Clinical Trials

Multiple clinical trials spanning Phase 1 through Phase 4 have evaluated tranylcypromine across psychiatric, cardiovascular, and oncologic indications, including major depressive disorder, bipolar depression, autonomic failure with orthostatic hypotension, and acute myeloid leukemia. Sponsored by academic, governmental, and pharmaceutical organizations, these studies have explored combination regimens and biomarker predictors of treatment response. The trial landscape encompasses completed, terminated, and unknown recruitment statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
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 2018-10-18)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tranylcypromine sulfate irreversibly binds to and inhibits monoamine oxidase, thereby blocking the oxidative breakdown of monoamine neurotransmitters and elevating synaptic levels of serotonin, norepinephrine, and dopamine. This neurochemical modulation reinstates balanced central neurotransmission, providing the therapeutic rationale for its clinical utility in treating major depressive disorder, bipolar depression, and non-M3 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>).

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