EuropeDECountry Report

Psychedelic Research in

Germany

Germany remains a tightly regulated but increasingly important European market for psychedelic research. No classical psychedelic currently has routine market authorisation in Germany, and core compounds such as psilocybin, LSD, MDMA, DMT and 5-MeO-DMT remain controlled under Anlage I of the BtMG.

Key Insights

A concise read of the policy, research, and stakeholder signals shaping psychedelic medicine in Germany.

  • 1

    No classical psychedelic is authorised for routine medical use in Germany; the relevant compounds remain controlled under Anlage I BtMG.

  • 2

    Germany's first psilocybin compassionate use programme started on 11 July 2025 and is publicly listed by BfArM through 11 July 2026; it is limited to justified exceptional cases in adult treatment-resistant depression and is not a substitute for approval.

  • 3

    Berlin matters because it combines a treatment site inside the compassionate use pathway, a university trial hub, and a nonprofit training and education node in one city.

  • 4

    EPIsoDE is now a published German landmark study rather than an ongoing project. Public summaries show a non-significant primary response endpoint but significant secondary antidepressant effects for 25 mg psilocybin versus placebo.

  • 5

    Real-world patient access in Germany today is still dominated by esketamine on-label and ketamine off-label. Public sources reviewed for this refresh do not establish routine statutory reimbursement for psilocybin compassionate use.

  • 6

    The verified German pipeline is broader than psilocybin alone: Berlin has documented work in LSD for GAD, psilocin for depression, 5-MeO-DMT for treatment-resistant depression, and completed MDMA-assisted psychotherapy feasibility work for PTSD.

Research Snapshot

Blossom currently tracks 23 psychedelic clinical trials connected to Germany, including 5 active studies.

Active trials
5

Currently active in Blossom

Total trials
23

Country-linked records

Stakeholders
18

Linked organisations

Events
5

Linked event records

Top Compounds

  • Esketamine(7)
  • Ketamine(7)
  • Psilocybin(4)
  • 5-MeO-DMT(2)
  • LSD(1)

Top Study Topics

  • Treatment-Resistant Depression (TRD)(14)
  • Major Depressive Disorder (MDD)(4)
  • PTSD(2)
  • Anxiety Disorders(1)
  • Bipolar Disorder(1)

Medical Access Snapshot

Germany offers on-label supervised access to esketamine for treatment-resistant depression and selected off-label ketamine care, but no routine statutory reimbursement pathway for classical psychedelics is publicly established. Psilocybin access is limited to clinical trials and the BfArM-confirmed compassionate use programme for adult treatment-resistant depression in justified exceptional cases; this route is time-limited, capacity-constrained and not general prescribing.

Regulatory Status

Germany does not currently permit routine prescribing of any classical psychedelic. Psilocybin, LSD, MDMA, DMT and 5-MeO-DMT remain Anlage I BtMG substances, so patient access depends on special legal channels. In practice, Germany now has four distinct routes: authorised medicines such as esketamine, which is EU-authorised and used under direct professional supervision; off-label ketamine, which the national depression guideline says should not be used outside an inpatient psychiatric setting; authorised clinical trials; and a BfArM-confirmed psilocybin compassionate use cohort programme for adult patients with treatment-resistant depression in justified exceptional cases, listed from 11 July 2025 to 11 July 2026 under the responsibility of the Central Institute of Mental Health in Mannheim. Compassionate use is a confirmed notification procedure under the AMG/AMHV framework, not general market authorisation, and BfArM states that this framework applies to cohort programmes rather than named-patient requests.

History of Research in Germany

Germany's modern psychedelic story is best understood through regulation and psychiatry rather than discovery chemistry. The decisive legal fact is that core classical psychedelics remain in Anlage I of the BtMG, which sharply restricts ordinary medical traffic and helps explain why psychedelic clinical work remained marginal for decades after the prohibition era. Even today, BfArM's compassionate use framework sits explicitly outside ordinary marketing authorisation. # #

The modern re-entry came through academic psychopharmacology, neuroimaging and rapid-acting antidepressant research. An important adjacent development was esketamine. The European Medicines Agency authorised Spravato in 2019 for treatment-resistant depression, and the G-BA later noted that the medicine has been prescribable in Germany since 1 March 2021 under supervised psychiatric use. This gave German clinicians a lawful glutamatergic treatment route before any classical psychedelic reached even limited patient access. # #

