Psilocybin and related investigational therapies

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Current state

FDA seeks input on ibogaine trial safeguards through November 20. IBO-CARE proposes an opioid-use-disorder comparison but explicitly awaits funding and authorization; its IND is not filed. Psychedelic efficacy, supervised safety and non-psychedelic treatments remain distinct.

Status: active. Initial evidence brief completed 2026-09-12.

Questions to follow

• Follow formal human trials worldwide, at all phases, of psilocybin/psilocin and analogues, LSD, DMT, 5-MeO-DMT, and related therapeutic candidates. Include MDMA as a neighboring empathogen/entactogen class, with its different pharmacology clearly identified.
• Prioritize depression, anxiety, PTSD, substance-use disorders and other evidence-supported indications. Track efficacy, negative findings, durability, retreatment, safety, trial launches and U.S. regulatory decisions.
• Distinguish peer-reviewed results, sponsor toplines, exploratory/open-label findings, and regulatory authorization. Track both old and new program/sponsor names.
• Investigational trials, state-regulated services and FDA-approved treatment are different access categories. No self-treatment or dosing guidance is part of this watch.
• Follow routine SSRI development, tolerability and non-psychedelic alternatives in SSRIs and newer antidepressants. Cross-link direct comparisons and concomitant-antidepressant studies; these drug classes are distinct.

Programs and next milestones

Focused update — 2026-10-16

Johns Hopkins registers controlled psilocybin driving-impairment research

Development stage: Johns Hopkins first posted NCT07877987 on October 16. The planned 80-person phase 1 study uses a randomized, masked crossover design in adults aged 21 or older, with participants completing psilocybin, placebo and alcohol conditions.

Evidence and limitations: Outcomes include simulated lane-position variability and a global driving score, field-sobriety performance, perceived drug effects and confidence to drive, with assessments extending to 24 hours. This addresses functional safety rather than depression remission or clinical efficacy. It does not yet establish a safe interval for returning to driving or real-world crash risk.

U.S. status: Investigational human research, listed not yet recruiting. It provides no new FDA approval or routine access pathway.

Next milestones: Estimated start March 1, 2027; estimated primary/final completion June 30, 2030. No results posted.

Sources: Source 1.

Remaining gaps: Focused clinical-development/safety update. Saved named records and all 13 new-registration discovery records were retrieved. PEARL administrative update was deduplicated. New Johns Hopkins impairment study is a registered human safety protocol, not therapeutic efficacy. Full worldwide psychedelic pipeline, every FDA docket submission, original ibogaine workshop recording and all paid talk transcripts were not reviewed. Existing FDA ibogaine deadline/IBOCARE and COMP360 speculation were not re-alerted. No full successful-check advancement.

Informal-source coverage: Indexed original October 14–15 shroomstocks discussion speculates about timing COMP360 submission/approval around awareness events; no official new date was established. The saved anonymous CNPV 44–81-day prediction remains unconfirmed. A CRPS participant post is an anecdote about entering a study, not a new controlled pain result. No duplicate rumor alert; full talk/podcast review incomplete.

Full coverage record.

Focused update — 2026-10-13

FDA seeks input on the design and safety of ibogaine trials

Source/event date: October 5, 2026; recovered October 13. FDA's FDA-2026-N-10429 request seeks input on early-phase ibogaine study populations, dose escalation, monitoring, stopping rules and independent oversight. It specifically highlights cardiac and neurologic risks.

The notice describes federally supported research initially prioritizing adults with opioid-use disorder and PTSD. It also mentions permission for an early noribogaine hydrochloride alcohol-use-disorder study; a derivative, diagnosis and IND permission are separate from ibogaine efficacy or marketing authorization.

Limits/U.S.: This is consultation on development safeguards, not a declaration that ibogaine is safe/effective, a new completed trial, or general clinical availability. Registration of a study elsewhere must not be confused with an FDA-effective IND.

Next: The notice states comments close November 20, 2026. Subsequent protocols and policy remain to be verified; no efficacy readout date is announced.

Sources: Source 1.

IBO-CARE proposes an ibogaine comparison, pending funding and authorization

Source date: First posted October 13, 2026. IBO-CARE/NCT07871877, My-E-Health UK, plans 60 adults aged 18–65 with moderate/severe opioid-use disorder at a U.S. site.

