A Phase 1, Single Blind, Parallel-arm Trial to Assess the Potential for Pharmacodynamic Interaction of Centanafadine When Co-administered With Stimulants in Healthy Adults

This study will look at how centanafadine works when taken together with stimulant medicines in healthy adults, and whether combining them affects how the body responds.

开始日期2026-02-05

申办/合作机构

Otsuka Pharmaceutical Development & Commercialization, Inc.

NCT07087327

/ Recruiting临床3期

A Phase 3, Multicenter, Open-label, Uncontrolled, Long-term Japan-China Joint Trial to Evaluate the Safety and Efficacy of EB-1020 QD XR Capsules Administered Orally Once Daily in Children and Adolescents With Attention- Deficit/Hyperactivity Disorder

The purpose of this study is to evaluate the safety of long-term administration of mainly high doses of EB-1020 over 52 weeks in pediatric ADHD patients.

开始日期2025-09-16

申办/合作机构

Otsuka Pharmaceutical Co., Ltd.

NCT07086313

/ Recruiting临床2/3期

A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled, Japan-China Joint Trial to Evaluate the Efficacy and Safety of Two Dose Levels of EB-1020 QD XR Capsules Administered Orally Once Daily in Children and Adolescents With Attention-deficit/Hyperactivity Disorder

The purpose of this study is to evaluate the efficacy and examine the safety of two doses of EB-1020 QD XR capsule administered once daily orally in pediatric ADHD patients.

开始日期2025-09-03

申办/合作机构

Otsuka Pharmaceutical Co., Ltd.

100 项与 Centanafadine Hydrochloride 相关的临床结果

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100 项与 Centanafadine Hydrochloride 相关的转化医学

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100 项与 Centanafadine Hydrochloride 相关的专利（医药）

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项与 Centanafadine Hydrochloride 相关的文献（医药）

2026-06-01·JOURNAL OF THE AMERICAN ACADEMY OF CHILD AND ADOLESCENT PSYCHIATRY

Centanafadine for Attention-Deficit/Hyperactivity Disorder in Adolescents: A Randomized Clinical Trial

Article

作者: Ward, Caroline L ; Wilens, Timothy E ; Turkoglu, Osman ; Jin, Na ; Childress, Ann C ; Skubiak, Taisa

OBJECTIVE:

This randomized, double-blind, placebo-controlled trial evaluated the efficacy, safety, and tolerability of centanafadine-a norepinephrine, dopamine, serotonin reuptake inhibitor-in the treatment of attention-deficit/hyperactivity disorder (ADHD) in adolescents.

METHOD:

Adolescents (aged 13-17 years, inclusive) with a primary diagnosis of ADHD were randomized to once-daily centanafadine 164.4 mg, 328.8 mg, or placebo for 6 weeks. Dosing was not titrated. The primary endpoint was change from baseline in the ADHD Rating Scale, version 5 (ADHD-RS-5) symptoms total raw score at week 6. This trial is registered with ClinicalTrials.gov (NCT05257265).

RESULTS:

Of 459 participants (centanafadine 164.4 mg, n = 155; 328.8 mg, n = 155; placebo, n = 149), 451 received ≥1 dose of study drug and 371 (80.8%) completed the trial. At week 6, improvements in ADHD-RS-5 symptoms total raw score were significantly greater with centanafadine 328.8 mg than with placebo (-18.50 [0.93] vs -14.15 [0.93]; p = .0006); centanafadine 164.4 mg did not meet the primary endpoint. Centanafadine 328.8 mg showed separation from placebo at week 1, the first postbaseline timepoint, with the effect maintained throughout the study. Treatment-emergent adverse events (TEAEs) occurred in 48 of 153 (31.4%, 164.4 mg), 76 of 151 (50.3%, 328.8 mg), and 35 of 147 (23.8%, placebo) participants. The most common (≥5% any group) TEAEs were decreased appetite, nausea, headache, and rash. Most TEAEs were of mild or moderate severity; 3 events were severe: liver function test increase (n = 1, 164.4 mg); aggression (n = 1, 164.4 mg); and somnolence (n = 1, placebo).

CONCLUSION:

Centanafadine 328.8 mg was efficacious for ADHD treatment in adolescents. Both doses were generally safe and well tolerated.

