{"id":"entresto","rwe":[],"tags":[],"safety":{"boxedWarnings":["WARNING: FETAL TOXICITY When pregnancy is detected, discontinue ENTRESTO as soon as possible (5.1) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (5.1) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue ENTRESTO as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 )"],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[{"effect":"Hypotension","drugRate":"5%","severity":"common","organSystem":""},{"effect":"Hyperkalemia","drugRate":"5%","severity":"common","organSystem":""},{"effect":"Cough","drugRate":"5%","severity":"common","organSystem":""},{"effect":"Dizziness","drugRate":"5%","severity":"common","organSystem":""},{"effect":"Renal failure","drugRate":"5%","severity":"common","organSystem":""},{"effect":"Renal dysfunction","drugRate":"1.8%","severity":"common","organSystem":""},{"effect":"Orthostasis","drugRate":"2.1%","severity":"common","organSystem":""},{"effect":"Falls","drugRate":"1.9%","severity":"common","organSystem":""},{"effect":"Serum creatinine increase >50%","drugRate":"16%","severity":"common","organSystem":""},{"effect":"Hemoglobin/hematocrit decrease >20%","drugRate":"5%","severity":"common","organSystem":""}],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[{"effect":"Angioedema","drugRate":"0.5%","severity":"serious"},{"effect":"Angioedema in Black patients","drugRate":"2.4%","severity":"serious"}]},"trials":[],"_chembl":null,"aliases":["Entresto Tablets","Valsartan/sacubitril","valsartan/sacubitril","ARNI","Neprilysin inhibibitor"],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=Entresto","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:16:21.646339+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Entresto","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T01:16:29.158466+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:16:27.736894+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Entresto","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:16:28.513567+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL5315276/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:16:29.036460+00:00"}},"allNames":"lcz696","offLabel":[],"timeline":[],"_dailymed":{"setId":"000dc81d-ab91-450c-8eae-8eb74e72296f","title":"ENTRESTO (SACUBITRIL AND VALSARTAN) TABLET, FILM COATED ENTRESTO (SACUBITRIL AND VALSARTAN) PELLET [NOVARTIS PHARMACEUTICALS CORPORATION]"},"ecosystem":[],"mechanism":{"target":"Neprilysin (via LBQ657) and Angiotensin II Type-1 (AT1) receptor","modality":"Small molecule","drugClass":"Neprilysin Inhibitor/Angiotensin Receptor Blocker combination","explanation":"ENTRESTO is a dual-action agent combining sacubitril (a neprilysin inhibitor prodrug) and valsartan (an AT1 receptor antagonist). Sacubitril is metabolized to LBQ657, which inhibits neprilysin (neutral endopeptidase), preventing degradation of natriuretic peptides and other cardioprotective peptides. Simultaneously, valsartan selectively blocks AT1 receptors, inhibiting angiotensin II-mediated vasoconstriction and aldosterone release. This complementary mechanism increases beneficial peptide levels while suppressing the renin-angiotensin-aldosterone system, resulting in improved cardiovascular and renal hemodynamics in heart failure patients.","oneSentence":"ENTRESTO inhibits neprilysin to increase natriuretic peptides while blocking AT1 angiotensin II receptors to reduce angiotensin II effects in heart failure."},"_scrapedAt":"2026-03-27T23:29:22.782Z","_scrapedBy":"cloudflare-swarm","_wikipedia":{"url":"https://en.wikipedia.org/wiki/Sacubitril%2Fvalsartan","title":"Sacubitril/valsartan","extract":"Sacubitril/valsartan, sold under the brand name Entresto among others, is a fixed-dose combination medication for use in heart failure. It consists of the neprilysin inhibitor sacubitril and the angiotensin receptor blocker valsartan. The combination is sometimes described as an \"angiotensin receptor-neprilysin inhibitor\" (ARNi).\nIn 2016, the American College of Cardiology/American Heart Association Task Force recommended it as a replacement for an ACE inhibitor or an angiotensin receptor blocker in people with heart failure with reduced ejection fraction."