When will psilocybin, MDMA or LSD be approved in Europe? EMA tracker 2026
The short answer. Not yet, and there is no date. As of 23 October 2026, no psilocybin, MDMA or LSD medicine has an EU marketing authorisation, and none appears on EMA's list of applications under evaluation (October 2026 list, data to 5 October 2026) (EMA). Without an application, no approval date can be predicted.
The only psychedelic-related medicine authorised EU-wide is esketamine nasal spray (Spravato), since 18 December 2019 (EMA). Outside trials, limited access exists only through national routes in Czechia, Germany and Switzerland.
Where each programme stands with EMA, MHRA and FDA
The most advanced psychedelic and related medicines, with their status at each regulator. "Not reported" means we found no public statement of an application.
| Programme | Stage | EU / EMA | UK MHRA | US FDA | Updated |
|---|---|---|---|---|---|
| COMP360 (synthetic psilocybin) Compass Pathways (London/New York) · Treatment-resistant depression (TRD) | Filing (US) | No EMA application reported | ILAP designation for TRD (company statement); not authorised | Rolling NDA under review; final modules due Q4 2026; launch targeted H1 2027 if approved and after DEA rescheduling; draft label/REMS under FDA review | 20 October 2026 |
| MDMA-assisted therapy Resilient Pharmaceuticals (formerly MAPS PBC / Lykos) · PTSD | Resubmitted (US) | No EMA application visible; investigator-led trials (Netherlands Phase II approved Aug 2026; Norway Phase 2 pilot Jul 2026) | Not authorised; MDMA Schedule 1 | NDA resubmitted Aug 2026 without new Phase 3 (reported; FDA acceptance/PDUFA date not disclosed). Prior CRL 9 Aug 2024 | 13 October 2026 |
| DT120 ODT (lysergide / LSD; formerly MM120) Definium Therapeutics (formerly MindMed) · GAD; MDD; PTSD (Phase 3 planned) | Phase 3 | Panorama (GAD) enrolled in US and Europe; no EMA filing reported | Not reported | Phase 3: positive Voyage & Panorama (GAD) and Emerge (MDD); Ascend (MDD) ongoing; Breakthrough Therapy for GAD and MDD (MDD granted 8 Sep 2026) | 8 September 2026 |
| HLP003 (deuterated psilocin; formerly CYB003) Helus Pharma (formerly Cybin) · Adjunctive MDD | Phase 3 | Not reported | Not reported | Phase 3 APPROACH (n=223) fully enrolled, topline expected Q4 2026; EMBRACE ongoing; Breakthrough Therapy | 21 October 2026 |
| BPL-003 (intranasal mebufotenin / 5-MeO-DMT) AtaiBeckley (Eli Lilly subsidiary since 11 Sep 2026; Beckley Psytech roots, UK) · TRD | Phase 3 (starting) | Not reported | Not reported | Phase 3 programme (ReConnection-1/-2) initiation guided for Q2 2026 after End-of-Phase 2 meeting; no registry record seen as of 15 Sep 2026 (Psychedelic Brief) | 11 September 2026 |
| GH001 (inhaled mebufotenin / 5-MeO-DMT) GH Research (Dublin) · TRD | Pre-Phase 3 | Not reported | Phase 1 device study run in UK (completed) | Clinical hold lifted 5 Jan 2026; FDA says CMC/device plans appear Phase 3-ready (Jul 2026); global pivotal programme targeted to start 2026 | 6 August 2026 |
| Esketamine nasal spray (Spravato) Janssen (Johnson & Johnson) · TRD (with SSRI/SNRI) | Approved | Authorised EU-wide 18 Dec 2019; reimbursed in 13 European countries per PsyAccess | Licensed, but NICE TA854 does not recommend routine NHS use | Approved | 13 August 2026 |
How a medicine gets approved across the EU
New medicines like these would normally go through EMA's centralised procedure. EMA's scientific committee (CHMP) assesses the application, which "takes up to 210 active days" (EMA). EMA then sends its opinion to the European Commission, which takes the legally binding decision "within 67 days" (EMA). A centralised authorisation is valid in every EU Member State and in Iceland, Liechtenstein and Norway (EMA).
