Psychedelic-assisted therapy, minus the hype.
An independent weekly briefing on research, regulation and business in psychedelic medicine worldwide, with the UK & Europe angle nobody else covers, built for clinicians, researchers, clinic operators and investors. Every claim links to a primary source.
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Psilocybin stays in Schedule 1, Germany's compassionate use programme gets numbers, and a 5-MeO-DMT spray lands in JAMA
Issue #2: the Home Office rules out an early ACMD review of psilocybin, first numbers from Germany's psilocybin compassionate use programme, Switzerland's 775 patients, and BPL-003 Phase 2b results in JAMA.
Guides
Plain-English explainers on law, trials and access, with every claim linked to a primary source. All guides →
Psilocybin clinical trials in the UK: what is recruiting and how to join
Recruiting UK psilocybin trials from public registries, updated weekly, plus how to find and join a trial.
Is psychedelic therapy legal in the UK?
Psilocybin, MDMA, LSD, DMT and ketamine under UK law, what the NHS offers, and what may change. Every claim sourced.
When will psilocybin, MDMA or LSD be approved in Europe? EMA tracker 2026
Where psilocybin, MDMA and LSD medicines stand with EMA, MHRA and FDA, plus national routes in Czechia, Germany and Switzerland.
Legal psilocybin therapy in Czechia (2026): who qualifies and when it starts
Czechia's medical psilocybin framework: who can prescribe it, who qualifies, the dose rules, and when treatment is expected to start.
Psilocybin therapy in Germany (2026): the compassionate use programme explained
Germany's psilocybin compassionate use programme at ZI Mannheim and OVID Berlin: the law, who qualifies, costs, evidence and trials.
Psilocybin-Therapie in Deutschland (2026): das Härtefallprogramm erklärt
Auf Deutsch: das Arzneimittel-Härtefallprogramm mit Psilocybin, Rechtslage, Voraussetzungen, Kosten und Studien.
Approval tracker
Where key psychedelic and related programmes stand with regulators. Last reviewed 28 Oct 2026. "—" = not applicable / no sourced status.
| Programme | Indication | Stage | US FDA | UK MHRA | EU / Europe | Updated | Sources |
|---|---|---|---|---|---|---|---|
| COMP360 (synthetic psilocybin)Compass Pathways (London/New York) | Treatment-resistant depression (TRD) | Filing (US) | 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; Q3 results due 3 Nov 2026 | ILAP designation for TRD (company statement); not authorised | No EMA application reported Breakthrough Therapy (US); National Priority Voucher (US, Apr 2026) |
[1][2][3][4][5][6] | |
| MDMA-assisted therapyResilient Pharmaceuticals (formerly MAPS PBC / Lykos) | PTSD | Resubmitted (US) | NDA resubmitted Aug 2026 without new Phase 3 (reported; FDA acceptance/PDUFA date not disclosed). Prior CRL 9 Aug 2024 | Not authorised; MDMA Schedule 1 | No EMA application visible; investigator-led trials (Netherlands Phase II approved Aug 2026; Norway Phase 2 pilot Jul 2026) Australia: Authorised Prescriber pathway (psychiatrists) since 1 Jul 2023. Switzerland: limited medical use |
[1][2][3][4][5] | |
| Esketamine nasal spray (Spravato)Janssen (Johnson & Johnson) | TRD (with SSRI/SNRI) | Approved | Approved (the reference TRD product Compass benchmarks pricing against) | Licensed, but NICE TA854 does not recommend routine NHS use | Authorised EU-wide 18 Dec 2019; reimbursed in 13 European countries per PsyAccess Germany: post-dose observation billing kept restricted to psychiatric specialties (13 Aug 2026) |
[1][2][3][4] | |
| DT120 ODT (lysergide / LSD; formerly MM120)Definium Therapeutics (formerly MindMed) | GAD; MDD; PTSD (Phase 3 planned) | Phase 3 | Phase 3: positive Voyage & Panorama (GAD) and Emerge (MDD); Ascend (MDD) ongoing; Breakthrough Therapy for GAD and MDD (MDD granted 8 Sep 2026) | Not reported | Panorama (GAD) enrolled in US and Europe; no EMA filing reported | [1][2] | |
