Guide · Europe · Germany

Psilocybin therapy in Germany (2026): the compassionate use programme explained

Last updated 28 October 2026 · Trial statuses checked 28 October 2026 · Published by Psyche Vibes Ltd, London

The short answer. Psilocybin is not an approved medicine in Germany and is listed as a non-marketable narcotic (BtMG Annex I). Since 11 July 2025, a compassionate use programme (Arzneimittel-Härtefallprogramm) has allowed ZI Mannheim and OVID Clinic Berlin to treat a limited number of people with treatment-resistant depression, in exceptional cases (ZI Mannheim).

BfArM's list shows the programme's current period as 18 June 2026 to 17 June 2027 (BfArM). Both sites report long waiting lists, and there is no approval date for psilocybin in Germany or the EU.

The legal basis

German medicines law allows an unapproved medicine to be made available free of charge to patients with a disease that is life-threatening or would lead to serious disability, and who cannot be treated satisfactorily with an authorised medicine (AMG § 21(2) no. 6). The detailed rules are in the Medicines Hardship Ordinance:

There must be sufficient evidence of efficacy and safety, and the medicine must be in a clinical trial or under a marketing application (AMHV § 2).
The person responsible notifies BfArM, including the patient selection criteria and why the patients cannot join an ongoing trial (AMHV § 3).
The programme may start once BfArM has confirmed the notification and has not objected. BfArM can object later if safe use is no longer assured (AMHV § 4).
A programme ends at the latest one year after confirmation, but it may be notified again (AMHV § 5). This is why the psilocybin programme has dated periods on BfArM's list.

Separately, psilocybin and psilocin are listed in Annex I of the Narcotics Act (BtMG Annex I). For Annex I substances, BfArM can grant a permit only exceptionally, for scientific or other purposes in the public interest (BtMG § 3(2)).

Who qualifies

Both sites describe the same criteria: people with treatment-resistant depression for whom approved medicines have not worked well enough, and for whom joining a clinical trial with the medicine is not possible (ZI Mannheim; OVID). Each case is assessed individually, and the programmes are time-limited and tightly regulated.

ZI Mannheim says it receives very many enquiries and that waiting times are long. It also says privately insured and self-paying patients can contact OVID Clinic Berlin, where the programme is open only to those groups (ZI Mannheim).

How treatment is organised

Psychotherapy around the medicine. Psilocybin is given in single sessions combined with psychotherapy, using safety protocols developed from clinical trials (ZI Mannheim).
Setting. At ZI Mannheim, treatment can be outpatient or (day-)inpatient, with extra outpatient appointments to check eligibility and for preparation and follow-up (ZI). At OVID Clinic Berlin it takes place in the day clinic only (OVID).
Who leads it. Prof. Gerhard Gründer of ZI Mannheim is the responsible person on BfArM's list (BfArM). OVID says a doctor there holds the licence by delegation from him (OVID).

What has happened so far

At the TAIP conference in Tallinn on 8–9 October 2026, as reported by Psychedelic Alpha, speakers said the first patient was treated in Berlin on 1 April 2026; that both sites expected to have treated about 20 patients each by the end of 2026; that the programme was extended for a year in June 2026; and that statutory health insurance does not pay for the dosing day. They also said the psilocybin is supplied free of charge by its manufacturer, and that ZI Mannheim plans a group-based model in early 2027 (Psychedelic Alpha).

The German evidence: the EPIsoDE trial

Germany's largest psilocybin trial, EPIsoDE, randomised 144 adults with treatment-resistant depression at two German centres. Its main measure, the share of people responding at week 6, was not significantly better with high-dose psilocybin than with an active placebo (17.0% vs 10.6%). Secondary measures suggested a clinically meaningful reduction in depressive symptoms. Suicidal thoughts were reported more often on psilocybin dosing days (4% vs 1–2%), and there were two serious adverse reactions after high-dose psilocybin, one of them hallucinogen persisting perception disorder (JAMA Psychiatry, 2026).

When could psilocybin be approved?

No psilocybin medicine has an EU marketing authorisation or a visible EMA application: see our EMA approval tracker. ZI Mannheim says that, if current Phase 3 trials are positive, approval in Germany can be expected within three to five years, and probably sooner in the US (ZI Mannheim). Even after an EU approval, Germany's Federal Joint Committee (G-BA) assesses the added benefit of new medicines against a comparator, which speakers at TAIP flagged as a hurdle for psychedelics (Psychedelic Alpha). The only psychedelic-related medicine authorised EU-wide is esketamine nasal spray (EMA).

Tracker status

From the Germany tracker row (data as of 28 October 2026): National CUP approved 11 Jul 2025; renewed notification 18 Jun 2026, runs to 17 Jun 2027 (BfArM list). First patient treated in Berlin on 1 Apr 2026; each site expected about 20 patients by end of 2026; statutory health insurance does not cover the dosing day (reported Oct 2026)

Psychedelic trials with sites in Germany

Generated from the Psyche Insights directory. When we checked ClinicalTrials.gov on 28 October 2026, the four German sites of the HLP003 (CYB003) Phase 3 study were listed as not yet recruiting (NCT06793397), although ZI Mannheim's own page says recruitment has started (ZI). A ketamine study in chronic depression listed its Tübingen and Jena sites as recruiting (NCT06410599).

