Bystolic

(Nebivolol)

ApprovedSmall molecule

VVitae Pharmaceuticals Inc., an Allergan affiliate

Nebivolol is used to treat high blood pressure and heart failure by helping your heart beat more efficiently and relaxing blood vessels so blood flows more easily.[2] Bystolic is currently approved and in use across 23 indications[4].[1]

Bystolic is one of 556 small molecule programs targeting Coronary Artery Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

555

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Coronary Artery DiseaseActive, not recruiting

Metabolic SyndromeActive, not recruiting

Cardiovascular DiseaseActive, not recruiting

Endothelial DysfunctionActive, not recruiting

Essential HypertensionActive, not recruiting

StrokeApproved

AneurysmActive, not recruiting

Diastolic Heart FailureActive, not recruiting

Obstructive Sleep ApneaActive, not recruiting

Kidney TransplantActive, not recruiting

Coronary Artery DiseaseApproved

Active, not recruiting

Metabolic SyndromeApproved

Active, not recruiting

Cardiovascular DiseaseApproved

Active, not recruiting

Endothelial DysfunctionApproved

Active, not recruiting

Essential HypertensionPhase 2

Active, not recruiting

StrokeApproved

Approved

AneurysmApproved

Active, not recruiting

Diastolic Heart FailureApproved

Active, not recruiting

Obstructive Sleep ApneaApproved

Active, not recruiting

Kidney TransplantApproved

Active, not recruiting

Showing 10 of 22 indications

Competition

Competitive Landscape

1931 competitors in COVID-19

#DrugCompanyPhaseTrials

Bystolic

VVitae Pharmaceuticals Inc., an Allergan affiliate

Approved

82 2

Bnt162b2

BioNTech

Preclinical

29 3

Aimovig

Amgen

Preclinical

1 4

Singulair

AstraZeneca

Preclinical

1 5

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Preclinical

1 6

Benadryl

PParkedale

Preclinical

1 7

Glucocorticoid

AbbVie

Preclinical

1 8

HB-Admscs

HHope Biosciences Research Foundation

Preclinical

4 9

Vit D

PPost Graduate Institute of Medical Education and Research, Chandigarh

Preclinical

1 10

Biological Collection

AAssistance Publique - Hôpitaux de Paris

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2/3Recruiting

Efficacy

NCT06424834

Q1 2027

Phase 2Recruiting

Cardiotoxicity

NCT07233499

Q1 2030

Post-ApprovalNot yet recruiting

Aneurysm

NCT06249802

Q4 2035

Post-ApprovalActive, not recruiting

Myocardial Infarction

NCT03778554

Clinical

Trials by Indication[1]

Hypertension14 trials

Effects of the Beta-blocker Nebivolol (Bystolic) on Subjects With High Normal Blood Pressure and/or a Family History of Hypertension

Completed·UUniversity of California, San Diego·Phase 4·NCT01202175·50 enrolled

Study to Evaluate Symptoms in Patients Treated With Nebivolol or Metoprolol Extended-release (ER) for Hypertension

Terminated·FForest Laboratories·Phase 3·NCT00547300·49 enrolled

Blood Pressure Effects of Nebivolol Versus Lisinopril in New Onset or Worsening Hypertension Induced by Bevacizumab

Withdrawn·UUniversity of Mississippi Medical Center·N/A·NCT01076140

Show 11 more trials

Treatment of OSA Associated Hypertension With Nebivolol or Hydrochlorothiazide

Completed·UUniversity of California, San Diego·Phase 4·NCT02710071·41 enrolled

Study to Determine the Effects of Nebivolol and Hydrochlorothiazide in African Americans With Hypertension

Completed·IInVasc Therapeutics, Inc.·N/A·NCT00999752·40 enrolled

Economic Impact of Switching From Metoprolol to Nebivolol for Hypertension Treatment

Unknown status·FForest Laboratories··NCT01758263·3,000 enrolled

Non-invasive Haemodynamic Assessment in Hypertension

Completed·MMilitary Institute od Medicine National Research Institute·N/A·NCT01996085·144 enrolled

Nebivolol in Patients With Systolic Stage 2 Hypertension

Completed·FForest Laboratories·Phase 4·NCT01057251·433 enrolled

Nebivolol in the Supine Hypertension of Autonomic Failure

Completed·VVanderbilt University·N/A·NCT01044693·20 enrolled

Evaluation of the Long-term Safety and Tolerability of Metoprolol Versus Nebivolol in Patients With Hypertension