},"references":[],"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:16:30.919572+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[],"dataSources":[],"indications":{"approved":[],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT05168787","phase":"","title":"Efficacy and Safety of Sacubitril/Valsartan in African American Patients With Heart Failure With Reduced Ejection Fraction","status":"COMPLETED","sponsor":"Methodist Health System","startDate":"2020-08-13","conditions":"Heart Failure","enrollment":6558},{"nctId":"NCT07491718","phase":"NA","title":"Manganese-enhanced Magnetic Resonance Imaging in Takotsubo Cardiomyopathy","status":"RECRUITING","sponsor":"University of Edinburgh","startDate":"2025-08-08","conditions":"Takotsubo Cardiomyopathy","enrollment":100},{"nctId":"NCT07486453","phase":"PHASE1","title":"Bioequivalence Study of Sacubitril Alisartan Amlodipine Tablets","status":"NOT_YET_RECRUITING","sponsor":"Shenzhen Salubris Pharmaceuticals Co., Ltd.","startDate":"2026-03-09","conditions":"Primary Hypertension","enrollment":60},{"nctId":"NCT04649229","phase":"PHASE4","title":"Mechanisms Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 3","status":"COMPLETED","sponsor":"Yale University","startDate":"2021-05-27","conditions":"Heart Failure","enrollment":46},{"nctId":"NCT05194111","phase":"PHASE1, PHASE2","title":"Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan","status":"RECRUITING","sponsor":"Virginia Commonwealth University","startDate":"2022-08-11","conditions":"Heart Failure, Heart Dysfunction","enrollment":53},{"nctId":"NCT07465679","phase":"","title":"A Real-world Study of Clinical Treatment Guidelines for Patients With Heart Failure With Reduced Ejection Fraction Treated With Sacubitril/Valsartan","status":"ACTIVE_NOT_RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2026-01-28","conditions":"Heart Failure With Reduced Ejection Fraction","enrollment":500},{"nctId":"NCT07465653","phase":"PHASE1","title":"A Safety and Tolerability Study of HJB647 in Heart Failure Participants With Reduced Ejection Fraction","status":"NOT_YET_RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2026-03-19","conditions":"Heart Failure With Reduced Ejection Fraction","enrollment":12},{"nctId":"NCT07465666","phase":"","title":"A Real-world Study of the Effectiveness of Angiotensin Receptor-Neprilysin Inhibitor Therapy in Hypertensive Patients in the United Arab Emirates","status":"NOT_YET_RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2026-04-01","conditions":"Hypertension","enrollment":500},{"nctId":"NCT04153136","phase":"PHASE2","title":"The ENCHANTMENT HIV Study","status":"COMPLETED","sponsor":"Massachusetts General Hospital","startDate":"2020-09-11","conditions":"HIV/AIDS, Heart Failure With Preserved Ejection Fraction","enrollment":39},{"nctId":"NCT07444398","phase":"PHASE1","title":"Vericiguat in Decompensated Cardiac Failure: Clinical Insights on Addition to Guidelines Derived Medical Therapy-VERCIG Trial","status":"RECRUITING","sponsor":"Khawaja Danish Ali","startDate":"2026-01-01","conditions":"Decompensated Heart Failure","enrollment":130},{"nctId":"NCT06536309","phase":"PHASE4","title":"Neprilysin Inhibition to Reduce Myocardial Fibrosis in Heart Failure With Preserved Ejection Fraction","status":"NOT_YET_RECRUITING","sponsor":"Brigham and Women's Hospital","startDate":"2026-07","conditions":"Heart Failure With Preserved Ejection Fraction, Myocardial Fibrosis","enrollment":36},{"nctId":"NCT07417215","phase":"PHASE4","title":"The Effect of Sacubitril and Valsartan on Heart Function in Chronic Hemodialysis Patients With HFpEF","status":"NOT_YET_RECRUITING","sponsor":"University Clinical Hospital Mostar","startDate":"2026-01-30","conditions":"Heart Failure With Preserved Ejection Fraction (HFPEF), Hemodialysis, Sacubitril/Valsartan","enrollment":60},{"nctId":"NCT05528419","phase":"PHASE4","title":"Sacubitril Valsartan in Preventing the Recurrence of Atrial Fibrillation After Ablation in Elderly Hypertensive Patients With Atrial Fibrillation","status":"COMPLETED","sponsor":"Shanghai Jiao Tong University School of Medicine","startDate":"2023-02-06","conditions":"Atrial Fibrillation Recurrent, Hypertension","enrollment":320},{"nctId":"NCT07376265","phase":"","title":"A Real-world Study to Compare the Effectiveness of Sacubitril/Valsartan Versus ACEi/ARB in HFrEF Patients","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2023-10-20","conditions":"Heart Failure","enrollment":1249},{"nctId":"NCT07379788","phase":"","title":"ARNI Combined With SGLT2 Inhibitors on Functional Mitral Regurgitation Remodeling","status":"RECRUITING","sponsor":"Rehab Werida","startDate":"2025-12-25","conditions":"Heart Failure","enrollment":180},{"nctId":"NCT03872778","phase":"PHASE1, PHASE2","title":"[177Lu]-NeoB in