Probucol

Overview

A drug used to lower LDL and HDL cholesterol yet has little effect on serum-triglyceride or VLDL cholesterol. (From Martindale, The Extra Pharmacopoeia, 30th ed, p993).

Indication

Used to lower LDL and HDL cholesterol.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Expanded Access Program for R007 (Probucol) Tablets in Adults With Mitochondrial Disease and Chronic Kidney Disease	2025/04/17	NCT06931834	N/A	AVAILABLE	RiboNova Inc.
Efficacy of Probucol Combined with Statins Treatment for Ischemic Stroke	2024/09/19	NCT06604117	N/A	Recruiting	Xuanwu Hospital, Beijing
Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis	2024/01/26	NCT06225752	Phase 3	Recruiting	First Affiliated Hospital of Wannan Medical College
The Effect of InTensive Statin in Ischemic Stroke With inTracranial Atherosclerotic Plaques	2018/11/27	NCT03753555	Phase 4	Recruiting	General Hospital of Shenyang Military Region
Dosage and Efficacy of Probucol-induced apoE to Negate Cognitive Deterioration	2016/03/14	NCT02707458	Phase 1	Completed	Douglas Mental Health University Institute
PreventIon of IMT Progression in iSchemic Stroke Patients With High Risk of Cerebral HemOrrhage-IMT Study	2015/06/26	NCT02483169	Phase 4	UNKNOWN	Asan Medical Center
Efficacy and Safety Study of Probucol in Patients With Diabetic Nephropathy	2012/11/15	NCT01726816	Phase 2	Completed	Korea Otsuka Pharmaceutical Co., Ltd.
Pharmacokinetics and Safety Study of Probucol by Multiple Administration in Healthy Male Subjects	2012/05/03	NCT01590901	Phase 1	Completed	Otsuka Beijing Research Institute
Efficacy and Safety of Imported Probucol to Treat Hyperlipidemia	2011/05/06	NCT01349010	Phase 3	Completed	Otsuka Beijing Research Institute
Effect of Probucol and/or Cilostazol on Mean IMT in Patients With Coronary Heart dIsease	2011/02/08	NCT01291641	Phase 4	Completed	Seoul National University Hospital

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Probucol Tablets	颈复康药业集团有限公司	国药准字H10960161	化学药品	片剂	4/21/2020
Probucol Tablets	山东齐鲁制药有限公司	国药准字H20237019	化学药品	片剂	2/10/2023
Probucol Tablets	山东齐鲁制药有限公司	国药准字H10980054	化学药品	片剂	9/23/2019

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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