PLAIN LANGUAGE SUMMARY:

Centanafadine is a drug under investigation for the treatment of attention-deficit/hyperactivity disorder (ADHD). This clinical trial tested how well centanafadine worked in treating symptoms of ADHD in adolescents (ages 13 to 17 years) when compared to placebo. A total of 459 adolescents participated in this clinical trial. Adolescents treated with higher-dose centanafadine (328.8 mg) had greater improvement in ADHD symptoms at 6 weeks compared to those treated with placebo or centafadine at lower dose (164.4 mg). Centanafadine was generally safe and generally well tolerated in adolescents.

CLINICAL TRIAL REGISTRATION INFORMATION:

A Trial of Centanafadine Efficacy and Safety in Adolescents With Attention-Deficit/Hyperactivity Disorder; https://clinicaltrials.gov/study/NCT05257265 DIVERSITY & INCLUSION STATEMENT: We worked to ensure sex and gender balance in the recruitment of human participants. We worked to ensure race, ethnic, and/or other types of diversity in the recruitment of human participants. We worked to ensure that the study questionnaires were prepared in an inclusive way. One or more of the authors of this paper self-identifies as a member of one or more historically underrepresented racial and/or ethnic groups in science. One or more of the authors of this paper self-identifies as a member of one or more historically underrepresented sexual and/or gender groups in science. One or more of the authors of this paper self-identifies as living with a disability. We actively worked to promote sex and gender balance in our author group. The author list of this paper includes contributors from the location and/or community where the research was conducted who participated in the data collection, design, analysis, and/or interpretation of the work.

2026-06-01·JOURNAL OF CHILD AND ADOLESCENT PSYCHOPHARMACOLOGY

Efficacy of Centanafadine for Executive Functioning and Learning Problems in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder

Article

作者: Oberdhan, Dorothee ; Ward, Caroline L. ; Childress, Ann C. ; Wilens, Timothy E. ; Jin, Na ; Skubiak, Taisa ; van Stralen, Judy

Objective::

The objective of these analyses was to evaluate the efficacy of centanafadine for treatment of attention-deficit/hyperactivity disorder (ADHD) associated features of executive functioning and learning problems measured over 6 weeks in children and adolescents with ADHD.

Methods::

Two phase 3, randomized, double-blind, placebo-controlled trials were conducted in children and adolescents with a primary diagnosis of ADHD at sites in the United States and Canada. Data presented here are from the total population of children aged 6–12 years (NCT05428033) or adolescents aged 13–17 years (NCT05257265) who received high-dose centanafadine or placebo for 6 weeks. Secondary and other efficacy endpoints assessed change from baseline in the Conners 3–Parent Short Executive Functioning and Learning Problems Content Scale T-scores and the Conners 3–Self-report Short Learning Problems Content Scale T-scores, all analyzed using a mixed-effect model for repeated measures. Clinically meaningful within-patient change and findings from a caregiver and/or adolescent self-report exit survey are also presented.

Results::

Overall, 76.5% (367/480) of children (mean age 9.2 years, 41.7% female) and 80.8% (371/459) of adolescents (mean age 14.7 years, 40.7% female) completed their respective studies. There were clinically significant improvements with centanafadine treatment observed as early as Week 1 in the Conners 3–Parent Short Executive Functioning (T-score least squares mean change from baseline [standard error] to Week 6: children, −6.8 [1.1] vs. −11.3 [1.1], p = 0.0026 and adolescents, −8.1 [1.0] vs. −13.0 [1.0], p = 0.0003) and Learning Problems content scale T-scores when compared to placebo (children, −8.2 [1.0] vs. −2.8 [0.9], p < 0.0001 and adolescents, −8.0 [0.9] vs. −3.1 [0.9], p < 0.0001). Similar changes from baseline were observed by adolescent self-report (−6.1 [0.9] vs. −2.5 [0.9], p = 0.0023). Compared to placebo, there was a 50% and 88% greater chance of experiencing clinically meaningful within-patient change in executive functioning for children and adolescents, respectively, and a 79% and 81% chance for experiencing clinically meaningful within-patient change in learning problems, respectively. Exit survey data support findings from clinical outcome measures.

Conclusions::

In addition to its impact on the core symptoms of ADHD, centanafadine improved executive functioning, learning problems, and impact on daily tasks in children and adolescents with ADHD.

