Numerous clinical trials spanning Early Phase 1 through Phase 4 evaluate nebivolol across diverse cardiovascular and metabolic conditions, including essential hypertension, heart failure, pre-hypertension, type 2 diabetes mellitus, and erectile dysfunction, alongside drug-drug interaction studies in idiopathic pulmonary fibrosis. Sponsored by pharmaceutical companies and academic research institutions, these studies range from early pharmacokinetic assessments to extensive post-marketing safety and efficacy investigations. Although many trials are completed, others remain actively recruiting, terminated, withdrawn, or of unknown status.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT04432610 | WITHDRAWN | Bisoprolol Adverse Reaction; Nebivolol Adverse Reaction |
Clinical Hospital Center Zemun |
2030-01 | PHASE4 |
| NCT06249802 | NOT_YET_RECRUITING | Intracranial Aneurysm |
Jagiellonian University |
2025-01-01 | PHASE4 |
| NCT07568574 | ENROLLING_BY_INVITATION | Safety and Impact of Medically Supervised Performance Enhancing Substance Usage in Healthy Elite Athletes |
Enhanced Emirates Limited |
2026-03-12 | |
| NCT07233499 | RECRUITING | HER2-positive Breast Cancer |
Ain Shams University |
2025-01-01 | PHASE2 |
| NCT06424834 | RECRUITING | Angina Pectoris; Microvascular Angina; Vasospastic Angina; Myocardial Bridge of Coronary Artery |
Stanford University |
2024-10-10 | PHASE2; PHASE3 |
| NCT06035978 | UNKNOWN | Cardiovascular Diseases; Heart Failure With Reduced Ejection Fraction |
University Hospital Ostrava |
2024-03 | PHASE4 |
| NCT06201611 | RECRUITING | Diabetic Neuropathy Peripheral |
St. John's Research Institute |
2024-11-15 | PHASE2; PHASE3 |
| NCT03778554 | ACTIVE_NOT_RECRUITING | Acute Myocardial Infarction; Non-ST Elevation Myocardial Infarction (nSTEMI); ST Elevation Myocardial Infarction |
Bispebjerg Hospital |
2018-12-17 | PHASE4 |
| NCT07397481 | COMPLETED | Liver Cirrhosis; Arterial Hypertension |
Kafrelsheikh University |
2024-03-01 | PHASE4 |
| NCT06248099 | UNKNOWN | Healthy Subjects |
Bio-innova Co., Ltd |
2024-07-09 | PHASE1 |
| NCT06104423 | COMPLETED | Hypertension |
Menarini International Operations Luxembourg SA |
2023-10-02 | PHASE4 |
| NCT06004453 | Recruiting | Heart Failure |
Novartis Pharmaceuticals|Novartis |
2023-04-04 | -- |
| NCT05728632 | UNKNOWN | Breast Cancer; Lymphoma, Large B-Cell, Diffuse; Cardiotoxicity; Left Ventricular Dysfunction; Chemotherapy Effect |
Giulio Stefanini |
2019-01-01 | PHASE3 |
| NCT05328310 | UNKNOWN | Hypertension |
Korea University Anam Hospital |
2019-01-06 | |
| NCT05513937 | COMPLETED | Hypertension |
Menarini International Operations Luxembourg SA |
2022-05-12 | PHASE4 |
| NCT04513509 | COMPLETED | Atrial Fibrillation; Rate Control; Cardiopulmonary Exercise Test |
National Taiwan University Hospital |
2020-10-21 | |
| NCT04910100 | COMPLETED | Open-Angle Glaucoma; Ocular Hypertension |
Betaliq, Inc. |
2021-04-15 | PHASE2 |
| NCT04631536 | UNKNOWN | Covid19 |
Lebanese American University Medical Center |