Completed·MMylan Bertek Pharmaceuticals·Phase 3·NCT00142584·336 enrolled

Safety and Efficacy of Nebivolol in the Treatment of Hypertension in African Americans

Completed·MMylan Bertek Pharmaceuticals·Phase 3·NCT00145210·630 enrolled

A Pilot Study Comparing Nebivolol and Atenolol and Its Effects With Exercise in Patients With Mild to Moderate Hypertension

Completed·MMylan Bertek Pharmaceuticals·Phase 2·NCT00200421·110 enrolled

Dosing Study of the Effects of Nebivolol on Blood Pressure in Black Patients With Mild to Moderate Hypertension

Completed·MMylan Bertek Pharmaceuticals·Phase 3·NCT00145236·300 enrolled

A Study of the Efficacy and Safety of Nebivolol Added to Existing Antihypertensive Treatment in Patients With Hypertension

Completed·MMylan Bertek Pharmaceuticals·Phase 3·NCT00200434·600 enrolled

Hypertensive7 trials

The Effect of Nebivolol in Hypertensive Patients With Coronary Arterial Spasm

Completed·KKorea University Anam Hospital·Phase 4·NCT03930433·51 enrolled

Can Nebivolol Reverse Inappropriate Left Ventricular Mass in Hypertensive Patients?

Terminated·MMayo Clinic·Phase 4·NCT01605370·1 enrolled

A Study of the Effect of Nebivolol to Evaluate Its Vasodilatory Effects in Hypertensive Patients

Completed·FForest Laboratories·Phase 3·NCT00648895·12 enrolled

Show 4 more trials

Comparison of Nebivolol and Metoprolol With Exercise and Angiotensin II in Hypertensive Patients

Completed·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT01502787·46 enrolled

Clinical Application of Simcyp-Guided Doses of Antihypertensive Drugs in Cirrhotic Patients

Completed·KKafrelsheikh University·Phase 4·NCT07397481·40 enrolled

Effects of Nebivolol on Skeletal Muscle During Exercise in Hypertensive Patients

Completed·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT01501929·32 enrolled

Study of the Glycemic Effects of Nebivolol Compared With Metoprolol and HCTZ in Diabetic Hypertensive Patients

Completed·FForest Laboratories·Phase 4·NCT00744237·231 enrolled

Blood Pressure4 trials

A Study Evaluating the Effects of Nebivolol on Blood Pressure in Hypertensive Patients

Completed·MMylan Bertek Pharmaceuticals·Phase 3·NCT00200460·825 enrolled

Effect of Different Antihypertensive Drugs on Central Blood Pressure

Active, not recruiting·KKorea University Anam Hospital·N/A·NCT05328310·110 enrolled

Comparing the Effects of Two Beta Blockers,Metoprolol and Nebivolol,on Ambulatory Blood Pressure and Basal Metabolic Rate

Terminated·UUniversity of Mississippi Medical Center·N/A·NCT00849810·1 enrolled

Show 1 more trial

A Safety Evaluation of ECG Intervals and Blood Pressure in Normal Healthy Volunteers After Use of Nebivolol, Atenolol, Moxifloxacin, or Placebo

Completed·MMylan Bertek Pharmaceuticals·Phase 1·NCT00158093·260 enrolled

Heart Failure4 trials

Determination of Drug Levels for Pharmacotherapy of Heart Failure

Not yet recruiting·UUniversity Hospital Ostrava·Phase 4·NCT06035978·100 enrolled

Safety Study to Lower the Risk of Heart Failure is Also Effective in Reducing Stiffness of the Arteries

Completed·UUniversity of Chicago·Phase 2/3·NCT00829296·70 enrolled

Comparative Effects of Nebivolol and Carvedilol on Diastolic Function in the Elderly Heart Failure Patients

Unknown status·—·N/A·NCT02619526·62 enrolled

Show 1 more trial

Nebivolol Versus Bisoprolol Versus Carvedilol in Heart Failure

Completed·CCentro Cardiologico Monzino·Phase 4·NCT00517725·60 enrolled

Efficacy and Safety4 trials

A Study on the Efficacy and Safety of Nebivolol Monotherapy in Hispanic Hypertensive Patients

