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TOKYO, JAPAN and PRINCETON, N.J. – July 27, 2026 – Otsuka Pharmaceutical Co., Ltd. and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) today announced that the U.S. Food and Drug Administration (FDA) has approved SIMTRIYO® (centanafadine), a once-daily extended-release capsule, for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients aged 6 years and older weighing at least 20kg, effective July 24, 2026. As the first and only approved norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI), SIMTRIYO introduces a novel treatment approach for patients and healthcare professionals managing this complex and highly individualized condition. By inhibiting the reuptake of norepinephrine, dopamine, and serotonin, SIMTRIYO increases the availability of these neurotransmitters in pathways involved in attention and behavioral regulation. SIMTRIYO is expected to be available later this year following scheduling by the U.S. Drug Enforcement Administration (DEA).

The approval is supported by results from four pivotal Phase 3 clinical trials evaluating the efficacy and safety of SIMTRIYO across adult, adolescent, and pediatric patients with ADHD. Across these studies, SIMTRIYO demonstrated statistically significant and clinically meaningful improvements in ADHD symptoms compared with placebo, with improvements observed as early as week 1 using the ADHD Rating Scale-5 (children and adolescents) and the Adult ADHD Investigator Symptom Rating Scale (adults).

“The approval of SIMTRIYO marks an important milestone for people living with ADHD, as it introduces a novel treatment approach,” said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, OPDC.

Additional clinical research continues to expand the evidence base for centanafadine. In a recently completed Phase 3b study in adults with ADHD and comorbid anxiety, centanafadine demonstrated statistically significant improvements in ADHD symptoms compared with placebo.

“Having more therapeutic choices is important because ADHD is a highly individualized condition,” said Lenard A. Adler, M.D., director of the Adult ADHD Program at NYU Langone Health.

About the Clinical Data

The FDA approval of SIMTRIYO is supported by results from four randomized, double-blind, placebo-controlled Phase 3 clinical trials evaluating the efficacy and safety of centanafadine in children, adolescents, and adults with ADHD. In the two pivotal adult studies, both centanafadine dose groups demonstrated statistically significant improvements in Adult ADHD Investigator Symptom Rating Scale (AISRS) total scores compared with placebo, with improvements observed as early as week 1 and maintained throughout the six-week treatment period. In the pivotal pediatric and adolescent studies, high-dose centanafadine demonstrated statistically significant improvements in ADHD Rating Scale-5 (ADHD-RS-5) total scores compared with placebo, with improvements observed as early as week 1.

Across the Phase 3 clinical development program, centanafadine was generally well-tolerated, with a safety profile consistent across clinical and preclinical data. The most common adverse reactions were rash and decreased appetite in children 6 to 12 years of age; decreased appetite, nausea, rash, headache, and abdominal pain in adolescents 13 to 17 years of age; and headache, decreased appetite, insomnia, nausea, dry mouth, and diarrhea in adults.

About Attention-Deficit Hyperactivity Disorder (ADHD)

ADHD is a chronic neurodevelopmental disorder characterized primarily by impairments in attention, hyperactivity, and impulsivity. The disorder can affect academic performance, occupational functioning, and social relationships, presenting challenges that impact patients’ daily lives. Although ADHD is often diagnosed during childhood, symptoms frequently persist into adolescence and adulthood. ADHD 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).

About SIMTRIYO® (centanafadine)

SIMTRIYO® (centanafadine) is a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI) and CNS stimulant. Clinical studies have shown that SIMTRIYO significantly reduced core symptoms of ADHD in adults and pediatric patients aged 6 years and older weighing at least 20kg. Clinical data suggest SIMTRIYO has a well-studied and consistent safety profile.

About Otsuka

Otsuka Pharmaceutical Co., Ltd. is a total healthcare company that focuses on each individual’s potential to enhance their well-being. Our medical-related business provides treatments and diagnostics for both physical and mental health. Our nutraceutical business supports daily health maintenance and improvement. Otsuka’s unique products and services are based on scientific evidence, under the guidance of our corporate philosophy: Otsuka-people creating new products for better health worldwide.

Otsuka America Pharmaceutical, Inc. and Otsuka Pharmaceutical Development & Commercialization, Inc. are the US-based indirect subsidiaries of the global healthcare company Otsuka Pharmaceutical Co., Ltd. Otsuka’s US companies share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and immunology. Learn more at www.otsuka-us.com.