2026-05-04·Expert Review of Neurotherapeutics

Centanafadine for the treatment of attention-deficit/hyperactivity disorder in adults: a plain language summary of publication

Article

作者: Hobart, Mary ; Jin, Na ; Liebowitz, Michael ; Ward, Caroline L. ; Madera-McDonough, Jessica ; Chang, Denise ; Skubiak, Taisa

项与 Centanafadine Hydrochloride 相关的新闻（医药）

2026-06-14

·药事纵横

2026年下半年值得关注的五大药物

2026年上半年，全球医药研发在多个领域取得重要进展。进入下半年，多项处于审评关键阶段的药物值得密切关注。本文梳理了其中最具代表性的五项里程碑事件，涵盖肺癌靶向治疗、双抗药物、ADHD新机制药物以及肾病治疗等方向。一、Zidesamtinib（NVL-520）与 Neladalkib（NVL-655）研发公司：Nuvalent（2026年6月被GSK以106亿美元收购）适应症：ROS1阳性非小细胞肺癌 / ALK阳性非小细胞肺癌审评节点：2026年9月18日（Zidesamtinib）、2026年11月27日（Neladalkib） 2026年6月，GSK以106亿美元（每股124美元现金，溢价40%）收购Nuvalent，成为上半年生物医药领域最大的交易之一。GSK押注的核心资产，正是这两款即将进入FDA审评的下一代肺癌靶向药。 Neladalkib（ALK抑制剂）与Zidesamtinib（ROS1抑制剂）均为脑穿透选择性抑制剂，共同具备三大核心特征：一是设计用于在对现有抑制剂（包括第一、二、三代）产生耐药的肿瘤中保持活性，可覆盖治疗相关突变（如ALK G1202R、ROS1 G2032R）；二是具备中枢神经系统穿透能力，以改善脑转移患者的治疗选择；三是避免抑制结构相关的原肌球蛋白受体激酶家族，从而规避双重抑制剂常见的中枢神经系统不良事件。两者均旨在推动患者在所有治疗线中获得深层且持久的反应。两款药物均已获得FDA突破性疗法认定和孤儿药资格。Zidesamtinib 关键数据于2025年IASLC世界肺癌大会公布。在117例既往接受过ROS1-TKIs治疗的患者中，客观缓解率（ORR）为44%，缓解持续时间（DoR）在12个月和18个月时分别为78%和62%。在55例接受过1种ROS1-TKI（克唑替尼或恩曲替尼）化疗的患者亚组中，ORR为51%，12个月和18个月DoR均为93%。该药对脑转移患者展现出明确缓解能力，并能有效抑制ROS1 G2032R耐药突变。安全性方面，仅10%患者需降低剂量，2%因不良反应停药；设计上选择性靶向ROS1、保留TRK活性，减少了神经毒性风险。Neladalkib ALKOVE-1研究结果显示，在253例可评估的、既往接受过TKI治疗的患者中，总体ORR为31%。64%的缓解者疗效持续时间超过12个月，53%超过18个月。该药能有效克服G1202R耐药突变，脑转移患者的颅内总缓解率（IC-ORR）为32%。安全性良好，停药率仅为5%。二、依沃西（Ivonescimab）研发公司：康方生物 / Summit审评节点：2026年11月14日 2024年5月，依沃西在国内首次获批上市，用于治疗EGFR-TKI耐药的非鳞状非小细胞肺癌（nsq-NSCLC）。2025年4月，第二项适应症获批，用于一线治疗PD-L1阳性NSCLC。截至目前，依沃西已在数十项临床研究及真实世界应用中累计覆盖超过60,000例患者，其突破性临床价值得到充分验证，并推动了肿瘤免疫治疗的迭代与升级。本次向FDA提交的生物制剂许可申请（BLA），是依沃西在海外申报上市的首个适应症。这一进展不仅是依沃西全球市场拓展的重要里程碑，也标志着中国自主创新的双抗新药正加速走向国际舞台。该BLA基于依沃西首个全球多中心III期临床研究——HARMONi的总体数据。针对EGFR-TKI耐药的nsq-NSCLC，与FDA已批准的其他疗法相比，HARMONi研究在无进展生存期（PFS）和总生存期（OS）两项关键终点上均展现出明确的领先优势。与单纯化疗相比，依沃西联合化疗的PFS风险比（HR）为0.52，疾病进展或死亡风险降低48%；OS的HR为0.79（国内数据为0.80），获益趋势明确。该结果与中国HARMONi-A研究一致，验证了依沃西在跨区域研究中疗效的一致性。依沃西是康方生物全球首创的新一代肿瘤免疫基石药物。凭借其突破性临床价值，依沃西入选国际行业媒体FirstWord Pharma发布的《Spotlight On: The drugs that will shape 2026》榜单，被誉为有望主导2026年及之后全球医药行业发展脉络、改变疾病治疗逻辑的20款标杆药物之一，且是该榜单中唯一一款由中国创新药企自主研发的药物。