Zebeta

(Bisoprolol)

ApprovedSmall molecule

Bisoprolol is used to treat high blood pressure and heart failure by helping the heart work more efficiently and slowing down the heart rate.[2] Zebeta is currently approved and in use across 20 indications[4].[1]

Zebeta is one of 405 small molecule programs targeting Coronary Artery Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

404

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Coronary Artery DiseaseActive, not recruiting

Cardiovascular DiseaseUnknown

Essential HypertensionActive, not recruiting

Idiopathic Pulmonary Arterial HypertensionActive, not recruiting

IschemiaActive, not recruiting

Aortic StenosisActive, not recruiting

TachycardiaActive, not recruiting

Acute Myocardial InfarctionActive, not recruiting

Chronic Obstructive Pulmonary DiseaseActive, not recruiting

Myocardial InfarctionActive, not recruiting

Coronary Artery DiseaseApproved

Active, not recruiting

Cardiovascular DiseasePreclinical

Unknown

Essential HypertensionApproved

Active, not recruiting

Idiopathic Pulmonary Arterial HypertensionPhase 1

Active, not recruiting

IschemiaPreclinical

Active, not recruiting

Aortic StenosisApproved

Active, not recruiting

TachycardiaPreclinical

Active, not recruiting

Acute Myocardial InfarctionApproved

Active, not recruiting

Chronic Obstructive Pulmonary DiseasePhase 3

Active, not recruiting

Myocardial InfarctionApproved

Active, not recruiting

Showing 10 of 20 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Zebeta

Teva

Approved

56 2

Halaven

Eisai

Preclinical

38 3

DATROWAY

Daiichi Sankyo

Preclinical

4 4

Adenocard

Astellas

Preclinical

1 5

Spravato

WWim Janssens

Preclinical

2 6

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 7

Tricor

JJagotec

Preclinical

1 8

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

1 9

Avastin

Roche

Preclinical

4 10

Aquasol E

NNational Eye Institute (NEI)

Preclinical

—

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

Timeline

Expected Milestones

Q2 2027

Phase 3Not yet recruiting

Atrial Fibrillation

NCT06276127

Q4 2027

N/ARecruiting

Heart Failure

NCT07029906

Post-ApprovalRecruiting

Hypertrophic Cardiomyopathy

NCT05569382

Post-ApprovalRecruiting

Acute Myocardial Infarction

NCT06562582

Q3 2028

N/ARecruiting

Takotsubo Cardiomyopathy

NCT07491718

Q4 2035

Post-ApprovalActive, not recruiting

Myocardial Infarction

NCT03778554

Clinical

Trials by Indication[1]

Heart Failure8 trials

Association Between Genetic Polymorphism of Beta-adrenergic Receptor and Effects of Bisoprolol in Korean Heart Failure Patients.

Completed· Merck & Co. logo

Merck & Co.·Phase 4·NCT01104558·100 enrolled

Evaluation of Heart Failure Treatment Guided by N-terminal Pro B-type Natriuretic Peptide (NTproBNP) vs Clinical Symptoms and Signs Alone

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00391846·252 enrolled

Early Use of Ivabradine in Heart Failure

Unknown status·—·N/A·NCT03701880·50 enrolled

Show 5 more trials

Determination of Drug Levels for Pharmacotherapy of Heart Failure

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

The Cardiac Insufficiency BIsoprolol Study in Japanese Patients With Chronic Heart Failure (CIBIS-J)

Unknown status·MMebix Inc·N/A·NCT02137733·220 enrolled

Efficacy of Oral Bisoprolol on Heart Rate Reduction in Chinese Chronic Heart Failure Participants

Terminated· Merck & Co. logo

Merck & Co.·Phase 4·NCT03026088·20 enrolled

Nebivolol Versus Bisoprolol Versus Carvedilol in Heart Failure

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

pErsonalised Nocebo Assessment of Beta-blockEr Symptoms in Heart Failure

Recruiting·IImperial College London·N/A·NCT07029906·150 enrolled

Hypertension6 trials

An Active-controlled, Clinical Trial to Assess Central Hemodynamic Effects of Bisoprolol in Hypertensive Patients (Central Hemodynamic Assessment Measured in Patient With HypertensION [CHAMPION])

