Germany Breaks Ground with EU’s First Psilocybin Compassionate Use Approval

BERLIN – Germany has become the first European Union nation to authorize the compassionate use of psilocybin, the psychoactive compound in magic mushrooms, for patients with treatment-resistant depression (TRD).

Under this program, approved by the Federal Institute for Drugs and Medical Devices (BfArM), two leading facilities, the Central Institute of Mental Health (CIMH) in Mannheim and the OVID Clinic in Berlin, will administer Filament Health’s botanical psilocybin candidate, PEX010, under strict medical supervision. This historic move marks a significant step toward integrating psychedelic therapies into mainstream mental health care.

The compassionate use program, spearheaded by Prof. Dr. Gerhard Gründer of CIMH, targets adults with TRD, a condition affecting up to 30% of those diagnosed with major depressive disorder. Unlike traditional clinical trials, this initiative allows individualized treatment for patients who have exhausted approved therapies and cannot participate in ongoing studies.

“This is a pivotal moment for psychedelic medicine in the EU,” Gründer said, emphasizing the need for carefully controlled conditions to ensure safety and efficacy.

Reflecting similar pathways in Switzerland and Canada, the program is expected to face overwhelming demand. Experiences from Switzerland, where nearly 700 patients received psychedelic authorizations in 2024, suggest Germany’s clinics may struggle to meet interest. Treatment will involve single doses of PEX010 alongside psychotherapy, aiming to disrupt rigid thought patterns and foster new perspectives for patients. The OVID Clinic, closely tied to the MIND Foundation, underscores the importance of combining research, medical expertise, and ethical standards in this pioneering effort.

Germany’s decision comes at a time amid growing worldwide attention to psychedelics. The Czech Republic recently legalized psilocybin for medical use, and EU-funded trials are exploring its potential for conditions like depression and anxiety in patients with progressive diseases. However, full regulatory approval for psilocybin in Germany remains years away, making compassionate use a critical bridge for those in urgent need.

As Europe’s largest pharmaceutical market takes this bold step, the implications are profound. Advocates like the Psychedelic Access and Research European Alliance (PAREA) see the program as a model for collecting real-world data to support future approvals. For now, Germany’s trailblazing move offers hope to those battling TRD, signaling a new era for psychedelic-assisted therapy in the EU. With rigorous oversight and a commitment to patient care, this initiative could pave the way for broader acceptance, transforming mental health treatment across the continent.