{"id":"levosimendan","rwe":[{"pmid":"41892714","year":"2026","title":"Clinical Characteristics and Outcomes of 1894 Women with Peripartum Cardiomyopathy Treated with and Without Levosimendan in Germany.","finding":"","journal":"Journal of cardiovascular development and disease","studyType":"Clinical Study"},{"pmid":"41892507","year":"2026","title":"Preoperative Administration of Levosimendan to Prevent Low Cardiac Output Syndrome Following Pediatric Cardiac Surgery: A Retrospective Study.","finding":"","journal":"Clinics and practice","studyType":"Clinical Study"},{"pmid":"41890740","year":"2026","title":"Sepsis-induced cardiomyopathy: mechanisms, epidemiology, diagnosis, and treatments.","finding":"","journal":"Frontiers in immunology","studyType":"Clinical Study"},{"pmid":"41885778","year":"2026","title":"Performance of the LEVO-D score in patients with advanced heart failure at a referral hospital.","finding":"","journal":"Acta cardiologica","studyType":"Clinical Study"},{"pmid":"41879241","year":"2026","title":"[Inotropic therapy in outpatients with worsening or advanced heart failure: literature evidence and comparison of Italian management models].","finding":"","journal":"Giornale italiano di cardiologia (2006)","studyType":"Clinical Study"}],"tags":[{"label":"Moderate Risk QT Prolonging Agents","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Troponin C, slow skeletal and cardiac muscles","category":"target"},{"label":"TNNC1","category":"gene"},{"label":"KCNJ11","category":"gene"},{"label":"KCNJ8","category":"gene"},{"label":"C01CX08","category":"atc"},{"label":"Active","category":"status"},{"label":"Congestive heart failure","category":"indication"},{"label":"Cardiotonic Agents","category":"pharmacology"},{"label":"Cardiovascular Agents","category":"pharmacology"},{"label":"Enzyme Inhibitors","category":"pharmacology"},{"label":"Phosphodiesterase 3 Inhibitors","category":"pharmacology"},{"label":"Phosphodiesterase Inhibitors","category":"pharmacology"},{"label":"Protective Agents","category":"pharmacology"},{"label":"Vasodilator Agents","category":"pharmacology"}],"phase":"phase_3","safety":{"safetySignals":[{"llr":146.023,"date":"","count":24,"signal":"Lymphatic fistula","source":"DrugCentral FAERS","actionTaken":"Reported 24 times (LLR=146)"},{"llr":145.336,"date":"","count":24,"signal":"Femoral hernia incarcerated","source":"DrugCentral FAERS","actionTaken":"Reported 24 times (LLR=145)"},{"llr":136.834,"date":"","count":24,"signal":"Pancreatic steatosis","source":"DrugCentral FAERS","actionTaken":"Reported 24 times (LLR=137)"},{"llr":128.501,"date":"","count":24,"signal":"Wound infection pseudomonas","source":"DrugCentral FAERS","actionTaken":"Reported 24 times (LLR=129)"},{"llr":122.668,"date":"","count":25,"signal":"Arterial haemorrhage","source":"DrugCentral FAERS","actionTaken":"Reported 25 times (LLR=123)"},{"llr":115.096,"date":"","count":24,"signal":"Seroma","source":"DrugCentral FAERS","actionTaken":"Reported 24 times (LLR=115)"},{"llr":104.673,"date":"","count":34,"signal":"Tricuspid valve incompetence","source":"DrugCentral FAERS","actionTaken":"Reported 34 times (LLR=105)"},{"llr":102.582,"date":"","count":25,"signal":"Aortic valve stenosis","source":"DrugCentral FAERS","actionTaken":"Reported 25 times (LLR=103)"},{"llr":101.127,"date":"","count":25,"signal":"Haemarthrosis","source":"DrugCentral FAERS","actionTaken":"Reported 25 times (LLR=101)"},{"llr":95.346,"date":"","count":25,"signal":"Tachyarrhythmia","source":"DrugCentral FAERS","actionTaken":"Reported 25 times (LLR=95)"},{"llr":92.057,"date":"","count":24,"signal":"Hepatic cyst","source":"DrugCentral FAERS","actionTaken":"Reported 24 times (LLR=92)"},{"llr":90.283,"date":"","count":26,"signal":"Inflammatory marker increased","source":"DrugCentral FAERS","actionTaken":"Reported 26 times (LLR=90)"},{"llr":90.208,"date":"","count":24,"signal":"Wound dehiscence","source":"DrugCentral FAERS","actionTaken":"Reported 24 times (LLR=90)"},{"llr":89.038,"date":"","count":38,"signal":"Pulmonary hypertension","source":"DrugCentral FAERS","actionTaken":"Reported 38 times (LLR=89)"},{"llr":87.219,"date":"","count":25,"signal":"Diverticulum intestinal","source":"DrugCentral FAERS","actionTaken":"Reported 25 times (LLR=87)"}],"drugInteractions":[{"url":"/drug/high-risk-qt-prolonging-agents","drug":"High Risk QT Prolonging Agents","action":"Avoid combination","effect":"Moderate Risk QTc-Prolonging Agents may enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents","source":"DrugCentral","drugSlug":"high-risk-qt-prolonging-agents"}],"commonSideEffects":[{"effect":"Lymphatic fistula","drugRate":"LLR 146","severity":"common"},{"effect":"Femoral hernia incarcerated","drugRate":"LLR 145","severity":"common"},{"effect":"Pancreatic steatosis","drugRate":"LLR 137","severity":"common"},{"effect":"Wound infection pseudomonas","drugRate":"LLR 129","severity":"common"},{"effect":"Arterial haemorrhage","drugRate":"LLR 123","severity":"common"},{"effect":"Seroma","drugRate":"LLR 115","severity":"common"},{"effect":"Tricuspid valve incompetence","drugRate":"LLR 