What We Do
Our research facilities and collaborations around the world exist to serve the complex, underserved medical needs of patients and caregivers. Our mission—creating new products for better health worldwide—is at the center of everything we do.
Otsuka’s focus is on the patient and how we can support them, their caregivers, and our communities. Through collaboration with diverse experiences and backgrounds, we collectively work to meet the needs of those we serve.
John Kraus, MD, PhDExecutive Vice President,
Chief Medical Officer
Otsuka-people are talented, passionate, and work tirelessly to bring our novel treatments to the patients and communities we serve. Their drive is how we defy limitation.
Mary Hobart Senior Vice President,
Global Regulatory Affairs
The essence of the Otsuka culture is the chemical reaction that occurs when diverse values seriously clash, and a corporate organization that does not see the unconventional and new ideas that emerge as risks, but as innovations that lead to new solutions, which can then be implemented without the need to calculate Net Present Value (NPV).
Nick Kurahashi, MS Executive Vice President,
Global Pharmaceutical Strategy
Our Pipeline
Otsuka US companies' investigational programs:
CNS
| Development Status | |||||
|---|---|---|---|---|---|
| Phase | |||||
| Compound | Phase 1 | Phase 2 | Phase 3 | Filed | |
|
Brexpiprazole*
Posttraumatic stress disorder (PTSD)
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Centanafadine
Attention-deficit hyperactivity disorder (ADHD)
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Centanafadine
Major depressive disorder (MDD)
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OPC-214870
Epilepsy
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OPC-224333
Epilepsy
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SEP-363856
(ulotaront) Schizophrenia
|
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SEP-363856
(ulotaront) Adjunct treatment for major depressive disorder (aMDD)
|
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SEP-363856
(ulotaront) Generalized anxiety disorder
|
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|
SEP-380135
TBD
|
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Nephrology and Immune-mediated Diseases
| Development Status | |||||
|---|---|---|---|---|---|
| Phase | |||||
| Compound | Phase 1 | Phase 2 | Phase 3 | Filed | |
|
Tolvaptan
Pediatric autosomal recessive polycystic kidney disease (ARPKD)
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Sibeprenlimab§
Immunoglobulin A nephropathy
|
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VIS171§
Immune-mediated diseases
|
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Other Areas
| Development Status | |||||
|---|---|---|---|---|---|
| Phase | |||||
| Compound | Phase 1 | Phase 2 | Phase 3 | Filed | |
|
QuabodepistatII
Pulmonary tuberculosis
|
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|
OPC-131461
TBD
|
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|
VIS954§
TBD
|
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*Part of Otsuka/Lundbeck alliance.
§Developed by Otsuka and Visterra, Inc.
IISupported by a grant from the Bill &
Melinda Gates Foundation.
Our Focus
Our mission comes to life through 2 important categories.
Neuroscience
Otsuka’s commitment to providing innovative solutions for mental health disorders started more than 30 years ago. Our research in neuroscience maintains its focus on potential treatments for adults with schizophrenia and major depressive disorder (MDD), bipolar disorder, and other neurological and neuropsychiatric conditions, including Alzheimer disease, epilepsy, attention-deficit hyperactive disorder, posttraumatic stress disorder, borderline personality disorder, and autism. We seek to address the unmet medical needs of all those we serve as we explore our focus on anxiety disorders, frontotemporal dementia (FTD), Lewy Body dementia, Fragile X syndrome (FXS) and amyotrophic lateral sclerosis (ALS), among other conditions. Each central nervous system (CNS) disorder has its own set of treatment challenges and gaps in patient care, and we seek to address these challenges with each clinical and research milestone.
It took 20 years of perseverance, creativity, and innovation by our scientists to defy limitation and develop treatments for those living with CNS disorders, giving them additional medication options. At Otsuka, we respect the value within every mind. That's why our clinical development in this therapeutic area continues to address the gaps in mental health treatments by exploring the cutting edge of psychiatrics, so those affected by CNS disorders can have more options to meet their needs.
Nephrology
Otsuka’s enduring perseverance to advancing treatments for individuals living with kidney disease has lead to breakthroughs that significantly reshape treatment landscapes and pave the way for further innovation. The approval of a treatment for autosomal dominant polycystic kidney disease (ADPKD) was the result of decades of research and commitment and provides a first-in-class treatment option for ADPKD. We uphold our commitment to addressing the unmet medical needs within this space.
We are extending our legacy through ongoing investments in nephrology and in new areas. With changes in the measurement of outcomes that may impact disease progression, medical breakthroughs are on the horizon. With Visterra joining the Otsuka corporate family in 2018 and in collaborating with other like-minded companies that share our values, we are dedicated to enhancing our commitment in nephrology and addressing other critical areas with unmet needs.
Alongside drug development, we have devoted years to advocating for patients through programs and institutions focused on kidney disease. This steadfast commitment to patients, researchers, and healthcare professionals has fortified Otsuka’s expertise in advocacy. We remain steadfast in our mission to serve our patients and clinicians every day, so they can achieve even more than they thought was possible.
Learn more about our expanding portfolio.
Our History
2002
FDA approves ABILIFY® (aripiprazole)
2009
FDA approves SAMSCA® (tolvaptan)
2013
FDA approves ABILIFY MAINTENA® (aripiprazole)
2015
FDA approves REXULTI® (brexpiprazole)
2017
FDA approves ABILIFY MYCITE® (aripiprazole tablets with sensor)
2018
FDA approves JYNARQUE® (tolvaptan)
2023
FDA approves ABILIFY ASIMTUFII® (aripiprazole) for
extended release injectable suspension