The proposed phase 1/2a study has three 20-person cohorts: an opioid-free randomized comparison of extended-release naltrexone versus ibogaine, plus a separate nonrandomized recent-use ibogaine cohort. All receive continuing recovery support for 12 months. Three monitored oral-treatment admissions and individual repeat-dose safety releases are planned. The description proposes 72-hour telemetry and serial clinical ECGs; wearables are not cardiac-safety substitutes.

Status/limits: Not yet recruiting; IND not yet filed. Funding, FDA-effective IND, IRB and applicable DEA/state/site requirements must be met before enrollment. The structured masking field says none, while narrative describes a double-dummy randomized comparison and open recent-use pathway; retain that discrepancy pending protocol clarification. Dose/formulation elements remain unresolved. Preliminary safety/feasibility is the aim, not confirmatory recovery efficacy.

U.S./next: No approval or lawful trial initiation established. July 1, 2027 start; January 31, 2029 primary; December 31, 2029 final are estimates conditioned on authorization/funding.

Sources: Source 1.

Recovered APPROACH registry confirms primary follow-up has ended

Recovered registry context, not a new October result: September 28, 2026 posted update for APPROACH/NCT06564818, Cybin's adjunctive CYB003 deuterated psilocin phase 3 study, now independently verified through the live primary API.

The record lists actual primary completion September 4, 2026, active-not-recruiting, 220 estimated enrollment, and October 2026 estimated final completion. Participants continue a stable antidepressant, receive two supervised CYB003 or placebo sessions plus psychological support, and are assessed on MADRS to day 42.

Limits/U.S.: No result is posted. Completion is not a positive efficacy readout, proof of remission or FDA approval. Keep final completion estimate separate from actual primary completion and sponsor topline forecasts. This confirms the factual registry-date part of an earlier Reddit observation; it does not confirm predicted efficacy or a disclosure date.

Next: Await the sponsor's actual topline release and full harms/durability analyses; a precise release day remains unverified.

Sources: Source 1.

Remaining gaps: Read current topic, scope/state and September 5 overlap. Retrieved 11 saved registries and 12 new registrations; incidental LSD=procedure abbreviations excluded. Primary APPROACH actual-primary-completion access gap closed without efficacy claim; appraised FDA ibogaine RFI and conditional IBO-CARE plan.; Full FDA September hearing proceedings, all COMP/GH/Helus/Definium harms/durability tables, PMDD/new cancer-distress/BPD trial full appraisal and global registry census remain gaps. FDA consultation is not approval.

Informal-source coverage: Oct 12 original indexed CNPV timing calculation recorded explicitly as unconfirmed speculation; direct original access failed, author/full arithmetic unappraised. October 5 shroomstocks thread repeated registry-completion observations; only the actual registry date is now verified. MAPS original refiling statement revisited, no FDA acceptance independently verified. Full podcast/talk sweep incomplete.

Full coverage record.

Focused update — 2026-10-09

MLS101 registers a low-dose psilocybin trial for PMDD

Source/event date: First posted September 14, 2026; recovered October 9. Evidence: Phase 1 MLS101/NCT07818720 registration.

The randomized placebo-controlled study plans 32 premenopausal women aged 18–50 with PMDD who have tried at least one treatment. It tests 2, 4 or 8 mg psilocybin, six supervised doses approximately every three days during one luteal phase. Safety/tolerability is primary; follow-up extends approximately one month after treatment. At least eight hours of clinic monitoring and an escorted return home are specified after each dose.

Limits/safety: This is not proof that low-dose psilocybin works, is safe outside monitoring, or provides durable PMDD remission. A single-cycle early study cannot establish long-term benefit or harms. PMDD and major depression remain different diagnoses.

U.S. status / next milestone: Not yet recruiting, no new approval. December 2026 estimated start, September 2027 primary and December 2027 final completion estimates.

Original registry.

Remaining gaps: Read current topic/state, September5 overlap and all six saved trial records;13 newly registered search matches screened for psychedelic rather than incidental DMT abbreviation.; Selected formal PMDD study, with phase1 safety endpoints and supervised exposure explicit. Nicotine NCT07852832 is a three-person basic-science pilot, not cessation efficacy; ADEPT NCT07833761 and PEARL NCT07820033 were discovery leads not fully appraised.; APPROACH NCT06564818 surfaced via original Reddit and registry mirror; its live primary record still needs refresh, so Sept4 actual-completion claim not promoted. FDA hearing full transcript/outcome, all COMP/GH/Helus/Definium safety and complete international registry sweep remain gaps.

