Centanafadine Hydrochloride

Centanafadine showed significant improvements in ADHD symptoms compared with placebo. Credit: Inna Kot / Shutterstock.com. 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. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence 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.

PRINCETON, N.J. & TOKYO--(BUSINESS WIRE)--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 populations1,2,3. 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 adults1,2,3. “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 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.sutd.idm.oclc.org/10.1542/pedsos.2024-000349 . 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.sutd.idm.oclc.org/10.1016/j.jaac.2025.06.023 . 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.sutd.idm.oclc.org/10.1097/jcp.0000000000001575 . American Psychiatric Association (2022). Diagnostic and Statistical Manual of Mental Disorders (5 th ed., text rev). “Data and Statistics on ADHD.” Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, www.cdc.gov/adhd/data/index.html . “Facts about ADHD in Adults.” Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, www.cdc.gov/adhd/php/adults/ . JANUARY 2026 26US25EBC0003