The most important Germany-specific research inflection point was EPIsoDE, launched in 2021 and led by the Central Institute of Mental Health in Mannheim with Charite in Berlin and the MIND Foundation as partners. In late 2022 the project received an additional EUR 2.6 million from the German Federal Ministry of Education and Research, which expanded biomarker and mechanistic work and reinforced Germany's role in investigator-led psychedelic depression research. # # #

The next step was pre-authorisation clinical access. On 31 July 2025, ZI Mannheim announced that Germany had secured the first psilocybin compassionate use programme in the European Union, with treatment in Mannheim and at OVID Clinic Berlin in justified exceptional cases. In March 2026, EPIsoDE then produced the first major published Germany-led randomised psilocybin depression outcome paper, moving the country from speculative promise to a clearer evidence-based position. # # #

Berlin Spotlight

Berlin is now the most concentrated psychedelic node in Germany because treatment, trials, training, and public discourse all intersect there. That matters for researchers and policy observers: Berlin is where Germany's most visible clinical-access experiment, most visible university pipeline, and most visible independent training organisation coexist. # # #

According to OVID Clinic Berlin's own materials, the clinic is the Berlin treatment site inside the psilocybin compassionate use programme that was secured under the direction of Gerhard Gruender. OVID says the relevant licence has been delegated locally to Andrea Jungaberle and that treatment occurs in the day clinic, not as ordinary outpatient prescribing. OVID also presents itself as a private psychiatric-psychotherapeutic practice and day clinic serving privately insured patients and self-payers, which reinforces the point that this pathway is not general statutory care. This is an organisational source and should be read as such. #

The MIND Foundation gives Berlin a second role beyond treatment delivery. MIND describes itself as a Berlin-based nonprofit dedicated to research and education, as a partner of OVID Clinic Berlin, and as the operator of the 15-month Augmented Psychotherapy Training. It also runs science-communication and discourse formats such as the INSIGHT Forum. In practical terms, that makes MIND a training and convening institution in the Berlin ecosystem rather than a regulator, payer or market-authorisation holder. These are organisational sources. #

Charite anchors Berlin's academic side. Official pages from its Psychedelic Substances Research Group show Berlin participation in EPIsoDE, completed COMP006 psilocybin work, completed BPL-003 5-MeO-DMT work, and completed MDMA-assisted psychotherapy feasibility work in PTSD. Charite also lists ongoing CYB003 and MM120 studies and non-trial projects such as PsychedELSI and PsyTrans. That combination gives Berlin unusual depth across efficacy, implementation, ethics and harm-related research. #

TRYP EXPO may be mentioned only as a future ecosystem signal. Official sources place its founding edition at Funkhaus Berlin on 15-17 May 2026. That indicates that Berlin is becoming a major meeting point for psychedelic science and adjacent sectors. It should not, however, be read as evidence of regulatory liberalisation, reimbursement progress or expanded patient access. #

Research Focus

The main German focus remains depression, especially treatment-resistant depression. EPIsoDE enrolled 144 participants between 2021 and 2024 across Mannheim and Berlin and was published online in JAMA Psychiatry on 18 March 2026. The primary response endpoint at six weeks was not significantly different across groups, with response rates of 17.0% for 25 mg psilocybin, 12.5% for 5 mg psilocybin and 10.6% for placebo/nicotinamide, but secondary outcomes showed a significant antidepressant effect for 25 mg versus placebo, including a 4.6-point greater reduction on HAMD-17 at six weeks. Two serious adverse reactions were publicly reported. #

Berlin also now hosts a broader late-stage and multinational trial pipeline through Charite's Psychedelic Substances Research Group. Official Charite pages show Berlin as a study centre in completed COMP006 psilocybin treatment-resistant depression work, completed BPL-003 5-MeO-DMT treatment-resistant depression work, and a completed open-label phase II MDMA-assisted psychotherapy feasibility study in severe PTSD. Charite also lists ongoing participation in MM120 (LSD-tartrate) for generalised anxiety disorder and CYB003 (deuterated psilocin) for depression. #

