A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Investigate the Efficacy, Safety and Tolerability of Oral Administered AK0901 Capsules in Children Aged 6-12 Years Old With Attention Deficit Hyperactivity Disorder

This study is a Phase 3, multicenter, dose-optimized, double-blind, randomized, placebo-controlled study designed to evaluate the efficacy, safety, and tolerability of oral AK0901 capsules in children 6 to 12 years old with Attention Deficit Hyperactivity Disorder（ADHD）.

开始日期2024-05-28

申办/合作机构

上海爱科百发生物医药技术股份有限公司

NCT06000501

/ Completed临床4期IIT

An Open-Label Treatment, Investigator-Initiated Study, on the Duration and Efficacy of Azstarys (Serdexmethylphenidate and Dexmethylphenidate) on Adult ADHD Symptoms and Executive Function in Early Evening

This is a single-site study. One purpose of this trial is to extend the safety and efficacy evidence basis for Azstarys in adults with ADHD. This open-label, treatment study will examine the efficacy of Azstarys on ADHD symptoms using the AISRS 18-item total score on the AISRS-expanded; the Adult ADHD Investigator Symptom Rating Scale. The investigators will also examine Executive Function later in the day (early evening, about 12 hours after first morning dosing).

开始日期2023-11-13

申办/合作机构

NYU Langone Health

[+1]

100 项与丝右哌甲酯右哌甲酯相关的临床结果

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100 项与丝右哌甲酯右哌甲酯相关的转化医学

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100 项与丝右哌甲酯右哌甲酯相关的专利（医药）

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项与丝右哌甲酯右哌甲酯相关的文献（医药）

2022-01-01·Current topics in behavioral neurosciences

New Drugs to Treat ADHD: Opportunities and Challenges in Research and Development

Review

作者: Gosden, Jane ; Heal, David J ; Smith, Sharon L

Since the landmark MTA (Multimodal Treatment of ADHD) trial unequivocally demonstrated the efficacy of methylphenidate, catecholaminergic drugs, especially stimulants, have been the therapeutic mainstay in treatment of Attention-Deficit Hyperactivity Disorder (ADHD). We review the new drugs which have entered the ADHD formulary. The lessons learned from drug-candidates that have succeeded in clinical trials together with those that have not have also been considered. What emerges confirms and consolidates the hypothesis that clinically effective ADHD drugs indirectly or directly increase catecholaminergic neurotransmission in the prefrontal cortex (PFC). Attempts to enhance catecholaminergic signalling through modulatory neurotransmitter systems or cognitive-enhancing drugs have all failed. New drugs approved for ADHD are catecholaminergic reuptake inhibitors and releasing agents, or selective noradrenaline reuptake inhibitors. Triple reuptake inhibitors with preferential effects on dopamine have not been successful. The substantial number of failures probably accounts for a continued focus on developing novel catecholaminergic and noradrenergic drugs, and a dearth of drug-candidates with novel mechanisms entering clinical development. However, substantial improvements in ADHD pharmacotherapy have been achieved by the almost exclusive use of once-daily medications and prodrugs, e.g. lisdexamfetamine and Azstarys^®, which improve compliance, deliver greater efficacy and reduce risks for diversion and abuse.

2021-11-01·Journal of child and adolescent psychopharmacology3区 · 医学

A Randomized, Controlled Laboratory Classroom Study of Serdexmethylphenidate and d-Methylphenidate Capsules in Children with Attention-Deficit/Hyperactivity Disorder

3区 · 医学

Article

作者: Brams, Matthew N. ; Oh, Charles ; Kollins, Scott H. ; Marraffino, Andrea ; Mickle, Travis C. ; Barrett, Andrew C. ; Guenther, Sven ; Braeckman, Rene ; Cutler, Andrew J.

Objectives::

To evaluate the efficacy and safety of once-daily serdexmethylphenidate/dexmethylphenidate (SDX/d-MPH) capsules (Azstarys ™ ) compared with placebo in children with attention-deficit/hyperactivity disorder (ADHD) in a randomized, double-blind, dose-optimized laboratory classroom study.

