Otsuka Announces FDA Acceptance and Priority Review of New Drug Application for Centanafadine for ADHD Treatment

Centanafadine is a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI) for ADHD in children, adolescents, and adults.

Jan. 28, 2026 at 8:31am

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Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the New Drug Application (NDA) for centanafadine, an investigational, once-daily extended release capsule and the first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI), for the treatment of attention-deficit hyperactivity disorder (ADHD) in children, adolescents, and adults. The Prescription Drug User Fee Act (PDUFA) target action date is set for July 24, 2026.

Why it matters

ADHD is a chronic neurodevelopmental disorder that affects approximately 7 million children and an estimated 15.5 million adults in the U.S. The FDA's acceptance and priority review of the centanafadine NDA marks an important milestone in providing a novel treatment option for people living with ADHD, as centanafadine would offer a first-in-class NDSRI designed to support broad symptom management.

The details

The NDA for centanafadine is supported by results from four pivotal Phase 3 clinical trials evaluating the efficacy and safety of centanafadine across patient populations. In these trials, centanafadine demonstrated statistically significant and clinically meaningful improvements in ADHD symptoms compared with placebo, and was generally well tolerated across studies.

  • The Prescription Drug User Fee Act (PDUFA) target action date is set for July 24, 2026.

The players

Otsuka Pharmaceutical Development & Commercialization, Inc.

A subsidiary of Otsuka Pharmaceutical Co., Ltd. that develops and commercializes medicines in the areas of mental health and nephrology.

Otsuka Pharmaceutical Co., Ltd.

A global healthcare company with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.

U.S. Food and Drug Administration (FDA)

The federal agency responsible for regulating and supervising the safety of food, drugs, and other products in the United States.

Centanafadine

An investigational, once-daily extended release capsule and the first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI) for the treatment of ADHD in children, adolescents, and adults.

ADHD

A chronic neurodevelopmental disorder characterized primarily by impairments in attention, hyperactivity, and impulsivity that affects approximately 7 million children and an estimated 15.5 million adults in the U.S.

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What they’re saying

“ADHD manifests differently across patients, highlighting the importance of having multiple therapeutic approaches available.”

— John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka Pharmaceutical Development & Commercialization, Inc.

What’s next

The FDA will make a decision on the approval of centanafadine by the PDUFA target action date of July 24, 2026.

The takeaway

The FDA's acceptance and priority review of the centanafadine NDA represents a significant milestone in providing a novel treatment option for the millions of children, adolescents, and adults living with ADHD in the United States. If approved, centanafadine would offer a first-in-class NDSRI designed to broadly manage the core symptoms of ADHD.