Clinical Trials

Numerous clinical trials spanning early to late phases evaluate nebivolol hydrochloride across cardiovascular and metabolic disorders, including essential hypertension, heart failure, erectile dysfunction, pre-hypertension, and type 2 diabetes mellitus. Supported by academic medical institutions and pharmaceutical sponsors such as Forest Laboratories, Novartis, Menarini, and Daewoong Pharmaceutical, these studies assess key outcomes including blood pressure reduction, glycemic profiles, and heart failure management. Encompassing completed, recruiting, terminated, and unknown recruitment statuses, these trials collectively characterize the drug's overall therapeutic profile.

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NCT04432610 WITHDRAWN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)

Check the Nebivolol hydrochloride (R-65824) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Nebivolol selectively binds to and inhibits the β1-adrenergic receptor while stimulating endothelial nitric oxide synthase activity, thereby dampening intracellular cyclic AMP signaling and elevating nitric oxide levels. This dual mechanism suppresses vascular smooth muscle proliferation and induces systemic vasodilation, which effectively lowers peripheral vascular resistance and provides clinical therapeutic efficacy in conditions such as essential hypertension and heart failure.

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>).

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Note: Technical data last updated: Sep 1, 2026.