Patients With Advanced Solid Tumors and With [68Ga]-neoB Lesion Uptake","status":"COMPLETED","sponsor":"Advanced Accelerator Applications","startDate":"2019-05-24","conditions":"Neoplasms","enrollment":35},{"nctId":"NCT06142383","phase":"PHASE2","title":"A Proof of Concept and Dose-finding Study of XXB750 in Patients With Heart Failure","status":"TERMINATED","sponsor":"Novartis Pharmaceuticals","startDate":"2023-12-12","conditions":"Heart Failure","enrollment":136},{"nctId":"NCT07347925","phase":"","title":"Effect of Pre-Hospital ARNI Therapy on Short-Term Outcomes in HFrEF","status":"RECRUITING","sponsor":"Future University in Egypt","startDate":"2026-01-10","conditions":"Heart Failure","enrollment":140},{"nctId":"NCT07341893","phase":"NA","title":"Sacubitril-valsartan in Patients With Heart Failure.","status":"RECRUITING","sponsor":"Damanhour University","startDate":"2025-08-01","conditions":"Heart Failure","enrollment":60},{"nctId":"NCT06237309","phase":"PHASE2","title":"REGN5381 in Adult Participants With Heart Failure With Reduced Ejection Fraction","status":"TERMINATED","sponsor":"Regeneron Pharmaceuticals","startDate":"2024-04-11","conditions":"Heart Failure","enrollment":89},{"nctId":"NCT07335900","phase":"NA","title":"A Clinical Study Using FAPI-PET Imaging to Assess the Postoperative Effects of TAVI in Patients With Aortic Stenosis","status":"RECRUITING","sponsor":"RenJi Hospital","startDate":"2025-12-19","conditions":"Severe Aortic Valve Stenosis","enrollment":25},{"nctId":"NCT06236061","phase":"PHASE3","title":"Study of Efficacy and Safety of LCZ696/Amlodipine in Grade 1 and 2 Hypertension Patients Uncontrolled by LCZ696 Monotherapy","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2024-04-08","conditions":"Hypertension","enrollment":718},{"nctId":"NCT06029712","phase":"PHASE2","title":"Heart Failure Polypill at a Safety Net Hospital","status":"COMPLETED","sponsor":"University of California, San Francisco","startDate":"2024-02-27","conditions":"Heart Failure With Reduced Ejection Fraction, HIV Infections","enrollment":35},{"nctId":"NCT05764057","phase":"PHASE3","title":"DAPAgliflozine to Attenuate Cardiac RemOdeling afTEr aCuTe myOcardial Infarction","status":"RECRUITING","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2023-06-12","conditions":"AMI, STEMI, NSTEMI","enrollment":450},{"nctId":"NCT05991284","phase":"PHASE4","title":"Sacubitril-Valsartan in Heart Failure With Preserved Ejection Fraction and Secondary Mitral Valve Regurgitation","status":"ACTIVE_NOT_RECRUITING","sponsor":"Ziekenhuis Oost-Limburg","startDate":"2024-02-29","conditions":"Heart Failure With Preserved Ejection Fraction, Functional Mitral Regurgitation","enrollment":84},{"nctId":"NCT03744975","phase":"PHASE2","title":"PDD in Type 2 Diabetes w/wo Diastolic Dysfunction","status":"COMPLETED","sponsor":"Mayo Clinic","startDate":"2018-05-01","conditions":"Diabetes Mellitus, Type 2, Diastolic Dysfunction","enrollment":72},{"nctId":"NCT06643819","phase":"PHASE3","title":"Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-202A","status":"RECRUITING","sponsor":"Chong Kun Dang Pharmaceutical","startDate":"2024-10-14","conditions":"Essential Hypertension","enrollment":324},{"nctId":"NCT05498181","phase":"PHASE2","title":"Angiotensin-Neprilysin Inhibition in Hemodialysis Initiation","status":"RECRUITING","sponsor":"Brigham and Women's Hospital","startDate":"2022-10-11","conditions":"Hemodialysis","enrollment":100},{"nctId":"NCT07241338","phase":"PHASE4","title":"Sacubitril/Allisartan for Hypertensive Patients With Overweight or Obesity","status":"NOT_YET_RECRUITING","sponsor":"Jing Liu","startDate":"2025-11","conditions":"Hypertension","enrollment":104},{"nctId":"NCT05989503","phase":"PHASE4","title":"Initiation of ARNi and SGLT2i in Patients With HFrEF","status":"COMPLETED","sponsor":"Universidade do Porto","startDate":"2023-08-04","conditions":"Heart Failure With Reduced Ejection Fraction","enrollment":62},{"nctId":"NCT04023227","phase":"PHASE4","title":"Efficacy and Safety of Sacubitril/Valsartan Compared With Enalapril on Morbidity, Mortality, and NT-proBNP Change in Patients With CCC","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2019-12-10","conditions":"Chagas Disease, Heart Failure","enrollment":918},{"nctId":"NCT07232966","phase":"PHASE3","title":"Perirenal Adipose Tissue Modification Therapy for Resistant Hypertension","status":"NOT_YET_RECRUITING","sponsor":"Yan Li","startDate":"2025-11-20","conditions":"Resistant