{"id":"nebivolol","brandName":"Bystolic","genericName":"nebivolol","companyId":"allergan","companyName":"Allergan","phase":"marketed","status":"active","modality":"","aliases":[],"developmentCodes":[],"firstApprovalDate":null,"firstApprovalCountry":null,"aiSummary":"","enrichmentLevel":3,"visitCount":0,"mechanism":{"target":"5-hydroxytryptamine receptor 1A, Beta-1 adrenergic receptor, Beta-2 adrenergic receptor","_target_confidence":0.5},"administration":{"route":"Oral"},"safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"1812 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"1748 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"1683 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"1592 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"1573 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"1400 reports"},{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"1363 reports"},{"date":"","signal":"ACUTE KIDNEY INJURY","source":"FDA FAERS","actionTaken":"1267 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"1224 reports"},{"date":"","signal":"ASTHENIA","source":"FDA FAERS","actionTaken":"1072 reports"}],"drugInteractions":[],"commonSideEffects":[{"effect":"Headache","drugRate":"9%","severity":"common","organSystem":""},{"effect":"Dizziness","drugRate":"7%","severity":"common","organSystem":""},{"effect":"Fatigue","drugRate":"5%","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"3%","severity":"common","organSystem":""},{"effect":"Gastrointestinal Disorders","drugRate":"3%","severity":"common","organSystem":""},{"effect":"Dyspnea","drugRate":"4%","severity":"common","organSystem":""},{"effect":"Insomnia","drugRate":"1%","severity":"common","organSystem":""},{"effect":"Rash","drugRate":"1%","severity":"common","organSystem":""},{"effect":"Respiratory Disorders","drugRate":"1%","severity":"common","organSystem":""},{"effect":"Asthenia","drugRate":"1%","severity":"common","organSystem":""},{"effect":"Abdominal Pain","drugRate":"1%","severity":"common","organSystem":""},{"effect":"Paraesthesia","drugRate":"1%","severity":"common","organSystem":""},{"effect":"Hypercholesterolemia","drugRate":"1%","severity":"common","organSystem":""}],"contraindications":["Acute nephropathy","Bradycardia","Bronchospasm","Cardiogenic shock","Complete atrioventricular block","Decompensated cardiac failure","Diabetes mellitus","Disease of liver","Hepatic failure","Hypoglycemic disorder","Peripheral vascular disease","Second degree atrioventricular block","Sick sinus syndrome"],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[{"effect":"Bradycardia","drugRate":"0.2%","severity":"serious"},{"effect":"Cardiac Disorders","drugRate":"0.1%","severity":"serious"}]},"trials":["NCT04888728","NCT04575675","NCT07233499","NCT00832442","NCT00999102","NCT00849810","NCT02057328","NCT01522950","NCT01605370","NCT03930433","NCT03180593","NCT01996085","NCT04432610","NCT01057251","NCT01316952","NCT04513509","NCT04767061","NCT04130438","NCT07397481","NCT01358409","NCT01771406","NCT01499134","NCT03655964","NCT00145236","NCT06755801","NCT00145210","NCT03635125","NCT06035978","NCT01679652","NCT00893984","NCT06289881","NCT00673790","NCT00785512","NCT00992056","NCT02619526","NCT00547300","NCT00770861","NCT00517725","NCT00734630","NCT02817360","NCT01648634","NCT00775671","NCT01395329","NCT00995072","NCT01441570","NCT01161823","NCT00223717","NCT01920282","NCT01049009","NCT00295542"],"indications":{"approved":[{"name":"Hypertensive disorder","diseaseId":"hypertensive-disorder","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"commercial":null,"patents":[],"timeline":[],"rwe":[],"competitors":[],"ownershipHistory":[],"trialDetails":[{"nctId":"NCT04888728","phase":"Phase 1","title":"An Open Label, 2-part, One-sequence, 3-period Study to Evaluate Drug-drug Interactions Between \"DWN12088\" and \"Nebivolol\" or \"Paroxetine\" in Healthy Male Volunteers","status":"COMPLETED","sponsor":"Daewoong Pharmaceutical Co. LTD.","isPivotal":false,"enrollment":24,"indication":"Idiopathic Pulmonary Fibrosis","completionDate":"2021-07-27"},{"nctId":"NCT04575675","phase":"Phase 4","title":"Effects of Dapagliflozin on Hypotensive Patients With Depressed Left Ventricular Ejection Fraction After Sacubitril/Valsartan Therapy","status":"COMPLETED","sponsor":"Cheng-Hsin General Hospital","isPivotal":false,"enrollment":78,"indication":"Hypotension, Heart Failure","completionDate":"2020-12-30"},{"nctId":"NCT07233499","phase":"Phase 2","title":"Evaluation of the Cardioprotective Effect of Nebivolol on Trastuzumab-Induced Cardiotoxicity in Breast Cancer Patients","status":"RECRUITING","sponsor":"Ain Shams University","isPivotal":false,"enrollment":56,"indication":"HER2-positive Breast Cancer","completionDate":"2027-02-01"},{"nctId":"NCT00832442","phase":"N/A","title":"Collaborative Systematic Overview of Randomised Controlled Trials of Beta-Blockers in the Treatment of Heart Failure","status":"UNKNOWN","sponsor":"Royal Brompton & Harefield NHS Foundation Trust","isPivotal":false,"enrollment":18240,"indication":"Heart Failure","completionDate":"2012-12"},{"nctId":"NCT00999102","phase":"Phase 4","title":"Nebivolol Vs. Metoprolol: Comparative Effects on Fatigue and Quality of Life","status":"COMPLETED","sponsor":"Weill Medical College of Cornell University","isPivotal":false,"enrollment":37,"indication":"Hypertension","completionDate":"2011-01"},{"nctId":"NCT00849810","phase":"NA","title":"Comparative Effects of Nebivolol Versus Metoprolol on 24-hour Blood Pressures and Basal Metabolic Rate: An Open-Label Study","status":"TERMINATED","sponsor":"University of Mississippi Medical Center","isPivotal":false,"enrollment":1,"indication":"Hypertension","completionDate":"2010-11"},{"nctId":"NCT02057328","phase":"Phase 4","title":"Comparative Study of the Effects of Telmisartan and Nebivolol on 24-h Ambulatory Blood Pressure and Arterial Stiffness in Patients With Arterial Hypertension","status":"UNKNOWN","sponsor":"Aristotle University Of Thessaloniki","isPivotal":false,"enrollment":80,"indication":"Hypertension","completionDate":"2017-01"},{"nctId":"NCT01522950","phase":"Phase 2","title":"A Double-blind, Placebo-controlled, Randomized Study Examining the Effects of Nebivolol Compared to Atenolol on Endothelial Function and Cardiovascular Risk in Patients With Early Vascular Disease","status":"COMPLETED","sponsor":"University of Minnesota","isPivotal":false,"enrollment":76,"indication":"Hypertension","completionDate":"2016-10"},{"nctId":"NCT01605370","phase":"Phase 4","title":"Can Nebivolol Reverse Inappropriate Left Ventricular Mass in Hypertensive Patients?","status":"TERMINATED","sponsor":"Mayo Clinic","isPivotal":false,"enrollment":1,"indication":"Hypertension","completionDate":"2013-03"},{"nctId":"NCT03930433","phase":"Phase 4","title":"The Effect of Nebivolol in Hypertensive Patients With Coronary Arterial Spasm","status":"COMPLETED","sponsor":"Korea University Anam Hospital","isPivotal":false,"enrollment":51,"indication":"Coronary Vasospasm","completionDate":"2019-03-31"},{"nctId":"NCT03180593","phase":"Phase 4","title":"A Prospective, Randomized, Open-Label, 13 to 14-week Study of the Efficacy and Safety of Valsartan and Nebivolol/Valsartan in Hypertensive Subjects With Left Ventricular Hypertrophy (LVH)","status":"COMPLETED","sponsor":"Trinity Hypertension & Metabolic Research Institute","isPivotal":false,"enrollment":30,"indication":"Hypertension Complicated, Hypertrophy, Left Ventricular","completionDate":"2018-01-25"},{"nctId":"NCT01996085","phase":"NA","title":"The Usefulness of Non-invasive Assessment of Haemodynamic Profile in the Diagnosis and Treatment of Hypertension","status":"COMPLETED","sponsor":"Military