2021-01-10 | PHASE3 |
| NCT04130438 | TERMINATED | Myocardial Bridging |
Stanford University |
2020-10-15 | PHASE2 |
| NCT05257148 | COMPLETED | Hypertension |
Menarini International Operations Luxembourg SA |
2021-05-26 | PHASE4 |
| NCT04845061 | UNKNOWN | Copd |
Ain Shams University |
2021-10-01 | PHASE4 |
| NCT01648634 | COMPLETED | Duchenne Muscular Dystrophy; Cardiomyopathy; Heart Failure |
Assistance Publique - Hôpitaux de Paris |
2012-02-13 | PHASE3 |
| NCT04888728 | COMPLETED | Idiopathic Pulmonary Fibrosis |
Daewoong Pharmaceutical Co. LTD. |
2021-06-30 | PHASE1 |
| NCT04888728 | Completed | Idiopathic Pulmonary Fibrosis |
Daewoong Pharmaceutical Co. LTD. |
2021-06-30 | Phase 1 |
| NCT02053246 | TERMINATED | Pulmonary Hypertension; Diastolic Heart Failure; Heart Failure With Preserved Ejection Fraction |
University of Florida |
2014-01 | PHASE4 |
| NCT03655964 | COMPLETED | Stroke, Ischemic |
Aristotle University Of Thessaloniki |
2018-08-20 | PHASE2 |
| NCT03930433 | COMPLETED | Coronary Vasospasm |
Korea University Anam Hospital |
2018-01-01 | PHASE4 |
| NCT02619526 | UNKNOWN | Heart Failure |
Dong-A University |
2016-12 | |
| NCT03180593 | COMPLETED | Hypertension Complicated; Hypertrophy, Left Ventricular; Blood Pressure |
Trinity Hypertension & Metabolic Research Institute |
2017-02-07 | PHASE4 |
| NCT02467400 | COMPLETED | Osteoporosis, Age-Related |
Mayo Clinic |
2015-07-01 | EARLY_PHASE1 |
| NCT01595516 | COMPLETED | Prehypertension; Hypertension |
University of Colorado, Boulder |
2012-02 | PHASE4 |
| NCT00223717 | COMPLETED | Hypertension |
Vanderbilt University |
2001-01 | PHASE1 |
| NCT01395329 | COMPLETED | Prehypertension; Hypertension |
University of Colorado, Boulder |
2011-05 | PHASE4 |
| NCT01522950 | COMPLETED | Hypertension |
University of Minnesota |
2010-05 | PHASE2 |
| NCT03245996 | COMPLETED | Aortic Blood Pressure |
Tartu University Hospital |
2015-06 | PHASE4 |
| NCT01996085 | COMPLETED | Arterial Hypertension |
Military Institute od Medicine National Research Institute |
2013-01 | |
| NCT02710071 | COMPLETED | Hypertension |
University of California, San Diego |
2015-01 | PHASE4 |
| NCT01961323 | COMPLETED | Hypertension; Left Ventricular Diastolic Dysfunction |
Icahn School of Medicine at Mount Sinai |
2012-03 | PHASE4 |
| NCT01771406 | UNKNOWN | Hypertension; Endothelial Dysfunction; Obstructive Sleep Apnea |
Universitaire Ziekenhuizen KU Leuven |
2013-02 | PHASE4 |
| NCT01501929 | COMPLETED | Hypertension |
University of Texas Southwestern Medical Center |
2010-08 | PHASE4 |
| NCT03847350 | Completed | Essential Hypertension |
A.Menarini Asia-Pacific Holdings Pte Ltd |
2015-07-01 | -- |
| NCT01665508 | COMPLETED | Microvascular Angina |
Massachusetts General Hospital |
2013-04 | PHASE4 |
| NCT02057328 | UNKNOWN | Hypertension |
Aristotle University Of Thessaloniki |
2010-12 | PHASE4 |
| NCT05170061 | COMPLETED | Hypertension |
State University of New York at Buffalo |
2013-02 | PHASE3 |
| NCT01157234 | COMPLETED | Hypertension |
