CARVEDILOL
Carvedilol is an alpha/beta-adrenergic blocking agent indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in conjunction with diuretics, ACE inhibitors, and digitalis. It is also indicated to reduce cardiovascular mortality in clinically stable patients following the acute phase of a myocardial infarction who have a left ventricular ejection fraction (LVEF) ≤40%. Additionally, it is used for the management of essential hypertension, either as monotherapy or in combination with other antihypertensive agents.
How CARVEDILOL Works
Carvedilol is a racemic mixture that provides nonselective $\beta$-adrenoreceptor blocking activity and $\alpha_1$-adrenergic blocking activity. The S(-) enantiomer exhibits both $\beta$-blocking and $\alpha_1$-blocking activity, while the R(+) enantiomer exhibits $\alpha_1$-blocking activity with equal potency but lacks $\beta$-blocking properties. Carvedilol possesses no intrinsic sympathomimetic activity (ISA).
Details
- Status
- Discontinued
- First Approved
- 2007-09-05
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
CARVEDILOL Approval History
What CARVEDILOL Treats
4 FDA approvalsOriginally approved for its first indication in 2007 . Covers 4 distinct patient populations.
- Other (4)
CARVEDILOL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
50 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06844669 | 202502113 | Ph 2 | terminated | HER2HEART-US: Prevention of Cardiotoxicity in Breast Cancer Patients Receiving HER2-directed Therapy |
| NCT05872698 BOPPP | 255446 | Ph 4 | active not recruiting | Beta-blockers or Placebo for Primary Prophylaxis (BOPPP) of Oesophageal Varices Trial. |
| NCT07521332 APIXABAN-PK | AIMS/ERC/9853/26 | Ph 4 | recruiting | Apixaban-PK Trial: Preventing Portal Hypertension Complications in Cirrhosis |
| NCT04218968 | Study00000349 | Ph 2 | active not recruiting | Cardiac Changes in Early Parkinson's Disease: A Follow up Study |
| NCT03775096 | U1111-1223-7784 | Ph 2 | active not recruiting | Adrenergic Blockers for Cardiac Changes in Early Parkinson's Disease (Protocol 53136) |
| NCT07352228 | XJLL-KY-20252468 | Ph 4 | enrolling by invitation | Carvedilol vs. Propranolol for Preventing Rebleeding After Endoscopic Treatment of Cirrhotic Varices |
| NCT05931276 BRAVO | 2026 | Ph 3 | recruiting | CSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes |
| NCT07322237 DICE | PGI/IEC/2025/SPL-865 | Ph 4 | recruiting | DICE Study- Diastolic Improvement With Carvedilol & Empagliflozin in Patients With Cirrhosis |
| NCT03879629 | TACTIC R01CA233610, NCI-2019-08427 | Ph 2 | active not recruiting | Treating Breast Cancer Patients Undergoing Trastuzumab Treatment With Carvedilol to Reduce Incidence of Heart Failure |
| NCT04023110 CCTGuide Pilot results posted | UPCC12118 R21HL150723, 849569 | Ph 1 | completed | Risk-Guided Cardioprotection With Carvedilol in Breast Cancer Patients Treated With Doxorubicin and/or Trastuzumab |
| NCT03418961 | S1501 UG1CA189974, NCI-2016-01047 | Ph 3 | recruiting | S1501 Dual Observational and Randomized Cohort Study of Patients With Metastatic HER-2+ Breast Cancer at Risk of Cardiac Toxicity |
| NCT06964464 CARVTOP-ICD | STUDY00010093 PLACER-2023C3-33489 | Ph 4 | recruiting | Comparative Effectiveness of Carvedilol Versus Metoprolol Succinate in Heart Failure Patients With an Implantable Cardioverter Defibrillator |
| NCT06449339 BB_cACLD | 2023.521-T | Ph 4 | recruiting | Non-selective Beta-blocker in Compensated Advanced Chronic Liver Disease |
| NCT03778554 DANBLOCK | 2018-002699-42 2018-002699-42 | Ph 4 | active not recruiting | Danish Trial of Beta Blocker Treatment After Myocardial Infarction Without Reduced Ejection Fraction |
| NCT02717507 results posted | ALTE1621 NCI-2016-00232, ALTE1621 | Ph 2 | completed | Carvedilol in Preventing Heart Failure in Childhood Cancer Survivors |
| NCT04345796 PROVE | 2020-0127 | Ph 3 | completed | Pharmacological Reduction of Right Ventricular Enlargement |
| NCT06836856 | 2024-37 | Ph 1, Ph 2 | recruiting | Evaluating the Impact of Adjuvant Use of Beta Blockers on Clinical Outcomes in Patients With Traumatic Brain Injury |
| NCT06594744 P-HCC-CVL | 2024-02-016B | Ph 4 | recruiting | Endoscopic Variceal Ligation vs Carvedilol for the Prevention of First Esophageal Variceal Bleeding in Patients With HCC |
| NCT06470386 | CZXH-PH-ALV-2401 | Ph 2, Ph 3 | not yet recruiting | The Efficacy and Safety of Alverine in the Treatment of Portal Hypertension in Patients With Liver Cirrhosis |
| NCT02993198 | STU00200675 | Ph 2 | active not recruiting | A Prospective Study of Breast Cancer Patients With Abnormal Strain Imaging |
| NCT04190433 | 19-007547 NCI-2021-13928 | Ph 2 | withdrawn | Autophagy Activation for the Alleviation of Cardiomyopathy Symptoms After Anthracycline Treatment, ATACAR Trial |