Institute od Medicine National Research Institute","isPivotal":false,"enrollment":144,"indication":"Arterial Hypertension","completionDate":"2017-12"},{"nctId":"NCT04432610","phase":"Phase 4","title":"Echocardiographic Study of a Single Dose Bisoprolol Versus Nebivolol in Healthy Subjects: a Randomized, Double-blind, Cross-over Study","status":"WITHDRAWN","sponsor":"Clinical Hospital Center Zemun","isPivotal":false,"enrollment":0,"indication":"Bisoprolol Adverse Reaction, Nebivolol Adverse Reaction","completionDate":"2030-12"},{"nctId":"NCT01057251","phase":"Phase 4","title":"Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effect of 5 mg or 20 mg Nebivolol Once Daily on Blood Pressure in Patients With Systolic Stage 2 Hypertension","status":"COMPLETED","sponsor":"Forest Laboratories","isPivotal":false,"enrollment":433,"indication":"Hypertension","completionDate":"2011-01"},{"nctId":"NCT01316952","phase":"N/A","title":"A Nested Case-control Study of the Association Between Coreg IR and Coreg CR and Hypersensitivity Reactions: Anaphylactic Reaction/Angioedema-Updated Analysis","status":"COMPLETED","sponsor":"GlaxoSmithKline","isPivotal":false,"enrollment":1,"indication":"Hypersensitivity","completionDate":"2011-03"},{"nctId":"NCT04513509","phase":"NA","title":"The Surrogate Marker of Rate Control in Patients With Atrial Fibrillation","status":"COMPLETED","sponsor":"National Taiwan University Hospital","isPivotal":false,"enrollment":13,"indication":"Atrial Fibrillation, Rate Control","completionDate":"2022-07-01"},{"nctId":"NCT04767061","phase":"Phase 4","title":"N-of-1 Trials for Deprescribing Beta-blockers in HFpEF","status":"COMPLETED","sponsor":"Weill Medical College of Cornell University","isPivotal":false,"enrollment":9,"indication":"Heart Failure, Heart Failure, Diastolic","completionDate":"2023-04-28"},{"nctId":"NCT04130438","phase":"Phase 2","title":"Efficacy of Medical Therapy in Women and Men With Angina and Myocardial Bridging","status":"TERMINATED","sponsor":"Stanford University","isPivotal":false,"enrollment":5,"indication":"Myocardial Bridging","completionDate":"2024-10-17"},{"nctId":"NCT07397481","phase":"Phase 4","title":"Dose Prediction for Antihypertensive Medications in Cirrhotic Patients Using Simcyp Program: Applications in Clinical Practice","status":"COMPLETED","sponsor":"Kafrelsheikh University","isPivotal":false,"enrollment":40,"indication":"Liver Cirrhosis, Arterial Hypertension","completionDate":"2025-06-01"},{"nctId":"NCT01358409","phase":"EARLY/Phase 1","title":"Regression of Myocardial Steatosis by Nebivolol","status":"COMPLETED","sponsor":"Lidia Szczepaniak","isPivotal":false,"enrollment":31,"indication":"Cardiac Steatosis and Lipotoxicity","completionDate":"2013-02-11"},{"nctId":"NCT01771406","phase":"Phase 4","title":"Effects of Continuous Positive Airway Pressure (CPAP) and Nebivolol Treatment on Arterial Blood Pressure and Endothelial Function in Hypertensive OSA Patients.","status":"UNKNOWN","sponsor":"Universitaire Ziekenhuizen KU Leuven","isPivotal":false,"enrollment":36,"indication":"Hypertension, Endothelial Dysfunction","completionDate":"2016-02"},{"nctId":"NCT01499134","phase":"Phase 3","title":"Effect of Nebivolol Compared With Metoprolol in Hypertensive Patients With Peripheral Arterial Disease","status":"COMPLETED","sponsor":"Thomas Jefferson University","isPivotal":true,"enrollment":17,"indication":"Peripheral Artery Disease, Hypertension","completionDate":"2014-06"},{"nctId":"NCT03655964","phase":"Phase 2","title":"Olmesartan Versus Nebivolol in Management of Hypertension in Acute Ischemic Stroke","status":"COMPLETED","sponsor":"Aristotle University Of Thessaloniki","isPivotal":false,"enrollment":60,"indication":"Stroke, Ischemic","completionDate":"2019-08-20"},{"nctId":"NCT00145236","phase":"Phase 3","title":"A