{
 "as_of": "2026-10-21",
 "note": "Informational only. '—' = not applicable; 'Not reported' = no sourced status found. Every status is sourced; verify before relying on it.",
 "programs": [
  {
   "id": "comp360",
   "compound": "COMP360 (synthetic psilocybin)",
   "sponsor": "Compass Pathways (London/New York)",
   "indication": "Treatment-resistant depression (TRD)",
   "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_ema": "No EMA application reported",
   "other": "Breakthrough Therapy (US); National Priority Voucher (US, Apr 2026)",
   "stage": "Filing (US)",
   "last_update": "2026-10-20",
   "sources": [
    "https://ir.compasspathways.com/News--Events-/news/news-details/2026/Compass-Pathways-Announces-Second-Quarter-and-First-Half-2026-Financial-Results-and-Business-Highlights/default.aspx",
    "https://ir.compasspathways.com/News--Events-/news/news-details/2026/Compass-Pathways-New-52-Week-Topline-Open-Label-Data-from-Phase-3-COMP005-Trial-Demonstrates-Additional-Benefit-from-Another-COMP360-Dose-in-Part-C-Extending-Durability-Out-to-1-Year/default.aspx",
    "https://pod.psychedelicalpha.com/episodes/early-healthcare-forum-takeaways-fda-s-ibogaine-blueprint-and-compass-talks-pricing/transcript",
    "https://www.compasspathways.com/faq",
    "https://psyaccess.health/guides/where-in-europe/"
   ]
  },
  {
   "id": "mdma-at",
   "compound": "MDMA-assisted therapy",
   "sponsor": "Resilient Pharmaceuticals (formerly MAPS PBC / Lykos)",
   "indication": "PTSD",
   "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_ema": "No EMA application visible; investigator-led trials (Netherlands Phase II approved Aug 2026; Norway Phase 2 pilot Jul 2026)",
   "other": "Australia: Authorised Prescriber pathway (psychiatrists) since 1 Jul 2023. Switzerland: limited medical use",
   "stage": "Resubmitted (US)",
   "last_update": "2026-10-13",
   "sources": [
    "https://maps.org/2026/08/10/maps-responds-to-report-of-progress-for-mdma-assisted-therapy-for-ptsd-with-fda/",
    "https://psychedelicalpha.com/news/two-years-after-rejection-resilient-quietly-refiles-mdma-for-ptsd-application/",
    "https://psyaccess.health/guides/psychedelic-access-updates/",
    "https://www.tga.gov.au/news/news-articles/update-mdma-and-psilocybin-access-and-safeguards-1-july-2023",
    "https://politiek.app/stemming/motie-van-het-lid-sneller-c-s-over-mdma-therapie-bij-ptss-mogelijk-maken-voor-ee-548cdc023fa3/"
   ]
  },
  {
   "id": "spravato",
   "compound": "Esketamine nasal spray (Spravato)",
   "sponsor": "Janssen (Johnson & Johnson)",
   "indication": "TRD (with SSRI/SNRI)",
   "us_fda": "Approved (the reference TRD product Compass benchmarks pricing against)",
   "uk_mhra": "Licensed, but NICE TA854 does not recommend routine NHS use",
   "eu_ema": "Authorised EU-wide 18 Dec 2019; reimbursed in 13 European countries per PsyAccess",
   "other": "Germany: post-dose observation billing kept restricted to psychiatric specialties (13 Aug 2026)",
   "stage": "Approved",
   "last_update": "2026-08-13",
   "sources": [
    "https://www.ema.europa.eu/en/medicines/human/EPAR/spravato",
    "https://www.nice.org.uk/guidance/ta854/",
    "https://psyaccess.health/guides/where-in-europe/",
    "https://psyaccess.health/guides/psychedelic-access-updates/"
   ]
  },
  {
   "id": "dt120",
   "compound": "DT120 ODT (lysergide / LSD; formerly MM120)",
   "sponsor": "Definium Therapeutics (formerly MindMed)",
   "indication": "GAD; MDD; PTSD (Phase 3 planned)",
   "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_ema": "Panorama (GAD) enrolled in US and Europe; no EMA filing reported",
   "other": "",
   "stage": "Phase 3",
   "last_update": "2026-09-08",
   "sources": [
    "https://ir.definiumtx.com/news-events/press-releases/detail/247/definium-therapeutics-receives-breakthrough-therapy-designation-for-dt120-lysergide-orally-disintegrating-tablet-odt-in-major-depressive-disorder-mdd-following-positive-phase-3-results",
    "https://definiumtx.com/pipeline/dt120/"
   ]
  },
  {
   "id": "hlp003",
   "compound": "HLP003 (deuterated psilocin; formerly CYB003)",
   "sponsor": "Helus Pharma (formerly Cybin)",
   "indication": "Adjunctive MDD",
   "us_fda": "Phase 3 APPROACH (n=223) fully enrolled, topline expected Q4 2026; EMBRACE ongoing; Breakthrough Therapy",
   "uk_mhra": "Not reported",
   "eu_ema": "Not reported",
   "other": "HLP004 (deuterated DMT, GAD) Phase II planned Q1 2027",
   "stage": "Phase 3",
   "last_update": "2026-10-21",
   "sources": [
    "https://www.marketbeat.com/instant-alerts/event-cybin-eyes-q4-phase-iii-depression-data-as-anxiety-program-advances-2026-10-21/"