Informal-source coverage: Original Oct5 shroomstocks weekly thread contains speculation based on APPROACH registry dates; actual completion is not a topline announcement and no efficacy inference is justified. Oct8 investing post repeats COMP360 approval timing hopes without inside source. No material confirmation of saved MDMA resubmission rumor. Broader full podcast/talk review incomplete.

Full coverage record.

Focused update — 2026-10-06

No additional material finding was verified in the selected sources. Coverage remains incomplete; this is not a full-topic “no news” conclusion.

Coverage: psychedelic depression anxiety psilocybin trial October2026 after:2026-10-01 before:2026-10-07; site:ir.compasspathways.com "2026" "October"; site:investor.ghres.com "October" "2026"; site:ir.helus.com "October" "2026" clinical; site:ir.definiumtx.com "October" "2026" clinical; "Adverse Health Outcomes of Psilocybin,LSD,MDMA,Ibogaine,and5-MeO-DMT"

Remaining gaps: Read current topic/state; October 1 Helus legal-name and October 5 Compass office news add no clinical results or approval. Opened FDA hearing page and actual September 29 JAMA public-health survey.; FDA comment deadline October 5 at 23:59 ET elapsed; no new policy/product decision verified. Full hearing recording/transcript and HLP003 posters remain unappraised.; Safety survey appraised as context, not regulated-trial results: mixed/unsupervised use cannot quantify clinical-trial risks. Broad registry/sponsor-call coverage incomplete; no full-topic no-news claim.

Informal-source coverage: October 2 r/shroomstocks safety-paper thread traced to September 29 JAMA letter, not an October 2 trial. October 3 HLP003/HLP004 prediction thread is investor opinion without new original inside information. October 5 Alzheimer psilocybin case-report claim located but original post failed; excluded from formal therapy findings. Existing Resilient MDMA refiling remains unverified for FDA acceptance. Full podcast/transcript review incomplete.

Full coverage record.

Focused update — 2026-10-02

No additional material finding was verified in this focused pass. Coverage remains incomplete; this is not a full-topic “no news” conclusion.

Coverage: psilocybin LSD DMT clinical trial September 30 October 1 2026; site:fda.gov psychedelic September 2026 hearing transcript; COMP360 NDA September 2026; GH001 phase 3; HLP003 Psych Congress September 2026; Resilient MDMA NDA resubmitted FDA September 2026 Reddit; site:reddit.com/r/shroomstocks September 28 2026.

Remaining gaps: September 14 FDA hearing full recording/transcript not comprehensively appraised. HLP003 Psych Congress posters 121–124 not obtained; September 21 sponsor release gives analyses but no sufficiently detailed new quantitative table. All worldwide psychedelic trial registries, safety updates and podcast transcripts not exhaustively refreshed.

Informal-source coverage: Resilient/Lykos MDMA application reportedly resubmitted; https://www.reddit.com/r/PharmAla_MDMA/comments/1wtlput/introducing_the_pharmala_pulse_a_brief_roundup_of/; September 29 secondhand roundup repeats existing claim, not independent corroboration. No FDA acceptance verified; retain existing unresolved rumor status, no repeated alert. https://www.reddit.com/r/shroomstocks/comments/1wse09j/rshroomstocks_weekly_discussion_thread_september/; September 28 thread with September 30 comments contained approval/NDA expectations, not independently sourced new inside information.

Next update: COMP360 filing completion and DT120 pre-NDA meeting remain Q4 2026 forecasts. Optimi psilocybin start H1 2027 and MDMA start 2027 are sponsor plans.

Full coverage record.

Focused update — 2026-09-27

No additional finding was verified in the reviewed sources. Coverage remains partial; this is not a full-topic “no news” conclusion.

Coverage: Selected sponsor and clinical-publication discovery since September 5; FDA hearing/MDMA resubmission follow-up; Definium and GH developments checked against prior events.

Remaining gaps: September 14 FDA hearing full proceedings/transcripts not appraised; October 5 comment deadline remains future. Complete conference posters, current trial registries and underlying informal investor-call recordings not reviewed. No FDA acceptance/decision date independently verified for reported MDMA resubmission.

Informal-source coverage: Reviewed psychedelic-stock discussion threads and reported MDMA refiling. A September EPISODE repost points to a March paper, not new results. Anonymous Compass filing/review-timing comments lacked an appraised original recording and added no sufficiently verified material update to the saved filing outlook.

