The US FDA has accepted for priority review a new drug registration application (NDA) from Otsuka Pharmaceutical for centanafadine, a once-daily extended-release capsule for the treatment of ADHD in children, adolescents and adults.[1][2][5] Centanafadine is the first in the class of norepinephrine, dopamine, and serotonin reuptake inhibitors (NDSRIs).[1][2][4] The claim is supported by data from four phase 3 clinical trials that demonstrated statistically significant and clinically meaningful improvement in ADHD symptoms versus placebo.[1][2][4] In children and adolescents, the symptoms were evaluated with the ADHD-RS-5 scale, in adults with the AISRS scale.[2][4] The most common adverse effects were decreased appetite, nausea, rash, fatigue, abdominal pain, and drowsiness in children and adolescents, and decreased appetite and headache in adults.[1][2][4] The FDA has set a target date for action under the Prescription Drug User Fee Act (PDUFA) at July 24, 2026.[1][2][4]