| NCT02230891 results posted | CLNB-009-13F | Ph 2 | completed | Biomarker Guided Therapies in Stage A/B Heart Failure |
| NCT02177175 results posted | 14-099 | Ph 2 | completed | Carvedilol for the Prevention of Anthracycline/Anti-HER2 Therapy Associated Cardiotoxicity Among Women With HER2-Positive Breast Cancer Using Myocardial Strain Imaging for Early Risk Stratification |
| NCT02809820 PLATE-BLOCK | CE-9/14 | Ph 4 | completed | Effects of Beta-blockade on Platelet Aggregation in Acute Coronary Syndrome |
| NCT04121299 | IRB-300004152 | Ph 3 | withdrawn | Mechanism of Masked Hypertension - Intervention |
| NCT02946892 results posted | 062016-101 | Ph 4 | completed | Effect of Carvedilol on Exercise Performance in Fontan Patients |
| NCT01383044 | Carvedilol | Ph 4 | terminated | Banding Ligation With Carvedilol Versus Carvedilol for the Prevention of First Bleeding |
| NCT00827775 MATCH results posted | STU 102008-042 NIH K23 HL092297 | Ph 4 | completed | Mechanisms and Treatment of Intradialytic Hypertension |
| NCT02907749 FP-PH | Yang-20160905 | Ph 4 | completed | Spironolactone on Fibrosis Progrssion-Portal Hypertension(FP-PH)in Cirrhosis |
| NCT04499898 | nabeela protocol | Ph 2, Ph 3 | recruiting | Carvedilol Versus Endoscopic Band Ligation for Primary Prophylaxis of Oesophageal Variceal Bleeding |
| NCT02507011 results posted | 1504M69361 | Ph 2 | terminated | Beta-blockers in Pulmonary Arterial Hypertension |
| NCT02120339 | PAH | Ph 1 | terminated | Carvedilol PAH A Pilot Study of Efficacy and Safety |
| NCT02056626 results posted | 5R01HL105520 | Ph 4 | completed | Conditioned Pharmacotherapeutic Effects in Hypertension |
| NCT01656005 ANDA2 | ANDA2 2011-006008-11 | Ph 4 | completed | Beta Blocker Therapy in Moderate to Severe COPD |
| NCT03867994 CIN | beta-blockers and statins | Ph 2 | completed | Comparison of Carvedilol and Atorvastatin for Preventing of Contrast-Induced Nephropathy. |
| NCT02066649 | Pro2013003729 | Ph 3 | withdrawn | Carvedilol vs Band Ligation vs Combination Therapy for Primary Prophylaxis of Variceal Bleeding |
| NCT01568645 | 120093 12-H-0093 | Ph 1 | withdrawn | Imatinib and Carvedilol for High Blood Pressure in the Lungs in Adults With Sickle Cell Disease |
| NCT01354444 results posted | NA_00035546 | Ph 4 | completed | Trial of Carvedilol in Alzheimer's Disease |
| NCT01724450 Ceccy | Ceccy Trial | Ph 3 | completed | Carvedilol Effect in Preventing Chemotherapy - Induced Cardiotoxicity |
| NCT01059396 PREDESCI | PREDESCI | Ph 4 | completed | Study on B-blockers to Prevent Decompensation of Cirrhosis With HTPortal |
| NCT02504723 results posted | VGHKS11-CT10-11 | Ph 4 | completed | Carvedilol as an Adjunct to Endoscopic Cyanoacrylate Injection for Secondary Prophylaxis of Gastric Variceal Bleeding |
| NCT01155635 CAPITAL-RCT | C-417 | Ph 4 | completed | Carvedilol Post-intervention Long-term Administration in Large-scale Trial |
| NCT00964678 results posted | HM12120 | Ph 1, Ph 2 | completed | Pilot Study of the Safety and Efficacy of Carvedilol in Pulmonary Arterial Hypertension |
| NCT01723371 | 1000031903 | Ph 1, Ph 2 | withdrawn | Beta Blockers for Treatment of Pulmonary Arterial Hypertension in Children |
| NCT02547597 | CARVEDILOL | Ph 4 | completed | Comparison of Carvedilol and Atenolol on Anti-anginal and Metabolic Effects in Patients With Stable Angina Pectoris |
| NCT02286934 | CYP-CVDL-01 | Ph 1 | completed | Cytochrome P450 2D6 Genotype on the Clinical Effect of Carvedilol |
| NCT01178528 CARVIVA-HF results posted | CTG001-07 | Ph 3 | completed | Heart Rate Reduction in Heart Failure |
| NCT01577914 | Ipca/ARL/203 | Ph 1 | completed | Bioequivalence Study of Carvedilol Tablets USP 12.5 mg Under Fasting Condition |
| NCT00673075 results posted | NEB-MD-06 | Ph 4 | completed | The Effect of Nebivolol in Hypertensive Patients With Coronary Artery Disease |
| NCT05553314 | CARE-preserved HF | Ph 4 | completed | Carvedilol in HF With Preserved EF |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CARVEDILOL FDA Label Details
Indications & Usage
FDA Label (PDF)Carvedilol tablets are an alpha/beta-adrenergic blocking agent indicated for the treatment of: mild to severe chronic heart failure left ventricular dysfunction following myocardial infarction in clinically stable patients hypertension 1.1 Heart Failure Carvedilol tablets are indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitors, and digitalis, to increase survival and, also, to reduce the risk of hospitalization [see Drug Interactions , Clinical Studies ] . 1.2 Left Ventricular Dysfunction fo...
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Full clinical data, patents, trials, and competitive landscape for carvedilol.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.