Completed·FForest Laboratories·Phase 4·NCT00770861·277 enrolled

Open-label inteRventional Clinical Trial to Assess Efficacy and Safety of the exteMporaneous combInation of Nebivolol and Ramipril in hypertenSIve pAtients

Completed·MMenarini International Operations Luxembourg SA·Phase 4·NCT06104423·266 enrolled

Efficacy and Safety of Nebivolol (Added to Lisinopril or Losartan) in Hypertensive Patients

Completed·FForest Laboratories·Phase 4·NCT00734630·491 enrolled

Show 1 more trial

Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years)

Completed·FForest Laboratories·Phase 4·NCT01415531·641 enrolled

41 more indications

Endothelial Function3 trials

A Study Examining the Effects of Nebivolol Compared to Atenolol on Endothelial Function

Completed·UUniversity of Minnesota·Phase 2·NCT01522950·76 enrolled

Effects of Nebivolol Versus Metoprolol Succinate on Endothelial Function

Completed·BBerlin-Chemie AG Menarini Group·Phase 4·NCT01248338·80 enrolled

Nebivolol Effects on Endothelial Function and Erectile Function

Unknown status·—·Phase 4·NCT01885988·70 enrolled

Effectiveness2 trials

Effectiveness and Safety of Combination of Nebivolol and Amlodipine in Hypertensive Patients Versus Each Monotherapy

Completed·MMenarini International Operations Luxembourg SA·Phase 4·NCT05513937·301 enrolled

Effectiveness and Safety of Combination of Nebivolol and Zofenopril in Hypertensive patIents Versus Each Monotherapy

Completed·MMenarini International Operations Luxembourg SA·Phase 4·NCT05257148·283 enrolled

Safety and Efficacy2 trials

A Study of the Safety and Efficacy of Nebivolol in Hypertensive Patients

Completed·MMylan Bertek Pharmaceuticals·Phase 3·NCT00200473·800 enrolled

A Study of the Safety and Efficacy of Long-Term Nebivolol Use in Hypertensive Patients

Completed·MMylan Bertek Pharmaceuticals·Phase 3·NCT00200499·845 enrolled

Tolerance2 trials

Alternative in Beta Blocker Intolerance: The ABBI Trial

Terminated·MMinneapolis Heart Institute Foundation·Phase 4·NCT00893984·6 enrolled

Effects of Nebivolol on Exercise Tolerance and Left Ventricular Systolic and Diastolic Function

Completed·MMercy Research·N/A·NCT01056718·53 enrolled

Efficacy2 trials

Efficacy of Medical Therapy in Women and Men With Angina and Myocardial Bridging

Terminated·SStanford University·Phase 2·NCT04130438·5 enrolled

Efficacy of Targeted Medical Therapy in Angina and Nonobstructive Coronary Arteries

Recruiting·SStanford University·Phase 2/3·NCT06424834·150 enrolled

Arterial Stiffness1 trial

Nebivolol, Lifestyle Modification and Arterial Stiffness

Completed·VVirginia Polytechnic Institute and State University·Phase 4·NCT01920282·45 enrolled

Obstructive Sleep Apnea1 trial

CPAP and Nebivolol in Hypertensive Obstructive Sleep Apnea (OSA) Patients.

Unknown status·UUniversitaire Ziekenhuizen KU Leuven·Phase 4·NCT01771406·36 enrolled

Regression1 trial

Regression of Myocardial Steatosis by Nebivolol

Completed·LLidia Szczepaniak·Phase 1·NCT01358409·31 enrolled

Myocardial Infarction1 trial

Danish Trial of Beta Blocker Treatment After Myocardial Infarction Without Reduced Ejection Fraction

Active, not recruiting·—·Phase 4·NCT03778554·2,760 enrolled

ESS1 trial

Impact of Nebivolol on Central Aortic Pressure

Withdrawn·—·N/A·NCT01051947

COPD1 trial

Safety Study of Nebivolol for COPD Patients

Withdrawn·UUniversity of Chicago·Phase 2/3·NCT01939990

Oxygen Consumption1 trial

24 Hour Ambulatory Cardiac Oxygen Consumption

Completed·SState University of New York at Buffalo·Phase 3·NCT05170061·26 enrolled

