- Study met its primary endpoint, demonstrating statistically significant and clinically relevant improvements in ADHD symptoms in adults with ADHD and comorbid anxiety taking centanafadine compared to those taking placebo
- Centanafadine is currently under Priority Review by the FDA for the treatment of ADHD in children, adolescents, and adults, with a target action date of July 24, 2026
PRINCETON, N.J. & TOKYO--(BUSINESS WIRE)--Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced positive topline results in a Phase 3b study (NCT06973577) evaluating centanafadine XR 280 mg once daily in adults with attention-deficit/hyperactivity disorder (ADHD) and comorbid anxiety. Centanafadine is a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI).
The trial met its primary endpoint by demonstrating improvements from baseline on the Adult Investigator Symptom Rating Scale (AISRS) total score compared to placebo at week 8. Adult patients with ADHD and comorbid anxiety receiving centanafadine demonstrated statistically significant and clinically relevant improvements compared to placebo [LS mean change -18.5 vs -12.6, treatment difference -5.87; p<0.0001]. Statistical separation was seen as early as week 1; the first post-baseline timepoint and maintained over the 8-week trial. Statistically significant improvements versus placebo were also observed in the key secondary efficacy endpoint, change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at week 8 [LS mean change -12.5 vs -10.6, treatment difference -1.92; p=0.02] and other secondary efficacy endpoints supporting the primary outcome results.
“Adults with ADHD and comorbid anxiety represent a substantial and particularly challenging population to treat,” said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka. “These results provide additional insight into centanafadine’s clinical profile and expand the evidence base supporting its potential in adults with ADHD across diverse patient presentations.”
The most frequently observed side effects for centanafadine (>5 percent and more frequent than placebo) included nausea, decreased appetite, diarrhea, insomnia, dry mouth and vomiting. The safety and tolerability profile was consistent with the known safety profile for centanafadine and an ADHD and anxiety comorbid population. The findings continue to expand the overall scientific evidence supporting centanafadine’s impact on improving core ADHD symptoms.
Full results will be presented at an upcoming scientific meeting. Centanafadine is currently under regulatory review in the United States for the treatment of ADHD in children, adolescents, and adults and has been granted Priority Review by the Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) target action date of July 24, 2026.
About the Study
This randomized, double-blind, placebo-controlled Phase 3b study (NCT06973577) enrolled 315 adults aged 18–65 with ADHD and comorbid generalized anxiety disorder (GAD) and/or social anxiety disorder (SAD). The primary endpoint was change from baseline in Adult Investigator Symptom Rating Scale (AISRS) total score compared to placebo at week 8; key secondary endpoints included change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score. Other secondary endpoints included measures of ADHD associated features.
About Attention-Deficit Hyperactivity Disorder (ADHD) and Anxiety
ADHD is a chronic neurodevelopmental disorder characterized primarily by impairments in attention, hyperactivity, and impulsivity1. It affects approximately 7 million children in the U.S. and an estimated 15.5 million adults, according to the Centers for Disease Control and Prevention (CDC)2,3. Up to 50% of adults with ADHD have comorbid anxiety disorders and are associated with higher rates of hospitalization, suicidality, and psychotic symptoms4-6. Many individuals with comorbid anxiety have worse clinical presentation, achieve lower occupational outcomes and experience a reduced quality of life6,7.
About Centanafadine
Centanafadine is an investigational, first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI). Clinical studies have shown that centanafadine significantly reduced core symptoms of ADHD in children, adolescents, and adults. Additional clinical analyses characterized centanafadine’s potential impact on ADHD-associated features. Clinical data suggest centanafadine has an established safety and tolerability profile and low potential for abuse, with the most common adverse events including decreased appetite and headache.
About Otsuka
Otsuka Pharmaceutical Co., Ltd. is a total healthcare company that focuses on each individual's potential to enhance their well-being. Our medical-related business provides treatments and diagnostics for both physical and mental health. Our nutraceutical business supports daily health maintenance and improvement. Otsuka's unique products and services are based on scientific evidence, under the guidance of our corporate philosophy: Otsuka-people creating new products for better health worldwide.
Otsuka America Pharmaceutical, Inc. and Otsuka Pharmaceutical Development & Commercialization, Inc. are the US-based indirect subsidiaries of the global healthcare company Otsuka Pharmaceutical Co. Ltd. Otsuka’s US companies share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and immunology. At our core is perseverance—a fierce determination to overcome any obstacle, regardless of setbacks, on behalf of patients, caregivers, and their loved ones. We will not be bound by doing what’s been done before. Learn more at www.otsuka-us.com.
References
1. American Psychiatric Association (2022). Diagnostic and Statistical Manual of Mental Disorders (5th ed., text rev).
2. Staley, Brook S, et al. Attention-Deficit/Hyperactivity Disorder Diagnosis, Treatment, and Telehealth Use in Adults — National Center for Health Statistics Rapid Surveys System, United States, October–November 2023. US Centers for Disease Control and Prevention.
3. Data and Statistics on ADHD. Attention-Deficit/ Hyperactivity Disorder (ADHD). November 19. 2024. U.S. Centers for Disease Control and Prevention. https://www.cdc.gov/adhd/data/index.html.
4. Fu X, Wu W, Wu Y, Liu X, Liang W, Wu R, Li Y. Adult ADHD and comorbid anxiety and depressive disorders: a review of etiology and treatment. Front Psychiatry. 2025 Jun 6;16:1597559. doi: 10.3389/fpsyt.2025.1597559. PMID: 40547117; PMCID: PMC12179154.
5. León-Barriera R, Ortegon RS, Chaplin MM, Modesto-Lowe V. Treating ADHD and comorbid anxiety in children: a guide for clinical practice. Clin Pediatr (Phila). 2023;62(1):39-46. doi:10.1177/00099228221111246
6. Quenneville AF, Kalogeropoulou E, Nicastro R, Weibel S, Chanut F, Perroud N. Anxiety disorders in adult ADHD: a frequent comorbidity and a risk factor for externalizing problems. Psychiatry Res. 2022;310:114423. doi:10.1016/j.psychres.2022.114423
7. Katzman MA, Bilkey TS, Chokka PR, Fallu A, Klassen LJ. Adult ADHD and comorbid disorders: clinical implications of a dimensional approach. BMC Psychiatry. 2017;17(1):302. doi:10.1186/s12888-017-1463-3
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