So even if a company filed today, the timetable set out by EMA would take about nine months at least. Even after an EU authorisation, decisions on pricing and reimbursement are made country by country before patients can get the medicine (EMA).
EMA has been preparing. It held a multi-stakeholder workshop on psychedelics on 16–17 April 2024 (EMA). Its revised guideline on depression trials, in effect since 30 September 2025, includes a dedicated section on psychedelics (EMA guideline Rev. 3). These set expectations for trials and are not approvals.
Psilocybin: COMP360 and others
Compass Pathways' COMP360 is the most advanced psilocybin medicine. In the US, its rolling FDA submission is under way. The company says it expects to complete the final submission in Q4 2026 and, if the medicine is approved, a commercial launch in the first half of 2027 (Compass, Q2 2026 results). No EMA application has been reported (COMP360 tracker row). Helus Pharma's deuterated psilocin HLP003 (formerly CYB003) is in Phase 3, with trial sites in several European countries (HLP003 row).
MDMA-assisted therapy
No MDMA medicine has an EU authorisation or a visible EMA application. In the US, a new application for MDMA-assisted therapy for PTSD was reportedly resubmitted in August 2026, after a rejection in 2024. In Europe, the activity is investigator-led trials (MDMA tracker row).
LSD
Definium Therapeutics' DT120 (lysergide, formerly MM120) has reported positive Phase 3 results in generalised anxiety disorder and major depression. No EMA filing has been reported (DT120 tracker row).
National routes: Czechia, Germany and Switzerland
These routes are run by doctors for specific patients. They are not EU approvals and do not make the drugs available outside medical care.
| Route | Who it covers | Status | Notes | Updated |
|---|---|---|---|---|
| Psilocybin (national medical framework) Czech Republic (law 270/2025 Sb.) | Defined severe-depression indications | National route, not EMA: framework in force 1 Jan 2026 (Act 270/2025, Gov. Regulation 552/2025); NUDZ: no applications or waiting list yet, launch expected H2 2026 | — | 2 October 2026 |
| Psilocybin compassionate use programme Germany (BfArM; ZI Mannheim & OVID Berlin) | TRD | National CUP approved 11 Jul 2025; renewed notification 18 Jun 2026, runs to 17 Jun 2027 (BfArM list) | — | 2 October 2026 |
| LSD, MDMA & psilocybin (limited medical use) Switzerland (FOPH exceptional licences, Narcotics Act art. 8(5)) | Individual patients, when other treatments are exhausted | Not EU: case-by-case exceptional licence per patient, applied for by the treating doctor | Licences only for doctors authorised to practise in Switzerland, for patients resident in Switzerland | 23 October 2026 |
- Czechia. Since 1 January 2026, psilocybin can be prescribed for defined depressive disorders, only by psychiatrists (Regulation 552/2025). On 23 March 2026 the National Institute of Mental Health (NUDZ) said patients could not yet apply or join a waiting list, and expected the launch in the second half of 2026 (NUDZ). Full details: Legal psilocybin therapy in Czechia.
- Germany. The federal medicines agency BfArM lists a psilocybin compassionate use programme for treatment-resistant depression. It was renewed on 18 June 2026 and runs to 17 June 2027 (BfArM). It was first approved on 11 July 2025 and runs at ZI Mannheim and OVID in Berlin, in exceptional cases (ZI Mannheim).
- Switzerland (not in the EU). The Federal Office of Public Health can grant an exceptional licence for one patient at a time. Only the treating doctor can apply, for patients living in Switzerland, and only when available treatments have been exhausted (FOPH). The banned substances concerned include LSD (FOPH).
See all European services and trials in our directory. For the UK, see Is psychedelic therapy legal in the UK?
Questions and answers
When will psilocybin be approved in Europe?
No date can be given yet. As of 23 October 2026, no psilocybin medicine has an EU marketing authorisation, and none appears on EMA's October 2026 list of applications under evaluation. Once a company applies, EMA's assessment takes up to 210 active days and the European Commission then has up to 67 days to decide.
