Product Description
GH-001, also know as 5 Methoxy N,N Dimethyltryptamine, which is a clinical drug candidate for the treatment of depression. (Sourced from: https://clinicaltrials.gov/ct2/show/NCT04698603?term=GH-001&draw=2&rank=1)
Mechanisms of Action: 5-HT1A Agonist, 5-HT2A Agonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Inhalant
FDA Designation: *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Company: GH Research
Company Location: Europe
Company Founding Year: None
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Czech Republic, Germany, Ireland, Netherlands, Poland, Spain, United Kingdom, United States
Active Clinical Trial Count: 5
Recent & Upcoming Milestones
- Clinical Outcomes Expected - GH Research announced they will present P2 Depressive Disorder, Treatment-Resistant results on 2026-06-27 for Mebufotenin
- Clinical Outcomes Reported - GH Research presented P2 Depression, Postpartum results on 2026-06-04 for Mebufotenin
- Clinical Outcomes Reported - GH Research presented P2 Depressive Disorder, Treatment-Resistant results on 2026-05-26 for Mebufotenin
Highest Development Phases
Phase 2: Depressive Disorder|Depressive Disorder, Treatment-Resistant
Phase 1: Healthy Volunteers
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT05800860 |
GH001-TRD-201 | P2 |
Completed |
Depressive Disorder, Treatment-Resistant |
2024-10-04 |
50% |
2025-06-03 |
Patient Enrollment|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
2021-006879-42 |
2021-006879-42 | P2 |
Completed |
Depressive Disorder |
2024-02-29 |
2025-05-06 |
Treatments|Trial Status |
|
NCT07540494 |
GH001-HV-109 | P1 |
Not yet recruiting |
Healthy Volunteers |
2026-05-01 |
50% |
2026-04-23 |
Primary Endpoints|Treatments |
NCT06511947 |
GH001-HV-106-2 | P1 |
Recruiting |
Healthy Volunteers |
2025-02-01 |
50% |
2024-10-16 |
Primary Endpoints|Treatments |
2023-510047-37-00 |
GH001-TRD-201 | P2 |
Completed |
Depressive Disorder, Treatment-Resistant |
2025-03-11 |
2025-05-02 |