105","severity":"common"},{"effect":"Aortic valve stenosis","drugRate":"LLR 103","severity":"common"},{"effect":"Haemarthrosis","drugRate":"LLR 101","severity":"common"},{"effect":"Tachyarrhythmia","drugRate":"LLR 95","severity":"common"},{"effect":"Hepatic cyst","drugRate":"LLR 92","severity":"common"},{"effect":"Inflammatory marker increased","drugRate":"LLR 90","severity":"common"},{"effect":"Wound dehiscence","drugRate":"LLR 90","severity":"common"},{"effect":"Pulmonary hypertension","drugRate":"LLR 89","severity":"common"},{"effect":"Diverticulum intestinal","drugRate":"LLR 87","severity":"common"}]},"trials":[],"aliases":[],"patents":[],"pricing":[],"allNames":"simdax","offLabel":[],"synonyms":["levosimendan","(R)-Simendan","simdax"],"timeline":[],"approvals":[],"brandName":"Simdax","ecosystem":[{"indication":"Congestive heart failure","otherDrugs":[{"name":"acetyldigitoxin","slug":"acetyldigitoxin","company":"Novartis"},{"name":"enalapril","slug":"enalapril","company":"Valeant Pharms North"},{"name":"enalaprilat","slug":"enalaprilat","company":"Biovail Labs Intl"},{"name":"ubidecarenone","slug":"ubidecarenone","company":""}],"globalPrevalence":64000000}],"mechanism":{"target":"Troponin C, slow skeletal and cardiac muscles","targets":[{"gene":"TNNC1","source":"DrugCentral","target":"Troponin C, slow skeletal and cardiac muscles","protein":"Troponin C, slow skeletal and cardiac muscles"},{"gene":"KCNJ11","source":"DrugCentral","target":"ATP-sensitive inward rectifier potassium channel 11","protein":"ATP-sensitive inward rectifier potassium channel 11"},{"gene":"KCNJ8","source":"DrugCentral","target":"ATP-sensitive inward rectifier potassium channel 8","protein":"ATP-sensitive inward rectifier potassium channel 8"},{"gene":"PDE3A","source":"DrugCentral","target":"cGMP-inhibited 3',5'-cyclic phosphodiesterase A","protein":"cGMP-inhibited 3',5'-cyclic phosphodiesterase A"}],"modality":"Small Molecule","drugClass":"Moderate Risk QT Prolonging Agents","explanation":"Think of it like a key that unlocks the heart muscle, allowing it to work more efficiently without using more energy. This helps the heart pump more effectively, especially in people with heart failure. By doing so, it helps the heart work better without putting too much strain on it.","oneSentence":"Simdax works by binding to troponin C, increasing calcium sensitivity in cardiac muscle cells, allowing for improved heart function without increasing oxygen demand.","technicalDetail":"Levosimendan binds to troponin C, increasing the sensitivity of cardiac myofilaments to calcium, thereby enhancing cardiac contractility without increasing oxygen demand or causing significant increases in intracellular calcium levels."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Levosimendan","title":"Levosimendan","extract":"Levosimendan (INN) is a calcium sensitizer used in the management of acutely decompensated congestive heart failure. It is marketed under the trade name Simdax. Overall the drug has a two fold mechanism of action. It leads to greater inotropy by increasing the calcium sensitivity as it binds to troponin and this results in a greater positive inotrophic force. Secondly, the drug is able to open ATP-sensitive potassium channels in vascular smooth muscle cells, and the vascular dilatory effects of the drug lead to a decreased preload and afterload, putting less work on the heart. This drug is in the process of review by the FDA but has not been approved for use in the United States yet."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1576","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=LEVOSIMENDAN","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=LEVOSIMENDAN","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Levosimendan","fields":["history","overview"],"source":"Wikipedia"}],"_enrichedAt":"2026-03-30T12:20:33.961180","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T08:40:29.101553+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[{"drugName":"angiotensin II","drugSlug":"angiotensin-ii","fdaApproval":"2017-12-21","patentExpiry":"Nov 20, 2030","patentStatus":"Patent protected","relationship":"same-class"}],"genericName":"levosimendan","indications":{"approved":[{"name":"Congestive heart failure","source":"DrugCentral","snomedId":42343007,"regulator":"FDA","usPrevalence":6200000,"globalPrevalence":64000000,"prevalenceMethod":"curated","prevalenceSource":"ESC Heart Failure, 2023"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"angiotensin-ii","brandName":"angiotensin II","genericName":"angiotensin II","approvalYear":"2017","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT07436689","phase":"PHASE3","title":"Long-Term Open-Label Extension Study of Oral Levosimendan","status":"ENROLLING_BY_INVITATION","sponsor":"Tenax Therapeutics, Inc.","startDate":"2026-03-13","conditions":["Pulmonary Hypertension Associated With HFpEF"],"enrollment":800,"completionDate":"2029-03"},{"nctId":"NCT07288398","phase":"PHASE3","title":"LEVEL-2: LEVosimendan to Improve Exercise 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