Hypertension","enrollment":220},{"nctId":"NCT06149104","phase":"PHASE3","title":"A Safety Study of Sacubitril/Valsartan in Japanese Pediatric Patients With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction Who Have Completed CLCZ696B2319E1 Study","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2023-12-04","conditions":"Heart Failure","enrollment":8},{"nctId":"NCT05279742","phase":"PHASE1, PHASE2","title":"Enhancing the Natriuretic Peptide System in HFpEF","status":"ENROLLING_BY_INVITATION","sponsor":"Horng Chen","startDate":"2022-11-04","conditions":"Heart Failure With Preserved Ejection Fraction, Chronic Kidney Diseases","enrollment":60},{"nctId":"NCT06697353","phase":"","title":"An Observational Study to Learn More About the Real-world Outcomes in Patients With Heart Failure Who Initiate Treatment With Vericiguat in Japan","status":"COMPLETED","sponsor":"Bayer","startDate":"2024-11-01","conditions":"Chronic Heart Failure, Chronic Heart Failure With Reduced Ejection Fraction","enrollment":4936},{"nctId":"NCT06693674","phase":"PHASE3","title":"Effect of Sacubitril-Valsartan on Cardiac Structure and Function","status":"RECRUITING","sponsor":"Mayo Clinic","startDate":"2025-02-03","conditions":"Congenital Heart Disease","enrollment":45},{"nctId":"NCT07192341","phase":"NA","title":"Sacubitril/Valsartan in Patients With Prosthetic Heart Valves With Heart Failure and Reduced Ejection Fraction","status":"RECRUITING","sponsor":"Kafrelsheikh University","startDate":"2025-09-27","conditions":"Sacubitril/Valsartan, Prosthetic Heart Valve, Heart Failure","enrollment":220},{"nctId":"NCT07197372","phase":"","title":"Comparative Efficacy of ARNI Versus ACE Inhibitor Therapy in Egyptian Children With Dilated Cardiomyopathy","status":"NOT_YET_RECRUITING","sponsor":"Assiut University","startDate":"2026-05-30","conditions":"ARNI, Pediatric Dilated Cardiomyopathy, ACE Inhibitor","enrollment":70},{"nctId":"NCT06659393","phase":"","title":"Entresto Tablets and Granules for Pediatric Specified Drug-use Survey (Pediatric Chronic Heart Failure)","status":"RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2024-12-19","conditions":"Pediatric Chronic Heart Failure","enrollment":33},{"nctId":"NCT03508739","phase":"PHASE3","title":"Glucagon-like Peptide-1 Metabolism and Acute Neprilysin Inhibition","status":"SUSPENDED","sponsor":"University of Pennsylvania","startDate":"2018-06-01","conditions":"Diabetes Mellitus, Type 2, Pre-diabetic, Hypertension","enrollment":25},{"nctId":"NCT07157527","phase":"","title":"Impact of Sacubitril/Valsartan on LV Diastolic Function in HFrEF","status":"NOT_YET_RECRUITING","sponsor":"Assiut University","startDate":"2026-06-01","conditions":"Left Ventricular Diastolic Function","enrollment":70},{"nctId":"NCT06704633","phase":"PHASE4","title":"Sacubitril-valsartan in Patients With Heart Failure With Reduced Ejection Fraction From Rural Tanzania","status":"NOT_YET_RECRUITING","sponsor":"Martin Rohacek","startDate":"2026-01-05","conditions":"Heart Failure","enrollment":238},{"nctId":"NCT06917664","phase":"PHASE4","title":"Treatment of Moderate Ischemic Mitral Regurgitation in Patients With Coronary Artery Disease","status":"RECRUITING","sponsor":"China National Center for Cardiovascular Diseases","startDate":"2025-06-05","conditions":"Coronary Artery Disease, Ischemic Mitral Regurgitation, Angiotensin Receptor/Neprilysin Inhibitor","enrollment":220},{"nctId":"NCT04113109","phase":"PHASE4","title":"Mechanisms Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 2","status":"COMPLETED","sponsor":"Vanderbilt University Medical Center","startDate":"2019-11-01","conditions":"Heart Failure","enrollment":46},{"nctId":"NCT05636774","phase":"NA","title":"Empower the Heart of Patients With Terminal Cancer Using Cardiac Medicines Trial","status":"COMPLETED","sponsor":"University Hospital, Essen","startDate":"2022-12-12","conditions":"Patients With Advanced Cancer Receiving Specialized Palliative Care","enrollment":97},{"nctId":"NCT07130175","phase":"NA","title":"Radiofrequency Ablation for Polymorphic Ventricular Tachycardia With Heart Failure (RFCA for PMVT-HF)","status":"COMPLETED","sponsor":"Qian Feng","startDate":"2022-12-31","conditions":"Polymorphic Ventricular Tachycardia, Heart Failure","enrollment":118},{"nctId":"NCT03938389","phase":"PHASE4","title":"The Renin-Angiotensin-Aldosterone System in Adiposity, Blood Pressure and Glucose in African Americans","status":"ACTIVE_NOT_RECRUITING","sponsor":"Ohio State University","startDate":"2020-02-25","conditions":"PreDiabetes, Impaired