Double-Blind, Multicenter, Randomized, Placebo-Controlled, Parallel Group Dosing Study of the Effects of Nebivolol on Blood Pressure in Black Patients With Mild to Moderate Hypertension.","status":"COMPLETED","sponsor":"Mylan Bertek Pharmaceuticals","isPivotal":true,"enrollment":300,"indication":"Hypertension","completionDate":"2003-08"},{"nctId":"NCT06755801","phase":"Phase 3","title":"Microvascular Obstruction Treatment and Outcomes Randomized Study.","status":"NOT_YET_RECRUITING","sponsor":"Spanish Society of Cardiology","isPivotal":true,"enrollment":150,"indication":"ANOCA - Angina With Non-obstructive Coronary Arteries, Coronary Microvascular Dysfunction (CMD)","completionDate":"2026-09-30"},{"nctId":"NCT00145210","phase":"Phase 3","title":"A Double-Blind, Randomized, Placebo- and Active-Controlled, Forced Titration Study Evaluating the Effects of Nebivolol on Blood Pressure and Heart Rate in African American Patients With Hypertension","status":"COMPLETED","sponsor":"Mylan Bertek Pharmaceuticals","isPivotal":true,"enrollment":630,"indication":"Hypertension","completionDate":"2007-09"},{"nctId":"NCT03635125","phase":"Phase 4","title":"A Prospective, Randomized, Open-Label, Active-Comparator, Blinded-Endpoint, 12-week Forced-Titration Study of the Efficacy and Safety of Nebivolol Verses Metoprolol in Hypertensive Subjects Taking Aml","status":"COMPLETED","sponsor":"Trinity Hypertension & Metabolic Research Institute","isPivotal":false,"enrollment":40,"indication":"JNC 7 Stage 1 or 2 Hypertension","completionDate":"2011-07-18"},{"nctId":"NCT06035978","phase":"Phase 4","title":"Use of Determination of Drug Levels to Optimize Pharmacotherapy of Heart Failure","status":"NOT_YET_RECRUITING","sponsor":"University Hospital Ostrava","isPivotal":false,"enrollment":100,"indication":"Cardiovascular Diseases, Heart Failure With Reduced Ejection Fraction","completionDate":"2026-04"},{"nctId":"NCT01679652","phase":"Phase 2","title":"The Effects of Nebivolol on the NO-system in Patients With Essential","status":"COMPLETED","sponsor":"Erling Bjerregaard Pedersen","isPivotal":false,"enrollment":25,"indication":"Essential Hypertension","completionDate":"2013-09"},{"nctId":"NCT00893984","phase":"Phase 4","title":"Alternative in Beta Blocker Intolerance; the ABBI Trial","status":"TERMINATED","sponsor":"Minneapolis Heart Institute Foundation","isPivotal":false,"enrollment":6,"indication":"Coronary Artery Disease","completionDate":"2012-06"},{"nctId":"NCT06289881","phase":"Phase 1","title":"A Bioequivalence Study of Sildenafil 100 mg Tablets Relative to Viagra 100 mg Tablets in Healthy Thai Male Volunteers Under Fasting Condition","status":"UNKNOWN","sponsor":"Bio-innova Co., Ltd","isPivotal":false,"enrollment":36,"indication":"Healthy Subjects","completionDate":"2025-03-25"},{"nctId":"NCT00673790","phase":"Phase 4","title":"Blood Pressure and Metabolic Effects of Nebivolol Compared With Hydrochlorothiazide and Placebo in Hypertensive Patients With Impaired Glucose Tolerance or Impaired Fasting Glucose","status":"COMPLETED","sponsor":"Forest Laboratories","isPivotal":false,"enrollment":537,"indication":"Hypertension","completionDate":"2010-07-09"},{"nctId":"NCT00785512","phase":"Phase 4","title":"A Prospective, Randomized, Double-Blind, Placebo Controlled Study of the Long-Term Efficacy of Nebivolol in Hypertensive Patients After Withdrawal of Therapy","status":"COMPLETED","sponsor":"Forest Laboratories","isPivotal":false,"enrollment":207,"indication":"Hypertension","completionDate":""},{"nctId":"NCT00992056","phase":"Phase 4","title":"Comparative Effects of Nebivolol Versus Metoprolol on Sodium Sensitivity and Renal Sodium Handling in Hypertensive Hispanic Postmenopausal Women","status":"COMPLETED","sponsor":"University of Miami","isPivotal":false,"enrollment":24,"indication":"Hypertension","completionDate":"2012-05"},{"nctId":"NCT02619526","phase":"NA","title":"Comparative