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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Europe holds the line, the US gets ready to launch, and Big Pharma buys in
Europe holds the line, the US gets ready to launch, and Big Pharma buys in. Weekly psychedelic therapy news with the UK & Europe angle. Free preview: UK, Europe. Subscribe free for the full issue.
Approval tracker
Where key psychedelic and related programmes stand with regulators. Last reviewed 21 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 | 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] | |
| 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 expected Q4 2026; EMBRACE ongoing; Breakthrough Therapy | Not reported | Not reported HLP004 (deuterated DMT, GAD) Phase II planned Q1 2027 |
[1] | |
| 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 Lilly CVR milestone tied to US approval + DEA rescheduling |
[1][2][3][4] | |
| 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] | |
| 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; first treatments expected H2 2026 | [1][2] | |
| Psilocybin compassionate use programmeGermany (BfArM; ZI Mannheim & OVID Berlin) | TRD | Compassionate use | — | — | National CUP approved 11 Jul 2025; current listing runs to 17 Jun 2027 | [1][2] | |
| 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.