Otsuka Pharmaceutical Signs Research Agreement with Keio University to Advance Psychedelic Treatment Infrastructure in Japan
Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced that it has signed a non-clinical (basic research) agreement with Keio University (Keio) to collaborate on developing the necessary infrastructure for the future social implementation of psychedelic treatments in Japan.
Currently, conventional treatments for depression, anxiety, obsessive-compulsive disorder (OCD), and post-traumatic stress disorder (PTSD)—such as antidepressants, augmentation therapy, and cognitive behavioral therapy—often fall short in effectiveness and relapse prevention. As a result, many patients and their families continue to struggle with the burden of these illnesses, experiencing a decline in social functioning. Beyond the personal toll, the broader economic and social losses are substantial, underscoring the urgent need for new treatment options for refractory (treatment-resistant) mental disorders.
Clinical trials conducted outside Japan have shown promising results with psychedelics like psilocybin, a 5-HT2A receptor agonist. Studies suggest that even just one or two doses of psilocybin can provide rapid and long-lasting antidepressant effects, lasting from 6 to 12 months.*1,2
In the United States, psychedelic treatments have been granted breakthrough therapy status, and several pharmaceutical companies are already conducting phase 3 trials. Europe has also progressed, with multiple phase 2 trials underway. However, Japan has yet to conduct clinical trials for psychedelic candidates. The only efforts so far are limited, small-scale specific clinical research projects led by Professor Hiroyuki Uchida from the Department of Psychiatry and Neuroscience at Keio University School of Medicine. These are supported by a research grant from the Japan Agency for Medical Research and Development (AMED) under its Research and Development Grants for Comprehensive Research for Persons with Disabilities (focused on mental disorders).
To ensure that psychedelic treatments can be safely and effectively delivered to patients in Japan, numerous challenges must be addressed before they can be implemented in society. Otsuka and Keio aim to collaborate on tackling these challenges and advancing research infrastructure to pave the way for future clinical applications.
Key issues for social implementation of psychedelics
・ Optimal clinical trials designed to maximize the therapeutic potential of psychedelics
・ Establishment of a system for the professional development of psychiatrists and psychologists and the development of a system for implementing medical institutions
・ Addressing legal and ethical issues and regulatory compliance related to the use of psychedelics
・ Public awareness campaigns to correct social prejudices and misconceptions about psychedelics
Otsuka and Keio have outlined several development items in their joint basic research to deliver psychedelics developed overseas to patients in Japan in the future. These items include consideration of development policies for psychedelics, formulating treatment manuals and guidelines, developing expert training programs, addressing legal and ethical issues, conducting public relations and public awareness campaigns, and promoting corporate collaboration and intellectual property strategies. Otsuka and Keio are committed to addressing these challenges to establish a new standard for treating mental disorders in Japan through the clinical application of psychedelics.
