Trimetazidine

Overview

Trimetazidine is a piperazine derivative indicated for the symptomatic treatment of stable angina pectoris in patients inadequately controlled or intolerant to first line therapies. Trimetazidine has been studied as a treatment for angina pectoris since the late 1960s. Acidic conditions, caused by anaerobic metabolism and fatty acid oxidation, in response to myocardial ischemia, activate sodium-hydrogen and sodium-calcium antiport systems. The increased intracellular calcium decreases contractility. It is hypothesized that trimetazidine inhibits 3-ketoacyl coenzyme A thiolase, which decreases fatty acid oxidation but not glucose metabolism, preventing the acidic conditions that exacerbate ischemic injury. However, evidence for this mechanism is controversial. Trimetazidine is not FDA approved. However, it has been approved in France since 1978.

Indication

Trimetazidine is indicated for the symptomatic treatment of stable angina pectoris in patients inadequately controlled or intolerant to first line therapies.

Associated Conditions

Angina Pectoris
Chronic Stable Angina Pectoris
Tinnitus
Vertigo
Decreased visual acuity caused by Vascular Disorders

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
"The Effect of Trimetazidine on the Clinical Outcome of Acute Ischemic Stroke Patients"	2024/10/24	NCT06656442	Phase 3	Recruiting	Ain Shams University
Trimetazidine Efficacy in Attenuating Paclitaxel-Induced Peripheral Neuropathy	2024/06/14	NCT06459193	Phase 1	Completed	Minia University
Benefits of Trimetazidine in MASLD Patients	2023/11/21	NCT06140953	Phase 2	Completed	October 6 University
The Effect of Trimetazidine on Mitochondrial Function, Myocardial Performance, and Invasive Hemodynamics in Patients Diagnosed With Wild-Type Transthyretin Cardiac Amyloidosis	2022/12/01	NCT05633563	Phase 4	Completed	Steen Hvitfeldt Poulsen
Efficacy of Trimetazidine in Diabetic Patients	2022/09/27	NCT05556005	Phase 2	Recruiting	Ain Shams University
Allopurinol and Trimetazidine as a Preventive of Acute Kidney Injury in PCI Patients	2022/09/14	NCT05540184	Phase 4	Recruiting	Beni-Suef University
The Effects of TMZ on Diabetic Nephropathy	2021/12/07	NCT05147194	Phase 2	UNKNOWN	Tongji Hospital
Effect of Trimetazidine on Radiotherapy-induced Heart Damage.	2021/06/25	NCT04939857	Phase 2	UNKNOWN	Peking University Third Hospital
Targeting Metabolic Flexibility in Amyotrophic Lateral Sclerosis (ALS)	2021/03/09	NCT04788745	Phase 2	Completed	The University of Queensland
Prevention of Acute Myocardial Injury by Trimetazidine in Patients Hospitalized for COVID-19	2021/02/18	NCT04760821	Phase 2	UNKNOWN	Ministry of Health, Brazil

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
VASTAREL MR TABLET 35 mg	LES LABORATOIRES SERVIER INDUSTRIE, Kotra Pharma (M) Sdn Bhd	SIN12268P	TABLET, FILM COATED	35 mg	4/25/2003
TRIMEZEN MODIFIED-RELEASE TABLETS 35MG	Medreich Limited	SIN16614P	TABLET, FILM COATED, EXTENDED RELEASE	35mg	9/28/2022
METAZIN TABLET 20 mg	DAE HAN NEW PHARM. CO. LTD.	SIN11667P	TABLET, FILM COATED	20 mg	9/21/2001
VASTAREL XR EXTENDED-RELEASE HARD CAPSULE 80 mg	Egis Pharmaceuticals PLC (Production site of Körmend), Egis Pharmaceuticals PLC (Production site of Bökényföld) (primary and secondary packager)	SIN15877P	CAPSULE, EXTENDED RELEASE	80 mg	1/20/2020
METAGARD TABLET 20 mg	IPCA LABORATORIES LTD	SIN11607P	TABLET, FILM COATED	20 mg	8/3/2001
MAXCARD MODIFIED RELEASE TABLETS 35MG	USV Private Limited	SIN15092P	TABLET, FILM COATED, EXTENDED RELEASE	35mg	9/28/2016
VASTAREL TABLET 20 mg	LES LABORATOIRES SERVIER INDUSTRIE	SIN01673P	TABLET, FILM COATED	20 mg	6/8/1988

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Trimetazidine Hydrochloride Capsules	北京嘉林药业股份有限公司	国药准字H20080433	化学药品	胶囊剂	3/23/2023
Trimetazidine Hydrochloride Capsules	海南锦麟医药科技有限公司	国药准字H20100145	化学药品	胶囊剂	9/4/2020
Trimetazidine Dihydrochloride Sustained-release Tablets	江苏吴中医药集团有限公司苏州制药厂	国药准字H20213906	化学药品	片剂	11/30/2021
Trimetazidine Dihydrochloride Sustained-release Tablets	瑞阳制药股份有限公司	国药准字H20243573	化学药品	片剂	4/24/2024
Trimetazidine Dihydrochloride Sustained-release Tablets	北大医药股份有限公司	国药准字H20203452	化学药品	片剂	9/2/2020
Trimetazidine Dihydrochloride Sustained-release Tablets	石家庄市华新药业有限责任公司	国药准字H20223951	化学药品	片剂	5/22/2023
Trimetazidine Dihydrochloride Sustained-release Tablets	湖南明瑞制药股份有限公司	国药准字H20213446	化学药品	片剂	6/1/2021
Trimetazidine Dihydrochloride Sustained-release Tablets	合肥立方制药股份有限公司	国药准字H20213628	化学药品	片剂	8/3/2021
Trimetazidine Dihydrochloride Sustained-release Tablets	深圳翰宇药业股份有限公司;甘肃成纪生物药业有限公司	国药准字H20193188	化学药品	片剂	6/24/2019
Trimetazidine Dihydrochloride Sustained-release Tablets	施维雅（天津）制药有限公司	国药准字H20100077	化学药品	片剂	12/5/2019

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
TRIVEDON MR EXTENDED RELEASE TABLETS 35MG	N/A	CONTROLLED MEDICATIONS LIMITED	N/A	N/A	12/9/2014

TGA Drug Approvals

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

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