{"id":"trimetazidine","rwe":[],"tags":[{"label":"trimetazidine","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"C01EB15","category":"atc"},{"label":"Active","category":"status"},{"label":"Angina pectoris","category":"indication"},{"label":"Cardiovascular Agents","category":"pharmacology"},{"label":"Vasodilator Agents","category":"pharmacology"}],"phase":"discontinued","safety":{"safetySignals":[{"llr":241.868,"date":"","count":150,"signal":"Cardiac failure","source":"DrugCentral FAERS","actionTaken":"Reported 150 times (LLR=242)"},{"llr":147.962,"date":"","count":56,"signal":"Rales","source":"DrugCentral FAERS","actionTaken":"Reported 56 times (LLR=148)"},{"llr":139.314,"date":"","count":34,"signal":"Stenosis","source":"DrugCentral FAERS","actionTaken":"Reported 34 times (LLR=139)"},{"llr":133.572,"date":"","count":40,"signal":"Dyspnoea at rest","source":"DrugCentral FAERS","actionTaken":"Reported 40 times (LLR=134)"},{"llr":127.019,"date":"","count":60,"signal":"Ejection fraction decreased","source":"DrugCentral FAERS","actionTaken":"Reported 60 times (LLR=127)"},{"llr":126.597,"date":"","count":43,"signal":"Diastolic dysfunction","source":"DrugCentral FAERS","actionTaken":"Reported 43 times (LLR=127)"},{"llr":113.973,"date":"","count":47,"signal":"Tricuspid valve incompetence","source":"DrugCentral FAERS","actionTaken":"Reported 47 times (LLR=114)"},{"llr":113.551,"date":"","count":63,"signal":"Angina pectoris","source":"DrugCentral FAERS","actionTaken":"Reported 63 times (LLR=114)"},{"llr":106.527,"date":"","count":19,"signal":"Pulmonary valve disease","source":"DrugCentral FAERS","actionTaken":"Reported 19 times (LLR=107)"},{"llr":100.463,"date":"","count":20,"signal":"Pericardial disease","source":"DrugCentral FAERS","actionTaken":"Reported 20 times (LLR=100)"},{"llr":88.887,"date":"","count":34,"signal":"Coronary artery stenosis","source":"DrugCentral FAERS","actionTaken":"Reported 34 times (LLR=89)"},{"llr":86.735,"date":"","count":15,"signal":"Hepatic vein dilatation","source":"DrugCentral FAERS","actionTaken":"Reported 15 times (LLR=87)"},{"llr":81.278,"date":"","count":57,"signal":"Acute myocardial infarction","source":"DrugCentral FAERS","actionTaken":"Reported 57 times (LLR=81)"},{"llr":80.776,"date":"","count":31,"signal":"Bundle branch block left","source":"DrugCentral FAERS","actionTaken":"Reported 31 times (LLR=81)"},{"llr":80.769,"date":"","count":15,"signal":"Liver palpable","source":"DrugCentral FAERS","actionTaken":"Reported 15 times (LLR=81)"}],"commonSideEffects":[{"effect":"Cardiac failure","drugRate":"LLR 242","severity":"common"},{"effect":"Rales","drugRate":"LLR 148","severity":"common"},{"effect":"Stenosis","drugRate":"LLR 139","severity":"common"},{"effect":"Dyspnoea at rest","drugRate":"LLR 134","severity":"common"},{"effect":"Ejection fraction decreased","drugRate":"LLR 127","severity":"common"},{"effect":"Diastolic dysfunction","drugRate":"LLR 127","severity":"common"},{"effect":"Tricuspid valve incompetence","drugRate":"LLR 114","severity":"common"},{"effect":"Angina pectoris","drugRate":"LLR 114","severity":"common"},{"effect":"Pulmonary valve disease","drugRate":"LLR 107","severity":"common"},{"effect":"Pericardial disease","drugRate":"LLR 100","severity":"common"},{"effect":"Hepatic vein dilatation","drugRate":"LLR 87","severity":"common"},{"effect":"Acute myocardial infarction","drugRate":"LLR 81","severity":"common"},{"effect":"Bundle branch block left","drugRate":"LLR 81","severity":"common"},{"effect":"Liver palpable","drugRate":"LLR 