Completed· Merck & Co. logo

Merck & Co.·Phase 4·NCT01079962·209 enrolled

Optimum Treatment for Drug-Resistant Hypertension

Unknown status·UUniversity of Cambridge·Phase 4·NCT02369081·348 enrolled

Sequential Nephron Blockade vs. Dual Blockade Renin-angiotensin System + Bisoprolol in Resistant Arterial Hypertension

Completed·SSao Jose do Rio Preto Medical School·Phase 4·NCT02832973·72 enrolled

Show 3 more trials

Comparing Bisoprolol and Valsartan-Amlodipine for Hypertension

Completed·SShiraz University of Medical Sciences·Phase 4·NCT07327749·59 enrolled

Comparison of Effect of cARvedilol Compared To bISoprolol on cenTral Pulse Pressure in Hypertension (ARTIST) Study

Unknown status·YYoshio Matsui·Phase 4·NCT01243827·200 enrolled

HaemoDYNAMICs in Primary and Secondary Hypertension

Unknown status·TTampere University··NCT01742702·2,000 enrolled

Essential Hypertension4 trials

Effects of Bisoprolol and Atenolol on Sympathetic Nervous Activity and Central Aortic Pressure in Patients With Essential Hypertension

Completed·RRuijin Hospital·Phase 4·NCT01762436·109 enrolled

A Randomized Controlled Study to Assess the Effects of Bisoprolol and Atenolol on Resting Heart Rate and Sympathetic Nervous System's Activity in Subjects With Essential Hypertension

Completed· Merck & Co. logo

Merck & Co.·Phase 4·NCT01251146·177 enrolled

A Study on Molecular Genetics of Drug Responsiveness in Essential Hypertension

Completed·HHelsinki University Central Hospital·Phase 4·NCT03276598·233 enrolled

Show 1 more trial

BRAVE Study With Uncontrolled Essential Hypertension (BRAVE Study)

Completed·—·Phase 4·NCT02398929·100 enrolled

Atrial Fibrillation3 trials

Rate Control Therapy Evaluation in Permanent Atrial Fibrillation (RATE-AF)

Completed·UUniversity of Birmingham·Phase 4·NCT02391337·161 enrolled

Left Atrium Reservoir Function Modulation in Patients With Atrial Fibrillation: Digoxin Versus Beta Blocker

Unknown status·UUniversity of Monastir·Phase 3·NCT05540600·30 enrolled

Oral Bisoprolol Vs IV Diltiazem in Atrial Fibrillation or Flutter With Rapid Ventricular Rate.

Not yet recruiting·OOman Medical Speciality Board·Phase 3·NCT06276127·60 enrolled

Myocardial Infarction2 trials

Evaluation of Decreased Usage of Betablockers After Myocardial Infarction in the SWEDEHEART Registry (REDUCE-SWEDEHEART)

Active, not recruiting·KKarolinska Institutet·Phase 4·NCT03278509·5,000 enrolled

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

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

28 more indications

Tachycardia2 trials

Effect of Medical Treatment and Prognosis of Postural Orthostatic Tachycardia Syndrome (POTS)

Completed·SSeoul National University Hospital·Phase 4·NCT02171988·150 enrolled

Treating Clozapine-induced Sinustachycardia With Bisoprolol

Completed·UUniversity of Aarhus·N/A·NCT00882856·21 enrolled

Cardiotoxicity2 trials

Cardiotoxicity Prevention in Breast Cancer Patients Treated With Anthracyclines and/or Trastuzumab

Unknown status·—·Phase 3·NCT02236806·262 enrolled

Bisoprolol Administration to Prevent Anthracycline-induced Cardiotoxicity

Completed·SShahid Beheshti University of Medical Sciences·Phase 3·NCT05175066·80 enrolled

