Otsuka's Centanafadine Shows Broad Efficacy in ADHD-Anxiety…

Event summary

Otsuka presented Phase 3b results for centanafadine (SIMTRIYO®) at Psych Congress 2026, showing consistent improvements across ADHD symptoms, anxiety, and associated features in adults with comorbid conditions.
The study enrolled 315 adults aged 18–65 with ADHD and comorbid generalized anxiety disorder (GAD) and/or social anxiety disorder (SAD).
Centanafadine demonstrated statistically significant improvements over placebo on the Adult ADHD Investigator Symptom Rating Scale (AISRS) and Hamilton Anxiety Rating Scale (HAM-A).
The safety profile was consistent with known safety data for centanafadine, with the most common adverse events being nausea, decreased appetite, and diarrhea.

The big picture

Otsuka's Phase 3b results for centanafadine underscore the growing focus on treating comorbid psychiatric conditions with a single therapeutic approach. The study's comprehensive dataset highlights the need for differentiated treatments in a market where up to 50% of adults with ADHD also suffer from anxiety disorders. The findings could position SIMTRIYO as a key player in the ADHD treatment landscape, particularly if the DEA's scheduling review is favorable.

What we're watching

Regulatory Approval: The pace at which the DEA completes its scheduling review for SIMTRIYO will determine its market accessibility and prescription potential.
Market Differentiation: Whether Otsuka can position SIMTRIYO as a superior option for ADHD patients with comorbid anxiety disorders, given its broad efficacy profile.
Clinical Adoption: How quickly clinicians adopt centanafadine for complex ADHD-anxiety cases, given the study's consistent improvements across multiple measures.