Methods::

Children ages 6–12 with ADHD were enrolled. During a 3-week, open-label, Dose Optimization Phase, subjects initiated treatment with 39.2 mg/7.8 mg/day of SDX/d-MPH and were titrated weekly to an optimal dose (maximum dose of 52.3/10.4 mg). During the double-blind Treatment Phase, subjects were randomized to receive their optimal dose of SDX/d-MPH or placebo for 7 days. On day 7, efficacy was assessed in the laboratory classroom using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale and Permanent Product Measure of Performance (PERMP). To evaluate safety, adverse events (AEs), vital signs, and electrocardiograms were assessed, and suicide risk was assessed.

Results::

A total of 149 subjects completed the study. In the primary efficacy analysis, the mean postdose change from baseline in SKAMP-Combined scores averaged over the laboratory classroom day was significantly improved with SDX/d-MPH versus placebo (least-squares mean treatment difference [95% confidence interval]: −5.41 [−7.10 to −3.71]; p < 0.001). A significant treatment effect for SDX/d-MPH compared with placebo was observed from 1 to 10 hours postdose. A post hoc analysis more comparable with that conducted in similar studies indicated a 0.5- to 13-hour onset and duration of efficacy. Both average postdose PERMP-Attempted and PERMP-Correct score changes from baseline were significantly improved among those treated with SDX/d-MPH versus placebo ( p < 0.001 for both). No serious AEs were reported. During the Dose Optimization Phase, two-thirds of subjects reported AEs; the most common being insomnia and decreased appetite.

Conclusions::

SDX/d-MPH showed significant improvement in ADHD symptoms compared with placebo in children 6–12 years of age, with a rapid onset and extended duration of treatment effect. SDX/d-MPH was safe, with AEs comparable with those observed with other stimulant treatments.

2021-10-04·The Medical letter on drugs and therapeutics4区 · 医学

Azstarys (serdexmethylphenidate/dexmethylphenidate) for ADHD.

4区 · 医学

Article

269

项与丝右哌甲酯右哌甲酯相关的新闻（医药）

2026-10-21

·BioSpace

Collegium to Present Pediatric and Real-World Research Across ADHD Portfolio at AACAP and NEI Fall Congresses

