Posted by Michael Wonder on 26 Nov 2025
Otsuka Pharmaceutical submits new drug application to US FDA for centanafadine for the treatment of ADHD in children, adolescents, and adults
24 November 2025 - Otsuka today announce the filing of a new drug application with the US FDA for centanafadine, once daily extended release capsules, a novel norepinephrine, dopamine, and serotonin reuptake inhibitor, for the treatment of attention-deficit hyperactivity disorder in children, adolescents, and adults.
The new drug application submission is supported by results from four pivotal Phase 3 clinical trials evaluating the efficacy and safety of centanafadine across patient population.