University of Florida |
2010-07 | PHASE4 |
| NCT01044693 | COMPLETED | Hypertension; Pure Autonomic Failure; Multiple System Atrophy |
Vanderbilt University |
2010-01 | |
| NCT01499134 | COMPLETED | Peripheral Artery Disease; Hypertension |
Thomas Jefferson University |
2011-08 | PHASE3 |
| NCT01885988 | UNKNOWN | Erectile Dysfunction |
Martin M. Miner, MD |
2013-03 | PHASE4 |
| NCT01041287 | COMPLETED | Hypertension |
Emory University |
2009-12 | PHASE4 |
| NCT01056718 | COMPLETED | Hypertension |
Mercy Research |
2009-11 | |
| NCT01230892 | COMPLETED | Atherosclerosis; Endothelial Function |
Emory University |
2010-02 | PHASE4 |
| NCT01679652 | COMPLETED | Essential Hypertension |
Erling Bjerregaard Pedersen |
2012-08 | PHASE2 |
| NCT01441570 | TERMINATED | Transplant; Failure, Kidney; Hypertension |
Brigham and Women's Hospital |
2012-02 | |
| NCT00683124 | UNKNOWN | Marfan Syndrome |
Fondazione IRCCS Policlinico San Matteo di Pavia |
2008-07 | PHASE3 |
| NCT01502787 | COMPLETED | Hypertension |
University of Texas Southwestern Medical Center |
2009-04 | PHASE4 |
| NCT00995072 | COMPLETED | Hypertension; Female Sexual Dysfunction |
East Coast Institute for Research |
2009-10 | |
| NCT01508026 | COMPLETED | Stage 1 Hypertension; Stage 2 Hypertension |
Forest Laboratories |
2012-01 | PHASE3 |
| NCT01939990 | WITHDRAWN | High Blood Pressure |
University of Chicago |
2012-01 | PHASE2; PHASE3 |
| NCT01605370 | TERMINATED | Hypertension |
Mayo Clinic |
2012-06 | PHASE4 |
| NCT01885988 | Unknown status | Erectile Dysfunction |
Martin M. Miner MD|Forest Laboratories|The Miriam Hospital |
2013-03 | Phase 4 |
| NCT01358409 | COMPLETED | Cardiac Steatosis and Lipotoxicity |
Lidia Szczepaniak |
2011-04-01 | EARLY_PHASE1 |
| NCT01415505 | COMPLETED | Hypertension |
Forest Laboratories |
2011-08 | PHASE3 |
| NCT01206439 | TERMINATED | Hypertension |
Jack Rubinstein |
2010-09 | PHASE4 |
| NCT01920282 | COMPLETED | Hypertension |
Virginia Polytechnic Institute and State University |
2010-01 | PHASE4 |
| NCT01049009 | COMPLETED | High Blood Pressure |
Emory University |
2009-12 | PHASE4 |
| NCT00893984 | TERMINATED | Coronary Artery Disease |
Minneapolis Heart Institute Foundation |
2009-05 | PHASE4 |
| NCT01202175 | COMPLETED | Pre-hypertension; Hypertension |
University of California, San Diego |
2010-07 | PHASE4 |
| NCT00829296 | COMPLETED | Hypertension; Diabetes |
University of Chicago |
2009-01 | PHASE2; PHASE3 |
| NCT01415531 | COMPLETED | Hypertension |
Forest Laboratories |
2011-08 | PHASE4 |
| NCT00992056 | COMPLETED | Hypertension |
University of Miami |
2010-12 | PHASE4 |
| NCT03517020 | COMPLETED | Healthy Subjects |
Torrent Pharmaceuticals Limited |
2011-04 | PHASE1 |
| NCT03517033 | COMPLETED | Healthy Subjects |
Torrent Pharmaceuticals Limited |
2011-05 | PHASE1 |
| NCT00775671 | COMPLETED | Metabolic Syndrome |
Vanderbilt University |
2008-10 | PHASE4 |
| NCT03635125 | COMPLETED | JNC 7 Stage 1 or 2 Hypertension |
Trinity Hypertension & Metabolic Research Institute |