Glucose Tolerance, Obesity","enrollment":90},{"nctId":"NCT07088471","phase":"","title":"Cardiac Left Atrial Evaluation and Response in HFrEF With Sacubitril/Valsartan","status":"ACTIVE_NOT_RECRUITING","sponsor":"Connolly Hospital Blanchardstown","startDate":"2024-11-01","conditions":"Heart Failure and Reduced Ejection Fraction","enrollment":334},{"nctId":"NCT03738878","phase":"PHASE4","title":"Mechanism(s) Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 1","status":"TERMINATED","sponsor":"Vanderbilt University Medical Center","startDate":"2018-11-15","conditions":"Hypertension","enrollment":4},{"nctId":"NCT04055428","phase":"PHASE2","title":"NAUTICAL: Effect of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals","status":"RECRUITING","sponsor":"University of Alabama at Birmingham","startDate":"2020-08-15","conditions":"Diabetes Mellitus, Cardiovascular Diseases, Insulin Sensitivity/Resistance","enrollment":200},{"nctId":"NCT05976230","phase":"","title":"Special Drug Use Surveillance of Entresto Tablets (Hypertension)","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2023-09-04","conditions":"Hypertension","enrollment":1125},{"nctId":"NCT03553810","phase":"PHASE2","title":"Role of ARNi in Ventricular Remodeling in Hypertensive LVH","status":"COMPLETED","sponsor":"National Heart Centre Singapore","startDate":"2019-04-12","conditions":"Hypertensive Heart Disease","enrollment":80},{"nctId":"NCT07023016","phase":"PHASE2, PHASE3","title":"Comparative Assessment of Efficacy & Safety of Sacubitril/Valsartan Versus Ramipril in Patients With Renal Dysfunction Hospitalized With Acute Decompensated Heart Failure","status":"COMPLETED","sponsor":"National Heart Institute, Egypt","startDate":"2023-11-01","conditions":"Acute Decompensated Heart Failure (ADHF), Chronic Kidney Disease (CKD)","enrollment":515},{"nctId":"NCT05353166","phase":"PHASE2","title":"REGN5381 in Heart Failure Adult Participants With Elevated Pulmonary Capillary Wedge Pressure","status":"COMPLETED","sponsor":"Regeneron Pharmaceuticals","startDate":"2022-06-30","conditions":"Heart Failure","enrollment":59},{"nctId":"NCT03928158","phase":"PHASE2","title":"LCZ696 in Advanced LV Hypertrophy and HFpEF","status":"COMPLETED","sponsor":"National Medical Research Center for Cardiology, Ministry of Health of Russian Federation","startDate":"2019-05-31","conditions":"Heart Failure, Essential Hypertension","enrollment":61},{"nctId":"NCT04491136","phase":"PHASE4","title":"Effective Study of ARNI on Ventricular Arrhythmia in HFrEF Patients With ICD or CRT-D (RHYTHM)","status":"TERMINATED","sponsor":"Novartis Pharmaceuticals","startDate":"2020-11-11","conditions":"Heart Failure","enrollment":201},{"nctId":"NCT03785405","phase":"PHASE3","title":"Open-label Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With HF","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2019-05-02","conditions":"Heart Failure","enrollment":216},{"nctId":"NCT04164732","phase":"PHASE2","title":"Study of Efficacy of Oral Sacubitril/Valsartan in Adult Patients With Non-obstructive Hypertrophic Cardiomyopathy","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2020-01-08","conditions":"Cardiomyopathy, Hypertrophic","enrollment":46},{"nctId":"NCT04971720","phase":"PHASE2, PHASE3","title":"PRECISION-BP: Precision Chronopharamacotherapy Targeting NP-RAAS-BP Rhythm Axis","status":"RECRUITING","sponsor":"University of Alabama at Birmingham","startDate":"2022-02-18","conditions":"Obesity, Cardiovascular Diseases, Hypertension","enrollment":160},{"nctId":"NCT05637853","phase":"PHASE4","title":"Telemonitored Fast Track Medical Sequencing for Heart Failure With Reduced Ejection Fraction","status":"ACTIVE_NOT_RECRUITING","sponsor":"Göteborg University","startDate":"2022-10-22","conditions":"Heart Failure With Reduced Ejection Fraction","enrollment":60},{"nctId":"NCT06922253","phase":"PHASE1","title":"Bioequivalence Study to Compare Sacubitril and Valsartan Tablets (97mg/103mg) Versus Entresto® (Sacubitril and Valsartan) Tablets (97 mg/103 mg)","status":"COMPLETED","sponsor":"Humanis Saglık Anonim Sirketi","startDate":"2024-12-28","conditions":"Chronic Heart Failure","enrollment":48},{"nctId":"NCT06900803","phase":"NA","title":"Evaluating Dashboard-Integrated Pharmacist-Led Education on Improving Sacubitril/Valsartan Adherence in Heart Failure (PharmD ASSIST HFrEF)","status":"NOT_YET_RECRUITING","sponsor":"National Taiwan University Hospital","startDate":"2025-04-07","conditions":"Heart