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 0.49

Rules 1.1.0 · as of 14 Sep 2026

Quote

“By 2024, 2025, there should be FDA approval for psilocybin, for depression, potentially for alcohol use disorder, other indications, and they'll be administered in these exact kind of centers.”
· The Joe Rogan Experience #1661 - Rick Doblin (transcript) · podcast

Doblin on Joe Rogan #1661 forecasts FDA approval of psilocybin for depression and possibly alcohol use disorder by 2024-2025.

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 ›
FDA approval of a psilocybin drug product
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 ›
31 Dec 2025 AnchorThe fixed table that turns the person's own words ('by 2026', 'Q2', 'within two years') into a deadline. The coder never invents a date. Method › · “By 2024, 2025”
Probability
0.70 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 › B · “there should be FDA approval for psilocybin, for depression”
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 ›
phase2_to_approval_all · 0.15 · 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 0.07 (window shorter than the median 72 months)
Tags
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-0003 · deadline 31 Dec 2025 · bin B
Registry entry

The FDA approves a drug product whose active ingredient is psilocybin for any indication.

TRUE on the date of the first FDA approval letter or Drugs@FDA entry (or the sponsor's approval announcement) for a drug product whose active ingredient is psilocybin, for any indication and under any sponsor (COMP360 by Compass Pathways, or another psilocybin product). A complete response letter, a positive advisory vote, a breakthrough therapy designation, a filing acceptance or a state program that permits psilocybin use is not an FDA approval. Approval of a psilocybin analogue (for example a deuterated psilocybin) or of another tryptamine (5-MeO-DMT, DMT) does not count. Resolution source: Drugs@FDA. FALSE at the deadline when no such approval appears in Drugs@FDA.

Resolution source: Drugs@FDA

Readings: The forecaster names no indication or sponsor, so any psilocybin product for any indication counts.; 'behind us' reads as reaching FDA approval after MDMA-assisted therapy; the event resolves on the FDA approval of psilocybin alone, without reference to the MDMA approval date.; 'These substances' (MDMA and psilocybin, with 'psilocybin soon to follow' in the same passage) names the substance, not a sponsor or indication, so any psilocybin NDA approval for a psychiatric indication counts.; The event is on products whose active ingredient is psilocybin (as COMP360 is), not on analogues or other tryptamines.

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 ›
31 Dec 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
Not approved as of 2026-09-13. Drugs@FDA (openFDA mirror) returns no drug product with psilocybin as active ingredient, and FDA's 2026 novel drug approvals list (current to 2026-09-11) contains no psilocybin product. The most advanced application, Compass Pathways' COMP360 for treatment-resistant depression, is a rolling NDA: the 2026-08-05 Q2 results say final submission is expected in Q4 2026 and launch in H1 2027 if approved. Rolling review, the Commissioner's National Priority Vouchers (Compass, Usona), breakthrough designations, and state or foreign psilocybin programmes are not FDA approvals; deuterated analogues (CYB003/HLP003) are excluded by the criterion.
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 ›
0.49 = (0.70 − 0)²
Base-rate Brier
0.01
How to read
State at window close; the outcome comes from the registry, the score from the rule.

Registry

Receding horizon

Doblin promised FDA approval of a psilocybin drug product 2 times; it has not happened.

promised datehappened
202120222023202420252026202120222023202420252026TODAY2020-05-01: by 2022-05-01 · p 0.702021-06-04: by 2025-12-31 · p 0.70X SAID ON · Y PROMISED BY · DASHED: PROMISED = SAID · DOT AREA = P

Cluster E-0003

Timeline

1 claim against 60 events in the field.

saiddueevent
5 Jan 2022 · Health Canada: Canada Gazette publishes SOR/2021-271, restoring Special Access Program requests14 Jan 2022 · DEA: DEA proposes placing five tryptamine hallucinogens (4-OH-DiPT, 5-MeO-AMT, 5-MeO-16 Feb 2022 · FDA: FDA alerts health care professionals to potential risks of compounded ketamine n27 Jul 2022 · DEA: DEA withdraws its proposed Schedule I placement of five tryptamines after hearin19 Aug 2022 · Axsome Therapeutics (Auvelity, AXS-05): FDA approves Auvelity (dextromethorphan-bupropion), the first oral NMDA receptor29 Aug 2022 · DEA: DEA withdraws its April 2022 proposal to place DOI and DOC in Schedule I, citing6 Sep 2022 · Magnus Medical (SAINT): FDA grants 510(k) clearance to Magnus Medical's SAINT Neuromodulation System (MR8 Nov 2022 · Colorado voters: Colorado voters approve Proposition 122 (Natural Medicine Health Act), decrimina27 Dec 2022 · Oregon Health Authority: OHA adopts final administrative rules implementing Measure 109 psilocybin servic2 Jan 2023 · Oregon Psilocybin Services: Oregon Psilocybin Services begins accepting applications for manufacturer, servi3 Feb 2023 · TGA (Australia): TGA announces final decision to reschedule psilocybin (TRD) and MDMA (PTSD) to S1 Mar 2023 · DEA: DEA publishes proposed rules on telemedicine prescribing of controlled substance5 May 2023 · Oregon Psilocybin Services: Oregon issues its first psilocybin service center license (EPIC Healing Eugene);10 May 2023 · DEA and HHS: First temporary extension of COVID-19 telemedicine flexibilities for controlled 23 May 2023 · Colorado Governor Polis: Governor signs SB23-290 (Natural Medicine Regulation and Legalization), creating26 Jun 2023 · FDA: FDA issues draft guidance 'Psychedelic Drugs: Considerations for Clinical Invest1 Jul 2023 · TGA (Australia): Rescheduling takes effect: authorised psychiatrists may prescribe MDMA for PTSD 4 Aug 2023 · Sage Therapeutics / Biogen (zuranolone): FDA approves Zurzuvae (zuranolone) as the first oral treatment for postpartum de29 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.FDA APPROVAL OF A…FDA approval of a psilocybin drug product · stated 4 Jun 2021FDA approval of a psilocybin drug product · restated 4 Jun 2021 · p 70%FDA approval of a psilocybin drug product · miss 31 Dec 202570%TODAY20222023202420252026

Regulatory decisions