Clinical Trials

Multiple Phase 1, Phase 3, and non-phased clinical trials have investigated tyramine's physiological effects in healthy volunteers and cohorts with conditions including autonomic nervous system disorders, orthostatic hypotension, dopamine beta-hydroxylase deficiency, Parkinson's disease, PKU carrier states, obesity, and major depressive disorder. Academic and industry sponsors—such as Vanderbilt University Medical Center, Celgene, Teva Branded Pharmaceutical Products, Boehringer Ingelheim, and Trius Therapeutics—have supported these studies. Protocol statuses encompass completed pressor challenge and Parkinson's sub-study trials, alongside actively recruiting, terminated, and unassigned protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06548048 UNKNOWN
Overweight; Obesity
Brightseed
 2024-07-31
NCT05958784 Recruiting
Autosomal Recessive Disorder (Genetic Carriers of PKU)
University of Guelph|McMaster University
 2023-07-01 Not Applicable
NCT04978298 COMPLETED
Healthy Volunteers
Celgene
 2021-07-19 PHASE1
NCT00748059 COMPLETED
Autonomic Nervous System Diseases; Orthostatic Hypotension; Dopamine Beta-Hydroxylase Deficiency; Orthostatic Intolerance
Vanderbilt University Medical Center
 1996-12 PHASE1
NCT03979820 TERMINATED
Healthy
Boehringer Ingelheim
 2019-07-31 PHASE1
NCT03694119 COMPLETED
Healthy Volunteer
Celgene
 2018-07-24 PHASE1
NCT01539473 COMPLETED
Healthy Volunteers
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
 2012-02 PHASE1
NCT01633437 COMPLETED
Major Depressive Disorder
CeNeRx BioPharma Inc.
 2010-09 PHASE1
NCT00203125 COMPLETED
Parkinson's Disease
Teva Branded Pharmaceutical Products R&D, Inc.
 2000-10 PHASE3

(data from https://clinicaltrials.gov, updated on 2024-08-12)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tyramine acts as a trace amine that enters presynaptic adrenergic neurons via membrane transporters, displacing endogenous catecholamines such as norepinephrine from storage vesicles into the synaptic cleft. The resulting surge in extracellular catecholamines stimulates vascular alpha-1 adrenergic receptors, inducing smooth muscle contraction and elevating systemic blood pressure, which provides the functional basis for its clinical application in evaluating orthostatic hypotension and pressor responsiveness during autonomic testing.

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.