Peripheral Arterial Disease1 trial

Comparison of 2 Beta Blocker Drugs on Peripheral Arterial Disease in Patients With High Blood Pressure

Completed·TThomas Jefferson University·Phase 3·NCT01499134·17 enrolled

Stress1 trial

Evaluation of The Effects of Nebivolol in Comparison to Atenolol on Wall Shear Stress and Rupture Prone Coronary Plaques

Completed·EEmory University·Phase 4·NCT01230892·29 enrolled

Fatigue1 trial

Nebivolol Versus Metoprolol: Comparative Effects on Fatigue and Quality of Life

Completed·WWeill Medical College of Cornell University·Phase 4·NCT00999102·37 enrolled

ART1 trial

Comparative Study of the Effects of Telmisartan and Nebivolol

Unknown status·—·Phase 4·NCT02057328·80 enrolled

High Blood Pressure1 trial

Effect of Nebivolol on the Blood Flow in Hearts of Adults With High Blood Pressure and Abnormal Filling of Heart

Completed·IIcahn School of Medicine at Mount Sinai·Phase 4·NCT01961323·70 enrolled

Pulmonary Function1 trial

Effects of Nebivolol Versus Carvedilol on Cardiopulmonary Function at High Altitude in Healthy Subjects.

Completed·IIstituto Auxologico Italiano·Phase 4·NCT00924833·27 enrolled

Coronary Artery Disease1 trial

The Effect of Nebivolol in Hypertensive Patients With Coronary Artery Disease

Completed·FForest Laboratories·Phase 4·NCT00673075·39 enrolled

Essential Hypertension1 trial

The Effects of Nebivolol on the NO-system in Patients With Essential Hypertension

Completed·EErling Bjerregaard Pedersen·Phase 2·NCT01679652·25 enrolled

Endothelial Dysfunction1 trial

The Effect of Nebivolol on Endothelial Dysfunction in African Americans With Hypertension

Completed·EEmory University·Phase 4·NCT01049009·91 enrolled

Advanced1 trial

An Advanced Echocardiographic Evaluation of Nebivolol

Terminated·JJack Rubinstein·Phase 4·NCT01206439·2 enrolled

Duchenne Muscular Dystrophy1 trial

Nebivolol for the Prevention of Left Ventricular Systolic Dysfunction in Patients With Duchenne Muscular Dystrophy

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT01648634·51 enrolled

Metabolic Syndrome1 trial

Comparative Effect of Nebivolol vs. Metoprolol on Insulin Sensitivity and Fibrinolytic Balance in Metabolic Syndrome

Completed·VVanderbilt University·Phase 4·NCT00775671·46 enrolled

Oxidative Stress1 trial

Effect of Nebivolol on Oxidative Stress and Endothelial Progenitor Cells

Completed·EEmory University·Phase 4·NCT01041287·96 enrolled

Drug Interactions1 trial

To Evaluate Drug-drug Interactions Between DWN12088 and Nebivolol or Paroxetine in Healthy Volunteers

Completed· Daewoong Pharmaceutical Co. LTD. logo

Daewoong Pharmaceutical Co. LTD.·Phase 1·NCT04888728·24 enrolled

Elective1 trial

Evaluating the Outcome of Cardio Selective beta1- Blockers Use in Patients With Copd

Unknown status·—·Phase 4·NCT04845061·30 enrolled

Cardiotoxicity1 trial

Evaluation of the Cardioprotective Effect of Nebivolol on Trastuzumab-Induced Cardiotoxicity in Breast Cancer Patients

Recruiting·—·Phase 2·NCT07233499·56 enrolled

Insulin Sensitivity1 trial

The Effect of Nebivolol on Insulin Sensitivity

Completed·IImperial College London·N/A·NCT00125853·54 enrolled

Aneurysm1 trial

Beta-blockade in Unruptured Intracranial Aneurysm

Not yet recruiting·JJagiellonian University·Phase 4·NCT06249802·100 enrolled

Kidney Transplant1 trial

Nebivolol Effect on Nitric Oxide Levels, Blood Pressure, and Renal Function in Kidney Transplant Patients

Completed·UUniversity of Florida·Phase 4·NCT01157234·32 enrolled

Vascular Disease1 trial

Study to Evaluate Effect of Nebivolol on Angina in Women With Microvascular Disease