Seven presentations include pediatric Phase 4 studies of AZSTARYS® (Serdexmethylphenidate/dexmethylphenidate) CII and real-world research of JORNAY PM® (Delayed-Release/Extended-Release Methylphenidate) CII in adults and impact on caregivers STOUGHTON, Mass., Oct. 21, 2026 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a leading biopharmaceutical company focused on improving the lives of people living with serious and often misunderstood conditions, today announced that seven abstracts from its attention-deficit/hyperactivity disorder (ADHD) portfolio have been accepted for presentation at two scientific congresses this fall. The presentations span pediatric clinical studies and research examining daily functioning among adults and caregivers, reflecting Collegium’s commitment to building a broader understanding of ADHD across ages and real-life settings. The data will be presented at the American Academy of Child and Adolescent Psychiatry (AACAP) 2026 Annual Meeting, taking place October 26–31 in Atlanta, and the Neuroscience Education Institute (NEI) Fall Congress, taking place November 5–8 in Colorado Springs. The abstracts include Phase 4 studies of AZSTARYS® (Serdexmethylphenidate/dexmethylphenidate) CII in pediatric populations, as well as retrospective analyses of JORNAY PM® (Delayed-Release/Extended-Release Methylphenidate) CII from routine clinical practice in adults, and survey research with caregivers of children and adolescents. The real-world analyses are observational, and the investigators describe their findings as hypothesis-generating. An estimated 15.5 million adults and 7 million children and adolescents in the United States have ADHD. 1,2 Published research has associated ADHD symptom severity with greater family burden, reduced family functioning, and lower quality of life among parents. 3 Subsequent work indicates that when ADHD symptoms are inadequately controlled, routine aspects of the morning can create one of the most stressful parts of the day for both parents and children. 4 "People living with ADHD, and the families who support them, need care they can count on throughout the day, so they can focus on school, work, and time with the people around them,” said Thomas Smith, M.D., Executive Vice President and Chief Medical Officer, Collegium Pharmaceutical, Inc. “The clinical studies and real-world research we’re presenting this fall help deepen the understanding of those daily needs and advance how ADHD is managed.” Presentations American Academy of Child and Adolescent Psychiatry (AACAP) 2026 Annual Meeting October 26–31, 2026 | Atlanta, Georgia A Phase 4 Safety, Tolerability, and Efficacy Study of Serdexmethylphenidate/dexmethylphenidate in Children with Attention-Deficit/Hyperactivity Disorder Childress AC, Newcorn JH, Tashjian R, Corliss M. Friday, October 30 Neuroscience Education Institute (NEI) Fall Congress November 5–8, 2026 | Colorado Springs, Colorado A Phase 4, Randomized, Double-blind Study of Serdexmethylphenidate/dexmethylphenidate in Children with Attention-Deficit/Hyperactivity Disorder Childress AC, Newcorn JH, Lewis L, Adusumilli S, Tashjian R, Corliss M. Friday, November 7 A Phase 4 Safety, Tolerability, and Efficacy Study of Serdexmethylphenidate/dexmethylphenidate in Children Aged 4–5 Years with Attention-Deficit/Hyperactivity Disorder Childress AC, Newcorn JH, Lewis L, Tashjian R, Corliss M. Friday, November 7 Modeling Clinical Response Patterns of AZSTARYS (SDX/d-MPH) and Other ADHD Pharmacotherapies Using Real-World Clinical Data Young J, Powell R, Powell A, Welling L, Saal J, Friedman Fechter E, Friedman H, Nash M. Friday, November 7 The Association Between Delayed-Release/Extended-Release Methylphenidate Starting Dose and Treatment Persistence in Adults with ADHD Young J, Powell R, Powell A, Welling L, Friedman Fechter E, Friedman H, Saal J, Nash M. Friday, November 7 Morning Functioning During Evening-Dosed Delayed-Release/Extended-Release Methylphenidate in Adults With ADHD: A Retrospective Real-World Analysis Young J, Powell R, Powell A, Welling L, Friedman Fechter E, Friedman H, Saal J, Nash M. Friday, November 7 Morning Functioning and Caregiver Strain Across ADHD Medication Regimens: A Real-World Survey Study Young J, Powell R, Powell A, Welling L, Friedman Fechter E, Friedman H, Saal J, Nash M. Friday, November 7 About Collegium Pharmaceutical, Inc. Collegium Pharmaceutical is a dynamic biopharmaceutical company delivering medicines with formulation and delivery innovation for people living with complex central nervous system (CNS) and