Registered trial

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

Condition: Major Depressive Disorder (MDD), Depression in Adults, Depression - Major Depressive Disorder
Sponsor: Cybin IRL Limited
Phase: Phase 3
German sites: Homburg (Saarland), Berlin (Charité), Frankfurt am Main and Mannheim (ZI), all listed as not yet recruiting
Overall status: Recruiting (ClinicalTrials.gov)
Registry record: ClinicalTrials.gov NCT06793397
Last checked: 28 October 2026

Registered trial

Pharmacologic Treatment Augmentation in Chronic Depression

Condition: Major Depressive Disorder
Sponsor: University Hospital Tuebingen
Phase: Phase 2
German sites: Tübingen and Jena university hospitals, both listed as recruiting
Overall status: Recruiting (ClinicalTrials.gov)
Registry record: ClinicalTrials.gov NCT06410599
Last checked: 28 October 2026

Questions and answers

Is psilocybin therapy legal in Germany?

Only in narrow, regulated settings. Psilocybin is listed in Annex I of the Narcotics Act (BtMG) as a non-marketable narcotic and is not an approved medicine. Since 11 July 2025, a compassionate use programme notified to the federal medicines agency BfArM allows ZI Mannheim and OVID Clinic Berlin to treat a limited number of patients with treatment-resistant depression. Otherwise, access is only through approved clinical trials.

Who can get psilocybin through the German compassionate use programme?

People with treatment-resistant depression for whom approved treatments have not worked well enough and who cannot take part in a clinical trial. Each case is assessed individually by the treating team, and both sites report long waiting lists.

How long does the programme run?

Under German rules a compassionate use programme ends no later than one year after BfArM confirms the notification, but it can be notified again. BfArM's list shows the psilocybin programme's current period as 18 June 2026 to 17 June 2027.

Does health insurance pay for psilocybin therapy in Germany?

The medicine itself must be provided free of charge in a compassionate use programme. Speakers at a conference in October 2026 reported that statutory health insurance does not pay for the dosing day. ZI Mannheim says the Berlin site is open only to privately insured and self-paying patients.

When will psilocybin be approved in Germany?

There is no date. No psilocybin medicine has an EU marketing authorisation or a visible EMA application. ZI Mannheim says that, if current Phase 3 trials are positive, approval in Germany can be expected within three to five years.

Are magic mushrooms legal in Germany?

No. Psilocybin and psilocin are Annex I narcotics under the BtMG, and ZI Mannheim notes that psychedelics are illegal outside medical and scientific settings. This guide covers only the medical route.

Get UK and Europe access news each week

New trials, regulator decisions and law changes, with every claim linked to its source. Free, one email a week.

Subscribe free →

Sources

Hand-written facts and links checked 28 October 2026. Trial records checked on the dates shown.

Betäubungsmittelgesetz (BtMG) Anlage I (nicht verkehrsfähige Betäubungsmittel). https://www.gesetze-im-internet.de/btmg_1981/anlage_i.html
BtMG § 3 (Erlaubnis). https://www.gesetze-im-internet.de/btmg_1981/__3.html
Arzneimittelgesetz (AMG) § 21 Abs. 2 Nr. 6. https://www.gesetze-im-internet.de/amg_1976/__21.html
Arzneimittel-Härtefall-Verordnung (AMHV) § 2. https://www.gesetze-im-internet.de/amhv/__2.html
AMHV § 3 (Anzeige des Härtefallprogramms). https://www.gesetze-im-internet.de/amhv/__3.html
AMHV § 4 (Beginn, Widerspruch). https://www.gesetze-im-internet.de/amhv/__4.html
AMHV § 5 (Dauer, erneute Anzeige). https://www.gesetze-im-internet.de/amhv/__5.html
BfArM: Liste der angezeigten Arzneimittel-Härtefallprogramme (Compassionate Use). https://www.bfarm.de/DE/Arzneimittel/Klinische-Pruefung/Compassionate-Use/compUse-tabelle.html
ZI Mannheim: Psychedelika in Psychiatrie und Psychotherapie. https://www.zi-mannheim.de/behandlung/klinik-psychiatrie/psychedelika-in-psychiatrie-und-psychotherapie.html
ZI Mannheim: Compassionate Use Programm und klinische Studien. https://www.zi-mannheim.de/behandlung/klinik-psychiatrie/psychedelika-in-psychiatrie-und-psychotherapie/compassionate-use-programm-und-klinische-studien.html
OVID Clinic Berlin: Psilocybin-Therapie (Compassionate Use). https://ovid-clinics.de/psilocybin-therapie-berlin/
Psychedelic Alpha: TAIP Conference 2026 report (23 October 2026). https://psychedelicalpha.com/news/before-the-approvals-arrive-norway-germany-switzerland-the-uk-and-estonia-at-taip-conference-2026/
Gründer et al., EPIsoDE randomised clinical trial, JAMA Psychiatry 2026 (open access, PMC). https://pmc.ncbi.nlm.nih.gov/articles/PMC13000742/
ClinicalTrials.gov NCT06793397 (CYB003 / HLP003, Phase 3), site list. https://clinicaltrials.gov/study/NCT06793397
ClinicalTrials.gov NCT06410599 (ketamine augmentation in chronic depression). https://clinicaltrials.gov/study/NCT06410599
EMA: Spravato (esketamine) European public assessment report. https://www.ema.europa.eu/en/medicines/human/EPAR/spravato