81","severity":"common"}]},"trials":[],"aliases":[],"patents":[],"pricing":[],"allNames":"vastarel","offLabel":[],"synonyms":["kyurinett","trimetazidine","vastarel","trimetazidine hydrochloride","trimetazidine dihydrochloride","trimetazidine HCl"],"timeline":[{"date":"1978-01-01","type":"positive","source":"DrugCentral","milestone":"YEAR INTRODUCED approval"}],"approvals":[{"date":"1978-01-01","orphan":false,"company":"","regulator":"YEAR INTRODUCED"}],"brandName":"Vastarel","ecosystem":[{"indication":"Angina pectoris","otherDrugs":[{"name":"amlodipine","slug":"amlodipine","company":"Pfizer"},{"name":"atenolol","slug":"atenolol","company":"Alvogen Ipco Sarl"},{"name":"atorvastatin","slug":"atorvastatin","company":"Pfizer"},{"name":"bepridil","slug":"bepridil","company":""}],"globalPrevalence":112000000}],"mechanism":{"modality":"Small Molecule","drugClass":"trimetazidine","explanation":"Imagine your heart as a car engine. Trimetazidine helps the engine run more efficiently, using less fuel (oxygen) to produce the same amount of power. This reduces the strain on the heart and helps alleviate symptoms of Angina pectoris.","oneSentence":"Trimetazidine works by optimizing the heart's energy production, reducing the amount of oxygen required by the heart muscle.","technicalDetail":"Trimetazidine is a metabolic modulator that inhibits long-chain 3-ketoacyl CoA thiolase (3-KAT), an enzyme involved in the regulation of fatty acid oxidation. By inhibiting 3-KAT, trimetazidine reduces the amount of energy required by the heart muscle, thereby improving cardiac efficiency and reducing symptoms of Angina pectoris."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Trimetazidine","title":"Trimetazidine","extract":"Trimetazidine is a drug used in the treatment of angina pectoris, a condition characterized by chest pain due to reduced blood flow to the heart. Developed and first marketed by Laboratoires Servier (France), it is described as the first cytoprotective anti-ischemic agent. Trimetazidine is an antianginal metabolic drug of the fatty acid oxidation inhibitor class; it shifts cardiac energy metabolism from fatty acid utilization toward glucose oxidation, thereby improving the efficiency of energy production in ischemic conditions."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/2750","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=TRIMETAZIDINE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=TRIMETAZIDINE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Trimetazidine","fields":["history","overview"],"source":"Wikipedia"}],"_enrichedAt":"2026-03-30T16:03:18.685921","biosimilars":[],"competitors":[{"drugName":"camphor","drugSlug":"camphor","fdaApproval":"","relationship":"same-class"},{"drugName":"indomethacin","drugSlug":"indomethacin","fdaApproval":"1965-06-10","patentExpiry":"Apr 23, 2030","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"ubidecarenone","drugSlug":"ubidecarenone","fdaApproval":"","relationship":"same-class"},{"drugName":"adenosine","drugSlug":"adenosine","fdaApproval":"1989-10-30","genericCount":15,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"ibuprofen","drugSlug":"ibuprofen","fdaApproval":"1974-09-19","patentExpiry":"Sep 30, 2029","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"ivabradine","drugSlug":"ivabradine","fdaApproval":"2015-04-15","patentExpiry":"Feb 22, 2026","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"ranolazine","drugSlug":"ranolazine","fdaApproval":"2006-01-27","patentExpiry":"Jan 24, 2038","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"regadenoson","drugSlug":"regadenoson","fdaApproval":"2008-04-10","patentExpiry":"Feb 2, 2027","patentStatus":"Patent 