Forecast Ledgerinterventional psychiatry and psychedelic medicineQuoted, dated predictions scored against public outcomes under one written method. Every score links to the words, the rule and the evidence.

False · Brier 0.81

Rules 1.1.0 · as of 14 Sep 2026

Quote

“I think even like if you would talk to a pharma CEO, to a scientist, they're all like, look, your data, and by the way, the same is true for MAPS yeah, is really very, very solid ... Yes, this should be approved, will be approved, whatever.”
· Democratizing Psychedelics: From Ancient Rituals to Modern Medicalization - Christian Angermayer (Psychedelic Podcast Ep. 207) · podcast

Speaking about Compass, atai and MAPS in a podcast transcript under his name, Angermayer states flatly that the psychedelic compounds will be approved. No year is named.

Intake

EventA proposition written from a template on the asset, with a resolution criterion and a named public source, before the outcome is looked up. The same event resolves every person's items on it. Method ›
First FDA approval of a psychedelic medicine (class)
AreaOne of five topic classes: regulatory decisions, clinical trial outcomes, company and market outcomes, payer and policy, practice adoption. Every event has one area. Method ›
Regulatory decisions
DeadlineThe date by which the event must happen for the item to be true. It comes only from the person's words through the anchor table. Method ›
None stated · undated panelItems with no deadline in the person's words, scored on a uniform 24-month window from the statement date. Part of the headline panel since rules 1.1.0; also shown on its own. Method ›, 24-month window to 7 Aug 2025
Probability
0.90 LexiconThe fixed five-bin table that turns a phrase into a probability. The strongest phrase in the claim sentence decides; coders never read tone. Method › · binOne of five lexicon steps: A 'will' 0.90, B 'probably' 0.70, C 'may' 0.50, D 'unlikely' 0.30, E 'never' 0.10. A stated number goes to the nearest bin for calibration only. Method › A · “will be approved”
Base rateThe probability a published external study gives an event of that class and stage, fixed at intake. Halved when the item window is shorter than the class median time to decision. Never learned from the ledger's own items. Method ›
phase3_to_approval_psychiatry · 0.56 · halvedWhen the item window is shorter than the base-rate class's median time to decision, the base rate is halved. The halved value is an upper bound that favours the person. Method › to 0.28 (window shorter than the median 36 months)
Tags
affiliated, retrospective
Coder BCohen's kappa: agreement between two coders beyond chance, from -1 to 1. Reported for admit, event, deadline, bin and asserts from the second-coder match test. Method ›
admittedA statement that passed intake: sincere, the person's own claim, forward-looking, inside the five areas, and not excluded by a reason code. Only admitted statements become items. Method › · event E-0024 · deadline none · bin A
Registry entry

The FDA approves at least one psychedelic medicine (class reading) for any indication.

TRUE on the date of the first FDA approval letter or Drugs@FDA entry (the sponsor's approval announcement is the secondary source) for a drug in the psychedelic class: MDMA (midomafetamine), psilocybin, ibogaine, or another compound that its sponsor or the FDA describes as a psychedelic or an entactogen; esketamine and ketamine are excluded. Any indication counts. A complete response letter, a positive advisory vote, a filing acceptance or a breakthrough therapy designation is not an approval. FALSE when no such approval appears in Drugs@FDA by the deadline.

Resolution source: Drugs@FDA; sponsor press release as a secondary source

Readings: Same class reading as the main event.; Novel psychedelics reaching clinical care = FDA approval of a psychedelic for a psychiatric indication.

How to read
The event, criterion and deadline were written at intake, before the outcome1 if the registry event happened on or before the item's deadline, 0 if it did not. Written by a resolver who never sees p. Method › was looked up. Coder B coded the statement independently.

Coder A

Resolution

State
False
Effective deadlineAn item enters the score only when its deadline has passed and the outcome is true or false. A claim already known true still waits for its deadline. Method ›
7 Aug 2025
Outcome1 if the registry event happened on or before the item's deadline, 0 if it did not. Written by a resolver who never sees p. Method ›
not occurred · checked through 13 Sep 2026
Resolver note
No FDA approval letter or Drugs@FDA entry exists for any psychedelic-class drug as of 2026-09-13 (esketamine and ketamine excluded). openFDA Drugs@FDA returns no match for psilocybin, psilocin, midomafetamine/MDMA, lysergide, ibogaine, mebufotenin or DMT, and FDA Novel Drug Approvals 2026 lists 39 approvals through 2026-09-11, none in the class. Closest programs: COMP360 (psilocybin) NDA in rolling submission, all modules due Q4 2026, launch expected H1 2027 subject to approval (Compass, 2026-08-05); midomafetamine NDA resubmitted August 2026 by Resilient Pharmaceuticals (formerly Lykos), decision pending (MAPS, 2026-08-10); DT120/MM120 (lysergide) has two positive Phase 3 readouts (June and August 2026) and no NDA; BPL-003 is at Phase 2b. CRLs, priority vouchers, rolling review and breakthrough designations are not approvals. Not occurred as of 2026-09-13.
BrierThe squared gap between a probability and the outcome, (p - o)^2. 0 is perfect, 0.25 is the constant coin flip, 1 is confidently wrong. Lower is better. Method ›
0.81 = (0.90 − 0)²
Base-rate Brier
0.08
How to read
State at window close; the outcome comes from the registry, the score from the rule.

