bisoprolol
Trade name: zebeta
Approved
Jul 31, 1992
Bisoprolol is a cardioselective beta1-adrenergic blocking agent. It lower the heart rate and blood pressure and may be used to reduce workload on the heart and hence oxygen demands. This results in a reduction of heart rate, cardiac output, systolic and diastolic blood pressure, and possibly reflex orthostatic hypotension. Bisoprolol can be used to treat cardiovascular diseases such as hypertension, coronary heart disease, arrhythmias, ischemic heart diseases, and myocardial infarction after the acute event. General side effects are: fatigue, asthenia, chest pain, malaise, edema, weight gain, angioedema. Concurrent use of rifampin increases the metabolic clearance of bisoprolol fumarate, shortening its elimination half-life. — NCATS
Clinical trial activity
85 trials · 117 clinical orgs · 27 marketing orgs
Earliest trial started Feb 1, 1992 (NCT00382421)
Timeline
1990s
- Jul 31, 1992
Earliest FDA Approval
- Jul 31, 1992
Teva — NDA Secondary Org
2000s
- Sep 25, 2000
Mylan — Marketing Organization
- Sep 25, 2000
Sandoz — Marketing Organization
- Sep 25, 2000
Actavis — Marketing Organization
- Sep 25, 2000
Chartwell Pharmaceuticals — Marketing Organization
- Sep 25, 2000
Epic Pharma Llc — Marketing Organization
- Sep 25, 2000
Teva — Marketing Organization
- Nov 16, 2000
Rubicon Research — Marketing Organization
- Nov 16, 2000
CASI Pharmaceuticals, Inc. — Marketing Organization
- Dec 27, 2000
Apothecon — Marketing Organization
- Oct 25, 2002
Frontida BioPharm — Marketing Organization
- Oct 25, 2002
UNITED RES LABS — Marketing Organization
- Oct 25, 2002
TRUPHARMA — Marketing Organization
- Jan 1, 2003
Earliest Phase 3 Sponsor(trial)
- Jan 1, 2005
Earliest Phase 1 Sponsor(trial)
- Jan 1, 2005
Earliest Phase 2 Sponsor(trial)
- Dec 14, 2005
Dash Pharms — Marketing Organization
- Dec 27, 2006
Aurobindo Pharma — Marketing Organization
2010s
- Jul 28, 2010
Unichem — Marketing Organization
- Jan 11, 2017
Orit Labs Llc — Marketing Organization
- Jan 11, 2017
Alembic — Marketing Organization
2020s
- Jul 9, 2020
Edenbridge Pharms — Marketing Organization
- Oct 29, 2021
Novitium Pharma — Marketing Organization
- Oct 29, 2021
Ani Pharmaceuticals — Marketing Organization
- Jan 26, 2022
Glenmark Pharmaceuticals — Marketing Organization
- Jul 25, 2022
Zydus Discovery DMCC — Marketing Organization
- Jul 25, 2022
Cadila Healthcare — Marketing Organization
- Jul 14, 2023
Prinston Inc — Marketing Organization
- Jan 18, 2024
Harman Finochem — Marketing Organization
- Apr 16, 2025
Unique Pharmaceuticals Ltd, India — Marketing Organization
Indications
Approved for
Studied for
- Acute Coronary Syndrome · Phase 2
- Angina Pectoris · Phase 4
- Angina Pectoris, Variant · Phase 4
- Angina, Stable · Phase 4
- Aortic Aneurysm, Abdominal · Early Phase 1
- Aortic Valve Stenosis · Phase 4
- Atrial Fibrillation · Phase 4
- Atrial Flutter · Phase 3
- Atrial Function, Left · Phase 3
- Blood Loss, Surgical · Early Phase 1
- Blood Pressure · Phase 4
- Breast Neoplasms · Phase 3
- Cardiomyopathies · Phase 4
- Cardiomyopathy, Dilated · Phase 2/Phase 3
- Cardiotoxicity · Phase 3
- Cardiovascular Diseases · Phase 4
- Chagas Cardiomyopathy · Phase 3
- Coronary Artery Bypass · Phase 4
- Coronary Artery Disease · Phase 4
- Coronary Disease · Phase 4
- Coronary Vasospasm · Phase 4
- Diabetes Mellitus · Phase 2/Phase 3
- Diabetes Mellitus, Type 2 · Phase 4
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Essential Hypertension · Phase 4
- Familial Primary Pulmonary Hypertension · Phase 1/Phase 2
- Fasting · Phase 1
- General Surgery · Early Phase 1
- Healthy Volunteers · Phase 1
- Heart Diseases · Phase 4
- Heart Failure · Phase 4
- Heart Failure, Diastolic · Phase 3
