Nebivolol
- Generic Name
- Nebivolol
- Brand Names
- Bystolic
- Drug Type
- Small Molecule
- Chemical Formula
- C22H25F2NO4
- CAS Number
- 118457-14-0
- Unique Ingredient Identifier
- 030Y90569U
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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/05/22 | Phase 2 | Recruiting | |||
2024/02/08 | Phase 4 | Not yet recruiting | Jagiellonian University | ||
2023/10/27 | Phase 4 | Completed | |||
2023/09/13 | Phase 4 | Not yet recruiting | University Hospital Ostrava | ||
2023/02/15 | Phase 3 | Active, not recruiting | |||
2022/08/24 | Phase 4 | Completed | |||
2022/04/14 | Not Applicable | Active, not recruiting | |||
2022/02/25 | Phase 4 | Completed | |||
2021/12/27 | Phase 3 | Completed | |||
2021/06/02 | Phase 2 | Completed |
FDA Approved Products
Product Name | Manufacturer | Route | Strength | Approved | NDC Code |
|---|---|---|---|---|---|
ORAL | 5 mg in 1 1 | 2024/01/31 | 31722-586 | ||
ORAL | 5 mg in 1 1 | 2022/04/13 | 50090-5752 | ||
ORAL | 20 mg in 1 1 | 2023/07/13 | 70756-293 | ||
ORAL | 2.5 mg in 1 1 | 2023/07/13 | 70756-025 | ||
ORAL | 10 mg in 1 1 | 2023/07/13 | 70756-292 | ||
ORAL | 5 mg in 1 1 | 2023/07/13 | 70756-291 | ||
ORAL | 10 mg in 1 1 | 2022/02/14 | 0904-7190 | ||
ORAL | 10 mg in 1 1 | 2023/06/20 | 60687-652 | ||
ORAL | 10 mg in 1 1 | 2022/04/13 | 50090-5761 | ||
ORAL | 20 mg in 1 1 | 2021/09/17 | 62559-278 |
EMA Approved Products
Product Name | EMA Number | Auth. Holder | Country | Drug Type | Status | Issued | Opinion | Revision |
|---|
No EMA products found
No EMA products found for this drug
HSA Approved Products
Product Name | Manufacturer | Dosage Form | Strength | Approved | Approval Number |
|---|---|---|---|---|---|
TABLET | 5 mg | 2024/03/22 | SIN16976P | ||
TABLET | 5 mg | 2022/05/06 | SIN16486P | ||
TABLET | 5mg | 2001/11/19 | SIN11728P | ||
TABLET | 5 mg | 2022/05/04 | SIN16481P | ||
TABLET | 5mg | 2020/06/16 | SIN15958P | ||
TABLET | 5mg | 2022/03/18 | SIN16446P |
NMPA Approved Products
Product Name | Approval Number | Manufacturer | Dosage Form | Trade Name | Strength | Type | Status | Date | Import |
|---|
No NMPA products found
No NMPA products found for this drug
PPB Approved Products
Product Name | Registration Code | Company | Category | Sale Type | Registration Date |
|---|
No PPB products found
No PPB products found for this drug
TGA Approved Products
Product Name | ARTG ID | Sponsor | Status | Registration Date | Ingredient |
|---|---|---|---|---|---|
311726 | Active | 2020/04/03 | nebivolol hydrochloride | ||
149679 | A Menarini Australia Pty Ltd | Active | 2009/06/26 | nebivolol hydrochloride | |
311734 | Active | 2020/04/03 | nebivolol hydrochloride | ||
281796 | Active | 2018/02/21 | nebivolol hydrochloride | ||
311725 | Active | 2020/04/03 | nebivolol hydrochloride | ||
148883 | A Menarini Australia Pty Ltd | Active | 2009/06/26 | nebivolol hydrochloride | |
421911 | Active | 2023/11/16 | nebivolol hydrochloride | ||
421909 | Active | 2023/11/16 | nebivolol hydrochloride | ||
421917 | Active | 2023/11/16 | nebivolol hydrochloride | ||
281797 | Active | 2018/02/21 | nebivolol hydrochloride |