Germany establishes the EU's first psilocybin compassionate access program for adults with treatment-resistant depression via two licensed clinics

Psilocybin compassionate use in Germany is being authorized through a new federal program, making Germany the first EU country to allow legal access to a psychedelic before regulatory approval. Adults with treatment-resistant depression (TRD) can be admitted at two facilities, Central Institute of Mental Health (CIMH, Mannheim) and OVID Clinic Berlin, after qualifying for the program’s eligibility rules. Licensed psychiatrists at these sites decide patient participation, which is positioned as faster than patient-by-patient regulatory approvals used in some other countries. The program uses Filament Health’s botanical psilocybin candidate, PEX010 (provided to patients for free), and is limited by scale and time. Treatment is paired with broader psychiatric care, includes strict safety monitoring, and is expected to close if and when market approval for the indication becomes available.