TOKYO, Japan & PRINCETON, N.J., June 26, 2026
Otsuka Pharmaceutical Co., Ltd. and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) announced positive topline results from a Phase 3b clinical trial evaluating centanafadine XR 280 mg in adults with attention-deficit/hyperactivity disorder (ADHD) and comorbid anxiety disorders. The investigational therapy successfully achieved its primary endpoint, demonstrating statistically significant improvements in ADHD symptoms compared with placebo while also delivering meaningful reductions in anxiety symptoms, an important outcome for a patient population with limited treatment options. Centanafadine is a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI) currently under U.S. FDA Priority Review for the treatment of ADHD in children, adolescents, and adults, with a Prescription Drug User Fee Act (PDUFA) target action date of July 24, 2026. The latest Phase 3b findings further strengthen the growing body of clinical evidence supporting the investigational medicine and highlight its potential to address both the core symptoms of ADHD and commonly associated anxiety disorders.
Phase 3b Trial Meets Primary and Secondary Endpoints
The randomized, double-blind, placebo-controlled Phase 3b study enrolled 315 adults aged 18 to 65 years diagnosed with ADHD and generalized anxiety disorder (GAD) and/or social anxiety disorder (SAD). The study successfully met its primary endpoint, with patients receiving centanafadine experiencing significantly greater improvement in Adult Investigator Symptom Rating Scale (AISRS) total scores compared with placebo after eight weeks of treatment. Clinical benefit was observed as early as Week 1 and remained consistent throughout the study period.
The therapy also met its key secondary endpoint, demonstrating statistically significant improvements in Hamilton Anxiety Rating Scale (HAM-A) scores, confirming meaningful reductions in anxiety symptoms alongside improvements in attention, impulsivity, and hyperactivity. Additional secondary analyses further supported the treatment’s positive impact across multiple ADHD-associated clinical measures, reinforcing its therapeutic potential in patients experiencing both neurological and psychiatric symptoms.
Novel NDSRI Mechanism Supports Unmet Clinical Need
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Centanafadine represents a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI) specifically designed to address the neurochemical pathways involved in ADHD. Unlike traditional stimulant medications, the investigational therapy combines activity across three neurotransmitter systems while demonstrating low abuse potential, an important consideration for long-term ADHD management. Clinical development has consistently shown meaningful improvements in core ADHD symptoms while maintaining a favorable safety profile. In the latest Phase 3b study, the most frequently reported adverse events included nausea, decreased appetite, diarrhea, insomnia, dry mouth, and vomiting, with the overall safety and tolerability profile remaining consistent with previous clinical studies.
Given that up to 50% of adults with ADHD experience comorbid anxiety disorders, the ability of centanafadine to improve both ADHD and anxiety symptoms could address a significant unmet medical need and potentially improve quality of life, daily functioning, and long-term clinical outcomes for a large patient population.
FDA Priority Review Advances Regulatory Pathway
The positive Phase 3b data further support Otsuka’s ongoing regulatory submission for centanafadine in the United States. The investigational therapy is currently undergoing FDA Priority Review, with a PDUFA target action date of July 24, 2026, reflecting the agency’s recognition of its potential to provide meaningful therapeutic advancement. Full study results will be presented at an upcoming scientific meeting, adding to the growing evidence supporting centanafadine across diverse ADHD patient populations. If approved, centanafadine could become the first NDSRI therapy available for ADHD treatment, expanding therapeutic options beyond existing stimulant and non-stimulant medications.
For Otsuka, the latest clinical success reinforces its commitment to advancing innovative neuroscience therapies while addressing complex psychiatric and neurological disorders. The encouraging findings position centanafadine as a promising new treatment candidate capable of transforming care for adults living with ADHD and comorbid anxiety, potentially setting a new standard for comprehensive symptom management in this challenging patient population.
Source: Otsuka Pharmaceutical press release