Exercise2 trials

Effects of Beta-blockade on Cardiopulmonary Exercise Testing

Completed·MMichelle Mossa·Phase 1·NCT02106286·55 enrolled

Chronic Beta-blockade and Cardiopulmonary Exercise in COPD

Completed·UUniversity of Dundee·Phase 4·NCT02380053·10 enrolled

Coronary Artery Bypass2 trials

Bisoprolol Versus Corticosteroid and Bisoprolol Combination for Prophylaxis Against Atrial Fibrillation After on Pump Coronary Artery Bypass Surgery

Completed·—·Phase 4·NCT03800264·176 enrolled

Once Versus Twice Bisoprolol Dosage Regimen in Prevention of Atrial Fibrillation Post Coronary Artery Bypass Graft Surgery

Unknown status·—·Phase 4·NCT05730413·122 enrolled

Blood Pressure2 trials

Comparison of Bisoprolol With Metoprolol Succinate Sustained-release on Heart Rate and Blood Pressure in Hypertensive Patients

Completed· Merck & Co. logo

Merck & Co.·Phase 4·NCT01508325·186 enrolled

Phase 4 Study to Assess the Effect of Bisoprolol on Glycemic Level in Type II Diabetic Subjects With Suboptimal Blood Pressure Control

Completed· Merck & Co. logo

Merck & Co.·Phase 4·NCT01066039·202 enrolled

Chronic Obstructive Pulmonary Disease1 trial

Bisoprolol in Patients With Heart Failure and Chronic Obstructive Pulmonary Disease

Terminated·NNHS Greater Glasgow and Clyde·Phase 2·NCT00702156·27 enrolled

Hemodynamic Changes1 trial

Hemodynamic Changes of Patients Receiving Atenolol/Bisoprolol

Completed·HHospital Italiano de Buenos Aires·Phase 4·NCT01939509·80 enrolled

Postmenopausal Women1 trial

Comparative Effects of Moxonidine on Bone Metabolism, Vascular and Cellular Aging in Hypertensive Postmenopausal Women

Completed·NNational Research Center for Preventive Medicine·N/A·NCT02355821·114 enrolled

Cardiac1 trial

Preventing Adverse Cardiac Events in COPD

Completed·TThe George Institute·Phase 3·NCT03917914·280 enrolled

Aortic Stenosis1 trial

Effect of Bisoprolol on Progression of Aortic Stenosis

Terminated·—·Phase 4·NCT01579058·20 enrolled

Fed1 trial

Bioequivalence Study of Bisoprolol Fumarate Tablet 10 mg Under Fed Condition

Completed·IIPCA Laboratories Ltd.·Phase 1·NCT01744873·24 enrolled

Interaction1 trial

Pharmacokinetic Drug-Drug Interaction Between Bisoprolol and Ivabradine in Healthy Volunteers

Completed·—·Phase 3·NCT03485482·18 enrolled

Hypertrophic Cardiomyopathy1 trial

Treatment Effects of Bisoprolol and Verapamil in Symptomatic Patients With Non-obstructive Hypertrophic Cardiomyopathy

Recruiting·MMorten Steen Kvistholm Jensen·Phase 4·NCT05569382·100 enrolled

Moderate to Severe COPD1 trial

Beta Blocker Therapy in Moderate to Severe COPD

Completed·UUniversity of Dundee·Phase 4·NCT01656005·18 enrolled

General Anaesthesia1 trial

Comparative Study Between the Efficacy of Verapamil and Bisoprolol on Reduction of Bleeding During Endoscopic Sinus Surgery Under General Anaesthesia.

