Japan

Key Insights

1
No psychedelic therapy is approved in Japan; patients currently have no legal access to psilocybin, MDMA or similar treatments.
2
Blossom shows 1 active trial in Japan, and the only tracked compound is placebo across 1 total study.
3
Keio University and AMED-backed work are notable: Otsuka says Japan had no psychedelic clinical trials before 2025.
4
Momentum now centres on Keio’s 2025 tie-up with Otsuka to build domestic infrastructure for future psychedelic trials.

Medical Only (Private)

Reimbursed Care Access

Japan maintains a conservative, prohibition‑focused legal framework for classical psychedelic compounds (psilocybin, MDMA, DMT, 5‑MeO‑DMT, mescaline, ayahuasca, ibogaine and 2C‑X) — these are controlled under national drug control statutes and have no authorised medical use outside approved research. Ketamine is an established, licensed anesthetic and analgesic in Japan and is available via the medical system; psychiatric/off‑label use for depression is conducted as clinical care or research with limited reimbursement. Esketamine (the S‑enantiomer marketed internationally as SPRAVATO) has been the subject of clinical trials in Japan but there is no clear, publicly available PMDA/MHLW marketing authorisation and routine national reimbursement for esketamine is not established; other classical psychedelics are restricted to clinical trials only or are criminally controlled.

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