Belgium Could Get Its First Legal Psilocybin Treatment Outside a Clinical Trial
A Brussels psychiatric hospital group is seeking permission to give psilocybin to people with treatment-resistant depression outside a clinical trial, which would be a first for Belgium. The nonprofit Epsylon would run the compassionate use program under psychiatrist Dr. Daniel Souery, with psilocybin supplied by Filament Health, a subsidiary of Canada's Rhelion Life Sciences (formerly Red Light Holland), the companies announced. Filament's drug, PEX010, is psilocybin extracted from whole mushrooms in standardized 1mg, 5mg and 25mg doses. The program still needs approval from Belgium's medicines agency (FAMHP), an ethics committee and import permits; no start date or patient numbers have been given. Psychedelic Society Belgium, an advocacy group that says Belgium's 1921 drug law is overdue for "a framework of compassion," backs the plan.
The model: Germany already runs the EU's first psilocybin compassionate use program, using the same Filament drug, at the Central Institute of Mental Health in Mannheim since 2025. Belgium would be the second EU country, while psilocybin elsewhere in the bloc remains trial-only. In the U.S., two psilocybin applications are now under FDA review. See Belgium on our global legal map and Filament's programs on our trials tracker.