Effects of Nebivolol and Carvedilol on Diastolic Function of the Left Ventricle in the Elderly Heart Failure Patients With Preserved Ejection Fraction: Study Protocol for a Randomized Cont","status":"UNKNOWN","sponsor":"Dong-A University","isPivotal":false,"enrollment":62,"indication":"Heart Failure","completionDate":"2018-12"},{"nctId":"NCT00547300","phase":"Phase 3","title":"Tolerability of Nebivolol Compared With Metoprolol ER in Patients With Mild to Moderate Hypertension Taking Hydrochlorothiazide (HCTZ)","status":"TERMINATED","sponsor":"Forest Laboratories","isPivotal":true,"enrollment":49,"indication":"Hypertension","completionDate":"2008-01-02"},{"nctId":"NCT00770861","phase":"Phase 4","title":"A Multicenter, Prospective, Randomized, Double-blind, Placebo-Controlled, Dose-Titration Study of Nebivolol Monotherapy in Hispanic Patients With Stage 1 or Stage 2 Hypertension","status":"COMPLETED","sponsor":"Forest Laboratories","isPivotal":false,"enrollment":277,"indication":"Hypertension","completionDate":""},{"nctId":"NCT00517725","phase":"Phase 4","title":"Nebivolol Versus Bisoprolol Versus Carvedilol in Heart Failure: Effects on Exercise Capacity and Hypoxia, Chemoreceptor Response, Pulmonary Function","status":"COMPLETED","sponsor":"Centro Cardiologico Monzino","isPivotal":false,"enrollment":60,"indication":"Chronic Heart Failure","completionDate":"2010-05"},{"nctId":"NCT00734630","phase":"Phase 4","title":"A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Nebivolol Added To Antihypertensive Treatment With Lisinopril or Losartan in Patients With Hypertension.","status":"COMPLETED","sponsor":"Forest Laboratories","isPivotal":false,"enrollment":491,"indication":"Hypertension","completionDate":"2010-05"},{"nctId":"NCT02817360","phase":"Phase 4","title":"NT-proBNP Selected PreventiOn of Cardiac eveNts in a populaTion of dIabetic Patients Without A History of Cardiac Disease: a Prospective Randomized Trial","status":"RECRUITING","sponsor":"Martin Huelsmann","isPivotal":false,"enrollment":2400,"indication":"Heart Diseases, Diabetes Mellitus, Type 2","completionDate":"2026-12"},{"nctId":"NCT01648634","phase":"Phase 3","title":"A Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Examine the Effect of Nebivolol, a Beta-Blockade Drug, for the Prevention of Ventricular Systolic Dysfunction in Patients With Duc","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","isPivotal":true,"enrollment":51,"indication":"Duchenne Muscular Dystrophy, Cardiomyopathy","completionDate":"2021-07-20"},{"nctId":"NCT00775671","phase":"Phase 4","title":"Comparative Effect of Nebivolol vs. Metoprolol on Insulin Sensitivity and Fibrinolytic Balance in Metabolic Syndrome","status":"COMPLETED","sponsor":"Vanderbilt University","isPivotal":false,"enrollment":46,"indication":"Metabolic Syndrome","completionDate":"2011-06"},{"nctId":"NCT01395329","phase":"Phase 4","title":"Nebivolol and the Endothelin (ET)-1 System","status":"COMPLETED","sponsor":"University of Colorado, Boulder","isPivotal":false,"enrollment":42,"indication":"Prehypertension, Hypertension","completionDate":"2016-12"},{"nctId":"NCT00995072","phase":"NA","title":"Comparative Effects of Nebivolol and Metoprolol on Female Sexual Function","status":"COMPLETED","sponsor":"East Coast Institute for Research","isPivotal":false,"enrollment":29,"indication":"Hypertension, Female Sexual Dysfunction","completionDate":"2013-04"},{"nctId":"NCT01441570","phase":"NA","title":"The Impact of Nebivolol Versus Metoprolol on Quality of Life Measures and Cost-effectiveness in Stable Renal Transplant Recipients","status":"TERMINATED","sponsor":"Brigham and Women's Hospital","isPivotal":false,"enrollment":11,"indication":"Transplant; Failure, Kidney, Hypertension","completionDate":"2013-07"},{"nctId":"NCT01161823","phase":"N/A","title":"Effect