Compound tracker
5-MeO-DMT.
A source-backed research page for trial rows and update notes connected to this compound or investigational product. The page is generated from the Notion tracker and should be read as a living research map, not a medical conclusion.
15 trial rows 3 update rows Latest checked: May 12, 2026 All trials Claim boundary
Trial registration, company topline, CNPV/rolling-review status, recruitment status, public-dashboard data, or review literature do not equal approval, label, reimbursement, access, safety, or efficacy. Check each source note before turning a row into a claim.
Backlinks
This page links out to registry/source records, the global trial tracker, the updates feed, and matching wiki dossiers when available.
Phase 1 / Phase 1/2 / Phase 2
Phases tracked
Completed / Not yet recruiting / Recruiting
Statuses seen
Trial rows
NCT07540494 Phase 1 Not yet recruiting updated Apr 14, 2026
- Condition
- Healthy Adult
- Sponsor / institution
- GH Research Ireland Limited
- Start date
- Apr 1, 2026
Tracker note / source boundary
ClinicalTrials.gov v2 verification on 2026-04-24 | Overall status: NOT_YET_RECRUITING | Exact phase: PHASE1 | Lead sponsor: GH Research Ireland Limited | Conditions: Healthy Adult | Interventions: DRUG: 5 Methoxy N,N Dimethyltryptamine; DEVICE: GH001 Aerosol Delivery System | Registry start date type: ESTIMATED (2026-04).
NCT07444788 Phase 1 Recruiting updated Feb 24, 2026
- Condition
- Healthy Participants
- Sponsor / institution
- University Hospital, Basel, Switzerland
- Start date
- Mar 31, 2026
Tracker note / source boundary
ClinicalTrials.gov v2 verification on 2026-04-24 | Overall status: RECRUITING | Exact phase: PHASE1 | Lead sponsor: University Hospital, Basel, Switzerland | Conditions: 5-methoxy-dimethyltryptamine (5-MeO-DMT) | Interventions: DRUG: 0.2 mg/min 5-MeO-DMT; DRUG: 0.4 mg/min 5-MeO-DMT; DRUG: 0.6 mg/min 5-MeO-DMT; DRUG: 0.8 mg/min 5-MeO-DMT; DRUG: Placebo | Registry start date type: ESTIMATED (2026-03-31).
NCT06810765 Phase 2 Stopped updated Aug 22, 2025
- Condition
- PTSD - Post Traumatic Stress Disorder; Cognitive Dysfunction; Brain Trauma; Brain Injuries
- Sponsor / institution
- Johns Hopkins University
- Start date
- —
Tracker note / source boundary
ClinicalTrials.gov manual QA on 2026-04-17 | Exact registry status: Withdrawn | Official title: Trifecta Research Study: Examining Hormone Replacement Therapy, Magnetic e-Resonance Therapy, Ibogaine, and 5-MeO-DMT in the Treatment of Posttraumatic Stress Disorder and Traumatic Brain Injury-related Cognitive Symptoms | Sponsor: Johns Hopkins University | Conditions: PTSD - Post Traumatic Stress Disorder; Cognitive Dysfunction; Brain Trauma; Brain Injuries | Interventions: Hormone Replacement Therapy (HRT); Magnetic Resonance Therapy (MeRT); ibogaine with magnesium treatment; 5-MeO-DMT | Study type: Interventional
NCT05870540 Phase 2 Completed updated Jul 17, 2025
- Condition
- Treatment Resistant Depression
- Sponsor / institution
- Beckley Psytech Limited
- Start date
- Sep 14, 2023
Tracker note / source boundary
ClinicalTrials.gov v2 verification on 2026-04-24 | Overall status: COMPLETED | Exact phase: PHASE2 | Lead sponsor: Beckley Psytech Limited | Conditions: Treatment Resistant Depression | Interventions: DRUG: BPL-003; DRUG: BPL-003 | Asset identity checked against atai/Beckley 2025-10-16 source: BPL-003 is intranasal mebufotenin (5-MeO-DMT) benzoate.
NCT05800860 Phase 2 Completed updated May 31, 2025
- Condition
- Treatment-resistant Depression
- Sponsor / institution
- GH Research Ireland Limited
- Start date
- May 24, 2023
Tracker note / source boundary
ClinicalTrials.gov v2 sync on 2026-04-10 | Overall status: COMPLETED | Exact phase: Phase 2 | Lead sponsor: GH Research Ireland Limited | Conditions: Treatment-resistant Depression
NCT06812221 Phase 1/2 Completed updated Apr 9, 2025
- Condition
- Mild Cognitive Impairment; Anxiety State; Depression Anxiety Disorder
- Sponsor / institution
- Biomind Labs Inc.