Failure With Reduced Ejection Fraction (HFrEF), Sacubitril/Valsartan, Medication Adherence","enrollment":200},{"nctId":"NCT05465031","phase":"PHASE4","title":"Sacubitril/Valsartan in PriMAry preventIoN of the Cardiotoxicity of Systematic breaST canceR trEAtMent (MAINSTREAM)","status":"RECRUITING","sponsor":"Silesian Centre for Heart Diseases","startDate":"2024-04-17","conditions":"Breast Cancer, Neoplasm, Breast, Breast Diseases","enrollment":600},{"nctId":"NCT05021419","phase":"NA","title":"Efficacy of a Streamlined Heart Failure Optimization Protocol","status":"COMPLETED","sponsor":"The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust","startDate":"2022-07-17","conditions":"Heart Failure with Reduced Ejection Fraction, Chronic Heart Failure","enrollment":60},{"nctId":"NCT03988634","phase":"PHASE3","title":"Changes in NT-proBNP, Safety, and Tolerability in HFpEF Patients With a WHF Event (HFpEF Decompensation) Who Have Been Stabilized and Initiated at the Time of or Within 30 Days Post-decompensation (PARAGLIDE-HF)","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2019-06-29","conditions":"Heart Failure With Preserved Ejection Fraction (HFpEF)","enrollment":467},{"nctId":"NCT04637152","phase":"PHASE2","title":"Sacubitril/Valsartan in Resistant Hypertension","status":"COMPLETED","sponsor":"Hospital Geral Roberto Santos","startDate":"2020-11-11","conditions":"Resistant Hypertension, Blood Pressure","enrollment":80},{"nctId":"NCT06655480","phase":"PHASE2","title":"Triple Combination Therapy (ARNI, SGLT2i, MRA) in Advanced HFpEF","status":"NOT_YET_RECRUITING","sponsor":"National Medical Research Center for Cardiology, Ministry of Health of Russian Federation","startDate":"2025-03-18","conditions":"HFpEF, LVDD, Myocardial Fibrosis","enrollment":50},{"nctId":"NCT05498675","phase":"","title":"Effect of Sacubitril/Valsartan on Cardiac Function in Hypertensive Patients Stratified by BMI: A Real World Study","status":"RECRUITING","sponsor":"Beijing Friendship Hospital","startDate":"2021-09-01","conditions":"Sacubitril/Valsartan, Hypertension, Obesity","enrollment":180},{"nctId":"NCT03760588","phase":"PHASE2","title":"Prevention of Cardiac Dysfunction During Breast Cancer Therapy","status":"COMPLETED","sponsor":"Torbjorn Omland","startDate":"2019-01-31","conditions":"Breast Cancer Female, Heart Failure","enrollment":138},{"nctId":"NCT04149990","phase":"PHASE2","title":"Angiotensin-Neprilysin Inhibition in Diastolic Dysfunction After AMI","status":"TERMINATED","sponsor":"Jacob Moller","startDate":"2018-10-12","conditions":"Myocardial Infarction, Diastolic Dysfunction","enrollment":51},{"nctId":"NCT06716970","phase":"PHASE3","title":"QR12000 Compound Tablets in Patients with Moderate to Severe Essential Hypertension","status":"NOT_YET_RECRUITING","sponsor":"Wuhan Createrna Science and Technology Co., Ltd","startDate":"2024-12-30","conditions":"Essential Hypertension","enrollment":810},{"nctId":"NCT06712030","phase":"PHASE3","title":"Effect of Angiotensin Receptor/Neprilysin Inhibitors on Transthyretin Cardiac Amyloidosis and Heart Failure with Reduced Ejection Fraction","status":"NOT_YET_RECRUITING","sponsor":"Puerta de Hierro University Hospital","startDate":"2025-01","conditions":"Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)","enrollment":114},{"nctId":"NCT04872959","phase":"NA","title":"TRANSFORM Heart Failure with Reduced Ejection Fraction","status":"WITHDRAWN","sponsor":"Massachusetts General Hospital","startDate":"2021-10-22","conditions":"Heart Failure, Systolic","enrollment":""},{"nctId":"NCT05508035","phase":"PHASE3","title":"The Effect of Sacubitril/valsartan Versus Ramipril on Left Ventricular Function and Remodeling in Patients with Ischemic Heart Failure with Mid-range Ejection Fraction","status":"RECRUITING","sponsor":"John Paul II Hospital, Krakow","startDate":"2023-07-13","conditions":"Heart Failure with Moderately Reduced Ejection Fraction","enrollment":666},{"nctId":"NCT06604897","phase":"","title":"Effectiveness of Entresto (Sacubitril/Valsartan) in Japanese Patients With Hypertension","status":"ACTIVE_NOT_RECRUITING","sponsor":"Novartis","startDate":"2023-01-31","conditions":"Essential Hypertension","enrollment":1405},{"nctId":"NCT04587947","phase":"NA","title":"Influence of Sacubitril/Valsartan on Autonomic Cardiac Nervous System in Heart Failure Patients: an Exploratory Study","status":"COMPLETED","sponsor":"St. Josefs-Hospital Wiesbaden GmbH","startDate":"2020-04-01","conditions":"Heart Failure