Completed·MMassachusetts General Hospital·Phase 4·NCT01665508·12 enrolled

Fibrinolysis1 trial

Nebivolol and Endothelial Regulation of Fibrinolysis (NERF)

Completed·UUniversity of Colorado, Boulder·Phase 4·NCT01595516·44 enrolled

Withdrawal1 trial

A Study on the Long-term Efficacy of Nebivolol After Withdrawal of Therapy

Completed·FForest Laboratories·Phase 4·NCT00785512·207 enrolled

Ischemic stroke1 trial

Effect of Olmesartan and Nebivolol on Ambulatory Blood Pressure and Arterial Stiffness in Acute Stage of Ischemic Stroke

Completed·—·Phase 2·NCT03655964·60 enrolled

Diastolic Heart Failure1 trial

Improving Treatment Personalization of Pulmonary Hypertension Associated With Diastolic Heart Failure

Terminated·UUniversity of Florida·Phase 4·NCT02053246·11 enrolled

Chemotherapy1 trial

Cardioprotective Effects of Nebivolol Versus Placebo in Patients Undergoing Chemotherapy With Anthracyclines

Unknown status·GGiulio Stefanini·Phase 3·NCT05728632·80 enrolled

Quality of Life1 trial

The Impact of Nebivolol Versus Metoprolol on Quality of Life

Terminated·—·N/A·NCT01441570·11 enrolled

Metabolism1 trial

Dose Response and Receptor Selectivity of Beta-blocker Effects on Bone Metabolism

Completed·MMayo Clinic·Phase 1·NCT02467400·165 enrolled

Dilation1 trial

Nebivolol Versus Losartan Versus Nebivolol+Losartan Against Aortic Root Dilation in Genotyped Marfan Patients

Unknown status·FFondazione IRCCS Policlinico San Matteo di Pavia·Phase 3·NCT00683124·291 enrolled

Unspecified3 trials

Nebivolol and the Endothelin (ET)-1 System

Completed·UUniversity of Colorado, Boulder·Phase 4·NCT01395329·42 enrolled

Nebivolol Versus Metoprolol: Sodium Sensitivity

Completed·UUniversity of Miami·Phase 4·NCT00992056·24 enrolled

Regulatory Nebilet PMS

Completed· GSK logo

GSK··NCT01077661·743 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 17, 2007

BYSTOLIC

NDA NDA021742

Sources

References

[1]
ClinicalTrials.gov — 82 trial records for Nebivolol. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Bystolic drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Nebivolol compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Nebivolol. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021742). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Vitae Pharmaceuticals Inc., an Allergan affiliate company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Beta-1 Adrenergic Receptor Antagonist; Beta-2 Adrenergic Receptor Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: VVitae Pharmaceuticals Inc., an Allergan affiliate

Bystolic

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q1 2030

Q4 2035

Trials by Indication[1]

Hypertension14 trials

Hypertensive7 trials

Blood Pressure4 trials

Heart Failure4 trials

Efficacy and Safety4 trials

Endothelial Function3 trials

Effectiveness2 trials

Safety and Efficacy2 trials

Tolerance2 trials

Efficacy2 trials

Arterial Stiffness1 trial

Obstructive Sleep Apnea1 trial

Regression1 trial

Myocardial Infarction1 trial

ESS1 trial

COPD1 trial

Oxygen Consumption1 trial

Peripheral Arterial Disease1 trial

Stress1 trial

Fatigue1 trial

ART1 trial

High Blood Pressure1 trial

Pulmonary Function1 trial

Coronary Artery Disease1 trial

Essential Hypertension1 trial

Endothelial Dysfunction1 trial

Advanced1 trial

Duchenne Muscular Dystrophy1 trial

Metabolic Syndrome1 trial

Oxidative Stress1 trial

Drug Interactions1 trial

Elective1 trial

Cardiotoxicity1 trial

Insulin Sensitivity1 trial

Aneurysm1 trial

Kidney Transplant1 trial

Vascular Disease1 trial

Fibrinolysis1 trial

Withdrawal1 trial

Ischemic stroke1 trial

Diastolic Heart Failure1 trial

Chemotherapy1 trial

Quality of Life1 trial

Metabolism1 trial

Dilation1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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