The US Food and Drug Administration (FDA) has accepted for priority review Otsuka Pharmaceutical’s new drug application (NDA) submitted for centanafadine, an investigational, once-daily extended-release capsule for attention-deficit hyperactivity disorder (ADHD) treatment.
Otsuka’s NDA covers the use of centanafadine as a treatment for ADHD in adolescents, adults, and children.
Centanafadine is a norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI).
The Prescription Drug User Fee Act (PDUFA) target action date for the NDA is scheduled for 24 July 2026. The application is supported by findings from four pivotal Phase III trials assessing the safety and efficacy across various age groups.
In these trials, centanafadine showed significant improvements in ADHD symptoms compared with placebo, using the ADHD Investigator Symptom Rating Scale in adults, and the ADHD Rating Scale-5 in adolescents and children.
Centanafadine was found to be generally well-tolerated during the trials. The most common adverse events reported among adolescents and children included abdominal pain, decreased appetite, fatigue, nausea, rash, and somnolence. For adults, headache and decreased appetite were observed.
Otsuka development and commercialisation executive vice-president and chief medical officer John Kraus said: “ADHD manifests differently across patients, highlighting the importance of having multiple therapeutic approaches available.
“The FDA’s acceptance and priority review designation of our NDA for centanafadine marks an important milestone in our effort to bring forward a novel treatment option for people living with ADHD.
“If approved, centanafadine would offer a first-in-class NDSRI option designed to support broad symptom management. We extend our sincere gratitude to the patients, caregivers, and investigators whose participation made this milestone possible.”
In November 2025, Otsuka secured accelerated approval from the FDA for Voyxact (sibeprenlimab-szsi) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at disease progression risk.
