Compassionate Use
RegulatoryA regulatory pathway letting patients access an unapproved drug outside a clinical trial, typically for serious conditions with no other options.
Example: Germany's BfArM approved what's reportedly the EU's first compassionate-use psilocybin program in 2026 — see our coverage of how narrow that access actually is: two sites, a dosing cap added after an error, and its first statutory-insurance patient only in October 2026.
What is compassionate use?
A regulatory pathway letting patients access an unapproved drug outside a clinical trial, typically reserved for serious conditions with no other treatment options.
Is there a compassionate-use psilocybin program?
Germany's BfArM approved what's reportedly the EU's first compassionate-use psilocybin program in 2026 — though access is narrow: two sites, a dosing cap added after an error, and its first statutory-insurance-covered patient only in October 2026.
How is compassionate use different from a clinical trial?
A clinical trial is designed to generate data toward approval, with a defined protocol and typically a control group. Compassionate use is individual, case-by-case access for a specific patient outside that research structure, usually requiring sign-off from both the regulator and the drug maker each time.