- Start date
- Dec 15, 2024
Tracker note / source boundary
ClinicalTrials.gov manual QA on 2026-04-17 | Status: Completed | Sponsor: Biomind Labs Inc. | Official title: A Phase 1/2 Randomized, Double-Blind, Placebo-Controlled Trial of Multiple Sublingual 5-MeO-DMT Microdoses for Reducing Anxiety and/or Depression in Patients With Mild Cognitive Impairment. | Condition: Mild Cognitive Impairment; Anxiety State; Depression Anxiety Disorder | Intervention: Sublingual 5-MeO-DMT microdoses plus psychiatric, cognitive, biochemical, and EEG assessments | Study type: Interventional
NCT06816667 Phase 1/2 Completed updated Mar 5, 2025
- Condition
- Healthy Volunteers
- Sponsor / institution
- Biomind Labs Inc.
- Start date
- Oct 21, 2024
Tracker note / source boundary
ClinicalTrials.gov manual QA on 2026-04-17 | Status: Completed | Sponsor: Biomind Labs Inc. | Official title: A Phase 1/2 Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Safety, Tolerability and Efficacy of Multiple Sublingual Microdoses of 5-MeO-DMT in Reducing Symptoms of Depression and/or Anxiety. | Condition: Healthy Volunteers | Intervention: BMND08 sublingual 5-MeO-DMT formulation plus monitoring procedures | Study type: Interventional
NCT05839509 Phase 2 Stopped updated Feb 18, 2025
- Condition
- Bipolar II Disorder
- Sponsor / institution
- GH Research Ireland Limited
- Start date
- Apr 6, 2023
Tracker note / source boundary
ClinicalTrials.gov v2 sync on 2026-04-10 | Overall status: TERMINATED | Exact phase: Phase 2 | Lead sponsor: GH Research Ireland Limited | Conditions: Bipolar II Disorder
NCT05804708 Phase 2 Stopped updated Feb 18, 2025
- Condition
- Postpartum Depression, Postnatal Depression
- Sponsor / institution
- GH Research Ireland Limited
- Start date
- Mar 2, 2023
Tracker note / source boundary
ClinicalTrials.gov v2 sync on 2026-04-10 | Overall status: TERMINATED | Exact phase: Phase 2 | Lead sponsor: GH Research Ireland Limited | Conditions: Postpartum Depression; Postnatal Depression
NCT06511947 Phase 1 Recruiting updated Aug 7, 2024
- Condition
- Healthy Volunteers
- Sponsor / institution
- GH Research Ireland Limited
- Start date
- Aug 1, 2024
Tracker note / source boundary
ClinicalTrials.gov v2 sync on 2026-04-10 | Overall status: RECRUITING | Exact phase: Phase 1 | Lead sponsor: GH Research Ireland Limited | Conditions: Healthy Volunteers
NCT05698095 Phase 1 Completed updated Nov 30, 2023
- Condition
- Pharmacokinetics; Safety; Tolerability
- Sponsor / institution
- Usona Institute
- Start date
- Dec 27, 2022
Tracker note / source boundary
ClinicalTrials.gov manual QA on 2026-04-17 | Status: Completed | Sponsor: Usona Institute | Official title: A Phase 1, First-in-human, Double-blind, Placebo-controlled, Randomized, Single- and Multiple-ascending-dose Study to Determine the Safety, Tolerability, and Pharmacokinetics of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) Administered by Intramuscular Injection in Healthy Subjects | Condition: Pharmacokinetics; Safety; Tolerability | Intervention: 5-methoxy-N,N-dimethyltryptamine succinate salt; Placebo | Study type: Interventional
NCT04640831 Phase 1 Completed updated Aug 15, 2023
- Condition
- Healthy Volunteers
- Sponsor / institution
- GH Research Ireland Limited
- Start date
- Mar 13, 2019
Tracker note / source boundary
ClinicalTrials.gov v2 sync on 2026-04-10 | Overall status: COMPLETED | Exact phase: Phase 1 | Lead sponsor: GH Research Ireland Limited | Conditions: Healthy Volunteers
NCT04698603 Phase 1 Completed updated Aug 15, 2023
- Condition
- Treatment Resistant Depression, Major Depressive Disorder, Depression
- Sponsor / institution
- GH Research Ireland Limited
- Start date
- Nov 12, 2019
Tracker note / source boundary
