Otsuka Receives FDA Approval For First-in-Class Simtriyo For The Treatment Of ADHD In Adults & Children Aged 6 Years & Older

Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) approved Simtriyo (centanafadine), a once-daily extended-release capsule for attention-deficit hyperactivity disorder (ADHD) in adults and children aged six years and older weighing at least 20 kilograms (44 pounds). The drug is expected to become available later in 2026 following scheduling by the U.S. Drug Enforcement Administration (DEA).

Simtriyo is the first approved norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI), a class of central nervous system (CNS) stimulant. It works by increasing the availability of these three . . .