pain conditions. Collegium has spent more than a decade proving that responsible stewardship and bold, science-backed approaches can redefine what treatment looks like in categories too often shaped by complexity and misconceptions. With a portfolio of differentiated ADHD medications, anchored by JORNAY PM® (methylphenidate HCl) CII and AZSTARYS® (serdexmethylphenidate and dexmethylphenidate) CII, and an established leadership position in responsible pain management, Collegium leads with the scientific rigor and commercial expertise to deliver treatment options around how people live their lives. For more information, please visit collegiumpharma.com or find us on LinkedIn . IMPORTANT SAFETY INFORMATION BOXED WARNING: ABUSE, MISUSE, AND ADDICTION JORNAY PM and AZSTARYS have high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including JORNAY PM and AZSTARYS, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing JORNAY PM or AZSTARYS, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse and addiction. CONTRAINDICATIONS Known hypersensitivity to methylphenidate, serdexmethylphenidate, or other components of JORNAY PM or AZSTARYS. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate products. Concomitant treatment with monoamine oxidase (MAO) inhibitors, or within 14 days following discontinuation of a MAOI, because of the risk of hypertensive crisis. WARNINGS AND PRECAUTIONS Risks to Patients with Serious Cardiac Disease: Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease. Increased Blood Pressure and Heart Rate. Psychiatric Adverse Reactions: Prior to initiating JORNAY PM or AZSTARYS, screen patients for risk factors for developing a manic episode. Priapism: If abnormally sustained or frequent and painful erections occur, patients should seek immediate medical attention. Peripheral Vasculopathy, including Raynaud’s Phenomenon: Observe patients for digital changes during treatment. Long-Term Suppression of Growth in Pediatric Patients: Closely monitor growth (height and weight) in pediatric patients. Pediatric patients not growing or gaining height or weight as expected may need to have their treatment interrupted. Acute Angle Closure Glaucoma and Increased Intraocular Pressure (IOP): Patients considered at risk for acute angle closure glaucoma and IOP should be evaluated by an ophthalmologist. Motor and Verbal Tics, and Worsening of Tourette’s Syndrome. ADVERSE REACTIONS Based on accumulated data from other methylphenidate products, the most common (>5% and twice the rate of placebo) adverse reactions are appetite decreased, insomnia, nausea, vomiting, dyspepsia, abdominal pain, weight decreased, anxiety, dizziness, irritability, affect lability, tachycardia, and blood pressure increased. Additional adverse reactions (≥5% and twice the rate of placebo) in JORNAY PM-treated pediatric patients 6 to 12 years are headache, psychomotor hyperactivity, and mood swings. DRUG INTERACTIONS Adjust dosage of antihypertensive drug as needed. Monitor blood pressure. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or INDICATION JORNAY PM (methylphenidate HCl) extended-release capsules and AZSTARYS (serdexmethylphenidate and dexmethylphenidate) capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older. Limitations of Use: It is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage. Please click here for Full Prescribing Information for JORNAY PM and AZSTARYS , including Boxed Warning. Investor Contact: Ian Karp Head of Investor Relations ir@collegiumpharma.com Media Contact: Jessica Cotrone Senior Vice President, Corporate Communications & Corporate Affairs communications@collegiumpharma.com References Staley BS, Robinson LR, Claussen AH, 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. MMWR Morb Mortal Wkly Rep. 2024;73(40):890-895. Danielson ML, Claussen AH, Bitsko RH, et al. ADHD Prevalence Among U.S. Children and Adolescents in 2022: Diagnosis, Severity, Co-Occurring Disorders, and Treatment. J Clin Child Adolesc Psychol. 2024;53(3):343-360. doi:10.1080/15374416.2024.2335625 Peñuelas-Calvo I, Palomar-Ciria N, Porras-Segovia A, et al. Impact of ADHD symptoms on family functioning, family burden and parents' quality of life in a hospital area in Spain. Eur J Psychiatry. 2021;35(3):166-172. Sallee FR. Early Morning Functioning in Stimulant-Treated Children and Adolescents with Attention-Deficit/Hyperactivity Disorder, and its Impact on Caregivers. J Child Adolesc Psychopharmacol. 2015 Sep;25(7):558-65. doi: 10.1089/cap.2014.0160. Epub 2015 Jul 7. PMID: 26151738; PMCID: PMC4576958.

