Otsuka Pharmaceutical Co., Ltd. (U.S. affiliates include Otsuka America Pharmaceutical, Inc. and Otsuka Pharmaceutical Development & Commercialization, Inc.)
Global healthcare company with integrated capabilities across discovery, development, regulatory submission, and commercialization of pharmaceuticals and software-based prescription therapeutics. Focus areas include neuroscience, nephrology/immunology, cardiometabolic disease, and infectious disease. Activities in the provided content include Phase 2/3 clinical development (including decentralized elements), precision antibody discovery and engineering, regulatory filings and accelerated approvals for biologics, development and commercialization of prescription software therapeutics, strategic acquisitions and partnerships to expand biologics and CNS capabilities, and programs for clinical trial transparency and expanded access.
Industries
Nr. of Employees
medium (51-250)
Otsuka Pharmaceutical Co., Ltd. (U.S. affiliates include Otsuka America Pharmaceutical, Inc. and Otsuka Pharmaceutical Development & Commercialization, Inc.)
Patents
Use of (1R,5S)-(+)-1-(naphthalen-2-yl)-3-azabicyclo[3.1.0]hexane in the treatment of conditions affected by monoamine neurotransmitters
US-12042481-B2
View DetailsSystem and method for generating transaction trigger data structures for aggregated reporting
US-11810135-B2
View DetailsGenerating and searching data structures that facilitate measurement-informed treatment recommendation
US-11798675-B2
View DetailsDatabase, data structures, and data processing systems for recommending clinical trial sites
US-11755599-B2
View DetailsApplication programming interface using digital templates to extract information from multiple data sources
US-11657061-B2
View Details
Use of (1R,5S)-(+)-1-(naphthalen-2-yl)-3-azabicyclo[3.1.0]hexane in the treatment of conditions affected by monoamine neurotransmitters
US-12042481-B2
View DetailsSystem and method for generating transaction trigger data structures for aggregated reporting
US-11810135-B2
View DetailsGenerating and searching data structures that facilitate measurement-informed treatment recommendation
US-11798675-B2
View DetailsDatabase, data structures, and data processing systems for recommending clinical trial sites
US-11755599-B2
View DetailsApplication programming interface using digital templates to extract information from multiple data sources
US-11657061-B2
View DetailsProducts
Rejoyn
Prescription digital therapeutic delivered via smartphone intended as an adjunct to clinician-managed outpatient care to reduce symptoms of major depressive disorder in adults on antidepressant medication; clinically evaluated in a randomized remote trial.
VOYXACT (sibeprenlimab)
Humanized monoclonal antibody that neutralizes APRIL and is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk for disease progression; provided as a subcutaneous injection dosed every four weeks. Approved under accelerated approval based on proteinuria reduction; confirmatory trial assessing eGFR slope is ongoing.
SIMTRIYO (centanafadine)
Once-daily extended-release oral formulation approved for treatment of attention-deficit/hyperactivity disorder in adults and pediatric patients aged 6 years and older (as reported in news content).
Abilify Maintena 300 mg Suspension, Ext. Rel.
Aripiprazole for extended release injectable suspension.
Abilify Asimtufii
Extended-release injectable antipsychotic suspension for the treatment of schizophrenia or bipolar I disorder.
Abilify Asimtufii 720 mg/2.4 mL Suspension, Ext. Rel. Syringe
Abilify Asimtufii extended-release suspension syringe.
Rejoyn
Prescription digital therapeutic delivered via smartphone intended as an adjunct to clinician-managed outpatient care to reduce symptoms of major depressive disorder in adults on antidepressant medication; clinically evaluated in a randomized remote trial.
VOYXACT (sibeprenlimab)
Humanized monoclonal antibody that neutralizes APRIL and is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk for disease progression; provided as a subcutaneous injection dosed every four weeks. Approved under accelerated approval based on proteinuria reduction; confirmatory trial assessing eGFR slope is ongoing.
SIMTRIYO (centanafadine)
Once-daily extended-release oral formulation approved for treatment of attention-deficit/hyperactivity disorder in adults and pediatric patients aged 6 years and older (as reported in news content).
Abilify Maintena 300 mg Suspension, Ext. Rel.
Aripiprazole for extended release injectable suspension.
