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

The primary purpose of this study is to evaluate the efficacy of centanafadine once daily (QD) extended-release (XR) capsules in adults with attention-deficit/hyperactivity disorder (ADHD) and emotional dysregulation (ED).

Start Date20 Aug 2026

Sponsor / Collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

NCT07314333

/ CompletedPhase 1

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.

Start Date05 Feb 2026

Sponsor / Collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

NCT07087327

/ RecruitingPhase 3

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.

Start Date16 Sep 2025

Sponsor / Collaborator

Otsuka Pharmaceutical Co., Ltd.

100 Clinical Results associated with Centanafadine Hydrochloride

100 Translational Medicine associated with Centanafadine Hydrochloride

100 Patents (Medical) associated with Centanafadine Hydrochloride

Literatures (Medical) associated with Centanafadine Hydrochloride

01 Jun 2026·JOURNAL 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?

Author: 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.

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

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

Article

Author: 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.

01 Jun 2026·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

Author: 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.

News (Medical) associated with Centanafadine Hydrochloride

30 Jul 2026

·www.fiercepharma.com

Fierce Pharma Asia—Legend CEO exits; Merck’s hush-hush PD-1xVEGF plan; Otsuka’s novel ADHD nod

Legend Biotech's Ying Huang, Ph.D., resigned after a six-year stint as CEO. Merck briefly posted—and then quickly deleted—a clinical trial plan to test its PD-1xVEGF bispecific in combination with its Kelun-partnered TROP2 ADC. The FDA approved a new class of ADHD therapy in Otsuka's Simtriyo. And more. 1. Legend Biotech CEO abruptly steps down without permanent replacement Legend Biotech’s CEO, Ying Huang, Ph.D., has resigned. As Legend searches for a permanent replacement, Alan Bash, who has been leading Legend’s commercial activities as president of Carvykti since 2024, has become interim CEO. Huang’s resignation was not due to any disagreement with the company, Legend said. 2. Merck posts—then pulls—trial plan for PD-1xVEGF and TROP2 ADC combination Merck briefly posted and then deleted information on a phase 2 trial to combine its PD-1xVEGF bispecific antibody, MK-2010, and its TROP2-directed antibody-drug conjugate, sac-TMT, in advanced solid tumors. Merck has been keeping its PD-1xVEGF strategy close to its chest, citing a fiercely competitive market. Both drugs were originally developed by Chinese companies. 3. FDA approves Otsuka’s ADHD drug Simtriyo, teeing up its ‘next major CNS launch’ The FDA has approved Otsuka’s first-in-class triple norepinephrine, dopamine, serotonin reuptake inhibitor, Simtriyo (centanafadine) for attention-deficit/hyperactivity disorder (ADHD). Calling the drug Otsuka’s “next major CNS launch,” Jefferies analysts noted that an upcoming Drug Enforcement Administration classification will be key in determining its market potential. 4. GSK partner Hansoh reports another phase 3 win for priority ADC A phase 3 trial of the B7-H3-targeted ADC, risvutatug rezetecan (ris-rez) in relapsed osteosarcoma has hit its primary endpoint of progression-free survival. The Chinese trial was conducted by Hansoh Pharmaceutical, representing another positive phase 3 for the GSK-partnered drug mere weeks after a small cell lung cancer readout. 5. How 2 FDA citations complicate Hengrui, Elevar’s push for liver cancer combo approval Hengrui Pharma has quickly resolved an FDA Form 483 cited in the agency's recent complete response letter for its Elevar Therapeutics-partnered combination of camrelizumab and rivoceranib. However, a second Form 483, which arrived less than a week before the CRL and was not mentioned in the rejection letter, now stands in the way of a potential fourth approval bid by the companies. 6. Takeda scraps another phase 2 celiac disease therapy, narrowing pipeline to one 7. InnoCare’s oral TYK2 inhibitor clears phase 3 psoriasis test 8. Merck stages expanded access to monthly HIV PrEP pill ahead of approval