临床3期临床2期

2026-10-19

·动脉网

ArkBio宣布获得FDA批准，启动AK0406用于流感预防的II期临床试验ArkBio Announces FDA Clearance to Initiate Phase II Trial of AK0406 for Influenza Prevention

SHANGHAI 上海, ，Oct. 12, 2026 2026年10月12日/PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ('ArkBio') today announced that the U.S. Food and Drug Administration (FDA) has granted its investigational new drug (IND) application for AK0406, a long-acting antiviral drug-Fc conjugate (AFC), enabling the company to initiate a phase II clinical trial for influenza prevention in general population in the United States.. /美通社/ -- 上海阿科生物科技有限公司（“ArkBio”）今日宣布，美国食品药品监督管理局（FDA）已批准其长效抗病毒药物-Fc偶联物（AFC）AK0406的新药临床试验（IND）申请，使该公司能够在美国启动针对普通人群的流感预防II期临床试验。Addressing Gaps in Influenza Prevention 弥补流感预防方面的不足Seasonal vaccination remains central to influenza prevention. However, changes in circulating influenza viruses and variability in individual immune response can limit vaccine protection, particularly among older adults and people who are immunocompromised. Additional preventive approaches could help address these unmet needs.. 季节性疫苗接种仍然是预防流感的核心措施。然而，流行流感病毒株的变化以及个体免疫反应的差异可能会削弱疫苗的保护效果，尤其是在老年人和免疫功能受损人群中。额外的预防措施有助于满足这些尚未被充分解决的需求。According to the U.S. Centers for Disease Control and Prevention (CDC), despite the availability of influenza vaccines, the 2025–2026 influenza season resulted in at least 32 million illnesses, 380,000 hospitalizations and 24,000 deaths in the United States. 根据美国疾病控制与预防中心（CDC）的数据，尽管有流感疫苗可用，2025–2026年流感季节在美国仍导致至少3200万例感染、38万例住院和2.4万例死亡。About AK0406 关于 AK0406AK0406 is a novel AFC drug discovered and developed by ArkBio. By precisely conjugating multiple potent small-molecular antivirals to an antibody Fc domain, AK0406 is designed to combine direct antiviral activity with Fc-mediated immune clearance to prevent influenza, with potential therapeutic applications.. AK0406 是由 ArkBio 发现并开发的一种新型抗体偶联小分子抗病毒药物（AFC）。通过将多种强效小分子抗病毒药物精确偶联至抗体 Fc 结构域，AK0406 旨在结合直接抗病毒活性与 Fc 介导的免疫清除作用，用于预防流感，并具有潜在的治疗应用价值。In preclinical studies, AK0406 demonstrated broad-spectrum and highly potent antiviral activity against both influenza A and B strains. It has also been optimized for its pharmacokinetics (PK) properties and GMP manufacturing process. 在临床前研究中，AK0406 对甲型和乙型流感病毒株均显示出广谱且强效的抗病毒活性。此外，其药代动力学（PK）特性和 GMP 生产工艺也已得到优化。Global Clinical Development 全球临床开发In February 2026, AK0406 received approval from a Human Research Ethics Committee (HREC) in Australia to initiate a phase I clinical trial. In July 2026, ArkBio announced that enrollment and dosing of healthy adult participants had been completed across all cohorts and that the study had entered the follow-up phase.. 2026年2月，AK0406获得澳大利亚人类研究伦理委员会（HREC）的批准，启动一项I期临床试验。2026年7月，ArkBio宣布已完成所有队列中健康成年受试者的入组和给药，研究已进入随访阶段。In August 2026, National Medical Products Administration (NMPA) of China cleared the IND application for AK0406 for influenza prevention. The FDA clearance marks a further milestone in the global clinical development of AK0406. 2026年8月，中国国家药品监督管理局（NMPA）批准了AK0406用于流感预防的临床试验申请（IND）。这一获批标志着AK0406在全球临床开发进程中又迈出了重要一步。Planned U.S. Phase II Trial 计划中的美国II期临床试验The U.S. phase II clinical trial will be a multicenter, randomized, double-blind, placebo-controlled study in adults during an influenza season. Its primary objective is to evaluate AK0406 for influenza prevention. The study will also assess safety, tolerability, PK and immunogenicity. The resulting data will inform AK0406's future global development strategy.. 美国的II期临床试验将是一项在流感季节针对成人开展的多中心、随机、双盲、安慰剂对照研究。其主要目的是评估AK0406在预防流感方面的效果。该研究还将评估安全性、耐受性、药代动力学（PK）和免疫原性。所得数据将为AK0406未来的全球开发策略提供依据。ArkBio plans to continue discussions with the FDA and the Center for Drug Evaluation (CDE) of China's NMPA to advance phase II development in the United States and China. Through parallel development pathways, the company aims to accelerate the AK0406 program as an additional option for influenza prevention, addressing challenges posed by viral evolution and limited vaccine protection, including in populations at high-risk of severe disease.. ArkBio 计划继续与美国食品药品监督管理局（FDA）及中国国家药品监督管理局（NMPA）药品审评中心（CDE）开展讨论，以推动 AK0406 在美国和中国的 II 期临床开发。通过并行开发路径，公司旨在加速 AK0406 项目的进展，使其成为流感预防的补充选择，从而应对病毒进化以及疫苗保护力有限所带来的挑战，包括在重症高风险人群中的保护不足问题。About ArkBio 关于 ArkBioArkBio is a commercial-stage biopharmaceutical company focused on the discovery and development of innovative therapeutics for treatment of respiratory/lung and pediatric diseases. Founded in 2014, the company has established proprietary technology platforms and a differentiated innovative R&D pipeline through internal innovation and strategic collaborations.. ArkBio是一家处于商业化阶段的生物制药公司，专注于发现和开发用于治疗呼吸系统/肺部疾病及儿科疾病的创新疗法。该公司成立于2014年，通过内部创新和战略合作，建立了专有技术平台和差异化的创新研发管线。Key R&D pipeline assets include: ziresovir (AK0529), the first direct-acting antiviral for RSV with positive phase III results; AK3280, a potentially best-in-class anti-fibrotic agent with positive phase II results for treatment of idiopathic pulmonary fibrosis, currently in a phase III trial; AK0901, approved and commercialized in China for ADHD treatment. 核心研发管线资产包括：ziresovir（AK0529），首款针对呼吸道合胞病毒（RSV）的直接作用抗病毒药物，其III期临床试验结果积极；AK3280，一种潜在的同类最佳抗纤维化药物，在治疗特发性肺纤维化方面II期临床试验结果积极，目前正处于III期临床试验阶段；AK0901，已在中国获批上市并商业化，用于治疗注意力缺陷多动障碍（ADHD）。The company also has multiple first-in-class or best-in-class innovative drug candidates under clinical or preclinical development.. 该公司还拥有多个处于临床或临床前开发阶段的同类首创或同类最佳创新药候选药物。ArkBio has established strategic partnerships with multinational and domestic pharmaceutical companies including Roche, Genentech, and Qilu Pharmaceutical; leading academic institutions including The Scripps Research Institute and the Institute of Microbiology, Chinese Academy of Sciences; and other domestic and international biotech companies and CROs.. ArkBio已与罗氏、基因泰克和齐鲁制药等跨国及国内制药企业；斯克里普斯研究所和中国科学院微生物研究所等领先学术机构；以及其他国内外生物科技公司和合同研究组织（CRO）建立了战略合作伙伴关系。For more information, please visit: 更多信息，请访问：www.arkbiosciences.com www.arkbiosciences.comInvestor Inquiries: 投资者咨询：[emailprotected] [email protected]SOURCE Arkbio 来源 Arkbio21 二十一% %more press release views with 更多新闻稿浏览量，附带Request a Demo 申请演示

