Otsuka Pharmaceutical Development & Commercialization, Inc.
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
small (1-50)
Otsuka Pharmaceutical Development & Commercialization, Inc.
508 Carnegie Center Dr., Princeton, NJ 08540
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
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
End-to-end clinical trial services including protocol development, site management, data monitoring, and execution for Phase 1–3 programs.
Preparation and submission of regulatory filings and coordination with health authorities for product approvals and regulatory designations.
Treatment hotlines, patient assistance foundation operations, patient education and caregiver advocacy resources to support access and adherence.
Sourcing external innovation, evaluating proposals, conducting due diligence and negotiating alliances, partnerships and licensing agreements.
Administration of independent medical education grants, fellowships, and investigator-sponsored study (ISS) support with dedicated contact channels for applicants and investigators.
End-to-end clinical trial services including protocol development, site management, data monitoring, and execution for Phase 1–3 programs.
Preparation and submission of regulatory filings and coordination with health authorities for product approvals and regulatory designations.
Treatment hotlines, patient assistance foundation operations, patient education and caregiver advocacy resources to support access and adherence.
Sourcing external innovation, evaluating proposals, conducting due diligence and negotiating alliances, partnerships and licensing agreements.
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
News & Updates
The FDA accepted a Biologics License Application and granted priority review for an investigational monoclonal antibody that inhibits APRIL for the treatment of IgA nephropathy; PDUFA target action date noted.
A pre-specified interim analysis of a Phase 3 study reported a statistically significant reduction in 24-hour urine protein-to-creatinine ratio versus placebo at nine months.
The FDA issued a Complete Response Letter for a supplemental NDA seeking approval of a small-molecule combination in PTSD; the agency concluded the submission did not provide substantial evidence of effectiveness in its current form.
Topline results reported for a Phase 3 trial evaluating a deuterated active moiety plus metabolic inhibitor combination in agitation associated with dementia due to Alzheimer’s disease; the trial did not meet its primary efficacy endpoint at week 12.
Two Phase 3 trials demonstrated statistically significant improvements versus placebo for centanafadine in adult ADHD.
The FDA accepted a Biologics License Application and granted priority review for an investigational monoclonal antibody that inhibits APRIL for the treatment of IgA nephropathy; PDUFA target action date noted.
A pre-specified interim analysis of a Phase 3 study reported a statistically significant reduction in 24-hour urine protein-to-creatinine ratio versus placebo at nine months.
The FDA issued a Complete Response Letter for a supplemental NDA seeking approval of a small-molecule combination in PTSD; the agency concluded the submission did not provide substantial evidence of effectiveness in its current form.
Topline results reported for a Phase 3 trial evaluating a deuterated active moiety plus metabolic inhibitor combination in agitation associated with dementia due to Alzheimer’s disease; the trial did not meet its primary efficacy endpoint at week 12.
Two Phase 3 trials demonstrated statistically significant improvements versus placebo for centanafadine in adult ADHD.