Otsuka’s SIMTRIYO® Becomes First Approved NDSRI for ADHD

PRINCETON, N.J., July 27, 2026

Otsuka Pharmaceutical Co., Ltd. and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) have 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 20 kilograms. The approval marks a significant advancement in neuroscience by introducing the first and only approved norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI) for ADHD. As a first-in-class therapy, SIMTRIYO® provides healthcare professionals with a novel mechanism of action that increases the availability of norepinephrine, dopamine, and serotonin, neurotransmitters essential for attention, impulse control, and behavioral regulation. The approval represents a major regulatory milestone for Otsuka while expanding treatment options for millions of individuals living with this highly individualized neurodevelopmental disorder. Following scheduling by the U.S. Drug Enforcement Administration (DEA), the medicine is expected to become commercially available later this year, strengthening Otsuka’s growing neuroscience portfolio and commitment to innovative mental health therapies.

Four Phase 3 Clinical Trials Demonstrated Significant ADHD Symptom Improvement

The FDA approval is supported by robust evidence from four randomized, double-blind, placebo-controlled Phase 3 clinical trials evaluating SIMTRIYO® (centanafadine) across children, adolescents, and adults diagnosed with ADHD. In the pivotal adult studies, patients receiving centanafadine achieved statistically significant and clinically meaningful improvements in Adult ADHD Investigator Symptom Rating Scale (AISRS) scores compared with placebo, with symptom improvement observed as early as Week 1 and maintained throughout the treatment period. Similar outcomes were reported in pediatric and adolescent trials, where high-dose centanafadine produced significant improvements in ADHD Rating Scale-5 (ADHD-RS-5) scores. Across the comprehensive clinical development program, the therapy demonstrated a well-established and consistent safety profile, with commonly reported adverse events including decreased appetite, nausea, rash, headache, insomnia, abdominal pain, dry mouth, and diarrhea, depending on patient age. In addition, a recently completed Phase 3b study involving adults with ADHD and comorbid anxiety also demonstrated statistically significant symptom improvements, further strengthening the growing body of clinical evidence supporting centanafadine’s therapeutic potential.

Novel NDSRI Therapy Expands ADHD Treatment Options Across Age Groups

Attention-deficit hyperactivity disorder (ADHD) affects approximately 7 million children and 15.5 million adults in the United States, often persisting throughout adolescence and adulthood while impacting education, employment, social relationships, and daily functioning. The introduction of SIMTRIYO® provides clinicians with a new pharmacological approach for managing ADHD by targeting three key neurotransmitter pathways simultaneously, differentiating it from existing treatment options. According to Otsuka, the approval reflects years of research focused on delivering innovative therapies capable of addressing the diverse clinical needs of ADHD patients. Company executives emphasized that expanding treatment choices is essential because ADHD presents differently across individuals and often requires personalized therapeutic strategies. With continued research underway and additional clinical findings expected to be presented at future scientific meetings, SIMTRIYO® is positioned to become an important addition to the ADHD treatment landscape. The approval also reinforces Otsuka’s leadership in central nervous system (CNS) drug development, highlighting ongoing innovation in neuroscience, regulatory excellence, and patient-centered pharmaceutical research aimed at improving long-term outcomes for individuals living with ADHD.

Source: Otsuka Pharmaceutical press release