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 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).
Otsuka America, Inc., a subsidiary of Otsuka Pharmaceutical Co., Ltd. has completed the acquisition of Transcend Therapeutics, Inc., a clinical-stage biotechnology company developing a rapid-acting treatment for post-traumatic stress disorder (PTSD). This is the latest in a series of investments Otsuka has made to advance next-generation treatments for serious neuropsychiatric conditions.
Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced that VOYXACT® (sibeprenlimab-szsi) preserved kidney function compared to placebo over 12 months in adults with primary IgA nephropathy (IgAN) at risk for disease progression. VOYXACT demonstrated an increase in mean change for the estimated glomerular filtration rate (eGFR) from baseline of +0.7 mL/min/1.73 m2 compared to a decline of -4.8 mL/min/1.73 m2 in the placebo-treated group, providing early evidence that sibeprenlimab may stabilize eGFR decline in patients with IgA nephropathy, which will be further validated in the ongoing Phase 3 VISIONARY trial. These results were presented at the European Renal Association (ERA) Congress 2026 in Glasgow as part of a pre-specified interim analysis of the VISIONARY Phase 3 trial. In the VISIONARY study, VOYXACT was well tolerated with a favorable safety profile in line with previously reported data1. Full data from the VISIONARY study final analysis will be presented at a future medical conference. These findings provide clinical evidence linking upstream selective A-PRoliferation-Inducing Ligand (APRIL) inhibition to downstream preservation of kidney function, reinforcing VOYXACT’s ability to improve long-term outcomes.
Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. today announced new post hoc, exploratory analyses from two identical Phase 3 clinical trials evaluating centanafadine, an investigational, first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI), in adults with attention-deficit hyperactivity disorder (ADHD).
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Transcend Therapeutics, Inc. (Transcend) announce that the two companies entered into an agreement today, under which Otsuka, through its wholly owned subsidiary Otsuka America, Inc., will fully acquire Transcend. The acquisition is expected to be completed in the second quarter of 2026, subject to the fulfillment of customary closing conditions and required procedures. Read the full press release here.
Otsuka Pharmaceutical Development & Commercialization, Inc. today announced new analyses from the Phase 3 VISIONARY trial evaluating VOYXACT® (sibeprenlimab-szsi) in adults with IgA nephropathy (IgAN) at risk for disease progression, demonstrating clinically meaningful improvements across key markers of IgAN.
Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced new open-label extension study data for repinatrabit (JNT-517), demonstrating early and clinically meaningful reductions in blood phenylalanine (Phe) levels (-67% mean change from baseline) in adolescents with phenylketonuria (PKU). These new data, along with the study design for the pivotal global Phase 3 PheORD trial (NCT06971731) in adults, were presented at the 2026 American College of Medical Genetics and Genomics (ACMG) meeting.
Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announce that the U.S. Food and Drug Administration (FDA) has accepted for priority review the New Drug Application (NDA) for centanafadine, an investigational, once-daily extended release capsule and the first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI), for the treatment of attention-deficit hyperactivity disorder (ADHD) in children, adolescents, and adults. The Prescription Drug User Fee Act (PDUFA) target action date is set for July 24, 2026.
Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical, Co. Ltd. (Otsuka) announces today the initiation of the global Phase 3 clinical trial evaluating repinatrabit (JNT-517), an investigational, oral, small-molecule compound for the treatment of phenylketonuria (PKU). The goal of the PheORD Phase 3, randomized study is to assess the efficacy, safety and tolerability of oral repinatrabit, administered twice a day, in participants with PKU.1 Repinatrabit received orphan drug designation and rare pediatric disease designation for the treatment of PKU from the U.S. Food and Drug Administration (FDA).
Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical, Co. Ltd. (Otsuka) today announce the U.S. Food and Drug Administration (FDA) has granted accelerated approval of VOYXACT (sibeprenlimab-szsi) for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. VOYXACT is a self-administered, subcutaneous injection dosed every four weeks. VOYXACT was granted accelerated approval based on the VISIONARY Phase 3 interim analysis, where it achieved a significant placebo-adjusted treatment effect of 51% (P<0.0001) reduction in proteinuria at nine months (n=320) of treatment (-50% VOYXACT vs 2% placebo). VOYXACT is the first and only therapy to block A-PRoliferation-Inducing-Ligand (APRIL).
Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announce the filing of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for centanafadine, once daily extended release capsules, a novel norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI), for the treatment of attention-deficit hyperactivity disorder (ADHD) in children, adolescents, and adults. The NDA submission is supported by results from four pivotal Phase 3 clinical trials evaluating the efficacy and safety of centanafadine across patient populations.
Otsuka Pharmaceutical Development & Commercialization, Inc. and our parent company Otsuka Pharmaceutical Co. Ltd., announces the first patients have been successfully enrolled and dosed in its Phase 3 clinical trial evaluating quabodepistat, an investigational compound for the treatment of pulmonary multidrug-resistant tuberculosis (MDR-TB). TB, and particularly its resistant forms, remains a major global health challenge.
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce that Otsuka has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the supplemental New Drug Application (sNDA) for use of REXULTI® (brexpiprazole) in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD). The CRL states that the FDA has completed their review but cannot approve the application in the current form, further stating that the application does not provide substantial evidence of effectiveness to support the approval.