News & Media

Otsuka Pharmaceutical Development & Commercialization, Inc., announces that new data from the Phase 3 VISIONARY study will be presented at the GlomCon Hawaii 2026 conference taking place August 3-7, 2026. Building on recently reported topline results, the oral presentation will highlight key, two-year (24-month) VISIONARY estimated glomerular filtration rate (eGFR) and safety data in adults with primary IgA nephropathy (IgAN) at risk for disease progression. These data support Otsuka's rolling submission of a supplemental Biologics License Application (sBLA) to the U.S. FDA for traditional approval of VOYXACT® (sibeprenlimab-szsi). A complete analysis of the VISIONARY two-year eGFR results will be presented at an upcoming scientific congress.

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).