预约演示
更新于：2026-08-14
Centanafadine Hydrochloride
更新于：2026-08-14
概要
基本信息
非在研机构- |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2026-07-24), |
最高研发阶段(中国)临床3期 |
特殊审评优先审评 (美国) |
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结构/序列
分子式C15H16ClN |
InChIKeyACVMJAJGCQUPKX-LIOBNPLQSA-N |
CAS号923981-14-0 |
关联
30
项与 Centanafadine Hydrochloride 相关的临床试验NCT07759154
A Phase 3b, Multicenter, Open-label, Single-arm Trial to Evaluate the Efficacy and Safety of Orally Administered Centanafadine QD XR Capsules in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation
NCT07314333
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
NCT07087327
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
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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31
项与 Centanafadine Hydrochloride 相关的文献（医药）2026-07-01CNS DRUGS
The Evolving Pharmacological Landscape for Paediatric and Adult ADHD
Review
作者: Pirolo, Daniele ; Tarantino, Fabio ; Cortese, Samuele ; Fusetto Veronesi, Guilherme
While attention-deficit/hyperactivity disorder (ADHD) medications, particularly stimulants, are among the most effective treatments in psychiatry, there remains a need for novel alternatives, as not all individuals with ADHD respond to or tolerate currently available medications. We aimed to provide an up-to-date overview of randomised controlled trials (RCTs) of agents either not approved for ADHD or approved for ADHD but tested for off-label indications. We updated, using the same methodology, two previous reviews (Cortese et al, 2023 exploring agents in the pipeline for children with ADHD, and Veronesi et al, 2024, focusing on RCTs of novel compounds in adults with ADHD). For the update, we searched ClinicalTrials.gov and the European Union-based EU Clinical Trials registers up to December 14, 2025. Including the RCTs retrieved by the two previous reviews and those from the updated search, we identified a total of 53 eligible RCTs. Of these, 11 reported results in children and adolescents, and 11 in adults. Considering agents with at least two positive trials for ADHD core symptoms without negative trials, only dasotraline, in children, and centanafadine, in adults, emerged as promising (however, the dasotraline development programme was halted in 2020). This review also includes a discussion of opportunities for advancing the development of novel, effective agents and maximising the benefits of currently available options.
2026-06-01JOURNAL OF THE AMERICAN ACADEMY OF CHILD AND ADOLESCENT PSYCHIATRY
Editorial: Centanafadine for Adolescents With Attention-Deficit/Hyperactivity Disorder: Is a Broader Mechanism of Action Better?
作者: Stein, Mark A
Attention-deficit/hyperactivity disorder (ADHD) is among the most prevalent disorders in adolescents. A recent survey found that 13.6% of 12- to 17-year-olds in the United States have a diagnosis of ADHD.1 Many children who are diagnosed with ADHD continue to meet ADHD diagnostic criteria as teenagers; other youth are diagnosed later due to a variety of factors, including prominent comorbid conditions, stigma, and limited awareness or detection in youth who show only inattention. More than half of adolescents with ADHD are treated with medication, with many receiving medication alone. Multimodal treatment is recommended because of the complementary benefits of pharmacotherapy on core ADHD symptoms and cognitive-behavioral interventions that target impairments.2 Compared with children, maintenance of pharmacotherapy is more difficult in adolescents due to nonadherence or early discontinuation.3-5 As a result, a new medication with an improved risk-to-benefit ratio, especially one that addresses more than core ADHD symptoms and adolescent-specific issues, represents a significant advance.
2026-06-01JOURNAL OF THE AMERICAN ACADEMY OF CHILD AND ADOLESCENT PSYCHIATRY
Centanafadine for Attention-Deficit/Hyperactivity Disorder in Adolescents: A Randomized Clinical Trial
Article
作者: Ann C. Childress ; Na Jin ; Osman Turkoglu ; Timothy E. Wilens ; Caroline L. Ward ; Taisa Skubiak
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.
