Belgium

Key Insights

1
Only esketamine is legally available in Belgium for treatment-resistant depression; psilocybin and ketamine remain research-only, with no approved psychedelic therapy for patients. ([ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/spravato?utm_source=openai))
2
Blossom’s Belgium database shows 18 trials, 5 active, 8 research organisations, and four compounds studied; ketamine, placebo and psilocybin are in the active set. ([clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05973851?utm_source=openai))
3
Brugmann University Hospital launched Belgium’s first psilocybin-assisted therapy trial in March 2024, targeting severe alcohol use disorder under placebo control. ([clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06160232?utm_source=openai))
4
Momentum is centred on Brussels: Brugmann’s psilocybin programme and a 2024–2028 Phase 3 esketamine/ketamine depression trial show the field is still hospital-led. ([clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06160232?utm_source=openai))

Medical Only (Private)

Reimbursed Care Access

Belgium permits licensed psychedelic-derived medicines only within established regulatory pathways (e.g., esketamine nasal spray). Classical/recreational psychedelics (psilocybin, MDMA, DMT family, mescaline, ibogaine, 2C‑X, ayahuasca) remain controlled and have no routine reimbursed medical access outside authorised clinical trials. Off‑label medical use (for example ketamine infusions) can occur in clinical practice under the clinician’s responsibility but is not part of routine public reimbursement except where standard reimbursement rules for hospital/anaesthesia care apply.

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