Psychedelic therapy approval tracker
Where 12 psychedelic and related therapy programmes stand with the US FDA, the UK MHRA, the EMA and national regulators in Europe and beyond. Every status links to a primary or trade source.
| Programme | Indication | Stage | US FDA | UK MHRA | EU / Europe | Other | 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) | ||
| 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 | ||
| 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) | ||
| 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 | — | ||
| 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 | ||
| 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 | ||
| 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 | — | ||
| 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 | ||
| 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 | — | ||
| 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 | — | ||
| 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 | ||
| 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 | — | — | — |
Questions and answers
What is the regulatory status of COMP360 (synthetic psilocybin)?
As of 20 October 2026, COMP360 (synthetic psilocybin) (Compass Pathways (London/New York)) for Treatment-resistant depression (TRD) is at the stage “Filing (US)”. US FDA: 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. UK MHRA: ILAP designation for TRD (company statement); not authorised. EU / Europe: No EMA application reported. Elsewhere: Breakthrough Therapy (US); National Priority Voucher (US, Apr 2026).
What is the regulatory status of MDMA-assisted therapy?
As of 13 October 2026, MDMA-assisted therapy (Resilient Pharmaceuticals (formerly MAPS PBC / Lykos)) for PTSD is at the stage “Resubmitted (US)”. US FDA: NDA resubmitted Aug 2026 without new Phase 3 (reported; FDA acceptance/PDUFA date not disclosed). Prior CRL 9 Aug 2024. UK MHRA: Not authorised; MDMA Schedule 1. EU / Europe: No EMA application visible; investigator-led trials (Netherlands Phase II approved Aug 2026; Norway Phase 2 pilot Jul 2026). Elsewhere: Australia: Authorised Prescriber pathway (psychiatrists) since 1 Jul 2023. Switzerland: limited medical use.
What is the regulatory status of Esketamine nasal spray (Spravato)?
As of 13 August 2026, Esketamine nasal spray (Spravato) (Janssen (Johnson & Johnson)) for TRD (with SSRI/SNRI) is at the stage “Approved”. US FDA: Approved (the reference TRD product Compass benchmarks pricing against). UK MHRA: Licensed, but NICE TA854 does not recommend routine NHS use. EU / Europe: Authorised EU-wide 18 Dec 2019; reimbursed in 13 European countries per PsyAccess. Elsewhere: Germany: post-dose observation billing kept restricted to psychiatric specialties (13 Aug 2026).
What is the regulatory status of DT120 ODT (lysergide / LSD; formerly MM120)?
As of 8 September 2026, DT120 ODT (lysergide / LSD; formerly MM120) (Definium Therapeutics (formerly MindMed)) for GAD; MDD; PTSD (Phase 3 planned) is at the stage “Phase 3”. US FDA: Phase 3: positive Voyage & Panorama (GAD) and Emerge (MDD); Ascend (MDD) ongoing; Breakthrough Therapy for GAD and MDD (MDD granted 8 Sep 2026). UK MHRA: Not reported. EU / Europe: Panorama (GAD) enrolled in US and Europe; no EMA filing reported.
What is the regulatory status of HLP003 (deuterated psilocin; formerly CYB003)?
As of 21 October 2026, HLP003 (deuterated psilocin; formerly CYB003) (Helus Pharma (formerly Cybin)) for Adjunctive MDD is at the stage “Phase 3”. US FDA: Phase 3 APPROACH (n=223) fully enrolled, topline expected Q4 2026; EMBRACE ongoing; Breakthrough Therapy. UK MHRA: Not reported. EU / Europe: Not reported. Elsewhere: HLP004 (deuterated DMT, GAD) Phase II planned Q1 2027.
What is the regulatory status of BPL-003 (intranasal mebufotenin / 5-MeO-DMT)?
As of 11 September 2026, BPL-003 (intranasal mebufotenin / 5-MeO-DMT) (AtaiBeckley (Eli Lilly subsidiary since 11 Sep 2026; Beckley Psytech roots, UK)) for TRD is at the stage “Phase 3 (starting)”. US FDA: 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). UK MHRA: Not reported. EU / Europe: Not reported. Elsewhere: Lilly CVR milestone tied to US approval + DEA rescheduling.
What is the regulatory status of GH001 (inhaled mebufotenin / 5-MeO-DMT)?
As of 6 August 2026, GH001 (inhaled mebufotenin / 5-MeO-DMT) (GH Research (Dublin)) for TRD is at the stage “Pre-Phase 3”. US FDA: Clinical hold lifted 5 Jan 2026; FDA says CMC/device plans appear Phase 3-ready (Jul 2026); global pivotal programme targeted to start 2026. UK MHRA: Phase 1 device study run in UK (completed). EU / Europe: Not reported.
What is the regulatory status of Psilocybin 25 mg (PsiDeR trial)?
As of 6 August 2026, Psilocybin 25 mg (PsiDeR trial) (King's College London / South London and Maudsley NHS FT (NIHR-funded)) for TRD is at the stage “Phase 2 (academic)”. UK MHRA: Phase 2 feasibility RCT (n=60) positive, published Nature Medicine Aug 2026; psilocybin remains Schedule 1. Elsewhere: Academic programme.
What is the regulatory status of Psilocybin (national medical framework)?
As of 2 October 2026, Psilocybin (national medical framework) (Czech Republic (law 270/2025 Sb.)) for Defined severe-depression indications is at the stage “National access (rollout)”. EU / Europe: National route, not EMA: framework in force 1 Jan 2026; first treatments expected H2 2026.
What is the regulatory status of Psilocybin compassionate use programme?
As of 2 October 2026, Psilocybin compassionate use programme (Germany (BfArM; ZI Mannheim & OVID Berlin)) for TRD is at the stage “Compassionate use”. EU / Europe: National CUP approved 11 Jul 2025; current listing runs to 17 Jun 2027.
What is the regulatory status of Psilocybin & MDMA (Authorised Prescriber)?
As of 1 July 2023, Psilocybin & MDMA (Authorised Prescriber) (Australia (TGA)) for TRD (psilocybin); PTSD (MDMA) is at the stage “Restricted prescribing”. Elsewhere: Schedule 8 for these uses since 1 Jul 2023; psychiatrists need HREC approval + TGA authorisation.
What is the regulatory status of Ibogaine?
As of 5 October 2026, Ibogaine (US HHS-funded trials (OUD, PTSD)) for Opioid use disorder; PTSD is at the stage “Pre-clinical / early phase”. US FDA: FDA RFI on early-phase trial design (5 Oct 2026); comments due 20 Nov 2026.
Is psilocybin therapy legal in the UK?
Psilocybin is a Schedule 1, Class A controlled drug in the UK. It is not authorised by the MHRA as a medicine, so it can only be used in approved clinical trials or research under a Home Office licence. See the tracker rows above for the latest UK status of each programme.
How often is the Psyche Insights tracker updated?
The tracker is reviewed every week alongside the newsletter. It was last reviewed on 21 October 2026. Each row carries its own last-updated date and links to primary sources.
Can I reuse the tracker data?
Yes. Download it as CSV (https://psycheinsights.com/tracker.csv) or JSON (https://psycheinsights.com/tracker.json). It is published under CC BY 4.0: please credit “Psyche Insights (psycheinsights.com)” and link to the tracker. It is information only, not medical, legal or investment advice.
How we compile the tracker
We read regulator announcements (FDA, MHRA, EMA, TGA, national agencies), trial registries, company filings and specialist trade press each week. A status is only shown when we can link a source. Company claims are labelled as company statements. Spotted an error? Email support@psycheinsights.com.