Full coverage record.

Focused update — 2026-09-22

Bipolar II psilocybin pilot reports improvement and psychiatric adverse events

Source date: 2026-09-21. Event date: 2026-09-21. Evidence: Peer-reviewed open-label, single-arm pilot.

A 14-person bipolar II depression study adds preliminary efficacy and important mood-switching/suicidality observations. NCT05065294: 10 mg psilocybin with structured support, followed by 25 mg in nine persistent nonremitters. At 21 days after 10 mg, MADRS decreased 12.7 points (SE 2.7) from baseline.

Limitations: No control arm; highly selected/support-intensive sample and adapted hypomania duration criteria. The abstract and main text give different 25-mg MADRS estimates; omit that numerical comparison until clarified. Improvement cannot establish efficacy or population-wide safety.

Safety: Two participants had suicidal ideation after 10 mg (days 11 and 37; latter severe with intent but no plan); one had transient hypomanic symptoms after 25 mg (day 14). All resolved. Authors classified no regulatory serious adverse events; severe does not mean serious under that definition.

U.S. status: Psilocybin is not FDA-approved for bipolar depression.

Next milestone: Controlled replication needed; no next readout date verified.

Downey et al., Journal of Clinical Psychiatry, September 21; Trial registry.

Optimi plans Canadian phase 3 MDMA-assisted PTSD study

Source date: 2026-09-16. Event date: 2026-09-16. Evidence: Sponsor announcement of planned human trial; authorization sponsor-reported.

Optimi announced a Health Canada-authorized phase 3 study, expected to begin in 2027. Up to 100 participants across Canadian sites, focused on veterans and current/former frontline workers. Two supervised MDMA-plus-psychotherapy sessions; primary endpoint CAPS-5 PTSD severity change.

Limitations: No matched registry ID, comparator/blinding details or first dosing verified. Authorization to conduct research is not marketing approval. This is distinct from Resilient’s reported U.S. resubmission.

Safety: No results from this planned study.

U.S. status: No U.S. marketing approval; sponsor says its MDMA has no Health Canada market authorization.

Next milestone: 2027 initiation is a sponsor forecast, without a more precise date.

Optimi September 16 original announcement.

Optimi plans Canadian phase 2 naturally derived psilocybin study

Source date: 2026-09-10. Event date: 2026-09-10. Evidence: Sponsor announcement of planned human trial; authorization sponsor-reported.

A newly announced MDD program plans to study a supervised single dose of naturally derived psilocybin. Up to 200 participants at Canadian sites; primary endpoint MADRS change. Sponsor reports Health Canada authorization.

Limitations: No matched registry, dose, comparator/blinding specification or first dosing verified. Natural origin does not demonstrate superiority or equivalence to other formulations.

Safety: No results from this planned study; interim safety/efficacy reporting is intended without dates.

U.S. status: No FDA approval; sponsor says its psilocybin products lack Health Canada market authorization.

Next milestone: Sponsor forecasts initiation in first half 2027 and dosing completion by end-2027; full topline after follow-up, with no exact date.

Optimi September 10 original announcement.

Coverage: Read full topic and prior gaps; September5–22 human-stage, safety and regulatory searches. Appraised bipolar-II pilot, Optimi original phase2/3 planned-trial releases, FDA hearing page and original MDMA report/MAPS response. Previously reported Panorama, COMP005 and personality-disorder subgroup deduplicated. Checked L-130 lead against older 2023 study/2024 publication context.

Remaining gaps: FDA September14 full proceedings/transcript still not appraised. Official page checked; October5 comment deadline retained. No new binding policy/product approval inferred. Definium actual Psych Congress files and new analyses, GH001 phase3 registration and complete Helus/BPL003 status sweep remain gaps. Optimi registry IDs and design details not matched. L-130 planned September16 presentation not obtained; older ten-person phase1a results must not be relabeled new September efficacy. U.S. MDMA filing acceptance, decision date and approval remain unverified.

Informal-source coverage: Existing anonymous-source Resilient report and MAPS original response rechecked: MAPS expressly responds to reported refiling and says it has no active role in Resilient development. Reposts are not independent confirmation. September18 Alaina Jaster hearing commentary appraised as participant/observer interpretation, not FDA policy; no new approval-date rumor promoted. Original talk/podcast coverage remains selective.

