1. What the law is
Germany's psilocybin route is one program at one institute, renewed annually. It supplies psilocybin for treatment-resistant depression outside both a clinical trial and an ordinary prescription, and it reaches only patients enrolled at a participating center. That program runs from 18 June 2026 to 17 June 2027 at the Zentralinstitut fuer Seelische Gesundheit in Mannheim. It is not a national scheme any prescriber can use.
The route is set by section 21(2) no. 3 of the Medicines Act and the compassionate use regulation made under it. Nothing here is approved. The sponsor notifies the Federal Institute for Drugs and Medical Devices, which confirms the notification and keeps a right to object, including after the program has started. A confirmation runs one year and then has to be renewed. Possession outside the program remains an offense under the Narcotics Act.
2. Trials in Germany
Interventional psilocybin trials with at least one site in Germany, as their sponsors filed them with ClinicalTrials.gov, EU CTIS and ISRCTN. Each row links to the registry record, which sets out who may take part.
Recruiting or opening counts trials recruiting now, not yet recruiting, or enrolling by invitation. Closed counts trials terminated, suspended, withdrawn or left unverified by their sponsors.
| Registry ID | Trial | Phase | Sponsor | Status | Start date |
|---|---|---|---|---|---|
| NCT06793397 | A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder (opens in new tab)Sites in Berlin, Frankfurt am Main, Homburg | Phase Phase 3 | Sponsor Cybin IRL Limited | Status Recruiting | Start date |
| 2023-505268-12-00 | A Phase III, multicentre, randomised, double-blind, controlled study to investigate the efficacy, safety, and tolerability of two initial administrations of COMP360 in participants with treatment-resistant depression (opens in new tab)Sites in Berlin, Frankfurt Am Main, Luebeck | Phase Not stated | Sponsor Compass Pathfinder Limited | Status Authorised | Start date |
| NCT05711940 | Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD (opens in new tab)Sites in Berlin, Frankfurt, Lübeck | Phase Phase 3 | Sponsor COMPASS Pathways | Status Active, not recruiting | Start date |
| NCT04670081 | Efficacy and Safety of Psilocybin in Treatment-Resistant Major Depression (opens in new tab)Sites in Berlin and Mannheim | Phase Phase 2 | Sponsor Central Institute of Mental Health, Mannheim | Status Completed | Start date |
| NCT03775200 | The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression (opens in new tab)Site at Charité - Universitätsmedizin Berlin, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin, Berlin | Phase Phase 2 | Sponsor COMPASS Pathways | Status Completed | Start date |
ClinicalTrials.gov data courtesy of the U.S. National Library of Medicine.
3. History
The legal events behind this entry, dated and oldest first. Our own reviews and corrections are listed under Changes to this record.
Medical use status takes effect.
4. Proposed laws
No proposed law is on file in Germany that would change this entry, as of the 17 Aug 2026 review.
5. Common questions
Is psilocybin legal in Germany?
Psilocybin is legal for medical use in Germany.
Are magic mushrooms ("shrooms") legal in Germany?
"Magic mushrooms" and "shrooms" are common names for fungi that contain psilocybin, and this entry states the law on psilocybin itself, which some laws treat separately from the fungus. Psilocybin is legal for medical use in Germany.
Read the law
Compassionate use program (Haertefallprogramm) notified under section 21(2) no. 3 of the Medicines Act (AMG) and the compassionate use regulation (AMHV). The sponsor files a notification which the Federal Institute for Drugs and Medical Devices confirms under section 4 AMHV; this is a confirmed notification and not an approval. Section 1(2) AMHV excludes single-patient use, so the route is cohort-only, and section 5 AMHV caps a confirmation at one year. The regulator's table of notified programs lists one psilocybin program: Psilocybin bei therapieresistenter Depression, notified 18 June 2026 to 17 June 2027, responsible person Prof. Dr. med. Gerhard Gruender, Zentralinstitut fuer Seelische Gesundheit, Mannheim. General use remains illegal under BtMG Schedule I.1
Sources
This entry's status is checked against the primary sources below, and the methodology explains how each entry is graded for confidence.
- 1.bfarm.de (opens in new tab) · bfarm.de
- 2.zi-mannheim.de (opens in new tab) · zi-mannheim.de
This entry is for information only and is not legal or medical advice. Laws change, and enforcement can differ from the letter of the law, so check the current position against the primary sources above before relying on it.
Changes to this record
3 changes on file, the latest on . Show allHide
Every change we have made to this record, dated, corrections included. Nothing changes silently.
Germany's entry was a year out of date. The regulator lists one psilocybin programme, running from 18 June 2026 to 17 June 2027 at a single institute in Mannheim for treatment-resistant depression, and the entry now says that instead of describing a national scheme.
Germany's entry now describes how its compassionate use programme actually works. A sponsor notifies the regulator, which confirms the notification rather than granting an approval, and the confirmation has to be renewed each year.
Germany's compassionate use program was confirmed active and unchanged, though the regulator's psilocybin-specific listing could not be read directly at this review.
Psilocybin Media Group. "Germany: psilocybin legal status." The Psilocybin Record, accession DE-001, version of 23 Aug 2026. https://psilocybinlegalization.com/record/germany