三、Centanafadine 研发公司：Otsuka Pharmaceutical审评节点：2026年7月24日 Centanafadine是一款每日一次给药的缓释胶囊，为潜在“first-in-class”的去甲肾上腺素、多巴胺、5-羟色胺三重再摄取抑制剂（NDSRI），拟用于治疗儿童、青少年及成人注意缺陷-多动障碍（ADHD）。一旦获批，Centanafadine将成为首个获FDA批准的NDSRI类药物，也是ADHD领域20多年来首个新机制、非兴奋剂治疗药物。该NDA的递交主要基于四项关键III期临床试验数据的支持，分别评估了不同患者人群中的疗效与安全性：一项针对儿童（NCT05428033）、一项针对青少年（NCT05257265）以及两项针对成人（NCT03605680、NCT03605836）。临床研究表明，Centanafadine能显著减轻儿童、青少年和成人的ADHD核心症状。与安慰剂相比，Centanafadine在改善ADHD症状方面取得了具有统计学显著性及临床意义的疗效。此外，该药在各项研究中均表现出良好的安全性和耐受性，且滥用风险较低。儿童和青少年中最常见的不良事件包括食欲减退、恶心、皮疹、乏力、腹痛和嗜睡，成人中常见的不良事件为食欲减退和头痛。四、Povetacicept 研发公司：Vertex / 再鼎医药审评节点：2026年11月30日 Povetacicept是BAFF和APRIL的双重抑制剂。这两种细胞因子可促进B细胞的活化、分化和/或存活。通过抑制BAFF和APRIL驱动多种自身免疫性疾病发病机制的能力，Povetacicept可实现对抗体产生过程的有效调控，拟用于治疗免疫球蛋白A肾病（IgAN）。 III期RAINIER研究第36周的中期分析显示，治疗组尿蛋白肌酐比值（UPCR）较基线降低52.0%，与安慰剂相比降低49.8%（P<0.0001）；85.1%的患者实现血尿缓解（安慰剂组为23.4%）。安全性良好，无药物相关严重不良事件。若获批，患者可居家每四周一次自行皮下注射（＜0.5mL）。该药将成为Vertex肾脏病学管线中的首个商业化疗法。总结与展望 2026年下半年，全球创新药领域将迎来多个关键审评节点。从GSK百亿美元押注的下一代肺癌靶向药，到中国原研双抗依沃西的FDA上市申请；从ADHD领域二十余年来的首个非兴奋剂新机制药物Centanafadine，到IgA肾病中具备明确疗效优势的Povetacicept——这些药物不仅在各自治疗领域具有突破性意义，也折射出当前全球新药研发的几个重要趋势。其一，技术路径持续多元化。小分子靶向药、双特异性抗体等多技术路线并行推进，各自在适应症深度和安全性优化方面取得进展。其二，中国创新药企的全球影响力持续提升。依沃西作为唯一入选国际权威行业榜单的中国原研药物，其FDA审评进程具有标志性意义。其三，临床未满足需求仍是创新的核心驱动力，无论是在耐药突变覆盖、脑转移治疗，还是在非兴奋剂ADHD药物、免疫性肾病治疗等方向，新药的价值最终体现为对患者预后的切实改善。值得强调的是，药物审评结果存在不确定性，包括FDA可能要求补充数据、定价策略影响可及性、长期安全性与耐药性问题仍需真实世界验证等。总体而言，2026年下半年的审评窗口，将为全球医药行业提供一次重要的价值验证节点。上述药物的最终结果，不仅将影响相关企业的竞争格局，也将为后续同类产品的研发与监管路径提供参照。参考文献： Lin JJ, et al. ALKOVE-1 trial results of Neladalkib in ALK+ NSCLC. ASCO Annual Meeting. 2026. Summit Therapeutics. Summit Therapeutics Announces U.S. FDA Acceptance of Biologics License Application (BLA) Seeking Approval for Ivonescimab in Combination with Chemotherapy. January 29, 2026. Otsuka Pharmaceutical. Otsuka Announces FDA Acceptance and Priority Review of New Drug Application for Centanafadine for the Treatment of ADHD. January 27, 2026. Vertex Pharmaceuticals. FDA Accepts Vertex's BLA for Povetacicept in IgA Nephropathy; PDUFA Set for November. May 31, 2026. Zhong, et al. Ivonescimab mechanism of action. iScience. 2025. First Word Pharma. Spotlight On: The drugs that will shape 2026. Drilon A, et al. ARROS-1 trial results of Zidesamtinib in ROS1+ NSCLC. IASLC World Conference on Lung Cancer. 2025. 立即扫码加入药事纵横交流群