of Nebivolol on Climacteric Disorders in Postmenopausal Women. A Randomized, Open Label Trial","status":"UNKNOWN","sponsor":"Medical University of Vienna","isPivotal":false,"enrollment":60,"indication":"Hot Flashes, Heart Rate","completionDate":""},{"nctId":"NCT00223717","phase":"Phase 1","title":"The Pathophysiology and Treatment of Supine Hypertension in Patients With Autonomic Failure","status":"COMPLETED","sponsor":"Vanderbilt University","isPivotal":false,"enrollment":152,"indication":"Hypertension","completionDate":"2017-01"},{"nctId":"NCT01920282","phase":"Phase 4","title":"Effect of Nebivolol and Lifestyle Modification on Large Artery Stiffness in Middle-Aged and Older Hypertensive Adults","status":"COMPLETED","sponsor":"Virginia Polytechnic Institute and State University","isPivotal":false,"enrollment":45,"indication":"Hypertension","completionDate":"2012-08"},{"nctId":"NCT01049009","phase":"Phase 4","title":"The Effect of Nebivolol on Endothelial Dysfunction in African Americans With Hypertension","status":"COMPLETED","sponsor":"Emory University","isPivotal":false,"enrollment":91,"indication":"High Blood Pressure","completionDate":"2012-06"},{"nctId":"NCT00295542","phase":"Phase 4","title":"Prognostic Value of Ambulatory Blood Pressure Monitoring in the Prediction of Cardiovascular Events and Effects of Chronotherapy in Relation to Risk (the MAPEC Study).","status":"COMPLETED","sponsor":"University of Vigo","isPivotal":false,"enrollment":3344,"indication":"Hypertension","completionDate":"2009-04"}],"genericFilers":[],"biosimilarFilings":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.1980/EA","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$72","description":"NEBIVOLOL 10 MG TABLET","retrievedDate":"2026-04-07"}],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"labelChanges":[],"nice":null,"revenue":null,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2020-11-03T00:00:00.000Z","mah":"HETERO LABS LTD III","brand_name_local":null,"application_number":"ANDA203825"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2021-11-19T00:00:00.000Z","mah":"INDCHEMIE HEALTH","brand_name_local":null,"application_number":"ANDA203828"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2022-01-26T00:00:00.000Z","mah":"GLENMARK PHARMS LTD","brand_name_local":null,"application_number":"ANDA203821"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2023-08-25T00:00:00.000Z","mah":"UNICHEM","brand_name_local":null,"application_number":"ANDA213830"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2025-01-28T00:00:00.000Z","mah":"MACLEODS PHARMS LTD","brand_name_local":null,"application_number":"ANDA212661"},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":5,"withResults":2},"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=nebivolol","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:29:29.762802+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:29:36.162748+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:29:28.890226+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=nebivolol","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:29:36.467712+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:29:27.707473+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:29:27.707506+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T00:29:38.080337+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL434394/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:29:37.181858+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA208717","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:29:27.707510+00:00"}},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:29:40.942689+00:00","fieldsConflicting":1,"overallConfidence":0.8},"crossReferences":{"chemblId":"CHEMBL434394"},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}