| HLP003 (deuterated psilocin; formerly CYB003)Helus Pharma (formerly Cybin) | Adjunctive MDD | Phase 3 | Phase 3 APPROACH (n=223) fully enrolled, topline on track for Q4 2026; EMBRACE enrolling; NDA submission expected 2028 (company, 21 Oct 2026); Breakthrough Therapy | Not reported | Not reported HLP004 (deuterated DMT, GAD) Phase II planned Q1 2027 |
[1][2] | |
| BPL-003 (intranasal mebufotenin / 5-MeO-DMT)AtaiBeckley (Eli Lilly subsidiary since 11 Sep 2026; Beckley Psytech roots, UK) | TRD | Phase 3 (starting) | 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) | Not reported | Not reported Phase 2b results published in JAMA 26 Oct 2026 (193 analysed; 12 mg beat 0.3 mg control on MADRS at day 29, difference −5.3 points). Lilly CVR milestone tied to US approval + DEA rescheduling |
[1][2][3][4][5][6] | |
| GH001 (inhaled mebufotenin / 5-MeO-DMT)GH Research (Dublin) | TRD | Pre-Phase 3 | Clinical hold lifted 5 Jan 2026; FDA says CMC/device plans appear Phase 3-ready (Jul 2026); global pivotal programme targeted to start 2026 | Phase 1 device study run in UK (completed) | Not reported | [1][2][3] | |
| Bretisilocin (GM-2505; short-acting 5-HT2A agonist)AbbVie (acquired from Gilgamesh Pharmaceuticals, 2025) | Major depressive disorder (MDD) | Phase 2 | Phase 2a (NCT06236880) completed; no Phase 3 record found on ClinicalTrials.gov (checked 28 Oct 2026) | Phase 2a ran at UK sites (NCT06236880); not authorised | PRIME eligibility granted Feb 2026 (first psychedelic in PRIME) – not an approval or marketing application | [1][2][3] | |
| Psilocybin 25 mg (PsiDeR trial)King's College London / South London and Maudsley NHS FT (NIHR-funded) | TRD | Phase 2 (academic) | — | Phase 2 feasibility RCT (n=60) positive, published Nature Medicine Aug 2026; psilocybin remains Schedule 1 | — Academic programme |
[1] | |
| Psilocybin (national medical framework)Czech Republic (law 270/2025 Sb.) | Defined severe-depression indications | National access (rollout) | — | — | 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 | [1][2][3][4][5] | |
| Psilocybin compassionate use programmeGermany (BfArM; ZI Mannheim & OVID Berlin) | TRD | Compassionate use | — | — | 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) |
[1][2][3][4][5] | |
| LSD, MDMA & psilocybin (limited medical use)Switzerland (FOPH exceptional licences, Narcotics Act art. 8(5)) | Individual patients, when other treatments are exhausted | Limited medical use | — | — | 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 |
[1][2][3] | |
| Psilocybin & MDMA (Authorised Prescriber)Australia (TGA) | TRD (psilocybin); PTSD (MDMA) | Restricted prescribing | — | — | — Schedule 8 for these uses since 1 Jul 2023; psychiatrists need HREC approval + TGA authorisation |
[1] | |
| IbogaineUS HHS-funded trials (OUD, PTSD) | Opioid use disorder; PTSD | Pre-clinical / early phase | FDA RFI on early-phase trial design (5 Oct 2026); comments due 20 Nov 2026 | — | — | [1][2] |
Open the full tracker: sources for every row, Q&A and CSV/JSON download →
About
Evidence first
We summarise regulators, trial registries, peer-reviewed papers and company filings, and we link every claim. Corrections are published openly.
Global, with a UK & Europe lens
We cover the big stories worldwide, from the FDA to the TGA. Most coverage stops at the US, so we also explain what MHRA, NICE, EMA and national programmes mean for the UK and Europe.
Independent
Published by Psyche Vibes Ltd, London. Sponsorships are always clearly labelled and never influence editorial content or the tracker.