Full coverage record.

Next update: COMP360 filing completion and DT120 pre-NDA meeting remain Q4 2026 forecasts. Optimi psilocybin start H1 2027 and MDMA start 2027 are sponsor plans.

Elapsed window — September 14 FDA hearing: the scheduled date has passed. The agenda and stream were located, but full proceedings and any policy outcome were not appraised. Comments remain open through October 5 at 11:59 p.m. Eastern; a hearing is not product approval.

Focused update — 2026-09-18

COMP005 reports one-year follow-up with additional psilocybin doses

Source date: 2026-09-09. Evidence: sponsor topline open-label extension.

COMP005 Part C reported improvement through week 52 after permitted additional COMP360 dosing. Original trial randomized 258 people with TRD. Approximately 70% entered open-label weeks 26–52; 90 originally assigned 25 mg received a second or third dose and 52 originally assigned placebo received their first 25 mg dose. Sponsor reports a 13-point mean baseline-to-week-52 MADRS reduction in the original active-arm repeat-dose group, with 40–45% response and about 30% remission over six weeks after Part C dosing.

Limitations: Open-label, selected continuation, attrition and redosing. This is not randomized evidence that one dose lasts a year; confidence intervals and complete denominators at each time point not supplied.

Safety: No new safety findings reported; detailed rates absent.

U.S. status: Investigational; rolling filing is not approval.

Next milestone: Sponsor forecast: Rolling NDA completion Q4 2026; conditional U.S. launch H1 2027, subject to approval/rescheduling.

Compass September 9 extension topline.

Small psilocybin subgroup study includes personality disorders

Source date: 2026-09-16. Evidence: peer-reviewed accepted article; exploratory secondary analysis.

A September 16 paper reports a ten-person TRD subgroup with co-occurring personality disorders, usually excluded from psychedelic trials. NCT05029466; nine had cluster B and one cluster C personality disorder. Three dropped out. Mean MADRS was 30.4 before treatment and 22.3 at six months; trajectories varied substantially. Registry parent trial enrolled 30 and completed in 2023.

Limitations: No controlled efficacy estimate for this subgroup; tiny selected sample, secondary analysis and attrition. Abstract reviewed; accepted-manuscript PDF access failed. Do not describe this as proven personality-disorder treatment or suicide prevention.

Safety: No serious adverse events reported in abstract; inadequate size to establish psychiatric safety or exclude uncommon harm.

U.S. status: Psilocybin remains investigational for these indications.

Next milestone: No announced date: Larger controlled studies and complete safety reporting needed.

Lipsitz et al., npj Mental Health Research, September 16; Parent registry.

Related findings:

• KetSet will compare the therapeutic framing of ketamine: KetSet will compare psychedelic versus biomedical framing while keeping ketamine treatment the same.

Coverage: Read topic/state; checked COMP005, original FDA hearing page/agenda, Definium Psych Congress timetable, GH/Helus recent-search leads, psilocybin personality-disorder paper; direct Usona/GH001/Elumina/Redefine registries. Panorama and September 8 designation already recorded and deduplicated. This is a focused review, not a complete re-review of every program.

Remaining gaps: FDA hearing date elapsed; original page remains agenda/stream oriented. No complete transcript or policy/product decision verified. Keep October 5 comment deadline and mark proceedings appraisal pending. Definium original event lists September 17 and18 posters, but actual presentation files/new analyses not accessible; do not infer completion/data from timetable. GH001 phase3 registration, complete Helus/BPL003 status sweep remain unresolved. Elumina registry still May 11 recruiting snapshot despite July sponsor dosing-complete report; no contradictory termination inference. Accepted psilocybin subgroup PDF blocked; abstract used only. L-130 September 14 sponsor index previews phase1a results, but actual September 16 presentation not appraised; no new efficacy promoted.

Informal-source coverage: Original anonymous-source Resilient report re-opened; unchanged unconfirmed filing/acceptance status. Reddit hearing thread reviewed as commentary, not regulatory decision. AC102 irrelevant excluded from this category; podcast-specific approval dates not verified.

Full coverage record.

Next update: Panorama topline reported September 14. DT120 pre-NDA meeting Q4 2026, intended filing H1 2027; COMP360 filing completion and HLP003/VLS-01 readouts remain Q4 2026 sponsor forecasts. FDA hearing outcome is unverified; written comments close October 5.

