Otsuka's ADHD Drug Centanafadine Hits Phase 3b Trial Endpoint Ahead of FDA Decision
Otsuka's ADHD drug centanafadine met the primary endpoint in a Phase 3b trial in adults with comorbid anxiety, with results supporting its efficacy ahead of a July 24, 2026 FDA decision. The FDA has granted priority review to the New Drug Application for the first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI). If approved, centanafadine would be a novel treatment option for ADHD in children, adolescents, and adults.
Otsuka's investigational ADHD treatment centanafadine has met the primary endpoint in a Phase 3b trial, strengthening its case weeks before a U.S. Food and Drug Administration decision scheduled for July 24, 2026. The Phase 3b study evaluated the drug in adults with ADHD and comorbid anxiety, a population not well-represented in the earlier pivotal trials.
The Phase 3b trial enrolled 315 adults with ADHD and comorbid anxiety who received either centanafadine or placebo once daily for eight weeks. Results showed a statistically significant improvement in ADHD symptoms, as measured by the Adult Investigator Symptom Rating Scale (AISRS). AISRS scores fell by 18.5 points in the centanafadine group, compared to a 12.6-point drop in the placebo group. The placebo-adjusted reduction was 5.87 points, with statistical separation between the groups starting at Week 1.
As a secondary endpoint, the trial also assessed anxiety. At Week 8, the Hamilton Anxiety Rating Scale (HAM-A) total score decreased 12.5 points in the centanafadine group versus a 10.6-point decline in the placebo group, a statistically significant difference of 1.92 points. These results provide evidence for the drug's performance in patients with both ADHD and anxiety, a comorbidity affecting about one-third of individuals with ADHD.
The U.S. FDA has accepted Otsuka's New Drug Application (NDA) for centanafadine for priority review, with a Prescription Drug User Fee Act (PDUFA) target action date of July 24, 2026. The NDA submission was made on November 24, 2025. If approved, centanafadine would be the first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI) treatment for ADHD in children, adolescents, and adults.
The NDA is supported by results from four pivotal Phase 3 clinical trials. Across these studies, centanafadine demonstrated statistically significant and clinically meaningful improvements in ADHD symptoms compared with placebo. The trials included studies in children (NCT05428033) and adolescents (NCT05257265). In both, the high-dose groups showed statistically significant improvements versus placebo, while some low-dose groups did not reach statistical significance.
Centanafadine was generally well tolerated across all studies. The most common adverse events reported in children and adolescents were decreased appetite, nausea, rash, fatigue, abdominal pain, and somnolence. In adults, the most common adverse events were decreased appetite and headache. Clinical and preclinical data suggest the drug has a favorable safety and tolerability profile and a low potential for abuse and dependence.
The FDA decision is expected by July 24, 2026. Otsuka is building commercial infrastructure in anticipation of a potential launch. However, a review by the Drug Enforcement Administration (DEA) could delay the launch by approximately three months, according to the company.
Attention-deficit hyperactivity disorder is a chronic neurodevelopmental disorder characterized primarily by impairments in attention, hyperactivity, and impulsivity. According to the Centers for Disease Control and Prevention, ADHD affects approximately 7 million children and an estimated 15.5 million adults in the United States.