2010-08-30 | PHASE4 |
| NCT01218100 | COMPLETED | Stage 2 Diastolic Hypertension |
Forest Laboratories |
2010-10 | PHASE4 |
| NCT01076140 | WITHDRAWN | Hypertension |
University of Mississippi Medical Center |
2010-02 | |
| NCT00999102 | COMPLETED | Hypertension |
Weill Medical College of Cornell University |
2009-10 | PHASE4 |
| NCT01057251 | COMPLETED | Hypertension |
Forest Laboratories |
2010-03 | PHASE4 |
| NCT00849810 | TERMINATED | Hypertension |
University of Mississippi Medical Center |
2009-01 | |
| NCT00673790 | COMPLETED | Hypertension |
Forest Laboratories |
2008-05-15 | PHASE4 |
| NCT00744237 | COMPLETED | Hypertension; Type 2 Diabetes Mellitus |
Forest Laboratories |
2008-08 | PHASE4 |
| NCT01051947 | WITHDRAWN | Central Aortic Pressure |
Creighton University |
2009-12 | |
| NCT00734630 | COMPLETED | Hypertension |
Forest Laboratories |
2008-08 | PHASE4 |
| NCT01057251 | Completed | Hypertension |
Forest Laboratories |
2010-03 | Phase 4 |
| NCT00999752 | COMPLETED | Hypertension |
InVasc Therapeutics, Inc. |
2009-10 | |
| NCT00770861 | COMPLETED | Hypertension |
Forest Laboratories |
2008-09 | PHASE4 |
| NCT00673075 | COMPLETED | Hypertension; Coronary Artery Disease |
Forest Laboratories |
2008-05 | PHASE4 |
| NCT00785512 | COMPLETED | Hypertension |
Forest Laboratories |
2008-11 | PHASE4 |
| NCT00648895 | COMPLETED | Hypertension |
Forest Laboratories |
2007-11 | PHASE3 |
| NCT00295542 | COMPLETED | Hypertension |
University of Vigo |
2000-03 | PHASE4 |
| NCT00125853 | COMPLETED | Hypertension |
Imperial College London |
2006-07 | |
| NCT01248338 | COMPLETED | Hypertension |
Berlin-Chemie AG Menarini Group |
2006-03 | PHASE4 |
| NCT00942487 | COMPLETED | Primary Arterial Hypertension |
Berlin-Chemie Menarini |
2005-04 | PHASE3 |
| NCT00142584 | COMPLETED | Hypertension |
Mylan Bertek Pharmaceuticals |
2005-08 | PHASE3 |
| NCT00547300 | TERMINATED | Hypertension |
Forest Laboratories |
2007-10-31 | PHASE3 |
| NCT00145210 | COMPLETED | Hypertension |
Mylan Bertek Pharmaceuticals |
2005-04 | PHASE3 |
| NCT00924833 | COMPLETED | Hypoxia; Altitude; Heart Failure |
Istituto Auxologico Italiano |
2006-05 | PHASE4 |
| NCT00145236 | COMPLETED | Hypertension |
Mylan Bertek Pharmaceuticals |
2001-11 | PHASE3 |
| NCT00517725 | COMPLETED | Chronic Heart Failure |
Centro Cardiologico Monzino |
2007-07 | PHASE4 |
| NCT00200434 | COMPLETED | Hypertension |
Mylan Bertek Pharmaceuticals |
2002-10 | PHASE3 |
| NCT00200499 | COMPLETED | Hypertension |
Mylan Bertek Pharmaceuticals |
2002-03 | PHASE3 |
| NCT00200473 | COMPLETED | Hypertension |
Mylan Bertek Pharmaceuticals |
2001-09 | PHASE3 |
| NCT00200421 | COMPLETED | Hypertension |
Mylan Bertek Pharmaceuticals |
2002-05 | PHASE2 |
| NCT00200460 | COMPLETED | Hypertension |
Mylan Bertek Pharmaceuticals |
2001-09 | PHASE3 |
| NCT00158093 | COMPLETED | Hypertension |
Mylan Bertek Pharmaceuticals |
2003-06 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2022-12-20)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).