Clinical Trials

Probucol is evaluated across numerous clinical trials for cardiovascular, metabolic, and neurodegenerative conditions, including severe hypercholesterolemia, atherosclerosis, brain ischemia, and Alzheimer's disease or age-related cognitive decline. These investigations encompass Phase 1 pharmacokinetic evaluations, Phase 2 proof-of-concept trials, Phase 3 efficacy assessments, and Phase 4 post-marketing surveillance studies. Sponsored by diverse academic institutions, medical centers, and pharmaceutical companies—including McGill University, Xuanwu Hospital, and Otsuka Pharmaceutical—overall recruitment statuses range from actively recruiting to completed.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03753555 RECRUITING
Stroke, Ischemic; Atherosclerosis, Cerebral
General Hospital of Shenyang Military Region
 2018-12-01 PHASE4
NCT06225752 RECRUITING
Ischemic Stroke; TIA
First Affiliated Hospital of Wannan Medical College
 2024-06-15 PHASE3
NCT03026465 COMPLETED
Coronary Artery Disease
Fundacion Investigacion Interhospitalaria Cardiovascular
 2017-02-16 PHASE4
NCT00655330 UNKNOWN
Type 2 Diabetes Mellitus; Nephropathy
Guangdong Provincial People's Hospital
 2008-05
NCT02707458 COMPLETED
Dementia of the Alzheimer Type; Age-related Cognitive Decline; Mild Cognitive Impairment Due to Alzheimer Disease
Douglas Mental Health University Institute
 2016-04 PHASE1; PHASE2
NCT01291641 COMPLETED
Hyperlipidemias
Seoul National University Hospital
 2011-03 PHASE4
NCT01013532 UNKNOWN
Brain Ischemia; Intracranial Hemorrhages
Asan Medical Center
 2009-06 PHASE4
NCT02483169 UNKNOWN
Brain Ischemia; Intracranial Hemorrhages
Asan Medical Center
 2009-06 PHASE4
NCT02707458 Completed
Dementia of the Alzheimer Type|Age-related Cognitive Decline|Mild Cognitive Impairment Due to Alzheimer Disease
Douglas Mental Health University Institute|Weston Brain Institute|McGill University
 2016-04 Phase 1|Phase 2
NCT02098460 COMPLETED
Severe Hypercholesterolemia
Otsuka Beijing Research Institute
 2013-10 PHASE4
NCT01726816 COMPLETED
Diabetic Nephropathy
Korea Otsuka Pharmaceutical Co., Ltd.
 2012-10 PHASE2
NCT02098460 Unknown status
Severe Hypercholesterolemia
Otsuka Beijing Research Institute
 2013-10 Phase 4
NCT00426348 COMPLETED
Glomerulonephritis; IGA Nephropathy
Guangdong Provincial People's Hospital
 2007-05 PHASE4
NCT01252056 COMPLETED
Diabetic Nephropathy
Otsuka Beijing Research Institute
 2010-03 PHASE4
NCT01142284 COMPLETED
Peripheral Artery Disease
Korea Otsuka Pharmaceutical Co., Ltd.
 2010-05-19 PHASE2
NCT01349010 COMPLETED
Hyperlipidemia
Otsuka Beijing Research Institute
 2011-04 PHASE3
NCT01590901 COMPLETED
Healthy
Otsuka Beijing Research Institute
 2012-02 PHASE1
NCT01031667 COMPLETED
Therapy
Yonsei University
 2009-11 PHASE4
NCT00598533 COMPLETED
Coronary Heart Disease
Deutsches Herzzentrum Muenchen
 2008-02 PHASE4
NCT00823875 COMPLETED
Atherosclerosis Cerebral Infarction
Otsuka Beijing Research Institute
 2009-03 PHASE4
NCT02196805 COMPLETED
Chinese Healthy Volunteers
Otsuka Beijing Research Institute
 2009-03
NCT01000467 COMPLETED
Healthy
Korea Otsuka Pharmaceutical Co., Ltd.
 2009-02 PHASE4
NCT00823849 COMPLETED
Type 2 Diabetes Mellitus; Arteriosclerosis Obliterans
Otsuka Beijing Research Institute
 2008-10 PHASE4
NCT00549978 COMPLETED
Healthy
Korea Otsuka Pharmaceutical Co., Ltd.
 2007-10 PHASE4
NCT00276133 COMPLETED
Chronic Nephropathy
Yokohama City University Medical Center
 2004-01 PHASE4

(data from https://clinicaltrials.gov, updated on 2026-04-27)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Probucol acts as an antihyperlipidemic agent that enhances the systemic catabolic rate of low-density lipoprotein (LDL) while simultaneously inhibiting lipid peroxidation within cellular membranes. By promoting hepatic LDL clearance and suppressing atherogenic lipid modifications, it limits vascular plaque accumulation and cellular oxidative stress, offering therapeutic relevance in clinical conditions such as hyperlipidemia, atherosclerosis, and cognitive impairment.

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.