并购突破性疗法孤儿药上市批准

2026-06-14

·药时空

2026 年Q3 FDA 待批新药一览

2026 年第三季度，美国食品药品监督管理局（FDA）将对三款重点药物做出获批决定：用于注意缺陷多动障碍（ADHD）的 centanafadine、用于胃肠胰神经内分泌肿瘤（GEP-NETs）的177Lu-edotreotide，以及用于非小细胞肺癌（NSCLC）的 zidesamtinib。Centanafadine：ADHD 全新非兴奋剂治疗方案Centanafadine 是大冢制药开发的每日一次缓释型去甲肾上腺素-多巴胺-5-羟色胺再摄取抑制剂，适应症覆盖儿童、青少年及成人 ADHD。该药的新药申请（NDA）已获 FDA 优先审评受理，《处方药使用者付费法案》（PDUFA）目标审批日期为 2026 年 7 月 24 日。本次申报基于 4 项关键 III 期临床试验，覆盖全年龄段人群的疗效与安全性验证。结果显示：与安慰剂相比，centanafadine 可使 ADHD 症状得到统计学显著、且具备临床意义的改善（儿童采用 ADHD 评定量表第 5 版评估，成人采用成人 ADHD 研究者症状评定量表评估）。 4-17 岁儿童群体：高剂量方案可稳定减轻症状，低剂量组疗效一致性较差； 18-55 岁成人群体：每日 200mg、400mg 两个剂量组的症状评分均显著优于安慰剂。若顺利获批，centanafadine 将成为 ADHD 领域全新的非兴奋剂治疗选择，进一步丰富患者的治疗方案。177Lu-edotreotide：胃肠胰神经内分泌肿瘤核药新选择177Lu-edotreotide（研发代号 ITM-11）由 ITM 慕尼黑同位素技术公司开发，是一款靶向生长抑素受体（SSTR）2、SSTR5 的放射性治疗药物，适应症为不可切除、进展性 1 级/2 级胃肠胰神经内分泌肿瘤。该药 NDA 已获 FDA 受理，PDUFA 目标日期为 2026 年 8 月 28 日。申报核心依据为 III 期 COMPETE 研究（随机、对照、开放标签，纳入 309 例患者）：与标准治疗药物依维莫司相比，177Lu-edotreotide 显著延长患者中位无进展生存期（23.9 个月 vs 14.1 个月），同时客观缓解率大幅提升（21.9% vs 4.2%），且安全性良好可控。若获批，该药将与诺华 2018 年上市的 SSTR 靶向核药 177Lu-dotatate（Lutathera）形成市场竞争。Zidesamtinib：ROS1 阳性肺癌下一代靶向药目前已获批的 ROS1 阳性 NSCLC 靶向药（克唑替尼、恩曲替尼、瑞波替尼）仍存在临床局限：中枢神经系统活性不足、G2032R 等耐药突变无法覆盖。 Zidesamtinib 是 Nuvalent 公司开发的高选择性 ROS1 酪氨酸激酶抑制剂，设计上针对性解决了上述痛点：保留对 G2032R 等耐药突变的活性，同时具备血脑屏障穿透能力，适应症为既往接受过 ROS1 靶向治疗的局部晚期/转移性 ROS1 阳性 NSCLC。该药 PDUFA 审批日期为 2026 年 9 月 18 日。申报数据来自全球 ARROS-1 I/II 期试验（纳入大量经多线治疗患者）：既往接受过 ROS1 抑制剂治疗的患者中，客观缓解率约 44%；脑转移患者颅内缓解率达 48%，填补了该领域的临床空白。若获批，zidesamtinib 将成为 ROS1 阳性肺癌的下一代治疗方案，为耐药、脑转移患者提供新的治疗选择。值得一提的是，2026 年 6 月 9 日葛兰素史克已宣布以 106 亿美元收购 Nuvalent，将 zidesamtinib 与同处于 FDA 审评阶段的 ALK 抑制剂 neladalkib 一并纳入管线。原文来源： DOI：https://doi.org/10.1038/d41573-026-00103-8

优先审批临床3期申请上市放射疗法上市批准

2026-05-28

·Business Wire

Otsuka Presents New Phase 3 Post Hoc Analyses of Centanafadine Highlighting Improvement in Executive Function and Emotional Dysregulation in Adults with ADHD at the 2026 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting

PRINCETON, N.J. & TOKYO--(BUSINESS WIRE)--Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced new post hoc, exploratory analyses from two identical Phase 3 clinical trials evaluating centanafadine, an investigational, first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI), in adults with attention-deficit hyperactivity disorder (ADHD). The data, presented at the 2026 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, showed that in addition to improving core ADHD symptoms, centanafadine was associated with improvements in patient-reported executive function and emotional dysregulation, two clinically meaningful and often underrecognized associated features of ADHD that contribute substantially to patient burden1. The findings add to previously reported positive Phase 3 data evaluating centanafadine in adults with ADHD. Centanafadine is currently under regulatory review in the United States for the treatment of ADHD and has been granted Priority Review by the Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) target action date of July 24, 2026. “Executive function deficits and emotional dysregulation are challenging aspects of ADHD for many adults and are not always adequately addressed by current treatments,” said Dr. Lenard A. Adler, director of the adult ADHD program at NYU Langone Health and an investigator on the studies. “Improvements across core ADHD symptoms and associated features, as the analyses show, are important considerations in the treatment of adults with ADHD, given the broad and variable symptom experience among patients and the need for approaches that address a range of manifestations of the condition.” A total of 744 adults were included in the post hoc analyses (centanafadine 200 mg, n=242; centanafadine 400 mg, n=241; placebo n=261). Centanafadine was associated with improvements across measures of executive function compared with placebo, as assessed by the Executive Functioning subscale of the Adult ADHD Self-Report Scale (ASRS) Expanded Version. At Week 6, patients treated with centanafadine reported improved executive function from baseline compared with placebo, reflecting reductions in the frequency of patient-reported executive functioning difficulties. This included but was not limited to improvements in aspects such as time management, planning and prioritization, task initiation and completion, and working memory. Centanafadine was also associated with improved emotional dysregulation among adults compared with placebo. Improvements were observed across emotional dysregulation items, including reductions in emotional overactivity, affective lability, and anger outbursts, as measured by the ASRS Emotional Dyscontrol subscale at Week 6. By showing improvements in associated features of ADHD, including executive function and emotional dysregulation, areas of unmet need in ADHD clinical care, these analyses help further characterize centanafadine across a broader range of patient-reported symptoms beyond core ADHD symptoms. “These findings in adults complement our previous research in pediatric and adolescent populations and provide new insights into centanafadine’s clinical profile, while reinforcing its potential to address ADHD more holistically,” said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka. “By showing improved symptoms in associated features, including executive function and emotional dysregulation, areas of unmet need in ADHD clinical care, these data add to the understanding of centanafadine’s clinical profile as a first-in-class NDSRI. This reflects our broader commitment to advancing a treatment approach that addresses the broader clinical profile experienced by adults with ADHD.” The two pivotal Phase 3 trials in adults (NCT03605680, NCT03605836) were randomized, double-blind, placebo-controlled studies designed to evaluate the efficacy, safety, and tolerability of centanafadine sustained-release (SR) tablet in adults aged 18 to 55 years with ADHD. Participants received either centanafadine or placebo over a 6-week treatment period. The primary endpoint was the change from baseline in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score at Week 6. Both centanafadine dose groups demonstrated statistically significant and clinically meaningful improvements versus placebo. In both studies, centanafadine showed a favorable safety and tolerability profile and a low potential for abuse and dependence, with the most common adverse events including decreased appetite and headache. About Attention-Deficit Hyperactivity Disorder (ADHD) ADHD is a chronic neurodevelopmental disorder characterized primarily by impairments in attention, hyperactivity, and impulsivity2. It affects approximately 7 million children in the U.S. and an estimated 15.5 million adults, according to the Centers for Disease Control and Prevention (CDC)3,4. About Centanafadine Centanafadine is an investigational, first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI). Clinical studies have shown that centanafadine significantly reduced core symptoms of ADHD in children, adolescents, and adults. Additional clinical analyses have further characterized centanafadine’s potential impact on ADHD-associated features, including executive function and emotional dysregulation. Clinical data suggest centanafadine has demonstrated a favorable safety and tolerability profile and low potential for abuse, with the most common adverse events including decreased appetite and headache. About Otsuka Otsuka Pharmaceutical Co., Ltd. is a total healthcare company that focuses on each individual's potential to enhance their well-being. Our medical-related business provides treatments and diagnostics for both physical and mental health. Our nutraceutical business supports daily health maintenance and improvement. Otsuka's unique products and services are based on scientific evidence, under the guidance of our corporate philosophy: Otsuka-people creating new products for better health worldwide. Otsuka America Pharmaceutical, Inc. and Otsuka Pharmaceutical Development & Commercialization, Inc. are the US-based indirect subsidiaries of the global healthcare company Otsuka Pharmaceutical Co. Ltd. Otsuka’s US companies share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and immunology. At our core is perseverance—a fierce determination to overcome any obstacle, regardless of setbacks, on behalf of patients, caregivers, and their loved ones. We will not be bound by doing what’s been done before. Learn more at www.otsuka-us.com. References Van Stralen, J. Emotional dysregulation in children with attention-deficit/ hyperactivity disorder. DOI 10.1007/s12402-016-0199-0. American Psychiatric Association (2022). Diagnostic and Statistical Manual of Mental Disorders (5th ed., text rev). Staley, Brook S, et al. Attention-Deficit/Hyperactivity Disorder Diagnosis, Treatment, and Telehealth Use in Adults — National Center for Health Statistics Rapid Surveys System, United States, October– November 2023. US Centers for Disease Control and Prevention. Data and Statistics on ADHD. Attention-Deficit/ Hyperactivity Disorder (ADHD). November 19. 2024. U.S. Centers for Disease Control and Prevention. https://www.cdc.gov/adhd/data/index.html .