A second German strength is the interface between biological psychiatry and psychosocial implementation. Charite lists ongoing projects such as PsychedELSI, PsyTrans, and PPaPS, indicating sustained interest not only in efficacy studies but also in ethics, law, sociocultural context and potential persistent adverse effects. That is important in Germany, where the likely route to adoption runs through tightly regulated hospital practice, health technology assessment and professional training rather than a rapid private-clinic roll-out of classical psychedelics. #

Ketamine and esketamine sit in a separate but clinically relevant category. Esketamine is an authorised medicinal product for adults with treatment-resistant major depression and must be initiated by a psychiatrist and administered under direct supervision. IV ketamine for depression remains off-label; the national depression guideline states that IV ketamine should not be used outside an inpatient psychiatric setting. That makes ketamine/esketamine the most realistic rapid-acting access route for German patients now, but they should not be conflated with lawful routine access to classical psychedelics. # #

Key Milestones

1971
Germany's BtMG creates the modern narcotics framework under which classical psychedelics remain tightly controlled.
2019
The European Medicines Agency authorises Spravato for treatment-resistant depression in the EU.
2021
EPIsoDE launches in Mannheim and Berlin; the initial G-BA decision on esketamine finds added benefit not proven on the data then available.
15 Nov 2022
ZI Mannheim announces an extra EUR 2.6 million in BMBF support for EPIsoDE.
21 Sep 2023
The G-BA revises its position and sees an indication of considerable added benefit for esketamine in severe treatment-resistant depression.
11 Jul 2025
BfArM's public table records "Psilocybin bei therapieresistenter Depression" as an active compassionate use programme running to 11 July 2026 under the responsibility of the Central Institute of Mental Health in Mannheim.
31 Jul 2025
ZI Mannheim publicly announces Germany's first and the EU's first psilocybin compassionate use programme, including treatment in Mannheim and at OVID Clinic Berlin.
18 Mar 2026
EPIsoDE is published online in JAMA Psychiatry; public summaries report a non-significant primary endpoint but significant secondary antidepressant effects for 25 mg psilocybin.

Future Outlook

The immediate regulatory question is not broad approval but continuity of the current exceptional pathway. BfArM's public table lists the psilocybin compassionate use programme only through 11 July 2026. Unless it is renewed or replaced, the publicly confirmed programme expires then. Even if extended, it would still remain a narrow cohort programme under compassionate use rules rather than a general prescribing route. #

The nearer-term research outlook is stronger than the access outlook. Berlin continues to host Charite participation in phase III CYB003 for depression and phase III MM120 for generalised anxiety disorder, while EPIsoDE investigators have publicly said that additional analyses on biomarkers and psychological mechanisms are still in preparation. On current evidence, Germany is likely to remain important in protocol development, site delivery and implementation thinking over the next 12-24 months. # #

Wider public reimbursement or routine clinical availability for a classical psychedelic still looks premature. The most plausible German route is the conventional one: marketing authorisation first, then G-BA evaluation and reimbursement negotiation. In other words, German psychedelic medicine is still moving through standard medicines regulation and health technology assessment, not around it. That makes the country highly credible scientifically, but still structurally cautious in access terms. # #

Sources and Verification

Last updated 18 May 2026. Source links are drawn from citation annotations in the country report.

  1. 1BfArM Compassionate Use table
  2. 2BtMG Anlage I
  3. 3Charite Psychedelic Substances Research Group
  4. 4EMA Spravato EPAR
  5. 5G-BA esketamine benefit assessment
  6. 6JAMA Psychiatry EPIsoDE publication
  7. 7MIND Foundation
  8. 8OVID Clinic Berlin psilocybin therapy page
  9. 9TRYP EXPO
  10. 10ZI Mannheim psilocybin compassionate use announcement

Country Details

Region
Europe
Last updated
18 May 2026

Country Report

Medical Only (Limited)

Medical Access and Reimbursement

Germany offers on-label supervised access to esketamine for treatment-resistant depression and selected off-label ketamine care, but no routine statutory reimbursement pathway for classical psychedelics is publicly established. Psilocybin access is limited to clinical trials and the BfArM-confirmed...

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Research Events in Germany

Conferences, trainings, and research gatherings connected to the country report.

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