Phase 3Phase 2Executive ChangeDrug ApprovalADC

30 Jul 2026

·www.biospace.com

Otsuka’s ADHD approval opens up new drug class with $615M opportunity

iStock, Pandagolik Otsuka Pharmaceutical plans to launch Simtriyo—the first norepinephrine, dopamine, serotonin reuptake inhibitor—later this year following scheduling by the U.S. Drug Enforcement Agency. The FDA has greenlit Otsuka Pharmaceutical’s daily pill centanafadine for patients with attention-deficit hyperactivity disorder, opening up a new treatment class for the indication. With its approval, Simtriyo is the first norepinephrine, dopamine, serotonin reuptake inhibitor on the U.S. market, Otsuka said in a news release on Friday. The drug is indicated for patients aged 6 years and older who weigh at least 20 kg. The FDA slapped a boxed warning on Simtriyo, flagging a risk of suicidal ideation and behaviors, as well as of abuse, misuse and addiction. Controlled substance scheduling is pending for the drug, according to its label. Otsuka said it expects to make Simtriyo available “later this year” after scheduling by the U.S. Drug Enforcement Agency. ezstandalone.cmd.push(function () { ezstandalone.showAds(129); }); Jefferies analysts were bullish about the approval, calling it an “important de-risking event,” in a note to investors on Sunday. The FDA’s verdict “marks the arrival of Otsuka’s next major CNS launch,” the firm continued, adding that the pharma has previously forecasted peak sales of more than ¥100 billion (around $615 million) for Simtriyo. “The ADHD market remains large and under-penetrated,” Jefferies said, particularly for non-stimulant agents like Simtriyo. “We believe Simtriyo is well positioned to address patients seeking alternatives to traditional stimulant therapies.” The group also appeared unbothered by Simtriyo’s pending designation as a controlled substance, instead viewing it as a potential opportunity for Otsuka to carve out an advantage in the market. “As with all newly approved ADHD therapies, Simtriyo must now undergo DEA review,” the analysts wrote. While being unscheduled is likely “the most favorable regulatory outcome” for the drug, even less restrictive scheduling “could prove commercially advantageous,” Jefferies noted, explaining that such schedules could position Simtriyo between traditional stimulants—which are typically given more stringent DEA schedules—and non-stimulants, “potentially enhancing its differentiation.” The FDA’s nod was supported by data from four Phase 3 trials. Two of these studies, which focused on adult patients, showed that the drug significantly improved ADHD symptoms versus placebo, according to Otsuka’s news release on Friday. These benefits occurred as early as week 1 and were sustained throughout six weeks of treatment. The two other trials focused on pediatric and adolescent patients, and likewise showed significant symptomatic improvement.

Drug ApprovalPhase 3Clinical ResultAccelerated Approval

28 Jul 2026

·www.biospace.com

Otsuka Receives FDA Approval for First-in-Class SIMTRIYO® (centanafadine) for the Treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in Adults and Pediatric Patients Aged 6 Years and Older