临床3期临床结果优先审批ASCO会议申请上市

100 项与 Centanafadine Hydrochloride 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10698	Centanafadine Hydrochloride	-	DB14841

研发状态

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	申请上市	美国	Otsuka Holdings Co., Ltd.	2025-11-25
广泛性焦虑障碍	临床3期	美国	Otsuka Pharmaceutical Development & Commercialization, Inc.	2025-03-26
注意缺陷障碍	临床3期	美国	Otsuka Pharmaceutical Development & Commercialization, Inc.	2019-01-16
重度抑郁症	临床2期	美国	Otsuka Pharmaceutical Development & Commercialization, Inc.	2022-09-12
暴食症	临床2期	美国	Otsuka Pharmaceutical Development & Commercialization, Inc.	2021-12-16
尼古丁成瘾	临床2期	美国	Otsuka Pharmaceutical Development & Commercialization, Inc.	2021-09-15
未指明的药物依赖	临床1期	美国	Otsuka Pharmaceutical Development & Commercialization, Inc.	2014-05-01

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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


NCT05113953 (CTgov)	临床2期	暴食症	147	Centanafadine (Centanafadine 400 mg)	齋製網選顧構鏇膚製鹽(積鹹鹽築築遞廠鹽糧餘) = 構餘願鹹窪憲淵糧壓艱簾範襯鑰蓋齋築構齋夢 (憲襯膚願簾壓積鏇壓壓, 0.23) 更多	-	2025-09-09
				Placebo+Centanafadine (Centanafadine 200 mg)	齋製網選顧構鏇膚製鹽(積鹹鹽築築遞廠鹽糧餘) = 壓簾襯廠憲網鹽選廠鹹簾範襯鑰蓋齋築構齋夢 (憲襯膚願簾壓積鏇壓壓, 0.23) 更多
NCT05257265 (A Trial of Centanafadine Efficacy and Safety in Adolescents With Attention-Deficit/Hyperactivity Disorder, Pubmed \| J Am Acad Child Adolesc Psychiatry)	临床3期	注意缺陷障碍伴多动	459	Centanafadine 164.4 mg	壓構壓齋鑰糧鑰顧齋齋(選艱鑰糧築蓋鏇夢觸壓) = 1 event in 164.4 mg group 壓鬱簾齋選襯襯築顧網 (壓鹽襯艱糧餘顧顧壓襯 ) 更多	积极	2025-07-01
				Centanafadine 328.8 mg
NCT05066724 (CTgov)	临床2期	尼古丁成瘾	50	Centanafadine	獵糧壓膚醖艱遞衊醖鏇 = 選鹽鑰選窪淵蓋網築醖窪構願鹹遞遞蓋鹽廠鬱 (構獵獵遞積鬱構構夢淵, 鬱獵淵製衊範願顧醖鏇 ~ 夢鑰鑰繭構廠醖窪遞網) 更多	-	2025-06-13
NCT03605849 (CTgov)	临床3期	注意缺陷障碍	662	Centanafadine SR (Prior Centanafadine SR 200 mg)	壓願願壓繭鏇淵鑰艱鹹 = 淵願製觸願製築築壓網觸觸簾鬱鑰範簾繭壓遞 (顧觸鹹獵觸壓齋壓鏇積, 鏇蓋觸鑰顧窪觸繭壓壓 ~ 網齋遞築製構廠鬱製選) 更多	-	2024-10-01
				Centanafadine SR (Prior Centanafadine SR 400 mg)	壓願願壓繭鏇淵鑰艱鹹 = 膚醖築齋繭簾構顧蓋夢觸觸簾鬱鑰範簾繭壓遞 (顧觸鹹獵觸壓齋壓鏇積, 繭遞鬱膚膚壓顧蓋憲糧 ~ 衊製構鬱夢夢衊齋簾鏇) 更多
