Otsuka Reports Positive Phase 3b Results for Centanafadine in Adults with ADHD and Anxiety

Otsuka Announces Positive Topline Results from Phase 3b Trial

Otsuka Pharmaceutical Co., Ltd. and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) have announced positive topline results from a Phase 3b clinical trial evaluating centanafadine XR 280 mg, taken once daily, in adults with attention-deficit/hyperactivity disorder (ADHD) and comorbid anxiety.

The study showed that centanafadine significantly improved ADHD symptoms while also reducing anxiety symptoms, offering encouraging results for a group of patients that often has limited treatment options.

Trial Meets Primary and Secondary Endpoints

The Phase 3b study successfully met its primary endpoint by showing a statistically significant improvement from baseline in the Adult Investigator Symptom Rating Scale (AISRS) total score compared with placebo after eight weeks of treatment.

Patients receiving centanafadine experienced meaningful improvements in ADHD symptoms, with benefits becoming visible as early as the first week of treatment. These improvements continued throughout the entire eight-week study period.

The trial also met its key secondary endpoint. Patients treated with centanafadine showed statistically significant improvements in anxiety symptoms, measured using the Hamilton Anxiety Rating Scale (HAM-A), compared with those receiving placebo.

Additional secondary efficacy endpoints also supported the overall positive findings of the study.

Why This Study Matters

Adults living with ADHD often experience anxiety alongside their core symptoms. Treating both conditions at the same time can be difficult because some medications may improve one condition without adequately addressing the other.

The latest findings suggest that centanafadine may help improve both ADHD symptoms and anxiety in the same patient population, making it a potentially valuable treatment option if approved.

Centanafadine Uses a Different Mechanism

Centanafadine is a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI).

Unlike many currently available ADHD treatments, the investigational medicine works by affecting three important neurotransmitters involved in attention, focus, and mood regulation. This unique mechanism may provide another treatment option for patients who need alternatives to existing therapies.

Safety Profile Remains Consistent

The safety results from the Phase 3b study were consistent with the known safety profile of centanafadine.

The most commonly reported side effects, occurring in more than 5% of patients and more frequently than placebo, included:

• Nausea
• Decreased appetite
• Diarrhoea
• Insomnia
• Dry mouth
• Vomiting

The company said the overall safety and tolerability profile remained consistent in adults with both ADHD and anxiety.

Company Highlights Clinical Findings

John Kraus, Executive Vice President and Chief Medical Officer at OPDC, said adults with ADHD and anxiety represent a particularly challenging group to treat.

He noted that these latest findings provide additional evidence supporting centanafadine's clinical profile and expand the understanding of its potential benefits across different adult ADHD patient populations.

Regulatory Review Continues in the United States

Centanafadine is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of ADHD in children, adolescents, and adults.

The investigational therapy has received Priority Review from the FDA, with a Prescription Drug User Fee Act (PDUFA) target action date of July 24, 2026.

Otsuka also announced that the complete results from the Phase 3b trial will be presented at an upcoming scientific meeting.

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