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Featured news
Otsuka Receives FDA Approval for First-in-Class SIMTRIYO® (centanafadine) for the Treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in Adults and Pediatric Patients Aged 6 Years and Older
Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has granted approval of 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. As the first and only approved norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI), SIMTRIYO introduces a new 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, an NDSRI and central nervous system (CNS) stimulant, is expected to be available later this year following scheduling by the U.S. Drug Enforcement Administration (DEA).
Otsuka Reports Positive Phase 3 VISIONARY Two-Year eGFR Results Demonstrating VOYXACT® (sibeprenlimab-szsi) Prevented Progression to Kidney Failure and Improved Kidney Function in IgA Nephropathy (IgAN)
Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. today announced positive topline full study results from the Phase 3 VISIONARY trial. VOYXACT® (sibeprenlimab-szsi) demonstrated statistically significant stabilization of kidney function, with evidence of improvement over two years, as assessed by annualized slope and mean change from baseline in estimated glomerular filtration rate (eGFR).
Otsuka Announces Positive Phase 3b Results for Centanafadine in Adults with ADHD and Comorbid Anxiety
Otsuka today announced positive topline results in a Phase 3b study (NCT06973577) evaluating centanafadine XR 280 mg once daily in adults with attention-deficit/hyperactivity disorder (ADHD) and comorbid anxiety. Centanafadine is a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI).