otsuka-us.com

Louis Allesandrine

With more than 20 years of experience leading marketing initiatives for some of the most well-known pharmaceutical brands, Louis is a seasoned executive known for invigorating teams with fresh ideas ...
otsuka-us.com

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 ...
otsuka-us.com

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 ...
otsuka-us.com

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 ...
otsuka-us.com

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 ...
otsuka-us.com

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 ...
otsuka-us.com

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 ...
otsuka-us.com

Otsuka Receives FDA Accelerated Approval for VOYXACT® (sibeprenlimab-szsi) for the Reduction of Proteinuria in Adults with Primary Immunoglobulin A Nephropathy (IgAN) at Risk ...

PRINCETON, N.J. and TOKYO, JAPAN – November 25, 2025 – Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical, Co. Ltd. (Otsuka) today announce the U.S. Food and Drug ...
otsuka-us.com

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 ...
otsuka-us.com

Otsuka’s JYNARQUE™ (tolvaptan) Approved by U.S. FDA as the First Treatment to Slow Kidney Function Decline in Adults at Risk of Rapidly Progressing Autosomal Dominant ...

TOKYO, JAPAN – April 24, 2018 – Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that the U.S. Food and Drug Administration (FDA) has approved JYNARQUE™ (tolvaptan) as the first drug treatment to ...
otsuka-us.com

Otsuka And Proteus® Announce The First U.S. FDA Approval of A Digital Medicine System: ABILIFY MYCITE® (aripiprazole tablets with sensor)

Tokyo, Japan and Redwood City, Calif. – November 14, 2017 – Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Proteus Digital Health (Proteus) today announce that the United States Food and Drug ...