New Phase 3 Post Hoc Analyses of Centanafadine for the Treatment of Adults With ADHD

Otsuka shared new post hoc, exploratory analyses from 2 identical phase 3 clinical trials evaluating centanafadine, which is an investigational, first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI) for the treatment of adults with attention-deficit/hyperactivity disorder (ADHD), at the 2026 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting.¹

This data showed that in addition to improving core ADHD symptoms, centanafadine was associated with improvements in patient-reported executive function and emotional dysregulation. These are 2 clinically meaningful, often underrecognized features associated with ADHD that contribute substantially to patient burden.²

The findings add to previously reported positive phase 3 data evaluating centanafadine in adults with ADHD. Centanafadine is currently under US Food and Drug Administration (FDA) regulatory review for the treatment of ADHD. It was previously granted Priority Review and has a Prescription Drug User Fee Act target action date of July 24, 2026.³

A total of 744 adult participants 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 Expanded Version. At week 6, patients treated with centanafadine reported improved executive function from baseline compared with placebo. 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. These analyses help further characterize centanafadine across a broader range of patient-reported symptoms beyond core ADHD symptoms.

References

1. Otsuka presents new phase 3 post hoc analyses of centanafadine highlighting improvement in executive function and emotional dysregulation in adults with ADHD at the 2026 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting. News release. May 28, 2026. Accessed June 26, 2026. https://www.otsuka-us.com/news/otsuka-presents-new-phase-3-post-hoc-analyses-centanafadine-highlighting-improvement-executive

2. Van Stralen J. Emotional dysregulation in children with attention-deficit/ hyperactivity disorder. Atten Defic Hyperact Disord. 2016;8(4):175-187.

3. Kuntz L. FDA accepts NDA for priority review: centanafadine for treatment of ADHD. Psychiatric Times. January 27, 2026. https://www.psychiatrictimes.com/view/fda-accepts-nda-for-priority-review-centanafadine-for-treatment-of-adhd