Patients","enrollment":63},{"nctId":"NCT06090487","phase":"NA","title":"Is Sacubitril-valsartan Superior to Dapagliflozin in Improving Myocardial Function Performance","status":"COMPLETED","sponsor":"Ain Shams University","startDate":"2024-02-01","conditions":"Heart Failure","enrollment":30},{"nctId":"NCT06283420","phase":"","title":"Metabolic Response to the Initiation of Heart Failure Therapy","status":"RECRUITING","sponsor":"Vojtech Melenovsky, MD, PhD","startDate":"2024-08-23","conditions":"Heart Failure","enrollment":120},{"nctId":"NCT05164653","phase":"PHASE4","title":"Program of Angiotensin-Neprilysin Inhibition in Admitted Patients With Worsening Heart Failure (PREMIER)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Saga University","startDate":"2021-12-27","conditions":"Heart Failure","enrollment":400},{"nctId":"NCT02884206","phase":"PHASE3","title":"Efficacy and Safety of LCZ696 Compared to Valsartan on Cognitive Function in Patients With Chronic Heart Failure and Preserved Ejection Fraction","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2016-11-23","conditions":"Chronic Heart Failure (CHF)","enrollment":592},{"nctId":"NCT06501651","phase":"PHASE4","title":"Sacubitril/Valsartan Treats Patients With Essential Hypertension and Type 2 Diabetic Nephropathy","status":"NOT_YET_RECRUITING","sponsor":"Sichuan Academy of Medical Sciences","startDate":"2024-08-01","conditions":"Essential Hypertension, Type 2 Diabetes, Nephropathy","enrollment":297},{"nctId":"NCT04883528","phase":"PHASE1, PHASE2","title":"Protecting With ARNI Against Cardiac Consequences of Coronavirus Disease 2019","status":"COMPLETED","sponsor":"Duke University","startDate":"2021-08-06","conditions":"Covid19","enrollment":42},{"nctId":"NCT04707261","phase":"PHASE4","title":"Association Between Dapagliflozin-induced Improvement and Anemia in Heart Failure Patients (ADIDAS)","status":"RECRUITING","sponsor":"Xiangtan Central Hospital","startDate":"2021-08-06","conditions":"Anemia, Heart Failure","enrollment":1990},{"nctId":"NCT06439069","phase":"","title":"BMI-Driven Tolerability and Efficacy of Entresto in Heart Failure Patients","status":"RECRUITING","sponsor":"Lithuanian University of Health Sciences","startDate":"2023-08-10","conditions":"Heart Failure, Obesity","enrollment":340},{"nctId":"NCT06357104","phase":"PHASE4","title":"Detoxification From the Lipid Tract","status":"COMPLETED","sponsor":"Pachankis, Yang I., M.D.","startDate":"2024-02-26","conditions":"COVID-19 Vaccine Adverse Reaction","enrollment":1},{"nctId":"NCT04853758","phase":"PHASE3","title":"Angiotensin Receptor-Neprilysin Inhibition in Chagas Cardiomyopathy With Reduced Ejection Fraction: ANSWER-HF.","status":"RECRUITING","sponsor":"University of Sao Paulo General Hospital","startDate":"2021-05-06","conditions":"Chagas Cardiomyopathy","enrollment":200},{"nctId":"NCT04103554","phase":"PHASE4","title":"Sacubitril/Valsartan in Left Ventricular Assist Device Recipients","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Zagreb","startDate":"2021-02-05","conditions":"Heart Failure","enrollment":60},{"nctId":"NCT05117736","phase":"NA","title":"ARNI Versus plAcebo in Patients With Congenital sYStemic Right Ventricle Heart Failure","status":"TERMINATED","sponsor":"Montreal Heart Institute","startDate":"2022-03-15","conditions":"Systemic Right Ventricle, Heart Failure","enrollment":15},{"nctId":"NCT03917459","phase":"PHASE3","title":"COmparing arNi and Ace For Improving Erectile Dysfunction in mEN With reduCed Ejection Fraction Heart Failure","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2019-04-16","conditions":"Heart Failure, Heart Failure, Systolic, Erectile Dysfunction","enrollment":27},{"nctId":"NCT06273254","phase":"PHASE1","title":"A Bioequivalence Study of Sacubitril/Valsartan Film-coated Tablets Under Fasting Conditions","status":"UNKNOWN","sponsor":"Viatris Inc.","startDate":"2024-04","conditions":"Bioequivalence Study","enrollment":48},{"nctId":"NCT06266988","phase":"PHASE1","title":"A Bioequivalence Study of Sacubitril/Valsartan Film-coated Tablets Under Fasting Conditions","status":"UNKNOWN","sponsor":"Viatris Inc.","startDate":"2024-03","conditions":"Chronic Heart Failure","enrollment":48},{"nctId":"NCT06248112","phase":"PHASE1","title":"Sacubitril 97 mg and Valsartan 103 mg Film-coated Tablets Relative to Entresto 97 mg/103 mg Film-coated Tablets","status":"UNKNOWN","sponsor":"Bio-innova Co., Ltd","startDate":"2024-05-06","conditions":"Healthy