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Featured news
Otsuka to Present Pivotal Two-Year eGFR Results from the Phase 3 VISIONARY Trial of VOYXACT® (sibeprenlimab-szsi) in IgA Nephropathy (IgAN) at GlomCon Hawaii 2026
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 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).