NCT03605836 \| NCT00334880 \| NCT00190736 \| NCT04016779 (Pubmed)	N/A	注意缺陷障碍伴多动	-	Centanafadine sustained-release	夢觸顧鑰膚獵網觸蓋鏇(夢網積構衊範廠築襯蓋) = 6.58-point difference 繭範選觸遞遞艱願淵構 (築築餘選簾築築廠醖鑰 )	积极	2024-06-01
NCT05428033 (NEWS) 人工标引	临床3期	注意缺陷障碍伴多动	-	Centanafadine (high dose)	醖壓鹹齋衊鏇築獵製網(艱蓋積艱選積鬱襯積積) = In a pooled analysis across the two studies, the most frequently observed side effects for centanafadine (>2 percent and more frequent than placebo) included decreased appetite, nausea, rash, fatigue, upper abdominal pain and somnolence.Overall, the safety and tolerability results were consistent with the profile of centanafadine seen within the wider clinical development program. 鹹膚壓遞蓋艱製製襯餘 (築廠窪製積艱餘齋網製 )	积极	2023-10-27
				Centanafadine (low dose)
NCT05257265 (NEWS) 人工标引	临床3期	注意缺陷障碍伴多动	-	Centanafadine (high dose)	餘齋獵窪餘構構壓淵構(網願憲醖憲觸艱積鹹壓) = In a pooled analysis across the two studies, the most frequently observed side effects for centanafadine (>2 percent and more frequent than placebo) included decreased appetite, nausea, rash, fatigue, upper abdominal pain and somnolence.Overall, the safety and tolerability results were consistent with the profile of centanafadine seen within the wider clinical development program. 淵蓋積範齋鑰艱齋鏇願 (遞積醖醖壓襯選網衊觸 )	积极	2023-10-27
				Centanafadine (low dose)
NCT04081363 (CTgov)	临床2期	注意缺陷障碍伴多动	13	Centanafadine (Swallowed Capsules Cohort)	願觸鑰夢遞窪襯窪積壓(衊簾鑰壓觸選衊獵積壓) = 鹹廠範憲鬱衊選膚製襯構壓遞願獵廠鑰範顧觸 (積齋範觸鑰鹹醖醖蓋網, 51.4) 更多	-	2023-01-13
				Centanafadine (Sprinkled Onto Applesauce Cohort)	願觸鑰夢遞窪襯窪積壓(衊簾鑰壓觸選衊獵積壓) = 願鹹糧築鑰選醖襯艱鏇構壓遞願獵廠鑰範顧觸 (積齋範觸鑰鹹醖醖蓋網, 52.8) 更多
NCT01939353 (CTgov)	临床2期	注意缺陷障碍伴多动	45	Placebo+CTN SR	醖壓願鏇醖遞顧網鹽網(築簾糧鏇衊簾襯築衊顧) = 膚遞蓋廠憲顧窪積遞淵遞鹽製襯鹽餘顧遞窪積 (繭艱簾鹽憲蓋鬱願淵鬱, 6.19) 更多	-	2021-10-18
NCT03605836 (CTgov)	临床3期	注意缺陷障碍	590	Centanafadine SR (Double-blind Treatment Period: Centanafadine SR 200 mg)	獵繭鹽鹹糧醖構製獵鬱(選築積繭膚鹹夢壓鹹壓) = 顧艱獵遞鹹獵鬱窪襯醖衊積憲製獵窪簾製襯顧 (範襯選繭糧壓簾醖鑰衊, 0.96) 更多	-	2021-10-18
				Centanafadine SR (Double-blind Treatment Period: Centanafadine SR 400 mg)	獵繭鹽鹹糧醖構製獵鬱(選築積繭膚鹹夢壓鹹壓) = 繭壓艱淵獵壓廠淵獵糧衊積憲製獵窪簾製襯顧 (範襯選繭糧壓簾醖鑰衊, 0.99) 更多