Is COMP360 psilocybin approved in Europe?
No. Compass Pathways is making a rolling submission to the US FDA. It expects to complete it in Q4 2026 and, if approved, to launch in the US in the first half of 2027. No EMA application for COMP360 has been reported, and none is on EMA's October 2026 list.
Is MDMA-assisted therapy approved in the EU?
No. No MDMA medicine has an EU marketing authorisation or a visible EMA application. In the US, a new marketing application for MDMA-assisted therapy for PTSD was reportedly resubmitted in August 2026.
Is LSD approved as a medicine in Europe?
No. The most advanced LSD medicine, DT120, is in Phase 3 trials and no EMA filing has been reported. Switzerland, which is not in the EU, can license limited medical use of LSD for individual patients.
Which psychedelic-related medicine is approved in the EU?
Esketamine nasal spray (Spravato) for treatment-resistant depression. The European Commission authorised it EU-wide on 18 December 2019.
Can patients get psilocybin therapy legally anywhere in Europe now?
Only through limited national routes run by doctors. Czechia has a national medical framework in force since 1 January 2026, Germany has a psilocybin compassionate use programme for treatment-resistant depression, and Switzerland grants case-by-case exceptional licences. Otherwise, access is through clinical trials.
Does FDA approval in the US mean approval in Europe?
No. An EU-wide authorisation is a separate decision by the European Commission, based on EMA's scientific assessment of an application made in the EU.
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Hand-written facts and links checked 23 October 2026. Tracker rows carry their own sources and dates.
- EMA: Applications for new human medicines under evaluation, October 2026 (data to 5 October 2026). https://www.ema.europa.eu/en/medicines/medicines-human-use-under-evaluation
- EMA: October 2026 list of applications under evaluation (spreadsheet, EMA/222468/2026). https://www.ema.europa.eu/en/documents/report/applications-new-human-medicines-under-evaluation-october-2026_en.xlsx
- EMA: Spravato (esketamine) European public assessment report. https://www.ema.europa.eu/en/medicines/human/EPAR/spravato
- EMA: Authorisation of medicines. https://www.ema.europa.eu/en/about-us/what-we-do/authorisation-medicines
- EMA: Obtaining an EU marketing authorisation, step by step. https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/obtaining-eu-marketing-authorisation-step-step
- EMA: Guideline on clinical investigation of medicinal products in the treatment of depression, Rev. 3 (in effect 30 September 2025). https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-treatment-depression-scientific-guideline
- EMA: Multi-stakeholder workshop on psychedelics, 16–17 April 2024. https://www.ema.europa.eu/en/events/ema-multi-stakeholder-workshop-psychedelics-towards-eu-regulatory-framework
- Compass Pathways: second quarter and first half 2026 results (SEC filing). https://www.sec.gov/Archives/edgar/data/1816590/000181659026000059/q22026pressrelease.htm
- BfArM: list of notified compassionate use programmes. https://www.bfarm.de/DE/Arzneimittel/Klinische-Pruefung/Compassionate-Use/compUse-tabelle.html
- Central Institute of Mental Health (ZI) Mannheim: psychedelics in psychiatry and psychotherapy. https://www.zi-mannheim.de/behandlung/klinik-psychiatrie/psychedelika-in-psychiatrie-und-psychotherapie.html
- Swiss Federal Office of Public Health (FOPH): limited medical use of banned narcotics. https://www.bag.admin.ch/en/limited-medical-use-of-banned-narcotics
- FOPH: exceptional licences for banned narcotics. https://www.bag.admin.ch/en/exceptional-licences-for-banned-narcotics
- Government Regulation No. 552/2025 Coll. on psilocybin for medical use (Czech, e-Sbírka). https://www.e-sbirka.cz/sb/2025/552
- National Institute of Mental Health (NUDZ): official statement on the availability of psilocybin treatment (23 March 2026). https://www.nudz.cz/en/news-and-events/official-statement-on-the-availability-of-psilocybin-treatment