2026-10-15

·arkbiosciences.com

爱智达®中国III期临床研究结果发表于《CNS Drugs》

中国上海，2026年10月15日——上海爱科百发生物医药技术股份有限公司（以下简称“爱科百发”）今日宣布，爱智达®（复方氯丝右哌甲酯胶囊）在中国6~12岁注意缺陷多动障碍（ADHD）儿童中开展的关键性Ⅲ期临床研究结果已发表于斯普林格 · 自然（Springer Nature）出版集团旗下的医学期刊《CNS Drugs》，研究结果达到主要终点及预设的桥接疗效一致性标准，安全性与耐受性良好。本研究由首都医科大学附属北京安定医院郑毅教授与北京大学第六医院刘靖教授共同牵头，在全国8家临床中心完成，采用随机、双盲、安慰剂对照设计，评估爱智达®在中国ADHD儿童中的疗效与安全性。研究结果显示，与安慰剂相比，爱智达®显著改善了患儿的ADHD核心症状，并全面改善了多项次要终点。在安全性方面，治疗期间出现的不良事件绝大多数为轻至中度，且多为一过性；未报告药物相关严重不良事件。上述结果为爱智达®在中国ADHD儿童中的临床应用提供了研究支持。爱智达®是全球首款、迄今唯一将速释右哌甲酯（d-MPH）与前药丝右哌甲酯（SDX）相结合的复方制剂，兼具快速起效与长效控制的双重优势。该产品于2021年3月获美国FDA批准，2025年12月获中国国家药品监督管理局批准用于6岁及以上ADHD患者，将为中国ADHD儿童及成人患者提供新的治疗选择，有望切实改善患者的学习、社交及家庭功能，助力提升我国ADHD的整体诊疗水平。爱智达®由齐鲁制药负责在中国大陆地区的商业化，预计将于2026年底前正式商业上市。原文链接：DOI：10.1007/s40263-026-01341-5 关于ADHD 注意缺陷多动障碍（ADHD）是一种常见的慢性神经发育障碍，起病于童年期，影响可延续至成年，主要特征是与发育水平不相称的注意缺陷和（或）多动冲动。我国儿童青少年ADHD患病率约为6.4%，患者总数超过2300万。ADHD不仅损害学习功能，还可伴随多方面的功能损害，目前治疗选择尤其是兼顾疗效与安全性的创新治疗方案仍显不足，存在显著的未满足临床需求。关于爱科百发爱科百发是一家处于商业化阶段的创新型生物医药企业，专注于呼吸系统及儿童疾病领域的重大未满足临床需求。公司成立于2014年，围绕具有创新作用机制的药物研发，构建了多项核心技术平台及全球专利布局，通过自主研发与战略合作相结合的模式，打造了差异化的产品管线。公司核心产品包括：齐瑞索韦（爱司韦®）：全球首个完成Ⅲ期临床试验并取得积极结果的RSV直接抗病毒药物，并被纳入国家突破性治疗品种；AK3280：具有“同类最佳（Best-in-Class）”潜力的抗纤维化创新药，已在中国完成Ⅱ期临床研究，并正在推进Ⅲ期注册性临床试验；复方氯丝右哌甲酯胶囊（爱智达®）：已在中国获批用于治疗注意缺陷多动障碍（ADHD），目前处于商业化阶段。此外，公司还有多款具有“同类首创（First-in-Class）”或“同类最佳”潜力的创新药处于临床或临床前开发阶段。爱科百发与罗氏/基因泰克、齐鲁制药等多个跨国及国内药企，美国Scripps研究所、中国科学院微生物研究所等学术机构，以及多家国内外生物技术公司与CRO建立了战略合作关系。如需了解更多信息，请访问公司官网：www.arkbiosciences.com 投资者垂询：IR@arkbiosciences.com

