Overview
Nebivolol is a racemic mixture of 2 enantiomers where one is a beta adrenergic antagonist and the other acts as a cardiac stimulant without beta adrenergic activity. Treatment with nebivolol leads to a greater decrease in systolic and diastolic blood pressure than atenolol, propranolol, or pindolol. Nebivolol and other beta blockers are generally not first line therapies as many patients are first treated with thiazide diuretics. Nebivolol was granted FDA approval on 17 December 2007.
Background
Nebivolol is a racemic mixture of 2 enantiomers where one is a beta adrenergic antagonist and the other acts as a cardiac stimulant without beta adrenergic activity. Treatment with nebivolol leads to a greater decrease in systolic and diastolic blood pressure than atenolol, propranolol, or pindolol. Nebivolol and other beta blockers are generally not first line therapies as many patients are first treated with thiazide diuretics. Nebivolol was granted FDA approval on 17 December 2007.
Indication
Nebivolol is indicated to treat hypertension.
Associated Conditions
- Hypertension
Clinical Trials
View More Clinical Trials
Sign in to access the complete clinical trial database with detailed study information.
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2008/10/20 | Phase 4 | Completed | |||
2008/10/10 | Phase 4 | Completed | Forest Laboratories | ||
2008/08/29 | Phase 4 | Completed | Forest Laboratories | ||
2008/08/14 | Phase 4 | Completed | Forest Laboratories | ||
2008/05/23 | Phase 3 | UNKNOWN | Fondazione IRCCS Policlinico San Matteo di Pavia | ||
2008/05/07 | Phase 4 | Completed | Forest Laboratories | ||
2008/05/07 | Phase 4 | Completed | Forest Laboratories | ||
2008/04/01 | Phase 3 | Completed | Forest Laboratories | ||
2007/10/22 | Phase 3 | Terminated | Forest Laboratories | ||
2007/08/17 | Phase 4 | Completed | Centro Cardiologico Monzino |
FDA Drug Approvals
View More FDA Approvals
Sign in to access additional FDA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Solco Healthcare US, LLC | 43547-526 | ORAL | 10 mg in 1 1 | 2/14/2022 | |
| Golden State Medical Supply, Inc. | 51407-483 | ORAL | 2.5 mg in 1 1 | 8/24/2023 | |
| Macleods Pharmaceuticals Limited | 33342-457 | ORAL | 2.5 mg in 1 1 | 4/8/2025 | |
| Modavar Pharmaceuticals LLC | 72241-032 | ORAL | 2.5 mg in 1 1 | 11/9/2023 | |
| Golden State Medical Supply, Inc. | 51407-484 | ORAL | 5 mg in 1 1 | 8/24/2023 | |
| A-S Medication Solutions | 50090-5761 | ORAL | 10 mg in 1 1 | 4/13/2022 | |
| Physicians Total Care, Inc. | 54868-5944 | ORAL | 5 mg in 1 1 | 1/3/2012 | |
| Physicians Total Care, Inc. | 54868-6018 | ORAL | 10 mg in 1 1 | 1/3/2012 | |
| Unichem Pharmaceuticals (USA), Inc. | 29300-377 | ORAL | 10 mg in 1 1 | 7/11/2023 | |
| Ascend Laboratories, LLC | 67877-391 | ORAL | 10 mg in 1 1 | 7/13/2023 |
EMA Drug Approvals
View More EMA Approvals
Sign in to access additional EMA-approved drug information with detailed regulatory data.
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
View More HSA Approvals
Sign in to access additional HSA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
View More NMPA Approvals
Sign in to access additional NMPA-approved drug information with detailed regulatory data.
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
View More PPB Approvals
Sign in to access additional PPB-approved drug information with detailed regulatory data.
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
View More TGA Approvals
Sign in to access additional TGA-approved drug information with detailed regulatory data.
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||