Harmine Hydrochloride (Telepathine) Clinical Trials

Size	Price	Qty
25mg	USD 217
1g	USD 1,970

Clinical Trials

Several clinical trials evaluate harmine hydrochloride, focusing on early-stage human research across Early Phase 1 and Phase 1 studies. Predominantly completed and sponsored by academic and clinical institutions such as the Psychiatric University Hospital Zurich and the Medical University of Vienna, these trials evaluate major depression, diabetes mellitus, ayahuasca constituents, and emotional and cognitive functions in healthy participants. Together, these investigations target both metabolic indications and central nervous system pathways, illustrating the broad therapeutic exploration of this alkaloid.

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
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 Hydrochloride (Telepathine) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Harmine acts as a cell-permeant, competitive inhibitor of ATP binding to dual-specificity tyrosine-phosphorylation-regulated kinase 1A (DYRK1A) and monoamine oxidases, thereby blocking downstream substrate phosphorylation and monoamine oxidation. This inhibition modulates central neurotransmission and cellular metabolic pathways, underlying its clinical evaluation in major depression, cognitive function, 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>).