September 14, 2026 — focused update

DT120 Panorama / NCT06809595 — sponsor Phase 3 topline, September 14. The trial randomized 245 adults with GAD: 96 to 100 micrograms, 52 to 50 micrograms and 97 to placebo. At week 12, HAM-A changed by −9.8 versus −4.7 in the 100-microgram and placebo groups (difference −5.1; p<0.0001; d=0.64); confidence intervals were not supplied. The sponsor reports the primary and key secondary endpoints met. Adverse events occurred in 94.8% versus 62.9%, including perceptual illusions, nausea and headache; no drug-related serious event was reported. Masking may be compromised, and the lower-dose arm was not powered for comparisons. Controlled follow-up was 12 weeks; extension retreatment does not prove permanent benefit or superiority to existing medicines. September 14 sponsor result; registry.

Separate MDD milestone — September 8: Definium reported Breakthrough Therapy designation for DT120 in MDD, following Emerge. This is a regulatory-development designation, not approval or another efficacy result. Dated sponsor announcement.

FDA public hearing — checked September 14 at 19:08 UTC: The official page and agenda schedule discussion for 12:30–4:30 p.m. Eastern today; the check occurred within that window. No transcript, completed proceedings, policy outcome or product decision was verified. Written comments close October 5 at 11:59 p.m. Eastern. FDA page; agenda.

Tracked programs and current evidence

Initial brief — evidence available through 2026-09-12

Current assessment: this field now has several positive phase 3 reports, particularly in depression and anxiety, but the programs below remain investigational in the U.S. Their results do not establish that psychedelic treatment works for everyone or that one treatment produces permanent benefit. Many important results are still sponsor toplines. FDA issued final trial guidance in July 2026; its September 14 public hearing concerns potential future therapeutic use and is not a product approval hearing. FDA guidance, hearing notice.

Psilocybin — COMP360 and Usona. Compass has reported two positive phase 3 studies in treatment-resistant depression (TRD). The February 17 COMP006 topline found a 3.8-point between-group MADRS depression-score difference at week 6 versus its low-dose comparator (95% CI 1.8–5.8 points favoring treatment). Its August 5 update describes six-month benefit in a subset and an ongoing rolling FDA application; these are sponsor reports, with durability depending on response selection and retreatment. Usona's separate uAspire phase 3 study, NCT06308653, addresses major depressive disorder (MDD), building on a peer-reviewed randomized phase 2 study. Its official FAQ says enrollment is closed; this check found no phase 3 readout or reliable release date. COMP006 filing, Compass current status, Usona status, Usona phase 2 publication.

HLP003, formerly CYB003 — a psilocin analogue. Helus Pharma, formerly operating as Cybin, is testing this deuterated psilocin analogue as an adjunct to existing antidepressants. APPROACH completed enrollment of 223 participants in July; EMBRACE is the second pivotal trial. Earlier small studies generated encouraging symptom and durability signals, but the phase 3 result is the more important next test. Extremely high remission percentages from small follow-up groups should not be read as expected population-wide outcomes. Enrollment/design disclosure, August 14 update.

DT120, formerly MM120 — LSD/lysergide. Definium Therapeutics, formerly MindMed, reported positive phase 3 Emerge results in MDD in June and Voyage results in generalized anxiety disorder (GAD) on August 12. Voyage randomized 214 participants and found a 5.4-point placebo-adjusted HAM-A anxiety-score improvement at week 12; Emerge's week-6 MADRS difference was 8.1 points in 149 participants. These sponsor toplines are substantial signals, not head-to-head superiority over existing drugs. Reported adverse effects were predominantly transient; full phase 3 publications and longer follow-up remain important. Voyage results, Emerge/current program.

GH001 — inhaled mebufotenin, or 5-MeO-DMT. Phase 2b NCT05800860 reported a 15.5-point placebo-adjusted MADRS advantage on day 8. That short primary endpoint is distinct from durable remission; the longer extension included retreatment. FDA lifted the clinical hold in January 2026. The August 6 update still describes phase 3 design discussions and a 2026 initiation target, not an already completed pivotal trial. Hold lifted and results context, August development update.

