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Otsuka Presents Landmark Final Phase 3 VISIONARY Results at ASN Demonstrating VOYXACT® (sibeprenlimab-szsi) Stabilized Kidney Function and Reduced Risk of Dis…

Results from the Phase 3 VISIONARY trial showed a 97.1% reduction in the risk of a composite kidney outcome event of kidney ...
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Otsuka Announces Transformative Phase 3 FUSION Results for Ulefnersen, Bringing the FUS-ALS Community Closer to a Potential Targeted Treatment

Ulefnersen demonstrated a statistically significant improvement versus placebo on the primary endpoint assessing functional impairment and survival in people living with FUS-ALS, supporting the ...
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Otsuka Presents New Phase 3b Results for SIMTRIYO® (centanafadine) Highlighting Consistent Improvements Across ADHD Symptoms, Anxiety, and Associated Features in Adults with ...

New Phase 3b results demonstrated consistent improvements with centanafadine across ADHD and anxiety symptoms, executive function and emotional dysregulation, as assessed by both clinicians and ...
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GlomCon Foundation and Otsuka Launch REIGNITE, to Advance Real-World Evidence in IgA Nephropathy (IgAN)

This International registry aims to enroll more than 6,000 patients with IgA nephropathy and evaluate treatment patterns and health outcomes, generating insights to help shape future disease ...
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Otsuka Unveils Unprecedented Phase 3 VISIONARY Two-Year eGFR Results Demonstrating VOYXACT® (sibeprenlimab-szsi) Stabilizes Kidney Function Decline to Baseline Physiologic ...

PRINCETON, N.J. and TOKYO, JAPAN – August 3, 2026 – Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced new data from the Phase 3 ...
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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

VOYXACT is the first-and-only U.S. FDA-approved selective APRIL inhibitor, offering an early, targeted therapy that addresses key drivers of IgAN to alter disease progression 1. VOYXACT was granted ...
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Otsuka Receives FDA Approval for First-in-Class SIMTRIYO® (centanafadine) for the Treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in Adults and Pediatric Patients ...

SIMTRIYO is the first and only norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI) approved for the treatment of ADHD in adults and pediatric patients aged 6 years and older weighing at ...
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Otsuka Reports Positive Phase 3 VISIONARY Two-Year eGFR Results Demonstrating VOYXACT® (sibeprenlimab-szsi) Prevented Progression to Kidney Failure and Improved Kidney ...

PRINCETON, N.J. and TOKYO, JAPAN – July 1, 2026 – Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced positive topline full study ...
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Otsuka Announces Positive Phase 3b Results for Centanafadine in Adults with ADHD and Comorbid Anxiety

Study met its primary endpoint, demonstrating statistically significant and clinically relevant improvements in ADHD symptoms in adults with ADHD and comorbid anxiety taking centanafadine compared to ...
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Otsuka Completes Acquisition of Transcend Therapeutics to Advance Next-Generation Neuropsychiatric Treatments

The acquisition will expand Otsuka’s continued investment in emerging, next-generation neuropsychiatric treatments for serious mental illness Princeton, N.J. — June 12, 2026 — Otsuka America, Inc., a ...
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Otsuka Presents New Phase 3 Post Hoc Analyses of Centanafadine Highlighting Improvement in Executive Function and Emotional Dysregulation in Adults with ADHD at the 2026 ...

PRINCETON, N.J. and TOKYO, JAPAN – May 28, 2026 – Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced new post hoc, exploratory ...