Articles from Otsuka Pharmaceutical Development & Commercialization, Inc.

Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka), 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., (Otsuka) and Lundbeck Pharmaceuticals LLC (Lundbeck) announce the Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) met to discuss the supplemental New Drug Application (sNDA) of REXULTI® (brexpiprazole) for the treatment of agitation associated with Alzheimer’s dementia (AAD). The committee voted 9-1 that Otsuka and Lundbeck provided sufficient data to allow the identification of a population in whom the benefits of treating AAD with REXULTI outweigh its risks.

Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) and Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the first patient has been enrolled in a Phase 2/3 clinical study to evaluate ulotaront (SEP-363856), a trace amine-associated receptor 1 (TAAR1) agonist with 5-HT1A agonist activity, as an adjunctive therapy in the treatment of adults living with major depressive disorder (MDD). Ulotaront, which is also being evaluated in Phase 3 clinical development for the treatment of schizophrenia, is the first TAAR1 agonist to be studied as an adjunctive therapy in the treatment of MDD.

Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) and H. Lundbeck A/S (Lundbeck) today presented positive results from a Phase 3 clinical trial of brexpiprazole in the treatment of agitation in patients with Alzheimer's dementia at the 2022 Alzheimer's Association International Conference.

Otsuka Pharmaceutical Development & Commercialization, Inc., and H. Lundbeck A/S (Lundbeck) today announce that new Phase 3 data for brexpiprazole will be presented at the 2022 Alzheimer’s Association International Conference (AAIC), which is being held virtually and in San Diego from July 31 through August 4. The oral presentation will be featured in the Neuropsychiatry and Behavioral Neurology: Agitation and Psychosis session on Thursday, August 4 from 9:45am to 11:00am PT.

Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka), a subsidiary of Otsuka Pharmaceutical Co., Ltd., announces that it has been awarded a grant for up to $17.8 million from the Bill & Melinda Gates Foundation. This will enable Otsuka to advance clinical trials of its investigational compound OPC-167832, in combination with its delamanid (DELTYBA® is the brand name where approved outside the U.S.) and Johnson & Johnson’s bedaquiline (SIRTURO® is the brand name), for patients with drug-susceptible pulmonary tuberculosis (DS-TB).

Otsuka Pharmaceutical Development & Commercialization, Inc. (“Otsuka”), announces today that it has entered a three-year collaboration with Holmusk Inc. (“Holmusk”), a global data science and digital health company building the world’s largest real-world evidence (RWE) platform for behavioral health.