Overview
Bisoprolol is a cardioselective β1-adrenergic blocking agent used to treat high blood pressure. It is considered a potent drug with a long-half life that can be used once daily to reduce the need for multiple doses of antihypertensive drugs. Bisoprolol is generally well tolerated, likely due to its β1-adrenergic receptor selectivity and is a useful alternative to non-selective β-blocker drugs in the treatment of hypertension such as Carvedilol and Labetalol. It may be used alone or in combination with other drugs to manage hypertension and can be useful in patients with chronic obstructive pulmonary disease (COPD) due to its receptor selectivity.
Background
Bisoprolol is a cardioselective β1-adrenergic blocking agent used to treat high blood pressure. It is considered a potent drug with a long-half life that can be used once daily to reduce the need for multiple doses of antihypertensive drugs. Bisoprolol is generally well tolerated, likely due to its β1-adrenergic receptor selectivity and is a useful alternative to non-selective β-blocker drugs in the treatment of hypertension such as Carvedilol and Labetalol. It may be used alone or in combination with other drugs to manage hypertension and can be useful in patients with chronic obstructive pulmonary disease (COPD) due to its receptor selectivity.
Indication
Bisoprolol is indicated for the treatment of mild to moderate hypertension. It may be used off-label to treat heart failure, atrial fibrillation, and angina pectoris.
Associated Conditions
- Atrial Fibrillation
- Cardiovascular Events
- Chronic Stable Angina Pectoris
- Heart Failure
- Hypertension
- Mild Hypertension
- Premature Ventricular Contraction (PVC)
- Supraventricular Arrhythmias
- Moderate Hypertension
- Perioperative arrhythmia
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/03/24 | Phase 4 | UNKNOWN | |||
2022/03/21 | Phase 3 | Completed | |||
2022/01/03 | Phase 3 | Completed | |||
2021/03/30 | Not Applicable | Completed | |||
2020/06/16 | Phase 4 | Withdrawn | Clinical Hospital Center Zemun | ||
2020/04/22 | Early Phase 1 | UNKNOWN | |||
2019/09/11 | Phase 4 | Completed | |||
2019/04/17 | Phase 3 | Completed | |||
2019/02/21 | Phase 4 | Completed | |||
2019/01/11 | Phase 4 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bryant Ranch Prepack | 71335-2244 | ORAL | 10 mg in 1 1 | 10/28/2022 | |
| GLENMARK PHARMACEUTICALS INC., USA | 68462-878 | ORAL | 2.5 mg in 1 1 | 1/18/2024 | |
| Viona Pharmaceuticals Inc | 72578-112 | ORAL | 10 mg in 1 1 | 11/10/2023 | |
| Unichem Pharmaceuticals (USA), Inc. | 29300-126 | ORAL | 5 mg in 1 1 | 10/28/2022 | |
| A-S Medication Solutions | 50090-6478 | ORAL | 2.5 mg in 1 1 | 10/5/2022 | |
| Solco Healthcare US, LLC | 43547-617 | ORAL | 10 mg in 1 1 | 6/26/2023 | |
| Bryant Ranch Prepack | 71335-1769 | ORAL | 5 mg in 1 1 | 8/31/2021 | |
| NorthStar Rx LLC | 16714-529 | ORAL | 5 mg in 1 1 | 6/13/2022 | |