Abilify Asimtufii
Extended-release injectable antipsychotic suspension for the treatment of schizophrenia or bipolar I disorder.
Abilify Asimtufii 720 mg/2.4 mL Suspension, Ext. Rel. Syringe
Abilify Asimtufii extended-release suspension syringe.
Services
Design and conduct of Phase 1–3 clinical trials including multicenter, randomized, placebo‑controlled studies with decentralized trial elements and protocol-defined biomarker endpoints.
Preparation and submission support for biologics filings and use of expedited regulatory pathways, and planning for confirmatory post-approval studies.
Commercial launch planning, market access and payer engagement activities for pharmaceutical and software prescription products in the U.S.
Clinical validation, regulatory submission, and distribution planning for software-based prescription medical treatments delivered via consumer devices.
Design and conduct of Phase 1–3 clinical trials including multicenter, randomized, placebo‑controlled studies with decentralized trial elements and protocol-defined biomarker endpoints.
Preparation and submission support for biologics filings and use of expedited regulatory pathways, and planning for confirmatory post-approval studies.
Commercial launch planning, market access and payer engagement activities for pharmaceutical and software prescription products in the U.S.
Clinical validation, regulatory submission, and distribution planning for software-based prescription medical treatments delivered via consumer devices.
Expertise Areas
- Clinical trial management (Phase 2/3, randomized controlled trials, decentralized elements)
- Biologics discovery and antibody engineering
- Nephrology therapeutics development with biomarker-driven endpoints
- Prescription digital therapeutics (software as a medical device) development and regulatory clearance
Key Technologies
- Monoclonal antibody therapeutics
- Antibody engineering (epitope-focused design, Fc modification)
- Computational and experimental antibody design platforms
- Prescription digital therapeutics (mobile/saMD platforms)
News & Updates
U.S. FDA cleared a prescription digital therapeutic for treatment of major depressive disorder symptoms as an adjunct to clinician-managed outpatient care for adults on antidepressant medication; clearance based on data from a randomized, remote pivotal trial.
U.S. FDA granted accelerated approval for an anti-APRIL monoclonal antibody for reduction of proteinuria in adults with primary immunoglobulin A nephropathy based on significant proteinuria reduction in a Phase 3 interim analysis; approval includes post-approval confirmatory trial commitments.
Final two-year results from the Phase 3 VISIONARY trial demonstrated sustained preservation of kidney function and were published in The New England Journal of Medicine; supported a rolling sBLA submission and reported major treatment effect on proteinuria and eGFR endpoints.
Filing of a Biologics License Application (BLA) to the U.S. FDA for sibeprenlimab for treatment of immunoglobulin A nephropathy; includes Phase 2/3 supporting datasets and proposes subcutaneous prefilled-syringe presentation.
U.S. FDA granted Breakthrough Therapy designation for an investigational APRIL-targeting monoclonal antibody for IgA nephropathy following favorable Phase 2 results.
Acquisition of a clinical-stage biotechnology company developing rapid-acting neuropsychiatric treatments to expand CNS pipeline and capabilities.
U.S. FDA cleared a prescription digital therapeutic for treatment of major depressive disorder symptoms as an adjunct to clinician-managed outpatient care for adults on antidepressant medication; clearance based on data from a randomized, remote pivotal trial.
U.S. FDA granted accelerated approval for an anti-APRIL monoclonal antibody for reduction of proteinuria in adults with primary immunoglobulin A nephropathy based on significant proteinuria reduction in a Phase 3 interim analysis; approval includes post-approval confirmatory trial commitments.
Final two-year results from the Phase 3 VISIONARY trial demonstrated sustained preservation of kidney function and were published in The New England Journal of Medicine; supported a rolling sBLA submission and reported major treatment effect on proteinuria and eGFR endpoints.
Filing of a Biologics License Application (BLA) to the U.S. FDA for sibeprenlimab for treatment of immunoglobulin A nephropathy; includes Phase 2/3 supporting datasets and proposes subcutaneous prefilled-syringe presentation.
U.S. FDA granted Breakthrough Therapy designation for an investigational APRIL-targeting monoclonal antibody for IgA nephropathy following favorable Phase 2 results.
Acquisition of a clinical-stage biotechnology company developing rapid-acting neuropsychiatric treatments to expand CNS pipeline and capabilities.