Unknown status·—·Phase 1·NCT04356196·135 enrolled

Ischemia1 trial

Study to Investigate Effects of Antiischemic Drug Therapy in Silent Ischemia

Completed·LLuzerner Kantonsspital·N/A·NCT00382421

Elective1 trial

Effects of Cardioselective β-blockers on Dynamic Hyperinflation in COPD

Completed·LLaval University·N/A·NCT01273298·27 enrolled

Takotsubo cardiomyopathy1 trial

Manganese-enhanced Magnetic Resonance Imaging in Takotsubo Cardiomyopathy

Recruiting·UUniversity of Edinburgh·N/A·NCT07491718·100 enrolled

Chagas cardiomyopathy1 trial

Chagas Cardiomyopathy Bisoprolol Intervention Study: Charity

Completed·FFundación Cardiovascular de Colombia·Phase 3·NCT00323973·500 enrolled

PAH1 trial

Beta-blockers in i-PAH

Unknown status·AAmsterdam UMC, location VUmc·Phase 1/2·NCT01246037·30 enrolled

Trial1 trial

Bioequivalence Trial of Concor AM® vs Bisoprolol and Amlodipine in Chinese Participants

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT03226275·32 enrolled

Cardiovascular1 trial

A Study in Healthy Young Men to Look at What Drives the Cardiovascular Effects After Dosing With Mirabegron.

Completed· Astellas logo

Astellas·Phase 1·NCT01284868·12 enrolled

Propranolol1 trial

In Vivo Specificity of KUC 7483 CL Co-administered With Bisoprolol, Propranolol, and Acipimox in Healthy Male Subjects

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02256722·12 enrolled

Coronary Artery Disease1 trial

Randomized Trial to Examine a Differential Therapeutic Response in Symptomatic Patients With Non-obstructive Coronary Artery Disease

Unknown status·—·Phase 4·NCT05294887·132 enrolled

Safety and Efficacy1 trial

A 12-week, Multicentric Study to Evaluate the Safety and Efficacy of Bisoprolol in Filipino Hypertensive Subjects With Diabetes

Completed· Merck & Co. logo

Merck & Co.·Phase 4·NCT01190436·125 enrolled

Acute Myocardial Infarction1 trial

STunning in Acute Myocardial Infarction - BAS

Recruiting·VVastra Gotaland Region·Phase 4·NCT06562582·120 enrolled

Sinus Surgery1 trial

Preoperative Gabapentin Versus Bisoprolol for Hemodynamic Optimization During Sinus Surgery

Completed·ZZagazig University·Phase 4·NCT03850093·63 enrolled

Unspecified1 trial

Bioequivalence Study of Bisoprolol Fumarate Tablet 10 mg Under Fasting Condition

Completed·IIPCA Laboratories Ltd.·Phase 1·NCT01741623·24 enrolled

Regulatory

FDA Approval Timeline[5]

Jul 31, 1992

ZEBETA

NDA NDA019982

Sources

References

[1]
ClinicalTrials.gov — 56 trial records for Bisoprolol. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Zebeta drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Bisoprolol compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Bisoprolol. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA019982). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Teva company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Beta-1 Adrenergic Receptor Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Teva

Zebeta

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q4 2027

Q3 2028

Q4 2035

Trials by Indication[1]

Heart Failure8 trials

Hypertension6 trials

Essential Hypertension4 trials

Atrial Fibrillation3 trials

Myocardial Infarction2 trials

Tachycardia2 trials

Cardiotoxicity2 trials

Exercise2 trials

Coronary Artery Bypass2 trials

Blood Pressure2 trials

Chronic Obstructive Pulmonary Disease1 trial

Hemodynamic Changes1 trial

Postmenopausal Women1 trial

Cardiac1 trial

Aortic Stenosis1 trial

Fed1 trial

Interaction1 trial

Hypertrophic Cardiomyopathy1 trial

Moderate to Severe COPD1 trial

General Anaesthesia1 trial

Ischemia1 trial

Elective1 trial

Takotsubo cardiomyopathy1 trial

Chagas cardiomyopathy1 trial

PAH1 trial

Trial1 trial

Cardiovascular1 trial

Propranolol1 trial

Coronary Artery Disease1 trial

Safety and Efficacy1 trial

Acute Myocardial Infarction1 trial

Sinus Surgery1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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