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2023"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"camphor","brandName":"camphor","genericName":"camphor","approvalYear":"","relationship":"same-class"},{"drugId":"indomethacin","brandName":"indomethacin","genericName":"indomethacin","approvalYear":"1965","relationship":"same-class"},{"drugId":"ubidecarenone","brandName":"ubidecarenone","genericName":"ubidecarenone","approvalYear":"","relationship":"same-class"},{"drugId":"adenosine","brandName":"adenosine","genericName":"adenosine","approvalYear":"1989","relationship":"same-class"},{"drugId":"ibuprofen","brandName":"ibuprofen","genericName":"ibuprofen","approvalYear":"1974","relationship":"same-class"},{"drugId":"ivabradine","brandName":"ivabradine","genericName":"ivabradine","approvalYear":"2015","relationship":"same-class"},{"drugId":"ranolazine","brandName":"ranolazine","genericName":"ranolazine","approvalYear":"2006","relationship":"same-class"},{"drugId":"regadenoson","brandName":"regadenoson","genericName":"regadenoson","approvalYear":"2008","relationship":"same-class"},{"drugId":"mavacamten","brandName":"mavacamten","genericName":"mavacamten","approvalYear":"2022","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT07325955","phase":"","title":"Effect of Long Term Trimetazidine Treatment on Final Myocardial Fibrosis for ST Eleviation Myocardial Infarction","status":"COMPLETED","sponsor":"Chinese PLA General Hospital","startDate":"2020-10-01","conditions":["ST Elevation Myocardial Infarction (STEMI)"],"enrollment":194,"completionDate":"2024-12-01"},{"nctId":"NCT07247071","phase":"","title":"Modifiable Risk Factors for Non-traumatic Subconjunctival Hemorrhage","status":"COMPLETED","sponsor":"Hallym University Kangnam Sacred Heart Hospital","startDate":"2022-12-22","conditions":["Subconjunctival Hemorrhage"],"enrollment":67,"completionDate":"2024-12-28"},{"nctId":"NCT04980716","phase":"PHASE3","title":"Early Specialized Cardiovascular Intervention Based on Impedance Cardiography in Locally Advanced Non-small Cell Lung Cancer Patients","status":"RECRUITING","sponsor":"Sun Yat-sen University","startDate":"2021-06-01","conditions":["Non-small Cell Lung Cancer","Cardiovascular 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Adjunct to Enhance Clopidogrel Response.","status":"COMPLETED","sponsor":"The University of The West Indies","startDate":"2018-07-01","conditions":["Platelet Dysfunction Due to Drugs"],"enrollment":24,"completionDate":"2019-04-01"},{"nctId":"NCT03273387","phase":"PHASE2,PHASE3","title":"The Role of Trimetazidine on Right Ventricle Function in Pulmonary Arterial Hypertension","status":"COMPLETED","sponsor":"Indonesia University","startDate":"2017-09-10","conditions":["Precapillary Pulmonary Hypertension"],"enrollment":26,"completionDate":"2018-12-14"},{"nctId":"NCT01857921","phase":"NA","title":"Combination Effects of High-dose Statin and Trimetazidine on Patients With Aspirin Mono Antiplatelet Therapy 12-months After Coronary Artery Bypass Surgery","status":"COMPLETED","sponsor":"Yonsei University","startDate":"2010-12","conditions":["Coronary Artery"],"enrollment":290,"completionDate":"2018-04-08"},{"nctId":"NCT03887013","phase":"PHASE4","title":"Cardiac Metabolic Modulator Treatment for Improvement of Diastolic Function in Patients With Coronary Heart Disease","status":"UNKNOWN","sponsor":"China National Center for Cardiovascular Diseases","startDate":"2019-03-25","conditions":["Coronary Heart Disease","Diastolic Dysfunction"],"enrollment":226,"completionDate":"2020-12"},{"nctId":"NCT03504202","phase":"NA","title":"Effect of Trimetazidine on