- Heart Failure, Systolic · Phase 4
- Heart Rate · Early Phase 1
- Hypertension · Phase 4
- Hypertension, Renal · Phase 4
- Insulin Resistance · Phase 4
- Metabolic Syndrome · Phase 4
- Microvascular Angina · Phase 4
- Muscular Dystrophy, Duchenne · Phase 2/Phase 3
- Myocardial Infarction · Phase 4
- Non-ST Elevated Myocardial Infarction · Phase 4
- Pharmacogenetics · Phase 4
- Pharmacokinetics · Phase 1
- Pheochromocytoma · Phase 2
- Postoperative Complications · Phase 4
- Postural Orthostatic Tachycardia Syndrome · Phase 4
- Pulmonary Disease, Chronic Obstructive · Phase 4
- ST Elevation Myocardial Infarction · Phase 4
- Systole · Phase 3
- Ventricular Dysfunction, Left · Phase 4
Mechanism of action
- Beta-1 adrenergic receptorANTAGONIST
ADRB1 antagonist
Combination products
ziac
with hydrochlorothiazide
Approval history
- approvedJul 31, 1992
Chemistry & pharmacology
SMILES
CC(C)NCC(O)COc1ccc(COCCOC(C)C)cc1- Mol. weight
- 325.45 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Racemic Mixture
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL645 ↗
- WikipediaBisoprolol ↗
- NCATSY41JS2NL6U ↗
- ChEMBLCHEMBL1472989 ↗
- ChEMBLCHEMBL1200708 ↗
Also known as
- (+-)-1-((alpha-(2-isopropoxyethoxy)-p-tolyl)oxy)-3-(isopropylamino)-2-propanol
- (+-)-1-((alpha-(2-isopropoxyethoxy)-p-tolyl)oxy)-3-(isopropylamino)-2-propanol
- bipranix
- bisoprolol
- bisoprolol
- bisoprolol
- bisoprolol
- bisoprolol
- bisoprolol
- bisoprolol
- bisoprolol
- bisoprolol fumarate
- bisoprolol fumarate
- bisoprolol fumarate
- bisoprolol fumarate
- bisoprolol fumarate and hydrochlorothiazide
- bisoprolol hemifumarate
- bisoprolol hemifumarate
- bisoprolol hemifumarate
- bisoprolol hemifumarate
- bisoprolol hemifumarate
- bisoprolol hemifumarate
- bisoprolol hemifumarate
- bisoprolol - hydrochlorothiazide
- bisoprolol, hydrochlorothiazide drug combination
- bisoprololum
- bisoprololum
- cardicor
- cardicor
- cl-297939
- cl-297939
- concor
- concor
- congescor
- congescor
- emcor
- emcor
- emcor ls
- emd-33512
- emd-33512
- emd-33-512
- emd-33-512
- isoten mitis
- maxsoten
- monocor
- monocor
- (rs)-1-(4-(2-isopropoxyethoxymethyl)phenoxy)-3-(isopropylamino)-2-propanol
- (rs)-1-(4-(2-isopropoxyethoxymethyl)phenoxy)-3-(isopropylamino)-2-propanol
- soloc
- soloc
- soprol
- soprol
- vivacor
- zebeta
- zebeta
- zebeta
- ziac
- ziac
- ziac
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07103655 | Phase 4 | Jan 1, 2026 | Zhejiang University |
| NCT07029906 | N/A | Apr 29, 2025 | Imperial College London, University of London |
| NCT06831864 | Phase 1 | Feb 15, 2025 | Government of India, University of New South Wales, Washington University in St. Louis |
| NCT06657404 | N/A | Oct 23, 2024 | Capital Medical University, Jiangmen Central Hospital, Shantou University, Southern Medical University, Sun Yat-Sen University, Xiamen University, Zhejiang University, Zhengzhou University |
| NCT06276127 | Phase 3 | Apr 30, 2024 | Oman Medical Board Specialty (OMSB) |
| NCT06035978 | Phase 4 | Nov 30, 2023 | University of Ostrava |
| NCT06853951 | Phase 3 | Jul 18, 2023 | Ain Shams University |
| NCT05880056 | Phase 4 | Jul 15, 2023 | Genuine Research Center, Egypt |
| NCT05930808 | Phase 1 | Feb 28, 2023 | Merck KGaA |
| NCT05540600 | Phase 3 | Sep 12, 2022 | University of Monastir |
| NCT05569382 | Phase 4 | Aug 10, 2022 | Aarhus University, University of Copenhagen, University of Southern Denmark, Viborg Regional Hospital |
| NCT05294887 | Phase 4 | Mar 4, 2022 | Charité University, Berlin, Germany, German Center for Cardiovascular Research e. V. (DZHK), Humboldt University, University of Zurich |
| NCT05536271 | Phase 2 | Sep 1, 2021 | Alexandria University, Damanhour University |
| NCT05536284 | Phase 2 | Sep 1, 2021 | Alexandria University, Damanhour University |
