FDA accepts Otsuka’s centanafadine application for ADHD treatment
- Drug: Centanafadine
- Sponsor: Otsuka Pharmaceutical
- Status: Priority Review
- PDUFA Date: 24 July 2026
- Class: NDSRI
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.
Mechanism and Target Population
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.
Clinical Trials: Efficacy and Safety
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
- Somnolence
For adults, headache and decreased appetite were observed.
Executive Commentary
— John Kraus, Otsuka EVP and Chief Medical Officer
Recent Otsuka Approvals
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.