the Improvement of Coronary Microvascular Dysfunction in Patients With INOCA(Ischemia and no Obstructive Coronary Artery Disease)","status":"UNKNOWN","sponsor":"Shanghai 10th People's Hospital","startDate":"2019-03-01","conditions":["Patients With INOCA(Ischemia and no Obstructive Coronary Artery Disease) Who Have Coronary Microvascular Dysfunction"],"enrollment":10,"completionDate":"2020-09-01"},{"nctId":"NCT03715582","phase":"PHASE3","title":"Trimetazidine in Myocardial Injury After Percutaneous Coronary Intervention in Patients With Angina and Diabetes","status":"UNKNOWN","sponsor":"University of Sao Paulo General 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University","startDate":"2017-07-18","conditions":["HCC"],"enrollment":300,"completionDate":"2021-07"},{"nctId":"NCT03072082","phase":"PHASE4","title":"Curative Effect Evaluation of Danlou Tablet on Coronary Artery Disease Not Amenable to Revascularization","status":"UNKNOWN","sponsor":"Jun Li","startDate":"2017-06","conditions":["Coronary Artery Disease(CAD)"],"enrollment":440,"completionDate":"2019-02"},{"nctId":"NCT03072121","phase":"PHASE4","title":"Curative Effect Evaluation of Shexiang Baoxin Pill on Coronary Artery Disease Not Amenable to Revascularization","status":"UNKNOWN","sponsor":"Jun Li","startDate":"2017-06","conditions":["Coronary Artery Disease(CAD)"],"enrollment":440,"completionDate":"2019-02"},{"nctId":"NCT02826616","phase":"NA","title":"Effect of Trimetazidine During the Primary PCI on Cardiac Function in Patients With ST-elevation Myocardial Infarction","status":"UNKNOWN","sponsor":"Chinese PLA General Hospital","startDate":"2016-07","conditions":["Cardiovascular Diseases"],"enrollment":240,"completionDate":""},{"nctId":"NCT02152527","phase":"","title":"Prospective Observational Study of Trimetazidine Influence on Mitochondrial Metabolism in Human Heart Ventricle","status":"COMPLETED","sponsor":"University of Split, School of Medicine","startDate":"2014-01","conditions":["Coronary Artery Disease"],"enrollment":55,"completionDate":"2015-04"},{"nctId":"NCT02102672","phase":"PHASE2","title":"Trimetazidine in Pulmonary Artery Hypertension","status":"UNKNOWN","sponsor":"Pontificia Universidad Catolica de Chile","startDate":"2014-03","conditions":["Pulmonary Artery Hypertension"],"enrollment":25,"completionDate":"2017-12"},{"nctId":"NCT01696370","phase":"PHASE2","title":"Trimetazidine Therapy in Hypertrophic Cardiomyopathy","status":"UNKNOWN","sponsor":"University College, London","startDate":"2012-04","conditions":["Hypertrophic Cardiomyopathy"],"enrollment":90,"completionDate":"2014-04"},{"nctId":"NCT00282360","phase":"PHASE4","title":"Effect of Metabolic Therapy in Patients With Chronic Ischemic Heart Disease","status":"COMPLETED","sponsor":"IRCCS San Raffaele","startDate":"1999-02","conditions":["Coronary Artery Disease","Type II Diabetes 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class. It is used to treat Angina pectoris, a condition characterized by chest pain due to reduced blood flow to the heart. The commercial status of Vastarel is not specified, but it is likely patented. Key safety considerations include unknown half-life, bioavailability, and potential side effects. As a treatment for Angina pectoris, Vastarel is likely to be used in patients with a history of heart disease.","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"OTHER","regulator":"YEAR INTRODUCED","status":"approved","approval_date":"1978-01-01T00:00:00.000Z","mah":"","brand_name_local":null,"application_number":""}],"trialStats":{"total":2,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}