SIMTRIYO is the first and only norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI) approved for the treatment of ADHD in adults and pediatric patients aged 6 years and older weighing at least 20kg SIMTRIYO will be commercially available later this year following scheduling by the U.S. Drug Enforcement Administration (DEA) Approval is supported by results from four pivotal Phase 3 clinical trials in adults and pediatric patients demonstrating statistically significant and clinically meaningful improvements in ADHD symptoms and a well-characterized safety profile ADHD is a chronic neurodevelopmental disorder that affects approximately 22.5 million children, adolescents, and adults in the U.S. Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced that the U.S. Food and Drug Administration (FDA) has granted approval of SIMTRIYO® (centanafadine), a once-daily extended-release capsule for the treatment of attention-deficit hyperactivity disorder (ADHD) in adults and pediatric patients aged 6 years and older weighing at least 20kg. As the first and only approved norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI), SIMTRIYO introduces a new treatment approach for patients and healthcare professionals managing this complex and highly individualized condition. By inhibiting the reuptake of norepinephrine, dopamine, and serotonin, SIMTRIYO increases the availability of these neurotransmitters in pathways involved in attention and behavioral regulation. SIMTRIYO, an NDSRI and central nervous system (CNS) stimulant, is expected to be available later this year following scheduling by the U.S. Drug Enforcement Administration (DEA). The approval is supported by results from four pivotal Phase 3 clinical trials evaluating the efficacy and safety of SIMTRIYO across adult, adolescent, and pediatric patients. In these Phase 3 clinical studies, SIMTRIYO demonstrated statistically significant and clinically meaningful improvements in ADHD symptoms compared with placebo, as measured by the ADHD Rating Scale-5 (ADHD-RS-5) in children and adolescents and the Adult ADHD Investigator Symptom Rating Scale (AISRS) in adults. In pediatric and adult studies, improvements in ADHD symptoms were seen as early as week 1. The most common adverse events include decreased appetite, nausea, rash, headache, and abdominal pain in children and adolescents, and headache, decreased appetite, insomnia, nausea, dry mouth, and diarrhea in adults. “The approval of SIMTRIYO marks an important milestone for people living with ADHD, as it introduces a novel treatment approach for this condition,” said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka. “ADHD is a complex and highly individualized disorder that can affect people throughout childhood, adolescence, and adulthood. Today’s approval reflects our commitment to advancing innovative treatment options that address the diverse needs of patients and families managing ADHD. We are deeply grateful to the patients, caregivers, investigators, and clinical teams whose participation made this achievement possible.” Additional clinical research continues to expand the evidence base for centanafadine. In a recently completed Phase 3b study in adults with ADHD and comorbid anxiety, centanafadine demonstrated statistically significant improvements in ADHD symptoms compared with placebo, providing additional insight into its clinical profile. Full study results will be presented at an upcoming scientific meeting. ADHD is a chronic neurodevelopmental disorder characterized primarily by impairments in attention, hyperactivity, and impulsivity1. The disorder can affect academic performance, occupational functioning, social relationships, and challenges that impact patients’ daily lives1. Although ADHD is often diagnosed during childhood, symptoms frequently persist into adolescence and adulthood1. “ADHD can significantly affect many aspects of daily life across school, work, and relationships,” said Dr. Lenard A. Adler, director of the adult ADHD program at NYU Langone Health. “Even when on treatment, because of the heterogenic nature of ADHD, many patients continue to experience symptoms that can interfere with daily functioning. The approval of SIMTRIYO introduces a novel mechanism of action and expands the range of options available to healthcare professionals and patients. Having more therapeutic choices is important because ADHD is a highly individualized condition and treatment decisions should reflect the unique needs of each patient.” The FDA approval of SIMTRIYO is supported by results from four randomized, double-blind, placebo-controlled Phase 3 clinical trials evaluating the efficacy and safety of centanafadine in children, adolescents, and adults with ADHD. In the two pivotal adult studies (NCT03605680 and NCT03605836), both centanafadine dose groups demonstrated statistically significant improvements in Adult ADHD Investigator Symptom Rating Scale (AISRS) total scores compared with placebo. Improvements were observed as early as Week 1 and maintained throughout the six-week treatment period. In the pivotal pediatric and adolescent studies (NCT05428033 and NCT05257265), high-dose centanafadine demonstrated statistically significant improvements in ADHD Rating Scale-5 (ADHD-RS-5) total scores compared with placebo. Improvements were observed as early as Week 1. Across the Phase 3 clinical development program, centanafadine was generally well-tolerated. Clinical and preclinical data demonstrated a well-studied and consistent safety profile. The most common adverse reactions were rash and decreased appetite in children 6 to 12 years of age; decreased appetite, nausea, rash, headache and abdominal pain in adolescents 13 to 17 years of age; and headache, decreased appetite, insomnia, nausea, dry mouth, and diarrhea in adults. ADHD is a chronic neurodevelopmental disorder characterized primarily by impairments in attention, hyperactivity, and impulsivity1. 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) 2,3. SIMTRIYO® (centanafadine) is a first-in-class norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI) and CNS stimulant. Clinical studies have shown that SIMTRIYO significantly reduced symptoms of ADHD in adults and pediatric patients aged 6 years and older weighing at least 20kg. Clinical data suggest SIMTRIYO has demonstrated a well-studied and consistent safety profile. 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. References 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. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultDrug Approval

100 Deals associated with Centanafadine Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D10698	Centanafadine Hydrochloride	-	DB14841

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Attention Deficit Disorder With Hyperactivity	United States	Otsuka Pharmaceutical Co., Ltd.	24 Jul 2026

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Nervous System Diseases	NDA/BLA	Canada	Otsuka Pharmaceutical Co., Ltd.	01 Jun 2026
Generalized anxiety disorder	Phase 3	United States	Otsuka Pharmaceutical Development & Commercialization, Inc.	26 Mar 2025
Attention Deficit Disorder	Phase 3	United States	Otsuka Pharmaceutical Development & Commercialization, Inc.	16 Jan 2019
Depressive Disorder, Major	Phase 2	United States	Otsuka Pharmaceutical Development & Commercialization, Inc.	12 Sep 2022
Binge-Eating Disorder	Phase 2	United States	Otsuka Pharmaceutical Development & Commercialization, Inc.	16 Dec 2021
Smoking Cessation	Phase 2	United States	Otsuka Pharmaceutical Development & Commercialization, Inc.	15 Sep 2021
Unspecified drug dependence	Phase 1	United States	Otsuka Pharmaceutical Development & Commercialization, Inc.	01 May 2014

