Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 evaluate trimetazidine across diverse pathological conditions, including chronic heart failure, acute ischemic stroke, acute-on-chronic liver failure, amyotrophic lateral sclerosis, acute kidney injury, and hepatocellular carcinoma. Conducted by academic institutions, university hospitals, and commercial sponsors—including The University of Queensland, Ain Shams University, and Martin Pharmaceuticals—these investigations encompass various recruitment statuses, including completed, recruiting, suspended, and unknown states.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07794475 RECRUITING
Diabetic Peripheral Neuropathic Pain (DPN)
Sara Refaat Azab Metry
 2026-08-01 PHASE1; PHASE2
NCT05540184 UNKNOWN
AKI - Acute Kidney Injury
Beni-Suef University
 2022-09-19 PHASE4
NCT06656442 COMPLETED
Acute Ischemic Stroke
Ain Shams University
 2024-09-01 PHASE3
NCT06459193 COMPLETED
Peripheral Neuropathy Due to Chemotherapy
Minia University
 2024-06-23 PHASE1; PHASE2
NCT06140953 COMPLETED
Metabolic Associated Fatty Liver Disease
October 6 University
 2023-12-10 PHASE2
NCT05147194 UNKNOWN
Diabetic Nephropathies
Tongji Hospital
 2022-01-01 PHASE2
NCT05556005 UNKNOWN
Diabetes Mellitus, Type 2; Diabetic Cardiomyopathies
Ain Shams University
 2022-09-18 PHASE2
NCT05633563 COMPLETED
Transthyretin Amyloid Cardiopathy; Mitochondrial Pathology
Steen Hvitfeldt Poulsen
 2021-10-01 PHASE4
NCT04788745 COMPLETED
Amyotrophic Lateral Sclerosis; Motor Neuron Disease
The University of Queensland
 2021-06-29 PHASE2
NCT04661709 UNKNOWN
Coronary Heart Disease; Unstable Angina; Chinese Herbal Medicine
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
 2021-03-01 PHASE4
NCT02107144 COMPLETED
Coronary Artery Disease; Microcirculation; Vascular Resistance
Clinical Hospital Center Zemun
 2014-04 PHASE4
NCT07074834 COMPLETED
Coronary Heart Disease (CHD)
Shiyan City Renmin Hospital
 2021-02-01
NCT04939857 UNKNOWN
Cardiotoxicity
Peking University Third Hospital
 2021-06-25 PHASE2; PHASE3
NCT03278444 UNKNOWN
HCC
The First Affiliated Hospital of Zhengzhou University
 2017-07-18 PHASE3
NCT03274427 UNKNOWN
HCC
The First Affiliated Hospital of Zhengzhou University
 2017-07-18 PHASE3
NCT03737448 SUSPENDED
Acute-On-Chronic Liver Failure
Martin Pharmaceuticals
 2018-11-28 PHASE1
NCT04702906 UNKNOWN
Aluminum Phosphide Poisoning
Tanta University
 2021-02
NCT04760821 UNKNOWN
Acute Respiratory Distress Syndrome; Covid19; Myocardial Injury
Ministry of Health, Brazil
 2020-12-10 PHASE2
NCT03809273 COMPLETED
Percutaneous Coronary Intervention
Shenyang Northern Hospital
 2019-08-01 PHASE4
NCT03715582 UNKNOWN
Diabetes Mellitus; Angina, Unstable
University of Sao Paulo General Hospital
 2018-10-01 PHASE3
NCT03887013 UNKNOWN
Coronary Heart Disease; Diastolic Dysfunction
China National Center for Cardiovascular Diseases
 2019-03-25 PHASE4
NCT03504202 UNKNOWN
Patients With INOCA(Ischemia and no Obstructive Coronary Artery Disease) Who Have Coronary Microvascular Dysfunction
Shanghai 10th People's Hospital
 2019-03-01
NCT03603249 COMPLETED
Platelet Dysfunction Due to Drugs
The University of The West Indies
 2018-07-01 PHASE2
NCT03333499 UNKNOWN
Chronic Heart Failure
Dalian University
 2017-11-01 PHASE1
NCT03072082 UNKNOWN
Coronary Artery Disease(CAD)
Jun Li
 2017-06 PHASE4
NCT03072121 UNKNOWN
Coronary Artery Disease(CAD)
Jun Li
 2017-06 PHASE4
NCT03273387 COMPLETED
Precapillary Pulmonary Hypertension
Indonesia University
 2017-09-10 PHASE2; PHASE3
NCT01857921 COMPLETED
Coronary Artery
Yonsei University
 2010-12
NCT02826616 UNKNOWN
Cardiovascular Diseases
Chinese PLA General Hospital
 2016-07
NCT04511520 COMPLETED
Atrial Fibrillation Paroxysmal
National Research Center for Preventive Medicine
 2013-07
NCT02102672 UNKNOWN
Pulmonary Artery Hypertension
Pontificia Universidad Catolica de Chile
 2014-03 PHASE2
NCT01696370 UNKNOWN
Hypertrophic Cardiomyopathy
University College, London
 2012-04 PHASE2
NCT00282360 COMPLETED
Coronary Artery Disease; Type II Diabetes Mellitus
IRCCS San Raffaele
 1999-02 PHASE4

(data from https://clinicaltrials.gov, updated on 2026-08-31)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Trimetazidine dihydrochloride acts as an inhibitor of mitochondrial fatty acid beta-oxidation by targeting 3-ketoacyl-CoA thiolase, which shifts myocardial metabolic pathways toward glucose oxidation. This metabolic realignment optimizes cellular energy efficiency and maintains intracellular ATP levels under ischemic conditions, conferring cytoprotective benefits in clinical settings such as chronic heart failure and acute ischemic stroke.

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.