In this Issue

• Otsuka Eyes Psychedelic Future in Japan with New Infrastructure Drive
• ASCP 2025 Preview: Psychedelic Therapies Dominate Clinical Psychopharmacology Agenda
• First Look at Gilgamesh’s Phase 2a Data: Psychedelic Candidate Yields Effect Size of ~1.0, But Sparse Details
• VA Secretary Pressed for Details on Psychedelics Plans
• and more…

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Yesterday, Japanese pharmaceutical giant Otsuka announced a joint research agreement with Keio University aimed at building infrastructure for “the social implementation of psychedelics in Japan.”

The non-clinical research agreement will see the pair focus on four key areas:

• “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 emphasised Japan’s unmet mental health needs and highlighted international momentum, noting U.S. breakthrough therapy designations and ongoing Phase 2 and 3 trials in the U.S. and Europe. In contrast, Japan has seen only limited, small-scale psychedelic research, mainly through Professor Hiroyuki Uchida’s government-funded work at Keio.

It appears, then, that Otsuka is aiming to shape the environment for the potential launch of psychedelics-based treatments in its HQ country, from clinical trial designs through to addressing the stigma attached to the class of drugs.

That stigma could be a substantial barrier. Japan is known for its strict drug laws rooted in a fraught history with substances like methamphetamine, with stimulants banned in the island nation…

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