| Unichem Pharmaceuticals (USA), Inc. | 29300-187 | ORAL | 2.5 mg in 1 1 | 1/10/2024 | |
| A-S Medication Solutions | 50090-6413 | ORAL | 5 mg in 1 1 | 2/4/2022 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| BISOZEN FILM COATED TABLET 10MG | SIN15865P | TABLET, FILM COATED | 10 MG | 12/3/2019 | |
| CONCOR 5 TABLET 5 mg | SIN01039P | TABLET, FILM COATED | 5 mg | 5/10/1988 | |
| BISOCCORD 5 FILM COATED TABLET 5 MG | SIN15852P | TABLET, FILM COATED | 5 mg | 11/12/2019 | |
| BISOPRO FILM-COATED TABLET 2.5MG | SIN15506P | TABLET, FILM COATED | 2.5mg | 6/20/2018 | |
| COSYREL FILM-COATED TABLET 5 mg/ 5 mg | SIN15398P | TABLET, FILM COATED | 5 mg | 12/28/2017 | |
| BISOZEN FILM COATED TABLET 5MG | SIN15866P | TABLET, FILM COATED | 5 MG | 12/3/2019 | |
| BISOCOR TABLET 2.5MG | SIN15805P | TABLET | 2.5mg | 9/12/2019 | |
| COSYREL FILM-COATED TABLET 5 mg/ 10 mg | SIN15399P | TABLET, FILM COATED | 5 mg | 12/28/2017 | |
| BISODAC 2.5 FILM-COATED TABLETS 2.5MG | SIN16300P | TABLET, FILM COATED | 2.5mg | 8/16/2021 | |
| BISODAC 5 FILM-COATED TABLETS 5MG | SIN16299P | TABLET, FILM COATED | 5 mg | 8/16/2021 |
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Bisoprolol Fumarate Tablets | 国药准字H20253940 | 化学药品 | 片剂 | 4/15/2025 | |
| Bisoprolol Fumarate Tablets | 国药准字H20253939 | 化学药品 | 片剂 | 4/15/2025 | |
| Bisoprolol Fumarate Tablets | 国药准字HJ20170261 | 化学药品 | 片剂 | 1/5/2021 | |
| Bisoprolol Fumarate Tablets | 国药准字HJ20170259 | 化学药品 | 片剂 | 1/5/2021 | |
| Bisoprolol Fumarate Tablets | 国药准字HJ20160475 | 化学药品 | 片剂 | 6/21/2021 | |
| Bisoprolol Fumarate Tablets | 国药准字H20205007 | 化学药品 | 片剂 | 7/16/2020 | |
| Bisoprolol Fumarate Tablets | 国药准字H20173037 | 化学药品 | 片剂 | 1/26/2022 | |
| Bisoprolol Fumarate Tablets | 国药准字H20243348 | 化学药品 | 片剂 | 3/19/2024 | |
| Bisoprolol Fumarate Tablets | 国药准字H20243009 | 化学药品 | 片剂 | 6/4/2024 | |
| Bisoprolol Fumarate Tablets | 国药准字H20243010 | 化学药品 | 片剂 | 6/4/2024 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| BISOPROLOL-WGR bisoprolol fumarate 10mg tablet blister pack | 182127 | Medicine | A | 12/13/2011 | |
| BICOR bisoprolol fumarate 2.5 mg tablet blister pack | 81604 | Medicine | A | 4/23/2002 | |
| BISOPROLOL-WGR bisoprolol fumarate 5mg tablet blister pack | 182129 | Medicine | A | 12/13/2011 | |
| GENRX BISOPROLOL bisoprolol fumarate 1.25mg tablet blister pack | 182113 | Medicine | A | 12/13/2011 | |
| BISOPROLOL SANDOZ bisoprolol fumarate 2.5 mg film-coated tablet blister pack | 144867 | Medicine | A | 3/4/2009 | |
| BISPRO bisoprolol fumarate 7.5 mg tablet blister pack | 130181 | Medicine | A | 2/2/2007 | |
| AURO-BISOPROLOL 3.75 | 175918 | Medicine | A | 10/20/2011 | |
| BICOR bisoprolol fumarate 3.75 mg tablet blister pack | 81605 | Medicine | A | 4/23/2002 | |
| BISOPROLOL-WGR bisoprolol fumarate 3.75mg tablet blister pack | 182112 | Medicine | A | 12/13/2011 | |
| APO-BISOPROLOL bisoprolol fumarate 5mg tablet blister pack | 182114 | Medicine | A | 12/13/2011 |