Our Clinical Trials

Clinical trials play a critical role in research and in making discoveries in healthcare. It’s these breakthroughs in science that help people defy the limitations of their disease. This would not be possible without the participation of patients, who are at the heart of everything we do.

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If we can get out of our comfort zone and embrace new ways of doing things, we have the potential to help so many more people who are in great need of our products and services.

Clinical Trial Information

When patients take part in a clinical trial, we can explore complex healthcare challenges and work together to find solutions. It is a vital part of the process in establishing the safety and efficacy of potential new therapies and in achieving the regulatory approval required to make these treatments available to the public. We deeply value the contribution of all those who have enrolled in trials. 

Find general information on publicly and privately supported clinical trials here.

More information about clinical research can also be found at The Center for Information and Study on Clinical Research Participation (CISCRP).

Clinical Trial Access

If you are a clinical researcher and would like more information on the clinical trial data–sharing program, please visit the Otsuka Clinical Trial Data Transparency website.

For patients who may want to participate in a clinical trial, but may not be able to, there is still a possibility to access an investigational drug through the Expanded Access program. 

Expanded access, also known as compassionate use, allows for an investigational medical product that has not yet been approved by the FDA to be used outside of a clinical trial. Otsuka accepts requests for expanded access from physicians currently treating patients for whom there are no other treatment options available. 

To be eligible for access to an investigational product, the applying physician must certify that the patient for whom the application is being submitted meets the following criteria*:

Is suffering from a serious or life-threatening disease or condition

Is not able to participate in any ongoing clinical study of the drug related to the treatment of the patient’s condition

Has undergone appropriate standard treatments without success and there is no alternative treatment available, or no standard treatment exists for the disease or condition

The potential benefits for the patient must outweigh the potential risks

The provision of the drug will not interfere with the development of the product

Note that meeting these criteria does not guarantee access to any investigational product. 

Contact us at expandedaccess@otsuka-us.com with any questions, or to request an application form or submit a completed application form.

Otsuka will confirm receipt of an application within one week and will advise of any additionally required information after the initial review of the application.