PsyPal Marks Historic First Patient Inclusion in EU Psilocybin Trial

Today, August 11, 2025, PsyPal has reached a major milestone with the inclusion of its first patient in the multi-site clinical trial investigating psilocybin therapy for psychological and existential distress in people with progressive, life-limiting illnesses. The first patient was enrolled at the University Medical Center Groningen (UMCG) in the Netherlands, one of four specialised clinical sites taking part in this unprecedented, EU-funded initiative.

PsyPal is the first EU-funded, multi-site clinical trial focused on psilocybin therapy. The study aims to evaluate whether psilocybin, delivered in a structured psychotherapeutic context, can help alleviate depression and anxiety, while improving quality of life in people with chronic obstructive pulmonary disease (COPD), multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), or advanced and atypical parkinsonian disorders (APD).

More than 100 patients across Europe are expected to take part, each receiving two therapy sessions involving either a high (therapeutic) or low (non-therapeutic) dose of psilocybin in a carefully monitored clinical setting. 

This marks the first time a psychedelic compound is being tested in a European clinical trial specifically for palliative care populations beyond cancer, signalling the start of a new era in mental health research and care in Europe. PAREA celebrates this landmark step and remains committed to advancing equitable access to psychedelic therapies across Europe.

Read the full press release here and sign up to the PsyPal newsletter to stay informed about patient recruitment, study progress, and more.