Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announces that it has signed a basic research (non-clinical research) agreement with Keio University (Keio) for infrastructure development toward the social implementation of psychedelics in Japan.

Conventional treatments for depression, anxiety, obsessive-compulsive disorder, and post-traumatic stress disorder (PTSD)--such as antidepressants, augmentation therapy, and cognitive behavioral therapy--are often insufficient in terms of treatment efficacy and relapse prevention. As a result, many patients and their families suffer from the illness and associated decline in social functioning. Economic and social losses are also significant, and there is a strong demand for the development of new treatments for refractory mental disorders.

Furthermore, clinical trial results conducted outside Japan on psychedelics such as psilocybin have indicated long-lasting antidepressant effects (6 to 12 months) with just one or two doses. Psilocybin acts as a 5-HT_2A receptor agonist and has been confirmed to have a strong and fast-acting antidepressant effect.^*1,2

Treatments using psychedelics have been designated as breakthrough therapies in the United States, with multiple pharmaceutical companies conducting phase 3 trials. Phase 2 trials are also underway in Europe. In contrast, in Japan, no clinical trials for psychedelic candidates have been conducted. Only small-scale specific clinical research, led by Professor Hiroyuki Uchida of the Department of Psychiatry and Neuroscience at Keio University School of Medicine, is being carried out with a research grant from the Japan Agency for Medical Research and Development (AMED) under the Research and Development Grants for Comprehensive Research for Persons with Disabilities (in the field of mental disorders) program. In order to safely and appropriately deliver psychedelics to patients in Japan, numerous challenges must be addressed for successful social implementation, as listed below.

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.

*1 Gukasyan N et al. J Psychopharmacol. 2022;36:151-158

*2 Carhart-Harris RL et al. Lancet Psychiatry. 2016;3:619-627; Goodwin G, et al. N Engl J Med. 2022;387:1637-1648