   ]
  },
  {
   "id": "bpl003",
   "compound": "BPL-003 (intranasal mebufotenin / 5-MeO-DMT)",
   "sponsor": "AtaiBeckley (Eli Lilly subsidiary since 11 Sep 2026; Beckley Psytech roots, UK)",
   "indication": "TRD",
   "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_ema": "Not reported",
   "other": "Lilly CVR milestone tied to US approval + DEA rescheduling",
   "stage": "Phase 3 (starting)",
   "last_update": "2026-09-11",
   "sources": [
    "https://investor.lilly.com/news-releases/news-release-details/lilly-completes-acquisition-ataibeckley-advance-therapies",
    "https://www.sec.gov/Archives/edgar/data/2081043/000114036126036283/ef20081247_8k.htm",
    "https://ir.ataibeckley.com/news-releases/news-release-details/bpl-003-phase-3-program-initiation-track-q2-2026-following/",
    "https://psychedelicbrief.com/companies/C001-ataibeckley/"
   ]
  },
  {
   "id": "gh001",
   "compound": "GH001 (inhaled mebufotenin / 5-MeO-DMT)",
   "sponsor": "GH Research (Dublin)",
   "indication": "TRD",
   "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_ema": "Not reported",
   "other": "",
   "stage": "Pre-Phase 3",
   "last_update": "2026-08-06",
   "sources": [
    "https://investor.ghres.com/news-releases/news-release-details/gh-research-reports-second-quarter-2026-financial-results-and/",
    "https://investor.ghres.com/news-releases/news-release-details/gh-research-announces-fda-lifts-clinical-hold-gh001-clearing/",
    "https://ghres.gcs-web.com/news-releases/news-release-details/gh-research-reports-first-quarter-2026-financial-results-and/"
   ]
  },
  {
   "id": "psider",
   "compound": "Psilocybin 25 mg (PsiDeR trial)",
   "sponsor": "King's College London / South London and Maudsley NHS FT (NIHR-funded)",
   "indication": "TRD",
   "us_fda": "—",
   "uk_mhra": "Phase 2 feasibility RCT (n=60) positive, published Nature Medicine Aug 2026; psilocybin remains Schedule 1",
   "eu_ema": "—",
   "other": "Academic programme",
   "stage": "Phase 2 (academic)",
   "last_update": "2026-08-06",
   "sources": [
    "https://www.kcl.ac.uk/news/promising-results-from-first-publicly-funded-uk-randomised-trial-of-psilocybin-for-depression"
   ]
  },
  {
   "id": "cz-psilocybin",
   "compound": "Psilocybin (national medical framework)",
   "sponsor": "Czech Republic (law 270/2025 Sb.)",
   "indication": "Defined severe-depression indications",
   "us_fda": "—",
   "uk_mhra": "—",
   "eu_ema": "National route, not EMA: framework in force 1 Jan 2026; first treatments expected H2 2026",
   "other": "",
   "stage": "National access (rollout)",
   "last_update": "2026-10-02",
   "sources": [
    "https://psyaccess.health/guides/psychedelic-access-updates/",
    "https://postupy-pece.ceskapsychiatrie.cz/lecba/lecba-psilocybinem"
   ]
  },
  {
   "id": "de-cup",
   "compound": "Psilocybin compassionate use programme",
   "sponsor": "Germany (BfArM; ZI Mannheim & OVID Berlin)",
   "indication": "TRD",
   "us_fda": "—",
   "uk_mhra": "—",
   "eu_ema": "National CUP approved 11 Jul 2025; current listing runs to 17 Jun 2027",
   "other": "",
   "stage": "Compassionate use",
   "last_update": "2026-10-02",
   "sources": [
    "https://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(25)00277-9/abstract",
    "https://psyaccess.health/guides/where-in-europe/"
   ]
  },
  {
   "id": "au-ap",
   "compound": "Psilocybin & MDMA (Authorised Prescriber)",
   "sponsor": "Australia (TGA)",
   "indication": "TRD (psilocybin); PTSD (MDMA)",
   "us_fda": "—",
   "uk_mhra": "—",
   "eu_ema": "—",
   "other": "Schedule 8 for these uses since 1 Jul 2023; psychiatrists need HREC approval + TGA authorisation",
   "stage": "Restricted prescribing",
   "last_update": "2023-07-01",
   "sources": [
    "https://www.tga.gov.au/news/news-articles/update-mdma-and-psilocybin-access-and-safeguards-1-july-2023"
   ]
  },
  {
   "id": "ibogaine",
   "compound": "Ibogaine",
   "sponsor": "US HHS-funded trials (OUD, PTSD)",
   "indication": "Opioid use disorder; PTSD",
   "us_fda": "FDA RFI on early-phase trial design (5 Oct 2026); comments due 20 Nov 2026",
   "uk_mhra": "—",
   "eu_ema": "—",
   "other": "",
   "stage": "Pre-clinical / early phase",
   "last_update": "2026-10-05",
   "sources": [
    "https://www.fda.gov/news-events/press-announcements/fda-seeks-public-input-support-ibogaine-research",
    "https://www.federalregister.gov/documents/2026/10/06/2026-20427/design-and-safety-considerations-for-clinical-trials-involving-ibogaine-drug-products-request-for"
   ]
  }
 ]
}