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FDA Accepts NDA for Priority Review of Centanafadine to Treat Adult, Pediatric ADHD
FDA prioritizes centanafadine's review for ADHD treatment, offering a novel first-in-class NDSRI option for adults, adolescents, and children.
The US Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for priority review of centanafadine, an investigational once-daily extended-release capsule for the treatment of ADHD in children, adolescents, and adults. Centanafadine was assigned a Prescription Drug User Fee Act (PDUFA) target action date of July 24, 2026.1
“ADHD manifests differently across patients, highlighting the importance of having multiple therapeutic approaches available,” said John Kraus, MD, PhD, executive vice president and chief medical officer at Otsuka Pharmaceutical Development & Commercialization, in a statement. “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.”1
Centanafadine, a norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI), can significantly reduce core symptoms of ADHD. The NDA was supported by results from 4 pivotal phase 3 clinical trials assessing the efficacy and safety of centanafadine across patient populations. The package included 1 trial with children aged 4 – 12 years, 1 with adolescents aged 13 – 17 years, and 2 with adults aged 18 – 55 years. In the adult trials, participants received either centanafadine 200 mg/day, 400 mg/day, or placebo over a 6-week treatment period.2
Phase 3 trials showed that centanafadine provided significant and clinically meaningful improvements in ADHD symptoms compared with placebo, as measured by the ADHD Rating Scale- 5 (ADHD-RS-5) in adolescents (P =.0099) and children (P =.0008), and the ADHD Investigator Symptom Rating Scale (AISRS) in adults.3 The data showed that centanafadine was generally well tolerated, with common adverse events including decreased appetite, nausea, rash, fatigue, abdominal pain, and somnolence in children and adolescents, and decreased appetite and headache in adults.2
In pediatric trials, only the high dose and the average effect of the high and low dose centanafadine reached statistical significance. Low-dose centanafadine alone did not provide significant improvement. Both pediatric trials showed improvements with centanafadine at week 1, with sustained improvements.3 In the adult trials, both centanafadine at 200 and 400 mg/day provided statistically significant improvement in ADHD symptoms over placebo.2
“If approved, centanafadine would offer a first-in-class NDSRI option designed to support broad symptom management,” Kraus added.1
References
Otsuka Announces FDA Acceptance and Priority Review of New Drug Application for Centanafadine for the Treatment of ADHD in Children, Adolescents, and Adults. BusinessWire. January 27, 2026. https://www.businesswire.com/news/home/20260127432877/en/Otsuka-Announces-FDA-Acceptance-and-Priority-Review-of-New-Drug-Application-for-Centanafadine-for-the-Treatment-of-ADHD-in-Children-Adolescents-and-Adults. Accessed January 27, 2026.
Derman C. Otsuka Pharmaceuticals Submits NDA for Centanafadine to Treat ADHD in Children. HCPLive. November 25, 2025. https://www.hcplive.com/view/otsuka-pharmaceuticals-submits-nda-centanafadine-treat-adhd-children. Accessed January 27, 2026.
Derman C. Centanafadine Shows Promise in Phase 3 Trials for Adolescent ADHD. HCPLive. October 30, 2023. https://www.hcplive.com/view/centanafadine-shows-promise-phase-3-trials-adolescent-adhd. Accessed January 27, 2026.