BPL-003 and VLS-01 — distinct 5-MeO-DMT and DMT programs. BPL-003 is intranasal mebufotenin; VLS-01 is a DMT formulation, not the same molecule. AtaiBeckley's July 6 announcement describes BPL-003 in phase 3 and completion of dosing in the 156-participant VLS-01 Elumina phase 2b trial (NCT06524830), with results pending. Lilly completed its acquisition of AtaiBeckley on September 11, 2026; future milestones should be checked under both names. Trial update, completed acquisition.

Evidence limits to retain: noticeable psychoactive effects can reveal assignment and amplify expectancy. Comparator choice, blinded raters, supportive care, missing data and retreatment matter. Selected trial populations and small samples also limit detection of uncommon psychiatric or cardiovascular harms. Short-term symptom-score changes, responder-only follow-up and uncontrolled extensions cannot establish lasting benefit for every participant. FDA's final guidance.

When to expect the next useful update

Rumors and informal signals

Speculation: COMP360 could receive a decision 44–81 days after final submission

Speculation/inference — unconfirmed. An anonymous October 12, 2026 r/Cmpsstock post titled FDA NDA and CNPV timelines to approval calculates roughly 44–81 calendar days from final COMP360 submission to an FDA decision. The original permalink was identified through search indexing, but direct page access failed; the full calculation and author identity were not appraised. This is a public timing inference, not inside information.

FDA's CNPV materials describe an approximately one to two-month review target alongside presubmission/completeness work. They do not promise approval or establish a COMP360-specific decision day. Final submission, filing acceptance, an official action target and actual decision remain distinct. Prior fast approvals do not guarantee this application will follow the same timetable.

Status/next: Record unconfirmed October 13. Seek the final sponsor filing and FDA acceptance/action communication; do not add the 44–81 day inference to the established milestone calendar. Reposts of the estimate are not independent confirmation.

Sources: Source 1; Source 2; Source 3.

MDMA-assisted therapy / Resilient, formerly Lykos. MDMA is an empathogen/entactogen, distinct from classic serotonergic psychedelics. FDA rejected the initial PTSD application in August 2024. On August 10, 2026, MAPS responded to reporting of a resubmission without a new phase 3 study, while stating it has no active role in Resilient's development program. Treat this as a reported resubmission, not independently verified FDA acceptance, approval, or a decision deadline. Durability, safety characterization and bias were central issues. MAPS statement and provenance.

Status checked September 14 — unchanged, unconfirmed: The August 12 original reporting attributes the reported resubmission to anonymous sources. It does not independently establish FDA acceptance or an action date. A September 7 weekly investor discussion contained unsubstantiated positive Panorama/NDA expectations; the subsequent primary trial announcement is the evidence event, not independent validation of every prediction.

Dated history

2026-10-02 — Scheduled focused review

0 newly recorded findings or milestones; primary evidence, uncertainty and incomplete coverage are detailed above and in the run record. Full-topic successful-check dates remain unchanged.

• 2026-09-27: 0 sourced entries and 0 cross-topic links from a focused scheduled check. Coverage and remaining gaps.

• 2026-09-22: Focused scheduled research retry; 3 sourced entries and 0 cross-topic links. Coverage and gaps.

September 14, 2026 — focused ad-hoc review

Recorded the September 14 Panorama topline and September 8 MDD designation separately; updated the pending Panorama forecast and checked today’s FDA hearing materials. Full findings and direct sources are in the focused update.

Coverage: Named-program searches included Definium, Compass, Helus and GH Research and followed the existing MDMA signal. Compass’s index exposed limited article text; Helus/GH indexes failed direct rendering. No comprehensive Usona/GH001/BPL-003/VLS-01 registry sweep or hearing transcript/podcast review was completed. Other program forecasts remain attached to their older sources, not newly reconfirmed results.

Dated findings

• 2026-09-12: Initial baseline established. Priority near-term checks: September FDA hearing and DT120 Panorama result; Q4 COMP360 filing completion, HLP003 and VLS-01 readouts; confirmation of GH001 phase 3 launch and MDMA regulatory status. This is a focused baseline, not an exhaustive trial census.

2026-09-18 — Scheduled focused review

Read topic/state; checked COMP005, original FDA hearing page/agenda, Definium Psych Congress timetable, GH/Helus recent-search leads, psilocybin personality-disorder paper; direct Usona/GH001/Elumina/Redefine registries. Panorama and September 8 designation already recorded and deduplicated. Original event dates, safety and limitations are retained in the September 18 update above. The complete-topic successful-check date was not advanced because the listed gaps remain. Run record.