Multiple clinical trials spanning Phase 1, Phase 2, and Phase 3 evaluate tryptamine-related monoaminergic and psychedelic compounds for diverse indications, including major depressive disorder, acute ischemic stroke, myocardial infarction, alveolar bone loss, and wound healing. Sponsored by academic institutions such as Yale University and University Hospital Basel alongside commercial entities like Algernon Pharmaceuticals, these active, recruiting, completed, and terminated studies assess safety, pharmacokinetics, and dose escalation in healthy volunteers and clinical cohorts.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06927076 | RECRUITING | Major Depressive Disorder; Psychedelic Experiences |
University Hospital, Basel, Switzerland |
2025-08-05 | |
| NCT04711915 | ACTIVE_NOT_RECRUITING | Major Depressive Disorder; Depression |
Yale University |
2021-03-17 | PHASE1 |
| NCT07540494 | NOT_YET_RECRUITING | Healthy Adult |
GH Research Ireland Limited |
2026-04 | PHASE1 |
| NCT05559931 | ACTIVE_NOT_RECRUITING | Stroke |
Algernon Pharmaceuticals |
2023-01-13 | PHASE1 |
| NCT06252506 | COMPLETED | Neuropharmacological Investigation of Ayahuasca Constituents DMT and Harmine |
Insel Gruppe AG, University Hospital Bern |
2024-01-22 | PHASE1 |
| NCT05753956 | COMPLETED | Healthy Volunteers |
GH Research Ireland Limited |
2022-12-22 | PHASE1 |
| NCT05698095 | COMPLETED | Pharmacokinetics; Safety; Tolerability |
Usona Institute |
2022-12-27 | PHASE1 |
| NCT05901012 | COMPLETED | Safety Issues; Healthy Volunteers |
Universidade Federal do Rio Grande do Norte |
2023-04-26 | PHASE1 |
| NCT05122130 | UNKNOWN | Wound Heal |
Salma Nabil |
2021-11-20 | PHASE2 |
| NCT05163691 | COMPLETED | Healthy Volunteers |
GH Research Ireland Limited |
2021-06-21 | PHASE1 |
| NCT04229719 | UNKNOWN | Alveolar Bone Loss |
University of Baghdad |
2019-11-01 | PHASE3 |
| NCT04640831 | COMPLETED | Healthy Volunteers |
GH Research Ireland Limited |
2019-03-13 | PHASE1 |
| NCT01172171 | COMPLETED | Acute Myocardial Infarction; Ischemia-reperfusion Injury |
Herlev Hospital |
2013-06 | PHASE2 |
| NCT01355523 | TERMINATED | Breast Cancer; Depression |
Melissa Voigt Hansen |
2011-07 | PHASE2; PHASE3 |
(data from https://clinicaltrials.gov, updated on 2026-04-02)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).