Otsuka's Centanafadine Shows Promise in ADHD and Anxiety Combo Trial — Otsuka Pharmaceutical Co., Ltd.

Event summary

Otsuka's Phase 3b trial of centanafadine XR 280 mg met primary endpoint, showing significant improvement in ADHD symptoms with comorbid anxiety vs. placebo.
Key secondary endpoint (Hamilton Anxiety Rating Scale) also achieved statistical significance at week 8.
FDA Priority Review designation for centanafadine in ADHD treatment maintains July 24, 2026 PDUFA target action date.
Study enrolled 315 adults aged 18–65 with ADHD and comorbid generalized anxiety disorder (GAD) or social anxiety disorder (SAD).
Common side effects included nausea, decreased appetite, diarrhea, insomnia, dry mouth, and vomiting.

The big picture

Otsuka's positive Phase 3b results for centanafadine expand the drug's potential beyond core ADHD into comorbid anxiety—a challenging patient population with significant unmet needs. The FDA's Priority Review designation underscores the therapeutic gap in treating adult ADHD, particularly when complicated by anxiety disorders. If approved, centanafadine could carve out a niche in a competitive neuroscience market dominated by stimulant and non-stimulant ADHD treatments.

What we're watching

Regulatory Approval: Whether the FDA will approve centanafadine by the July 24, 2026 PDUFA date and its potential labeling for ADHD with comorbid anxiety.
Market Positioning: How Otsuka positions centanafadine against existing ADHD treatments, particularly in the complex comorbid anxiety population.
Commercial Strategy: The pace at which Otsuka can commercialize centanafadine if approved, given its first-in-class NDSRI mechanism and potential for broader ADHD indications.