• Centanafadine is an investigational compound for the treatment of ADHD in children, adolescents, and adults. It is a novel norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI).
• The Prescription Drug User Fee Act (PDUFA) target action date is July 24, 2026.
• If approved, centanafadine would offer a first-in-class NDSRI treatment option for patients managing ADHD.
• ADHD is a chronic neurodevelopmental disorder characterized primarily by impairments in attention, hyperactivity, and impulsivity. It is often not diagnosed until adulthood, with an estimated 15.5 million adults in the U.S. currently diagnosed.

Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announce 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.

The NDA is supported by results from four pivotal Phase 3 clinical trials evaluating the efficacy and safety of centanafadine across patient populations^1,2,3. In these trials, centanafadine demonstrated statistically significant and clinically meaningful improvements in ADHD symptoms compared with placebo, as measured by the ADHD Rating Scale – 5 (ADHD-RS-5) in adolescents and children, and the ADHD Investigator Symptom Rating Scale (AISRS) in adults. Centanafadine was generally well tolerated across studies, with the most common adverse events including decreased appetite, nausea, rash, fatigue, abdominal pain, and somnolence in children and adolescents, and decreased appetite and headache in adults^1,2,3.

“ADHD manifests differently across patients, highlighting the importance of having multiple therapeutic approaches available,” said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka Pharmaceutical Development & Commercialization, Inc. “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.”

Although historically seen as a childhood disorder, research suggests that many individuals diagnosed with ADHD in childhood continue to experience symptoms into adulthood, with some patients experiencing significant impairment.

About Attention-Deficit Hyperactivity Disorder (ADHD)

ADHD is a chronic neurodevelopmental disorder characterized primarily by impairments in attention, hyperactivity, and impulsivity⁴. It affects approximately 7 million children in the U.S. and an estimated 15.5 million adults, according to the Centers for Disease Control and Prevention (CDC)^5,6.

About Centanafadine

Centanafadine is a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI). Clinical studies have shown that centanafadine significantly reduces core symptoms of ADHD in children, adolescents, and adults. Clinical and preclinical data suggest centanafadine showed a favorable safety and tolerability profile and low potential for abuse.

About Otsuka

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: Otsuka–people creating new products for better health worldwide. Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.

In pharmaceuticals, Otsuka is a leader in the challenging areas of mental, kidney, and cardiovascular health and has additional research programs in oncology and on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.

Otsuka established a presence in the U.S. in 1973 and today its U.S. affiliates include Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka America Pharmaceutical, Inc. (OAPI). These two companies’ 2,250 employees in the U.S. develop and commercialize medicines in the areas of mental health and nephrology, using cutting-edge technology to address unmet healthcare needs.

OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Co., Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 35,340 people worldwide and had consolidated sales of approximately USD 14.7 billion in 2024.

All Otsuka stories start by taking the road less traveled. Learn more about Otsuka in the U.S. at www.otsuka-us.com and connect with us on LinkedIn and Twitter at @OtsukaUS. Otsuka Pharmaceutical Co., Ltd.’s global website is accessible at https://www.otsuka.co.jp/en/.

References

1. Ward, Caroline L., et al. “Efficacy and safety of centanafadine for ADHD treatment in children: A randomized clinical trial.” Pediatrics Open Science, vol. 1, no. 3, 1 July 2025, pp. 1–11, https://doi.org/10.1542/pedsos.2024-000349.
2. Ward, Caroline L., Ann C. Childress, et al. “Centanafadine for attention-deficit/hyperactivity disorder in adolescents: A randomized clinical trial.” Journal of the American Academy of Child & Adolescent Psychiatry, July 2025, https://doi.org/10.1016/j.jaac.2025.06.023.
3. Adler, Lenard A., et al. “Efficacy, safety, and tolerability of Centanafadine sustained-release tablets in adults with attention-deficit/hyperactivity disorder.” Journal of Clinical Psychopharmacology, vol. 42, no. 5, 2 June 2022, pp. 429–439, https://doi.org/10.1097/jcp.0000000000001575.
4. American Psychiatric Association (2022). Diagnostic and Statistical Manual of Mental Disorders (5^th ed., text rev).
5. “Data and Statistics on ADHD.” Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, www.cdc.gov/adhd/data/index.html.
6. “Facts about ADHD in Adults.” Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, www.cdc.gov/adhd/php/adults/.

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