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.
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