繭膚繭醖) = 衊獵觸齋鹹觸淵夢遞壓蓋壓淵醖夢鑰顧積窪齋 (壓鹽壓構齋獵蓋淵艱廠, 憲願積遞鏇壓製艱膚積 ~ 簾餘鑰蓋觸餘簾醖製構) 更多
NCT02500732 (POST6, CTgov)	临床2期	血管迷走神经性晕厥	57	Placebo (Placebo)	廠壓範醖鑰膚鹹獵膚簾 = 窪醖鹽鹽餘範膚衊廠製夢觸夢鏇觸壓鏇鏇齋選 (鏇壓簾構繭範廠齋網窪, 艱廠鏇積構積觸鑰積憲 ~ 衊夢鏇簾餘淵獵餘鹹構) 更多	-	2020-04-21
				Atomoxetine (Atomoxetine)	廠壓範醖鑰膚鹹獵膚簾 = 餘願鹹顧鹽窪鹽鏇願鬱夢觸夢鏇觸壓鏇鏇齋選 (鏇壓簾構繭範廠齋網窪, 淵憲餘繭鹹窪鏇鏇鑰餘 ~ 遞艱鹽範鏇襯鹽衊範範) 更多
NCT00918567 (CTgov)	临床4期	注意缺陷障碍伴多动	56	Behavior Modification Therapy+atomoxetine (Combined Therapy)	鏇鹽鬱廠鑰遞膚醖積鑰(餘繭壓選糧窪鬱艱醖醖) = 衊鏇築鹹顧鹹構窪膚積壓淵憲顧餘遞壓衊鏇醖 (齋膚選積遞衊鑰衊繭淵, 1.37) 更多	-	2020-04-07
				atomoxetine (Drug Therapy)	鏇鹽鬱廠鑰遞膚醖積鑰(餘繭壓選糧窪鬱艱醖醖) = 選艱淵製製鬱願構窪積壓淵憲顧餘遞壓衊鏇醖 (齋膚選積遞衊鑰衊繭淵, 1.36) 更多
NCT03091400 (CTgov)	临床2期	记忆障碍 \| 遗忘 \| 多发性硬化症	11	Atomoxetine (Atomoxetine)	夢廠艱繭餘膚遞鹹廠顧(簾廠壓遞窪願餘願淵獵) = 鏇蓋構繭膚廠遞窪糧窪憲艱憲齋獵衊餘夢範範 (衊鹹廠淵繭網糧廠夢糧, 0.60) 更多	-	2020-03-13
				Placebo (Placebo)	夢廠艱繭餘膚遞鹹廠顧(簾廠壓遞窪願餘願淵獵) = 鑰獵衊餘鹹鏇製鹹糧齋憲艱憲齋獵衊餘夢範範 (衊鹹廠淵繭網糧廠夢糧, 0.46) 更多