ClinicalTrials.gov v2 sync on 2026-04-10 | Overall status: COMPLETED | Exact phase: Phase 1, Phase 2 | Lead sponsor: GH Research Ireland Limited | Conditions: Treatment Resistant Depression; Major Depressive Disorder; Depression
NCT05032833 Phase 1 Completed updated Oct 12, 2022
- Condition
- Pharmacokinetics in Healthy Adults
- Sponsor / institution
- Beckley Psytech Limited
- Start date
- Sep 22, 2021
Tracker note / source boundary
ClinicalTrials.gov manual QA on 2026-04-17 | Status: Completed | Sponsor: Beckley Psytech Limited | Official title: A Double-Blind, Randomized, Phase 1, First-in-Human, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of Intranasal 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) in Healthy Subjects | Condition: Pharmacokinetics in Healthy Adults | Intervention: 5-MeO-DMT; Placebo | Study type: Interventional
NCT05163691 Phase 1 Completed updated Dec 20, 2021
- Condition
- Healthy Volunteers
- Sponsor / institution
- GH Research Ireland Limited
- Start date
- Jun 21, 2021
Tracker note / source boundary
ClinicalTrials.gov v2 sync on 2026-04-10 | Overall status: COMPLETED | Exact phase: Phase 1 | Lead sponsor: GH Research Ireland Limited | Conditions: Healthy Volunteers
Related updates
May 12, 2026 Trial Update Company
AtaiBeckley company release says BPL-003 Phase 3 ReConnection remains on track for Q2 2026, with ReConnection-1 ~350 and ReConnection-2 ~230, MADRS Week 4 primary, and 52-week OLE; VLS-01 Phase 2 Elumina topline is anticipated Q4 2026; EMP-01 oral R-MDMA Phase 2a in SAD showed company-described convergent improvements; cash/securities were $209.9M with runway into 2029.
Source/tracker note
Last checked 2026-05-16 UTC. Claim boundary: company-reported pipeline/capitalization and Phase 3-design tracker only; not approval, label, reimbursement, access, independent efficacy/safety confirmation, or proof that planned Phase 3 studies will start/succeed. Keep BPL-003, VLS-01, and EMP-01 separate from unrelated CNPV/company-primary-pending items.
Mar 25, 2026 Publication Company
GH Research now has its randomized Phase 2b GH001 TRD data in a peer-reviewed journal, which is a stronger source layer than a topline press release alone. The cleaner claim is the Day 8 placebo-controlled antidepressant effect; the severity-independent remission analysis is post hoc and should be treated more cautiously.
Source/tracker note
GH001 vs Placebo in Patients with Treatment-Resistant Depression was published in JAMA Psychiatry. GH Research reiterates a -15.5 point placebo-adjusted MADRS reduction from baseline on Day 8 and says day-8 remission ranged from 53.9% to 63.6% across patients with 2 to at least 5 prior treatment failures.
Jan 5, 2026 Regulation Company
FDA lifted the GH001 IND clinical hold, allowing U.S. enrollment and giving GH Research a path to align a global Phase 3 program in TRD. The milestone matters, but the efficacy support still comes from earlier Phase 2b company-reported data rather than pivotal evidence.
Source/tracker note
GH001 cleared by FDA for U.S. clinical investigation, enabling U.S. subject enrollment. Company says global Phase 3 initiation is targeted for 2026 and cites prior Phase 2b data of a -15.5 placebo-adjusted MADRS reduction on Day 8 and 57.5% remission on Day 8.
Conditions touched
Bipolar II DisorderHealthy AdultHealthy ParticipantsHealthy VolunteersMild Cognitive Impairment; Anxiety State; Depression Anxiety DisorderPharmacokinetics in Healthy AdultsPharmacokinetics; Safety; TolerabilityPostpartum Depression, Postnatal DepressionPTSD - Post Traumatic Stress Disorder; Cognitive Dysfunction; Brain Trauma; Brain InjuriesTreatment Resistant DepressionTreatment Resistant Depression, Major Depressive Disorder, DepressionTreatment-resistant Depression