Clinical Trials

Multiple early-phase clinical trials evaluate the therapeutic and physiological effects of harmine across psychiatric, metabolic, and healthy volunteer cohorts. Sponsored by academic institutions and specialized research organizations, these investigations focus on indications including major depression, diabetes mellitus, neuropharmacological imaging of ayahuasca constituents, prosocial dynamics, and dose-safety profiles. Current trial statuses encompass both completed and actively recruiting studies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06252506 COMPLETED
Neuropharmacological Investigation of Ayahuasca Constituents DMT and Harmine
Insel Gruppe AG, University Hospital Bern
 2024-01-22 PHASE1
NCT06252506 Recruiting
Neuropharmacological Investigation of Ayahuasca Constituents DMT and Harmine
Insel Gruppe AG University Hospital Bern|Psychiatric University Hospital Zurich
 2024-01-22 Phase 1
NCT05829603 COMPLETED
Healthy
Reconnect Labs
 2023-05-05 PHASE1
NCT05780216 COMPLETED
Healthy Participants
Milan Scheidegger
 2023-02-20 EARLY_PHASE1
NCT05526430 COMPLETED
Diabetes Mellitus
James Murrough
 2022-09-13 PHASE1
NCT04716335 COMPLETED
Emotions; Mood; Cognitive Function 1, Social; Empathy
Psychiatric University Hospital, Zurich
 2020-12-01 EARLY_PHASE1

(data from https://clinicaltrials.gov, updated on 2025-03-19)

Check the Harmine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Harmine selectively binds to the ATP-binding pocket of dual-specificity tyrosine-phosphorylation-regulated kinase 1A (DYRK1A) and inhibits monoamine oxidase A (MAO-A), suppressing downstream substrate phosphorylation and neurotransmitter catabolism. This modulation alters intracellular signaling cascades and enhances monoaminergic neurotransmission, providing the mechanistic rationale for clinical evaluation in major depression, emotional processing, and diabetes mellitus.

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>).

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Note: Technical data last updated: Sep 1, 2026.