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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/19 | Not Applicable | Recruiting | |||
2024/10/16 | Early Phase 1 | Recruiting | |||
2024/08/20 | Phase 4 | Recruiting | Vastra Gotaland Region | ||
2024/02/23 | Phase 3 | Not yet recruiting | Oman Medical Speciality Board | ||
2023/09/13 | Phase 4 | Not yet recruiting | University Hospital Ostrava | ||
2023/02/15 | Phase 4 | Recruiting | |||
2022/10/06 | Phase 4 | Recruiting | Morten Steen Kvistholm Jensen | ||
2022/09/14 | Phase 3 | Recruiting | |||
2022/09/10 | Phase 2 | Completed | |||
2022/09/10 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Physicians Total Care, Inc. | 54868-4577 | ORAL | 2.5 mg in 1 1 | 12/15/2011 | |
| GLENMARK PHARMACEUTICALS INC., USA | 68462-880 | ORAL | 10 mg in 1 1 | 1/18/2024 | |
| Teva Pharmaceuticals USA, Inc. | 0093-3243 | ORAL | 10 mg in 1 1 | 2/9/2024 | |
| Viona Pharmaceuticals Inc | 72578-111 | ORAL | 5 mg in 1 1 | 11/10/2023 | |
| Proficient Rx LP | 63187-871 | ORAL | 5 mg in 1 1 | 11/1/2019 | |
| Zydus Lifesciences Limited | 70771-1762 | ORAL | 10 mg in 1 1 | 11/7/2022 | |
| Denton Pharma, Inc. dba Northwind Pharmaceuticals | 70934-705 | ORAL | 5 mg in 1 1 | 8/12/2021 | |
| Alembic Pharmaceuticals Limited | 46708-603 | ORAL | 5 mg in 1 1 | 2/7/2023 | |
| Alembic Pharmaceuticals Inc. | 62332-604 | ORAL | 10 mg in 1 1 | 10/8/2021 | |
| Bryant Ranch Prepack | 72162-2177 | ORAL | 5 mg in 1 1 | 1/13/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| BLOKBIS TABLET 2.5MG | SIN15804P | TABLET | 2.5 mg | 9/12/2019 | |
| COSYREL FILM-COATED TABLET 10 mg/ 5 mg | SIN15400P | TABLET, FILM COATED | 10 mg | 12/28/2017 | |
| COSYREL FILM-COATED TABLET 10 mg/ 10 mg | SIN15401P | TABLET, FILM COATED | 10 mg | 12/28/2017 | |
| BISOPRO FILM-COATED TABLET 5MG | SIN15507P | TABLET, FILM COATED | 5mg | 6/20/2018 | |
| BISOZEN FILM COATED TABLET 2.5MG | SIN15867P | TABLET, FILM COATED | 2.50 MG | 12/3/2019 | |
| BISOCOR TABLET 5MG | SIN15755P | TABLET | 5mg | 7/29/2019 | |
| CONCOR AMLO TABLET 5 mg/ 5 mg | SIN15033P | TABLET | 5mg | 6/21/2016 | |
| CONCOR TABLET 2.5 mg | SIN11349P | TABLET, FILM COATED | 2.5 mg | 7/13/2000 | |
| BISOCCORD 2.5 FILM COATED TABLET 2.5 MG | SIN15851P | TABLET, FILM COATED | 2.5 mg | 11/12/2019 | |
| BISOHEXAL TABLET 5 mg | SIN12568P | TABLET, FILM COATED | 5 mg | 7/21/2004 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Bisoprolol Fumarate Capsules | 国药准字H20073196 | 化学药品 | 胶囊剂 | 10/14/2020 | |
| Bisoprolol Fumarate Capsules | 国药准字H20073197 | 化学药品 | 胶囊剂 | 2/28/2020 | |
| Bisoprolol Fumarate Capsules | 国药准字H19990048 | 化学药品 | 胶囊剂 | 8/17/2020 | |
| Bisoprolol Fumarate Capsules | 国药准字H20000201 | 化学药品 | 胶囊剂 | 7/7/2020 | |
| Bisoprolol Fumarate Capsules | 国药准字H20000200 | 化学药品 | 胶囊剂 | 7/7/2020 | |
| Bisoprolol Fumarate Capsules | 国药准字H20000043 | 化学药品 | 胶囊剂 | 5/8/2020 | |
| Bisoprolol Fumarate Capsules | 国药准字H19990049 | 化学药品 | 胶囊剂 | 8/17/2020 | |
| Bisoprolol Fumarate Tablets | 国药准字H20243947 | 化学药品 | 片剂 | 8/28/2024 | |
| Bisoprolol Fumarate Tablets | 国药准字H20253013 | 化学药品 | 片剂 | 1/2/2025 | |
| Bisoprolol Fumarate Tablets | 国药准字H20253012 | 化学药品 | 片剂 | 1/2/2025 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| LODOZ MERCK TAB 5/6.25 | N/A | N/A | N/A | 1/11/2002 | |
| APO-BISOPROLOL TAB 5MG | N/A | N/A | N/A | 4/30/2007 | |
| BISOVELL TABLETS 2.5MG | N/A | N/A | N/A | 6/11/2025 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Medreich Bisoprolol 5 bisoprolol fumarate 5 mg film-coated tablet blister pack | 212059 | Medicine | A | 8/26/2014 | |
| GENRX BISOPROLOL bisoprolol fumarate 10mg tablet blister pack | 182130 | Medicine | A | 12/13/2011 | |
| GENRX BISOPROLOL bisoprolol fumarate 2.5mg tablet blister pack | 182107 | Medicine | A | 12/13/2011 | |
| BISOPROLOL SANDOZ bisoprolol fumarate 10 mg film-coated tablet blister pack | 144888 | Medicine | A | 3/4/2009 | |
| BISPRO bisoprolol furarate 10 mg tablet blister pack | 130182 | Medicine | A | 2/2/2007 | |
| AURO-BISOPROLOL 7.5 | 175920 | Medicine | A | 10/20/2011 | |
| AURO-BISOPROLOL 1.25 | 175928 | Medicine | A | 10/20/2011 | |
| BISOPROLOL AN bisoprolol fumarate 7.5mg tablet blister pack | 175913 | Medicine | A | 10/20/2011 | |
| BEPROL 1.25 bisoprolol fumarate 1.25mg tablet blister pack | 175924 | Medicine | A | 10/20/2011 | |
| BISOPROLOL-WGR bisoprolol fumarate 1.25mg tablet blister pack | 182109 | Medicine | A | 12/13/2011 |