Registry

Receding horizon

Angermayer promised First FDA approval of a psychedelic medicine (class) 2 times; it has not happened.

promised datehappened
20222023202420252026202720282029203020312022202320242025202620272028202920302031TODAY2021-05-10: by 2031-05-10 · p 0.902023-08-07: by 2025-08-07 · p 0.90X SAID ON · Y PROMISED BY · DASHED: PROMISED = SAID · DOT AREA = P

Cluster E-0024

Timeline

1 claim against 60 events in the field.

saiddueevent
29 Aug 2023 · HHS: HHS recommends to DEA that marijuana be moved from Schedule I to Schedule III of7 Oct 2023 · California Governor Newsom: Newsom vetoes SB 58, which would have decriminalized psilocybin and other plant 10 Oct 2023 · DEA and HHS: Second temporary extension of telemedicine flexibilities for controlled medicati10 Oct 2023 · FDA: FDA warns patients and providers about risks of compounded ketamine products, in18 Oct 2023 · FDA / Janssen: FDA approves Spravato labeling supplement S-012 (package insert update).13 Dec 2023 · DEA: DEA again proposes placing DOI and DOC (phenethylamine research hallucinogens) iDEA: DEA AGAIN PROPOSES PLACING DOI AND DOC (PHENETHYLAMINE RESEARCH HALLUCINOGENS) I13 Feb 2024 · FDA / Lykos Therapeutics: FDA accepts Lykos's NDA for midomafetamine (MDMA)-assisted therapy for PTSD with7 Mar 2024 · FDA / MindMed: FDA grants Breakthrough Therapy designation to MM120 (LSD D-tartrate) for genera13 Mar 2024 · Cybin (CYB003): FDA grants Breakthrough Therapy Designation to CYB003 for adjunctive treatment o13 Mar 2024 · FDA / Cybin: FDA grants Breakthrough Therapy designation to CYB003 (deuterated psilocybin ana21 Mar 2024 · Utah Legislature: SB 266 becomes law without the governor's signature, allowing large Utah health 26 Mar 2024 · Neuronetics (NeuroStar): FDA clears NeuroStar TMS as a first-line adjunct for MDD in adolescents aged 15 16 Apr 2024 · European Medicines Agency: EMA holds a multi-stakeholder workshop 'Psychedelics: towards an EU regulatory f21 May 2024 · DOJ / DEA: DOJ publishes proposed rule to transfer marijuana from Schedule I to Schedule II4 Jun 2024 · FDA PDAC / Lykos Therapeutics (midomafetamine): FDA Psychopharmacologic Drugs Advisory Committee votes against MDMA-assisted the4 Jun 2024 · FDA Psychopharmacologic Drugs Advisory Committee: Advisory committee votes 2-9 that MDMA-assisted therapy is not shown effective f7 Jun 2024 · DEA: DEA stays the June 10, 2024 administrative hearing on Schedule I placement of DO9 Aug 2024 · FDA / Lykos Therapeutics: FDA issues a complete response letter (dated August 8) for MDMA capsules for PTS9 Aug 2024 · Lykos Therapeutics (midomafetamine): FDA issues a Complete Response Letter for MDMA-assisted therapy in PTSD and asks29 Aug 2024 · DEA: DEA publishes notice of an administrative hearing on the proposed marijuana resc26 Sep 2024 · Bristol Myers Squibb (Cobenfy / KarXT): FDA approves Cobenfy (xanomeline-trospium), the first muscarinic agonist for sch4 Nov 2024 · FDA / Janssen: FDA approves Spravato labeling supplement S-015 (package insert revision).5 Nov 2024 · Massachusetts voters: Massachusetts Question 4, a regulated natural psychedelics measure, fails with 419 Nov 2024 · DEA and HHS: Third temporary extension of telemedicine flexibilities for controlled medicatio31 Dec 2024 · Colorado Natural Medicine Division: Colorado begins accepting natural medicine business license applications; the re31 Dec 2024 · FDA / Janssen: FDA approves Spravato REMS modification S-013.13 Jan 2025 · DEA Administrative Law Judge: DEA's chief ALJ cancels the January 21, 2025 marijuana rescheduling hearing pend17 Jan 2025 · DEA: DEA publishes proposed rule creating special registrations for telemedicine pres17 Jan 2025 · DEA and HHS: Final rules allow a six-month buprenorphine supply via audio-only telemedicine a21 Jan 2025 · FDA / Johnson & Johnson: FDA approves Spravato (esketamine) as monotherapy for adults with treatment-resi21 Jan 2025 · Johnson & Johnson (Spravato): FDA approves Spravato as the first monotherapy for treatment-resistant depressio24 Mar 2025 · DEA and HHS: DEA and HHS delay the effective date of the buprenorphine and VA telemedicine fi24 Mar 2025 · FDA / Janssen: FDA approves Spravato REMS modification S-018; the REMS still requires certified31 Mar 2025 · Colorado Natural Medicine Division: Colorado issues its first healing center license to The Center Origin (announced7 Apr 2025 · New Mexico Governor Lujan Grisham: Governor signs SB 219, the Medical Psilocybin Act (effective June 20, 2025): DOH15 May 2025 · FDA / Janssen: FDA approves Spravato REMS modification S-021: minor revision to the Patient Mon16 May 2025 · FDA Commissioner Marty Makary: Makary tells NewsNation the FDA will give psychedelic trial data 'an expeditious24 Jun 2025 · HHS Secretary Robert F. Kennedy Jr.: At a House Energy and Commerce hearing, Kennedy says HHS is 'working very hard' 10 Jul 2025 · Czech Senate: Czech Senate gives final approval to a law allowing medical use of psilocybin fr11 Jul 2025 · BfArM (Germany): BfArM approves the EU's first compassionate use programme for psilocybin in trea18 Jul 2025 · Otsuka / Lundbeck (Rexulti, PTSD): FDA advisory committee votes against brexpiprazole plus sertraline for PTSD, cit31 Jul 2025 · FDA / Janssen: FDA approves Spravato REMS modification S-024.4 Sep 2025 · FDA: FDA publicly releases the Lykos MDMA complete response letter, citing unreported4 Sep 2025 · FDA / Lykos Therapeutics: FDA publicly releases the August 2024 Lykos CRL, detailing concerns on safety re18 Sep 2025 · BrainsWay (Deep TMS): FDA clears BrainsWay's accelerated Deep TMS protocol for MDD, shortening treatme22 Sep 2025 · Otsuka / Lundbeck (Rexulti, PTSD): FDA issues a CRL for brexpiprazole plus sertraline in PTSD, citing insufficient 9 Oct 2025 · FDA / Janssen: FDA approves Spravato REMS modification S-025 with vendor-related changes to the6 Nov 2025 · Johnson & Johnson (Caplyta, adjunctive MDD): FDA approves Caplyta (lumateperone) as adjunctive treatment for MDD based on two13 Nov 2025 · BrainsWay (Deep TMS): FDA clears BrainsWay Deep TMS as an adjunct for MDD in adolescents aged 15 to 215 Dec 2025 · New Mexico Department of Health: At the Medical Psilocybin Advisory Board's first meeting, DOH says patient acces18 Dec 2025 · President Trump: Executive order directs the Attorney General to complete marijuana rescheduling 31 Dec 2025 · DEA and HHS: Fourth temporary extension of telemedicine flexibilities for controlled medicati1 Jan 2026 · Czech Republic: Czech medical psilocybin framework takes effect: psychiatrists may administer ps5 Jan 2026 · GH Research (GH001): FDA lifts the clinical hold on GH001, clearing a global phase 3 program in TRD t12 Jan 2026 · Neurolief (Proliv Rx): FDA grants PMA approval to Neurolief's Proliv Rx, the first at-home brain neurom23 Jan 2026 · FDA / Janssen: FDA approves Spravato REMS modification S-027, reverting the October 2025 vendor3 Mar 2026 · AtaiBeckley (BPL-003): AtaiBeckley reports a successful End-of-Phase 2 meeting with FDA for BPL-003 in 13 Apr 2026 · FDA / Janssen: FDA approves Spravato REMS modification S-028 adding Spanish translations of REM18 Apr 2026 · President Trump: EO 14401 orders FDA priority vouchers for breakthrough psychedelics, an ibogaine23 Apr 2026 · DOJ / DEA (Acting AG Blanche): Final order moves FDA-approved marijuana products and state-licensed medical marFIRST FDA APPROVA…First FDA approval of a psychedelic medicine (class) · stated 7 Aug 2023First FDA approval of a psychedelic medicine (class) · restated 7 Aug 2023 · p 90%First FDA approval of a psychedelic medicine (class) · miss 7 Aug 202590%TODAY202420252026

Regulatory decisions