Tranylcypromine HCl Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 670

Clinical Trials

Numerous clinical trials evaluate Tranylcypromine across Phases 1 through 4 and unassigned protocol stages, featuring completed, terminated, and unknown recruitment statuses. Research spans psychiatric, cardiovascular, and hematologic disorders, including major depressive disorder, treatment-resistant depression, bipolar disorder, autonomic failure with orthostatic hypotension, acute myeloid leukemia, and myelodysplastic syndrome. Sponsored by academic, psychiatric, and government institutions—such as Duke University, Vanderbilt University, the Centre for Addiction and Mental Health, and the National Institute of Mental Health—these evaluations highlight the compound's application in both oncologic combinatory regimens and neuro-psychiatric target binding assessments.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04841798	Completed	Major Depressive Disorder\|Treatment Resistant Depression	Centre for Addiction and Mental Health	2021-04-15	Not Applicable
NCT02717884	UNKNOWN	Acute Myeloid Leukemia; Myelodysplastic Syndrome	Michael Luebbert	2015-05	PHASE1; PHASE2
NCT02273102	COMPLETED	Acute Myelogenous Leukemia; Myelodysplastic Syndromes; Leukemia	University of Miami	2015-03-02	PHASE1
NCT02261779	UNKNOWN	AML	Martin-Luther-Universität Halle-Wittenberg	2014-09	PHASE1; PHASE2
NCT02374567	TERMINATED	Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders	Hannover Medical School	2015-01	PHASE3
NCT00223691	COMPLETED	Autonomic Failure; Orthostatic Hypotension	Vanderbilt University	2002-03	PHASE1
NCT01896349	UNKNOWN	Treatment Resistant Depression	Hospital de Clinicas de Porto Alegre	2013-04
NCT01430455	COMPLETED	Bipolar Disorder I or II	New York State Psychiatric Institute	2011-11	PHASE4
NCT01031810	TERMINATED	Major Depressive Disorder	New York State Psychiatric Institute	2009-11	PHASE4
NCT00612807	COMPLETED	Major Depressive Disorder; Partner Relational Disorder (V61.10)	Duke University	2006-07	PHASE1; PHASE2
NCT00296686	TERMINATED	Major Depression	New York State Psychiatric Institute	2001-09	PHASE4
NCT00653393	COMPLETED	To Determine the Bioavailability of Tranylcypromine	Par Pharmaceutical, Inc.	2004-10	PHASE1
NCT00012558	COMPLETED	Bipolar Disorder	National Institute of Mental Health (NIMH)	1998-09
NCT00021528	COMPLETED	Depression	National Institute of Mental Health (NIMH)	2001-07	PHASE4
NCT00177567	COMPLETED	Bipolar Disorder	University of Pittsburgh	2001-07	PHASE4

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tranylcypromine binds to and inhibits monoamine oxidase as well as CYP2A6, blocking the enzymatic degradation of monoamine neurotransmitters and disrupting downstream catabolic pathways. The resulting elevation in synaptic levels of serotonin, norepinephrine, and dopamine enhances central neurosignaling, which underlines its therapeutic relevance in clinical trial conditions such as major depressive disorder, bipolar depression, and acute myeloid leukemia.

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>).