临床3期临床成功突破性疗法申请上市上市批准

100 项与丝右哌甲酯右哌甲酯相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11989	-	N06BA15 N06BA11	-

研发状态

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	Commave Therapeutics SA	2021-03-02

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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


NCT05721235 (KP415P02, CTgov)	临床4期	注意缺陷障碍伴多动	123	Serdexmethylphenidate (SDX)+dexmethylphenidate (d-MPH)	醖網製襯醖淵獵衊蓋窪(網壓窪衊獵遞繭製鑰窪) = 鑰淵鑰窪築鏇鹹淵醖淵廠糧簾願鹹繭蓋餘遞淵 (鏇顧窪餘鬱顧憲醖鏇構, 壓夢範艱製廠觸選積餘 ~ 廠淵觸鏇膚壓膚觸選夢) 更多	-	2026-05-08
NCT06000501 (CTgov)	临床4期	注意缺陷障碍伴多动	29	Serdexmethylphenidate/dexmethylphenidate	蓋鬱醖築鹹遞鹽選鬱餘(築窪築廠遞網艱醖壓鏇) = 膚醖獵鹹鬱壓鏇觸鹽夢憲淵窪願襯廠願獵範夢 (鹹願淵醖襯繭齋艱積壓, 7.4) 更多	-	2025-07-29
NCT05685732 (KP415P01, CTgov)	临床4期	注意缺陷障碍伴多动	246	Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH) (Cohort 1: SDX/d-MPH in 4-5 Year Old)	鹽鑰網範醖壓網艱餘築(繭範選選獵顧顧觸鑰築) = 構積遞鹽觸製衊蓋壓製醖壓積廠鏇構製鹽衊鏇 (製積鏇鹽繭廠衊壓鹹積, 膚餘範鬱蓋膚膚鏇壓襯 ~ 襯獵鹽衊鹹膚膚淵鬱鹹) 更多	-	2025-05-13
NCT05685732 (KP415P01, CTgov)	临床4期	注意缺陷障碍伴多动	246	placebo (Cohort 1: Placebo in 4-5 Year Old)	鹽鑰網範醖壓網艱餘築(繭範選選獵顧顧觸鑰築) = 窪鏇範蓋壓願鬱憲餘網醖壓積廠鏇構製鹽衊鏇 (製積鏇鹽繭廠衊壓鹹積, 淵遞衊齋淵顧構繭遞簾 ~ 鬱壓簾製繭衊鏇築遞網) 更多	-	2025-05-13
NCT03460652 (CTgov)	临床3期	注意缺陷障碍伴多动	282	KP415 oral capsule	鑰獵鏇製憲蓋憲夢醖膚(遞鹹顧淵膚構鑰糧願醖) = 範製選選選憲製築醖衊醖願鏇遞醖窪憲鏇糧顧 (餘膚憲憲製夢憲窪鏇構, 11.21) 更多	-	2021-07-19
NCT03292952 (CTgov)	临床3期	注意缺陷障碍伴多动	155	KP415 oral capsule (Double-Blind KP415)	觸醖選襯夢獵網餘衊窪(鑰範獵夢廠觸願遞簾積) = 鹹鏇範膚獵餘壓獵鏇願繭網遞衊鏇積遞窪壓網 (鬱獵廠網範願鹽鬱範範, 3.44) 更多	-	2021-06-30
NCT03292952 (CTgov)	临床3期	注意缺陷障碍伴多动	155	Placebo oral capsule (Double-Blind Placebo)	觸醖選襯夢獵網餘衊窪(鑰範獵夢廠觸願遞簾積) = 壓顧獵廠鬱簾鏇積築餘繭網遞衊鏇積遞窪壓網 (鬱獵廠網範願鹽鬱範範, 3.05) 更多	-	2021-06-30