Otsuka is voluntarily recalling certain lots of ABILIFY® (aripiprazole) Tablets due to cross-contamination from extremely small amounts of another active pharmaceutical ingredient previously manufactured on the same equipment. Based on sample testing performed, there is no material patient risk associated with the trace level of contamination found. The voluntary recall has been initiated by Otsuka out of an abundance of caution, with the knowledge of the U.S. Food and Drug Administration. This recall is limited to the United States.

Consumers who have a product that is being recalled and who have concerns, should consult with their healthcare provider or pharmacy. Adverse reactions or quality problems experienced with the use of this product should be reported.

Otsuka America Pharmaceutical, Inc. can be reached by phone at 1-833-468-7852 Monday – Friday, 9 a.m. – 5 p.m. Eastern Time or by email: global_intake@otsuka-us.com or ProductComplaints@otsuka-us.com. The FDA's MedWatch Adverse Event Reporting program can be reached either online or by phone. To complete and submit the report Online: www.fda.gov/medwatch/report.htm or call 1-800-332-1088.

Read more here: https://www.otsuka-us.com/news/otsuka-us-voluntary-recall

April 2024 01US24EBC0008

What We Do

When it comes to research at Otsuka, our mission—creating new products for better health worldwide—is at the center of everything we do. That’s why we are dedicated to finding unconventional solutions for complex, underserved medical needs, whether we are developing new compounds at one of our research facilities in the United States, Europe, Japan, and beyond; or collaborating with another company to develop innovative therapies.

Image
image-full-bleed@2x

What Guides Us

Our commitment

We are committed to developing new treatments in neuroscience and nephrology, where the needs of patients are underserved.

Our perseverance

We persevere, no matter how long it takes, while putting the health and safety of patients first.

Our resources

We leverage our global resources to develop unique projects that defy limitation, so that others can too.

We had a common goal and would not relent until we succeeded. We were committed to helping a niche patient population with an unmet medical need.

Neuroscience

Otsuka’s commitment to providing innovative solutions for mental health disorders started more than 30 years ago. Our research in neuroscience has been focused on 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. 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 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 will continue to focus on addressing the gaps in mental health treatments, so those affected by CNS disorders can have more options to meet their needs.

Nephrology

Otsuka’s perseverance in developing treatments for people living with kidney disease has led to breakthroughs that have helped change the landscape of treatment options and set the stage for other new developments in nephrology. The approval of a treatment for autosomal dominant polycystic kidney disease (ADPKD) was the result of decades of research and commitment, and provided a first-in-class treatment option for ADPKD.  

We are continuing to build upon our legacy with an ongoing investment in nephrology. With changes in the measurement of outcomes that may impact disease progression, medical breakthroughs are on the horizon. We are working both internally and in collaboration with other companies that share   

Otsuka’s perseverance in developing treatments for people living with kidney disease has led to breakthroughs that have helped change the landscape of treatment options and set the stage for other new developments in nephrology. The approval of a treatment for autosomal dominant polycystic kidney disease (ADPKD) was the result of decades of research and commitment, and provided a first-in-class treatment option for ADPKD.  

We are continuing to build upon our legacy with an ongoing investment in nephrology. With changes in the measurement of outcomes that may impact disease progression, medical breakthroughs are on the horizon. We are working both internally and in collaboration with other companies that share our values and dedication to bring forth more options in nephrology care. In 2018, Visterra joined the Otsuka corporate family to further our commitment to establish our leadership in nephrology.

our values and dedication to bring forth more options in nephrology care. In 2018, Visterra joined the Otsuka corporate family to further our commitment to establish our leadership in nephrology.

Our dedication goes beyond clinical advancements. In addition to drug development, we have spent years advocating on behalf of patients through programs and institutions focused on kidney disease. This continued commitment to patients, researchers, and healthcare professionals has helped us develop a proven expertise in nephrology. We will continue to serve our patients and clinicians each and every day, so they can achieve more than they thought was possible. 

Our dedication goes beyond clinical advancements. In addition to drug development, we have spent years advocating on behalf of patients through programs and institutions focused on kidney disease. This continued commitment to patients, researchers, and healthcare professionals has helped us develop a proven expertise in nephrology. We will continue to serve our patients and clinicians each and every day, so they can achieve more than they thought was possible. 

Digital Innovation

When it comes to digital innovation in mental health, Otsuka is at the forefront of the healthcare industry. Despite significant advances in mental health treatment over the last two decades, many people still struggle with taking their medication as prescribed. We believe digital medicine will revolutionize how patients and their caregivers manage treatment in the CNS space.

Digital medicine provides both patients and their providers with insights that help inform treatment plans and encourage communication. We started this journey in 2012, and will continue to deepen our focus on digital medicine and digital therapeutics to treat various mental health conditions. In doing so, we can help empower patients, their care teams, and their families to make more-informed decisions about their health.

Our Pipeline

Otsuka US companies' investigational programs: 

CNS

  Development Status
  Phase
Compound Phase 1 Phase 2 Phase 3 Filed
Brexpiprazole*
Post-Traumatic stress disorder (PTSD)
       
AVP-786
Agitation in Alzheimer’s disease
       
Centanafadine
Attention-deficit hyperactivity disorder (ADHD)
       
Centanafadine
Major Depressive Disorder (MDD)
       
OPC-214870
Epilepsy
       
OPC-224333
Epilepsy
       
SEP-363856
(ulotaront)»
Schizophrenia
       
SEP-363856
(ulotaront)»
Adjunct treatment for Major Depressive Disorder (aMDD)
       
SEP-363856
(ulotaront)»
Generalized Anxiety Disorder
       
SEP-4199»
Bipolar Depression
       
SEP-378614»
TBD
       
SEP-380135»
TBD
       
CT-152
(medical device)
Adjunct treatment for Major Depressive Disorder (MDD)
       

Nephrology

  Development Status
  Phase
Compound Phase 1 Phase 2 Phase 3 Filed
Tolvaptan
Pediatric autosomal recessive polycystic kidney disease (ARPKD)
       
Sibeprenlimab§
Immunoglobulin A nephropathy
       
VIS171§
Immune-mediated diseases
       
OPC-131461
TBD
       

Other Areas

  Development Status
  Phase
Compound Phase 1 Phase 2 Phase 3 Filed
QuabodepistatII
Pulmonary tuberculosis
       

*Part of Otsuka/Lundbeck alliance.

»Part of Otsuka/Sunovion alliance.

§Developed by Otsuka and Visterra, Inc.

IISupported by a grant from the Bill & Melinda Gates Foundation.

Our Milestones

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