Subjects","enrollment":40},{"nctId":"NCT04434170","phase":"","title":"Effects of Sacubitril/Valsartan on Exercise Capacity, Natriuretic Peptides and Ventricular Remodeling in Heart Failure","status":"COMPLETED","sponsor":"Centro Cardiologico Monzino","startDate":"2018-10-15","conditions":"Heart Failure","enrollment":112},{"nctId":"NCT06218199","phase":"PHASE4","title":"Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts","status":"RECRUITING","sponsor":"Heart Center Research, LLC","startDate":"2021-07-08","conditions":"Heart Failure, Congestive","enrollment":80},{"nctId":"NCT06035978","phase":"PHASE4","title":"Determination of Drug Levels for Pharmacotherapy of Heart Failure","status":"NOT_YET_RECRUITING","sponsor":"University Hospital Ostrava","startDate":"2024-03","conditions":"Cardiovascular Diseases, Heart Failure With Reduced Ejection Fraction","enrollment":100},{"nctId":"NCT03300427","phase":"PHASE4","title":"The Effects of Sacubitril/Valsartan on Cardiac Oxygen Consumption and Efficiency of Cardiac Work in Heart Failure Patients","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2018-07-05","conditions":"Heart Failure","enrollment":55},{"nctId":"NCT06193187","phase":"PHASE1","title":"A Bioequivalence Study of Sacubitril/Valsartan Film-coated Tablets Under Fasting Conditions","status":"UNKNOWN","sponsor":"Dr. Reddy's Laboratories (Thailand) Limited","startDate":"2024-01","conditions":"Healthy Volunteers","enrollment":48},{"nctId":"NCT02468232","phase":"PHASE3","title":"Study of Efficacy and Safety of LCZ696 in Japanese Patients With Chronic Heart Failure and Reduced Ejection Fraction","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2015-06-15","conditions":"Heart Failure With Reduced Ejection Fraction (HF-rEF)","enrollment":225},{"nctId":"NCT06149806","phase":"","title":"National Registry of Adult Heart Failure Patients With Complex Congenital Heart Disease: Systemic Right Ventricle and Single Ventricle Treated With Sacubitril/Valsartan","status":"UNKNOWN","sponsor":"University Hospital, Grenoble","startDate":"2021-07-01","conditions":"Complex Congenital Heart Disease","enrollment":50},{"nctId":"NCT04736433","phase":"","title":"Replication of the PARADIGM-HF Heart Failure Trial in Healthcare Claims Data.","status":"COMPLETED","sponsor":"Brigham and Women's Hospital","startDate":"2020-09-22","conditions":"Heart Failure","enrollment":6066}],"_emaApprovals":[],"_faersSignals":[{"count":11461,"reaction":"HYPOTENSION"},{"count":9102,"reaction":"DEATH"},{"count":8906,"reaction":"DYSPNOEA"},{"count":8629,"reaction":"DIZZINESS"},{"count":8608,"reaction":"FATIGUE"},{"count":7824,"reaction":"COUGH"},{"count":7289,"reaction":"WRONG TECHNIQUE IN PRODUCT USAGE PROCESS"},{"count":5174,"reaction":"WEIGHT DECREASED"},{"count":4456,"reaction":"CARDIAC FAILURE"},{"count":4421,"reaction":"MALAISE"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{},"crossReferences":{"chemblId":"CHEMBL5315276"},"formularyStatus":[],"_approvalHistory":[{"date":"20240412","type":"SUPPL","sponsor":"NOVARTIS PHARMS CORP","applicationNumber":"NDA207620"},{"date":"20171122","type":"SUPPL","sponsor":"NOVARTIS PHARMS CORP","applicationNumber":"NDA207620"},{"date":"20150707","type":"ORIG","sponsor":"NOVARTIS PHARMS CORP","applicationNumber":"NDA207620"},{"date":"20191001","type":"SUPPL","sponsor":"NOVARTIS PHARMS CORP","applicationNumber":"NDA207620"},{"date":"20161221","type":"SUPPL","sponsor":"NOVARTIS PHARMS CORP","applicationNumber":"NDA207620"},{"date":"20160511","type":"SUPPL","sponsor":"NOVARTIS PHARMS CORP","applicationNumber":"NDA207620"},{"date":"20210216","type":"SUPPL","sponsor":"NOVARTIS PHARMS CORP","applicationNumber":"NDA207620"},{"date":"20231018","type":"SUPPL","sponsor":"NOVARTIS PHARMS CORP","applicationNumber":"NDA207620"},{"date":"20160212","type":"SUPPL","sponsor":"NOVARTIS PHARMS CORP","applicationNumber":"NDA207620"},{"date":"20240412","type":"ORIG","sponsor":"NOVARTIS","applicationNumber":"NDA218591"}],"developmentCodes":[],"ownershipHistory":[],"publicationCount":160,"therapeuticAreas":["Other"],"biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"Entresto","genericName":"Entresto","companyName":"Novartis Pharmaceuticals","companyId":"novartis-pharmaceuticals","modality":"Small molecule","firstApprovalDate":"","aiSummary":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":7,"withResults":1},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:16:30.919572+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":false,"safety":true,"trials":true,"score":3}}