| NCT05730413 | Phase 4 | Aug 25, 2021 | Cairo University |
| NCT04823442 | N/A | Jan 21, 2021 | Laval University, University of Sherbrooke |
| NCT05175066 | Phase 3 | Nov 12, 2020 | Shahid Beheshti University of Medical Sciences |
| NCT04513509 | N/A | Aug 7, 2020 | National Taiwan University |
| NCT04356196 | Early Phase 1 (Phase 1) | May 1, 2020 | Assiut University |
| NCT04432610 | Phase 4 | Mar 1, 2020 | Clinical Hospital Center Zemun |
Organizations
Research & Development (117)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Merck KGaA | For profit | 11 | 11 | 3 | 2008 |
| Merck | For profit | 6 | 0 | 1 | 2008 |
| Ain Shams University | Academic/Hospital | 4 | 4 | 3 | 2018 |
| Alexandria University | Academic/Hospital | 3 | 1 | 2 | 2019 |
| Damanhour University | Academic/Hospital | 3 | 2 | 2 | 2019 |
| Merck Serono | For profit | 3 | 0 | 1 | 2010 |
| Aarhus University | Academic/Hospital | 2 | 2 | 2 | 2009 |
| Accutest Research Laboratories (I) Pvt. Ltd. | For profit | 2 | 0 | 1 | 2012 |
| Cairo University | Academic/Hospital | 2 | 1 | 2 | 2019 |
| IPCA Laboratories Ltd. | For profit | 2 | 2 | 1 | 2012 |
| Jiao Tong University | Academic/Hospital | 2 | 1 | 1 | 2010 |
| Laval University | Academic/Hospital | 2 | 1 | 1 | 2008 |
| Seoul National University | Academic/Hospital | 2 | 2 | 1 | 2013 |
| University of Copenhagen | Academic/Hospital | 2 | 1 | 1 | 2018 |
| University of Dundee | Academic/Hospital | 2 | 2 | 1 | 2012 |
| University of Glasgow | Academic/Hospital | 2 | 2 | 2 | 2005 |
| University of New South Wales | Academic/Hospital | 2 | 1 | 2 | 2019 |
| University of Vienna | Academic/Hospital | 2 | 1 | 2 | 2007 |
| Zhejiang University | Academic/Hospital | 2 | 1 | 2 | 2024 |
| Aalborg University | Academic/Hospital | 1 | 0 | 1 | 2009 |
Marketing (36)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Actavis | For profit | MKTG | Sep 25, 2000 |
| Alembic | For profit | MKTG | Jan 11, 2017 |
| Alembic | For profit | SYN | Jan 11, 2017 |
| Ani Pharmaceuticals | For profit | MKTG | Oct 29, 2021 |
| Apothecon | For profit | MKTG | Dec 27, 2000 |
| Aurobindo Pharma | For profit | MKTG | Dec 27, 2006 |
| CASI Pharmaceuticals, Inc. | For profit | MKTG | Nov 16, 2000 |
| Cadila Healthcare | For profit | MKTG | Jul 25, 2022 |
| Chartwell Pharmaceuticals | For profit | MKTG | Sep 25, 2000 |
| Dash Pharms | For profit | MKTG | Dec 14, 2005 |
| Edenbridge Pharms | For profit | MKTG | Jul 9, 2020 |
| Epic Pharma Llc | For profit | MKTG | Sep 25, 2000 |
| Frontida BioPharm | For profit | MKTG | Oct 25, 2002 |
| Glenmark Pharmaceuticals | For profit | MKTG | Jan 26, 2022 |
| Harman Finochem | For profit | MKTG | Jan 18, 2024 |
| Lederle | For profit | NDA | — |
| Mylan | For profit | MKTG | Sep 25, 2000 |
| Novitium Pharma | For profit | MKTG | Oct 29, 2021 |
| Orit Labs Llc | For profit | MKTG | Jan 11, 2017 |
| Prinston Inc | For profit | MKTG | Jul 14, 2023 |
| Rubicon Research | For profit | MKTG | Nov 16, 2000 |
| Rubicon Research | For profit | SYN | Nov 16, 2000 |
| Sandoz | For profit | MKTG | Sep 25, 2000 |
| TRUPHARMA | For profit | MKTG | Oct 25, 2002 |
| Teva | For profit | SYN | Sep 27, 2000 |
| Teva | For profit | SYN | Jan 19, 2001 |
| Teva | For profit | SYN | Mar 26, 1993 |
| Teva | For profit | SYN | Jun 26, 2001 |
| Teva | For profit | NDA2 | Jul 31, 1992 |
| Teva | For profit | SYN | Sep 25, 2000 |
| Teva | For profit | MKTG | Sep 25, 2000 |
| UNITED RES LABS | For profit | MKTG | Oct 25, 2002 |
| Unichem | For profit | MKTG | Jul 28, 2010 |
| Unichem | For profit | SYN | Aug 18, 2009 |
| Unique Pharmaceuticals Ltd, India | For profit | MKTG | Apr 16, 2025 |
| Zydus Discovery DMCC | For profit | MKTG | Jul 25, 2022 |