Otsuka America
US affiliates of a global healthcare company focused on discovery, development, regulatory approval, manufacturing, and commercialization of therapeutics across neuroscience, nephrology/immunology, metabolism, and related areas. Activities include management of a diversified clinical pipeline (Phase 1–3 and filed programs), biologics and small-molecule development, regulatory submissions, external research funding and investigator-sponsored study support, digital therapeutics collaborations, and patient support and access programs.
Industries
Nr. of Employees
medium (51-250)
Otsuka America
Products
Investigational APRIL‑inhibiting monoclonal antibody for IgA nephropathy
An investigational monoclonal antibody designed to inhibit APRIL to reduce pathogenic IgA production and proteinuria in immunoglobulin A nephropathy; supported by Phase 2/3 data and a biologics license application under review.
Brexpiprazole (small-molecule serotonin-dopamine activity modulator)
A small-molecule antipsychotic with activity at serotonin and dopamine receptors; marketed for multiple psychiatric indications.
Centanafadine (oral triple reuptake inhibitor; investigational)
An investigational oral triple reuptake inhibitor evaluated in Phase 3 studies for adult ADHD with reported statistically significant improvements versus placebo.
Deuterated dextromethorphan + CYP2D6 inhibitor combination (investigational)
A combination therapy using a deuterated active moiety plus a metabolic inhibitor to increase bioavailability; evaluated in Phase 3 trials for agitation associated with dementia.
SEP-363856 (ulotaront) — investigational
Investigational compound under development for schizophrenia and adjunctive treatment for major depressive disorder.
OPC-224333 — investigational for epilepsy
Investigational neurology compound under clinical development for epilepsy.
Investigational APRIL‑inhibiting monoclonal antibody for IgA nephropathy
An investigational monoclonal antibody designed to inhibit APRIL to reduce pathogenic IgA production and proteinuria in immunoglobulin A nephropathy; supported by Phase 2/3 data and a biologics license application under review.
Brexpiprazole (small-molecule serotonin-dopamine activity modulator)
A small-molecule antipsychotic with activity at serotonin and dopamine receptors; marketed for multiple psychiatric indications.
Centanafadine (oral triple reuptake inhibitor; investigational)
An investigational oral triple reuptake inhibitor evaluated in Phase 3 studies for adult ADHD with reported statistically significant improvements versus placebo.
Deuterated dextromethorphan + CYP2D6 inhibitor combination (investigational)
A combination therapy using a deuterated active moiety plus a metabolic inhibitor to increase bioavailability; evaluated in Phase 3 trials for agitation associated with dementia.
SEP-363856 (ulotaront) — investigational
Investigational compound under development for schizophrenia and adjunctive treatment for major depressive disorder.
OPC-224333 — investigational for epilepsy
Investigational neurology compound under clinical development for epilepsy.
Services
Clinical development and trial operations
End-to-end clinical trial services including protocol development, site management, data monitoring, and execution for Phase 1–3 programs.
Regulatory submission and agency engagement
Preparation and submission of regulatory filings and coordination with health authorities for product approvals and regulatory designations.
Patient support and affordability programs
Treatment hotlines, patient assistance foundation operations, patient education and caregiver advocacy resources to support access and adherence.
Business development and external collaboration management
Sourcing external innovation, evaluating proposals, conducting due diligence and negotiating alliances, partnerships and licensing agreements.
External research funding and investigator-sponsored study support
Administration of independent medical education grants, fellowships, and investigator-sponsored study (ISS) support with dedicated contact channels for applicants and investigators.
Clinical development and trial operations
End-to-end clinical trial services including protocol development, site management, data monitoring, and execution for Phase 1–3 programs.
Regulatory submission and agency engagement
Preparation and submission of regulatory filings and coordination with health authorities for product approvals and regulatory designations.
Patient support and affordability programs
Treatment hotlines, patient assistance foundation operations, patient education and caregiver advocacy resources to support access and adherence.
Business development and external collaboration management
Sourcing external innovation, evaluating proposals, conducting due diligence and negotiating alliances, partnerships and licensing agreements.
External research funding and investigator-sponsored study support
Administration of independent medical education grants, fellowships, and investigator-sponsored study (ISS) support with dedicated contact channels for applicants and investigators.
Expertise Areas
- Clinical trial management
- Neuroscience drug development
- Nephrology and immune-mediated kidney disease development
- Small-molecule medicinal chemistry
Key Technologies
- Monoclonal antibody therapeutics
- Precision antibody engineering
- Deuteration chemistry for metabolic stabilization
- Small-molecule medicinal chemistry