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05257265 (A Trial of Centanafadine Efficacy and Safety in Adolescents With Attention-Deficit/Hyperactivity Disorder, Pubmed \| J Am Acad Child Adolesc Psychiatry)	Phase 3	Attention Deficit Disorder With Hyperactivity	459	Centanafadine 164.4 mg	gfeyajyzrl(tgirjbcrxi) = 1 event in 164.4 mg group mivwsjtygt (wmfodpatzt ) View more	Positive	01 Jun 2026
				Centanafadine 328.8 mg
NCT05113953 (CTgov)	Phase 2	Binge-Eating Disorder	147	Centanafadine (Centanafadine 400 mg)	uyynrilefp(ualpxxgijv) = qmkfopnqda rxbmwbjufj (ewkbpnplrq, 0.23) View more	-	09 Sep 2025
				Placebo+Centanafadine (Centanafadine 200 mg)	uyynrilefp(ualpxxgijv) = pnyqkwohbb rxbmwbjufj (ewkbpnplrq, 0.23) View more
NCT05257265 (A Trial of Centanafadine Efficacy and Safety in Adolescents With Attention-Deficit/Hyperactivity Disorder, Pubmed \| J Am Acad Child Adolesc Psychiatry)	Phase 3	Attention Deficit Disorder With Hyperactivity	459	Centanafadine 164.4 mg	ccuzzyshtd(fqfrbddgps) = 1 event in 164.4 mg group zzdvnftvql (cqgnvbtfvx ) View more	Positive	01 Jul 2025
				Centanafadine 328.8 mg
NCT05066724 (CTgov)	Phase 2	Smoking Cessation	50	Centanafadine	weelqkgxew = xzorehmixe pgtihhpmzm (slddahxnkn, pdqpucepvc - ilqdvsbhpx) View more	-	13 Jun 2025
NCT03605849 (CTgov)	Phase 3	Attention Deficit Disorder	662	Centanafadine SR (Prior Centanafadine SR 200 mg)	iopbmwbxfh = xqvbsfuuvi gpewzmnlbe (ikerjjcosc, xkfhgpudet - emklprkzbo) View more	-	01 Oct 2024
				Centanafadine SR (Prior Centanafadine SR 400 mg)	iopbmwbxfh = ktglezaaco gpewzmnlbe (ikerjjcosc, dgzdcxoskw - xtytrmcbjj) View more
NCT00334880 \| NCT03605836 \| NCT00190736 \| NCT04016779 (Pubmed)	Not Applicable	Attention Deficit Disorder With Hyperactivity	-	Centanafadine sustained-release	ahywscmqhg(unqwdjqlhj) = 6.58-point difference zbigbnpkna (tncshxxabw )	Positive	01 Jun 2024
NCT05428033 (NEWS) Manual	Phase 3	Attention Deficit Disorder With Hyperactivity	-	Centanafadine (high dose)	ypznlxejcw(liqfvigyet) = 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. qrbzmjfdce (lqfgjsixha )	Positive	27 Oct 2023
				Centanafadine (low dose)
NCT05257265 (NEWS) Manual	Phase 3	Attention Deficit Disorder With Hyperactivity	-	Centanafadine (high dose)	aypuhkoxnl(lrexvddjuq) = 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. tsjhbnyccu (teisxetpal )	Positive	27 Oct 2023
				Centanafadine (low dose)
NCT04081363 (CTgov)	Phase 2	Attention Deficit Disorder With Hyperactivity	13	Centanafadine (Swallowed Capsules Cohort)	onqcywplum(lzemzaghak) = jmxfjnfzce vognmttrwz (sdkyfcqlms, 51.4) View more	-	13 Jan 2023
				Centanafadine (Sprinkled Onto Applesauce Cohort)	onqcywplum(lzemzaghak) = srzejhshzy vognmttrwz (sdkyfcqlms, 52.8) View more
NCT03605836 (CTgov)	Phase 3	Attention Deficit Disorder	590	Centanafadine SR (Double-blind Treatment Period: Centanafadine SR 200 mg)	cmcxcimbmt(appokzrbia) = soiwmxoelx uryvgrjase (lcalfiykkz, 0.96) View more	-	18 Oct 2021
				Centanafadine SR (Double-blind Treatment Period: Centanafadine SR 400 mg)	cmcxcimbmt(appokzrbia) = qwvlxjchbw uryvgrjase (lcalfiykkz, 0.99) View more

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