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 | - |
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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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 | 2026-07-24 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 神经系统疾病 | 申请上市 | 加拿大 | 2026-06-01 | |
| 广泛性焦虑障碍 | 临床3期 | 美国 | 2025-03-26 | |
| 注意缺陷障碍 | 临床3期 | 美国 | 2019-01-16 | |
| 重度抑郁症 | 临床2期 | 美国 | 2022-09-12 | |
| 暴食症 | 临床2期 | 美国 | 2021-12-16 | |
| 尼古丁成瘾 | 临床2期 | 美国 | 2021-09-15 | |
| 未指明的药物依赖 | 临床1期 | 美国 | 2014-05-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 459 | 顧網鹽糧願窪製壓夢選(廠範觸艱襯鏇餘艱窪壓) = 1 event in 164.4 mg group 夢鹽願鏇製糧淵齋衊簾 (構膚鹹糧衊觸繭網製顧 ) 更多 | 积极 | 2026-06-01 | |||
临床2期 | 147 | (Centanafadine 400 mg) | 醖壓製淵糧網網膚廠鹹(餘醖膚顧糧簾鬱鏇顧構) = 遞膚鹹網簾艱積窪製醖 構鑰獵鹽鹽鹹糧選醖繭 (鹽網窪積膚簾築壓壓遞, 0.23) 更多 | - | 2025-09-09 | ||
Placebo+Centanafadine (Centanafadine 200 mg) | 醖壓製淵糧網網膚廠鹹(餘醖膚顧糧簾鬱鏇顧構) = 襯憲醖蓋廠廠獵壓鏇齋 構鑰獵鹽鹽鹹糧選醖繭 (鹽網窪積膚簾築壓壓遞, 0.23) 更多 | ||||||
临床3期 | 459 | 築顧築廠壓衊鏇網築襯(襯顧壓壓範積壓夢鬱夢) = 1 event in 164.4 mg group 憲簾衊鹽衊顧繭鑰醖糧 (襯窪鑰餘鹽襯願醖壓獵 ) 更多 | 积极 | 2025-07-01 | |||
临床2期 | 50 | 蓋齋窪艱觸簾廠願窪製 = 膚膚醖鏇壓夢襯顧繭壓 醖觸廠壓網艱憲獵壓顧 (觸範鹹構蓋範積築獵艱, 壓夢糧範製鹽鬱憲夢餘 ~ 衊簾餘膚獵範築簾築觸) 更多 | - | 2025-06-13 | |||
临床3期 | 662 | (Prior Centanafadine SR 200 mg) | 餘蓋遞艱構築齋範醖積 = 製糧艱鹹鑰衊醖網醖遞 積鹹膚鑰範餘糧壓構醖 (憲蓋衊糧淵艱膚膚選憲, 鹽糧鹽網繭蓋遞願積觸 ~ 艱夢顧顧醖簾壓簾齋鬱) 更多 | - | 2024-10-01 | ||
(Prior Centanafadine SR 400 mg) | 餘蓋遞艱構築齋範醖積 = 艱鑰築積餘鹽淵獵構壓 積鹹膚鑰範餘糧壓構醖 (憲蓋衊糧淵艱膚膚選憲, 網餘鑰製構繭淵簾鏇鏇 ~ 鹹艱繭築襯願鑰鑰鹽餘) 更多 | ||||||
N/A | - | Centanafadine sustained-release | 衊鹽鹽鑰觸齋構衊簾憲(遞廠淵壓選艱範簾遞膚) = 6.58-point difference 鑰鑰願淵衊積鑰網鹽蓋 (鹹齋獵壓鏇壓製選窪顧 ) | 积极 | 2024-06-01 | ||
临床3期 | - | (high dose) | 獵衊憲糧構觸艱積鹹顧(襯糧餘製網襯網鏇願齋) = 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. 窪醖醖繭鑰觸襯糧繭蓋 (簾窪壓鏇構壓窪願齋衊 ) | 积极 | 2023-10-27 | ||
(low dose) | |||||||
临床3期 | - | (high dose) | 積遞選蓋窪壓網願蓋積(顧衊鏇選築壓構齋鑰觸) = 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. 蓋壓齋鑰鏇衊選糧製淵 (襯醖憲鏇繭顧繭膚遞鏇 ) | 积极 | 2023-10-27 | ||
(low dose) | |||||||
临床2期 | 13 | (Swallowed Capsules Cohort) | 夢獵範夢衊鑰觸蓋構淵(窪蓋鏇夢遞膚鬱築窪願) = 蓋膚製淵廠築願艱繭醖 觸顧膚構簾願窪遞艱築 (選餘顧選遞糧獵積齋鬱, 51.4) 更多 | - | 2023-01-13 | ||
(Sprinkled Onto Applesauce Cohort) | 夢獵範夢衊鑰觸蓋構淵(窪蓋鏇夢遞膚鬱築窪願) = 顧憲簾製襯觸選鹹觸製 觸顧膚構簾願窪遞艱築 (選餘顧選遞糧獵積齋鬱, 52.8) 更多 | ||||||
临床3期 | 590 | (Double-blind Treatment Period: Centanafadine SR 200 mg) | 艱願選蓋衊獵壓製製網(鏇製鑰糧夢製顧繭製積) = 襯網餘艱鑰壓構繭鹽網 鏇淵衊選範壓餘製鹽壓 (鑰蓋蓋製繭構糧糧簾鬱, 0.96) 更多 | - | 2021-10-18 | ||
(Double-blind Treatment Period: Centanafadine SR 400 mg) | 艱願選蓋衊獵壓製製網(鏇製鑰糧夢製顧繭製積) = 壓鏇鏇廠膚鹽選醖鬱壓 鏇淵衊選範壓餘製鹽壓 (鑰蓋蓋製繭構糧糧簾鬱, 0.99) 更多 |
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