Otsuka’s centanafadine improved executive function and emotional regulation in adults with ADHD in new Phase 3 analyses presented at ASCP 2026, reinforcing efficacy beyond core symptoms as FDA Priority Review advances toward a July 24, 2026 decision.
Written By: Nalam Karthik, PharmD
Reviewed By: Pharmacally Editorial Team
Otsuka Pharmaceutical have reported new Phase 3 analyses of centanafadine, an investigational norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI), in adults with attention-deficit/hyperactivity disorder (ADHD).
The findings, presented at the 2026 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, suggest centanafadine may improve executive function and emotional regulation in addition to reducing core ADHD symptoms, broadening its potential clinical impact ahead of an FDA decision.
Centanafadine is currently under FDA Priority Review, with a Prescription Drug User Fee Act (PDUFA) target action date of July 24, 2026.
Study Design & Analyses
The post hoc exploratory analyses pooled data from two identical Phase 3 randomized, double-blind, placebo-controlled studies (NCT03605680 and NCT03605836). A total of 744 adults aged 18 to 55 years received centanafadine 200 mg (n=242), centanafadine 400 mg (n=241), or placebo (n=261) over six weeks.
The primary endpoint in both studies was change from baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) total score at Week 6. Both centanafadine dose groups achieved statistically significant and clinically meaningful improvements compared with placebo, supporting the therapy’s efficacy in reducing core ADHD symptoms.
Clinical Outcomes
Beyond improvements in core ADHD symptoms, centanafadine demonstrated benefits across measures of executive function and emotional regulation. On the Executive Functioning subscale of the Adult ADHD Self-Report Scale (ASRS) Expanded Version, patients reported improvements in time management, planning, prioritization, task completion, and working memory.
The therapy also improved scores on the ASRS Emotional Dyscontrol subscale, reducing emotional overactivity, affective lability, and anger outbursts compared with placebo. The results suggest centanafadine may address ADHD-associated impairments that often interfere with work performance, organization, planning, and emotional control, areas that remain significant unmet needs in adult ADHD care.
Safety & Tolerability
The safety profile remained favorable, with decreased appetite and headache reported as the most common adverse events. Investigators also noted a low potential for abuse and dependence, reinforcing centanafadine’s positioning as a non-stimulant treatment candidate. No new safety signals emerged in the analyses.
Expert Perspectives
Lenard A. Adler, M.D., director of the Adult ADHD Program at NYU Langone Health and a study investigator, emphasized that executive function deficits and emotional dysregulation are among the most challenging aspects of ADHD and are often inadequately addressed by existing treatments. He noted that improvements across both core symptoms and associated features are clinically meaningful given the broad and variable symptom burden experienced by adults with ADHD.
John Kraus, M.D., Ph.D., executive vice president and chief medical officer at Otsuka Pharmaceutical Development & Commercialization, said the findings complement previous research in pediatric and adolescent populations. He noted that the analyses further define centanafadine’s clinical profile and support a broader treatment approach that addresses multiple dimensions of ADHD.
Approaching FDA Decision
With an FDA decision expected in July 2026, these analyses strengthen the evidence package supporting centanafadine as a potential new non-stimulant treatment option for adults with ADHD. If approved, centanafadine would become the first NDSRI for ADHD, introducing a novel non-stimulant mechanism that may address both core symptoms and broader functional challenges associated with the disorder.
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About the Writer
Nalam Karthik (LinkedIn) is a healthcare writer and PharmD graduate with interests in pharmacovigilance, drug safety, clinical data analysis, and quality assurance. He is passionate about translating clinical and pharmaceutical knowledge into accessible healthcare content while staying engaged with advancements in drug development and patient safety initiatives.