Positive Phase 3 Data for Centanafadine to Treat Comorbid ADHD and Anxiety

Positive phase 3b data has been shared for centanafadine in treatment of adults with comorbid attention-deficit hyperactivity disorder (ADHD) and anxiety. Latest topline results showed primary and secondary endpoints met, with improvements in symptoms of both ADHD and anxiety and a consistent safety profile.

The randomized, double-blind, placebo-controlled phase 3b study investigated both ADHD and anxiety symptom changes. Participants were 315 adults, aged 18 to 65, who had comorbid generalized or social anxiety disorder and ADHD, according to DSM-5 criteria. A 280 mg dose of centanafadine was given once daily over the course of 8 weeks. Primary endpoints included change from baseline in the Adult Investigator Symptom Rating Scale (AIRS) score, and secondary endpoints included change from baseline in Hamilton Anxiety Rating Scale (HAM-A) score. Other secondary measures focused on ADHD and associated features. Participants were included if they had not derived therapeutic benefit from 2 or more ADHD and 2 or more anxiety therapies of different classes. Patients with any other diagnoses of posttraumatic stress disorder, bipolar disorder, autism spectrum disorder, substance use disorders, eating disorders, depression, or other anxiety disorders were excluded.

“Adults with ADHD and comorbid anxiety represent a substantial and particularly challenging population to treat,” said John Kraus, MD, PhD, executive vice president and chief medical officer of Otsuka. “These results provide additional insight into centanafadine’s clinical profile and expand the evidence base supporting its potential in adults with ADHD across diverse patient presentations,” he added.

The short-term phase 3b trial met its primary endpoint, showing statistically significant and clinically relevant improvements in AIRS scores compared with placebo at week 8. Adult patients with these comorbid conditions receiving centanafadine showed a least squares mean change of -18.5 vs -12.6 in placebo (P < 0.0001). Separation between the treatment and placebo groups was seen as early as week 1, which was the earliest post-baseline timepoint; improvements were sustained over the subsequent 8-week course. Secondary endpoint results were also significant: change from baseline in HAM-A scores at week 8 showed least squares mean change of -12.5 for treatment and -10.6 in placebo (P = 0.02). Side effects observed included nausea, decreased appetite, diarrhea, insomnia, dry mouth, and vomiting. The overall safety profile was consistent with known results from previous trials of the medication.

Centanafadine is a norepinephrine, dopamine, and serotonin reuptake inhibitor. It has been previously shown to reduce core symptoms of ADHD in children, adolescents, and adults. Clinical safety data has been established with strong tolerability and safety.

Centanafadine is currently under review by the US Food and Drug Administration (FDA) for treatment of ADHD in children, adolescents, and adults; the FDA action date is set for July 24, 2026.

References

1. Otsuka announces positive phase 3b results for centanafadine in adults with ADHD and comorbid anxiety. Press release. June 25, 2026. Accessed July 1, 2026. https://www.otsuka-us.com/news/otsuka-announces-positive-phase-3b-results-centanafadine-adults-adhd-and-comorbid-anxiety

2. P3b short-term study of CTN in patients with ADHD and comorbid anxiety. ClinicalTrials.gov. May 6, 2026. Accessed July 1, 2026. https://clinicaltrials.gov/study/NCT06973577