Drugs / Nebivolol
last change Jul 2026 re-read 2 minutes ago

Nebivolol

Other / unclassified targets ADRB1, ADRB2 via inhibition

Developed for
hypertensive disorder · essential hypertension · coronary microvascular disorder · type 2 diabetes mellitus · atrial fibrillation · diastolic heart failure · heart disorder · heart failure
+30 more · myocardial infarction · atrial flutter · brain aneurysm · cardiomyopathy · chemotherapy-induced toxicity · coronary artery disorder · coronary artery intramyocardial course · coronary vasospasm · COVID-19 · diabetic polyneuropathy · HER2 positive breast carcinoma · intermediate coronary syndrome · ischemic stroke · left ventricular failure · Marfan syndrome · nonobstructive coronary artery disease · ocular hypertension · open-angle glaucoma · peripheral arterial disease · pulmonary hypertension · ST-elevation myocardial infarction · symptomatic heart failure · triglyceride deposit cardiomyovasculopathy · atherosclerosis · chronic obstructive pulmonary disease · cirrhosis of liver · congestive heart failure · erectile dysfunction · metabolic syndrome X · postmenopausal osteoporosis
Investigated by
Forest Laboratories · Mylan Bertek Pharmaceuticals · Weill Medical College of Cornell University · Berlin-Chemie Menarini · Korea University Anam Hospital · Menarini Group
+98 more · University of California, San Diego · Vanderbilt University · Aalborg University Hospital · Aarhus University Hospital · Agenzia Italiana del Farmaco · Ain Shams University · Amager Hospital · American Heart Association · Aristotle University Of Thessaloniki · Assistance Publique - Hôpitaux de Paris · Association Française contre les Myopathies (AFM), Paris · Betaliq, Inc. · Bio-innova Co., Ltd · Bispebjerg Hospital · Bornholm Hospital · Chonbuk National University Hospital · Chonnam National University Hospital · Chosun University Hospital · Chungbuk National University Hospital · Chungnam National University Hospital · Clinical Hospital Center Zemun · Creighton University · Daewoong Pharmaceutical Co. LTD. · Dong-A University · East Coast Institute for Research · Erling Bjerregaard Pedersen · Ewha Womans University Seoul Hospital · Fondazione IRCCS Policlinico San Matteo di Pavia · Gentofte Hospital · Giulio Stefanini · Glostrup University Hospital, Copenhagen · Gyeongsang National University Hospital · Herlev Hospital · Holbaek Hospital · Hospital of Southern Jutland · Hospitalsenheden Midt · Hospitalsenheden Vest · Hvidovre University Hospital · Icahn School of Medicine at Mount Sinai · Inje University Ilsan Paik Hospital · Jack Rubinstein · Jagiellonian University · Jeju National University Hospital · Kangbuk Samsung Hospital · Keimyung University Dongsan Medical Center · Kyung Hee University Hospital · Lebanese American University Medical Center · Lidia Szczepaniak · Martin Huelsmann · Massachusetts General Hospital · Mayo Clinic · Merck Sharp & Dohme LLC · Mercy Research · Minneapolis Heart Institute Foundation · Mylan Laboratories · Naestved Hospital · National Cancer Institute, Egypt · National Center for Cardiovascular Research Carlos III · National Institute of General Medical Sciences (NIGMS) · National Institute on Aging (NIA) · National Taiwan University Hospital · Nordsjaellands Hospital · Nykoebing Hospital · Odense University Hospital · Presbyterian medical center · Regionshospitalet Horsens · Saint Vincent's Hospital, Korea · Samsung Changwon Hospital · Samsung Medical Center · Sejong General Hospital · Seoul National University Bundang Hospital · Silkeborg Sygehus · Slagelse Hospital · Spanish Society of Cardiology · all 104 on the full record

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) BYSTOLIC 2010-02-19 fda.gov
Approved US (FDA) BYSTOLIC 2007-12-17 fda.gov

Trials 66 · started per year

today
US approved 2007
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3
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4
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2001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028202920302031
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT01358409 Apr 2011 → Feb 2013 triglyceride deposit cardiomyovasculopathy Lidia Szczepaniak Completed No outcome recorded
Phase 14 trials
Phase 1 NCT06248099 Jul → Aug 2024 Bio-innova Co., Ltd Unknown No outcome recorded
Phase 1 NCT04888728 Jun → Jul 2021 idiopathic pulmonary fibrosis Daewoong Pharmaceutical Co. LTD. Completed No outcome recorded
Phase 1 NCT00158093 Jun → Jul 2003 essential hypertension Mylan Bertek Pharmaceuticals Completed No outcome recorded
Phase 1 NCT00223717 Jan 2001 → Jan 2017 hypertensive disorder Vanderbilt University Completed No outcome recorded
Phase 25 trials
Phase 2 NCT07233499 Jan 2025 → Feb 2027 expected HER2 positive breast carcinoma Ain Shams University Recruiting No outcome recorded
Phase 2 NCT04910100 Apr 2021 → Mar 2022 ocular hypertension, open-angle glaucoma Betaliq, Inc. Completed No outcome recorded
Phase 2 NCT03655964 Aug 2018 → Aug 2019 ischemic stroke Aristotle University Of Thessaloniki Completed No outcome recorded
Phase 2 NCT01679652 Aug 2012 → Sep 2013 essential hypertension Erling Bjerregaard Pedersen Completed No outcome recorded
Phase 2 NCT00200421 May 2002 → Aug 2003 hypertensive disorder Mylan Bertek Pharmaceuticals Completed No outcome recorded
Phase 2/33 trials
Phase 2/3 NCT06201611 Nov 2024 → Dec 2025 overdue diabetic polyneuropathy St. John's Research Institute Recruiting No outcome recorded
Phase 2/3 NCT06424834 Oct 2024 → Dec 2026 expected coronary artery intramyocardial course, coronary microvascular disorder, coronary vasospasm, intermediate coronary syndrome Stanford University Recruiting No outcome recorded
Phase 2/3 NCT00829296 Jan 2009 → Apr 2012 hypertensive disorder, type 2 diabetes mellitus University of Chicago Completed No outcome recorded
Phase 317 trials
Phase 3 NCT06755801 Apr 2025 → Mar 2026 overdue coronary microvascular disorder, nonobstructive coronary artery disease Spanish Society of Cardiology Not yet recruiting No outcome recorded
Phase 3 NCT04631536 Jan 2021 → Mar 2022 COVID-19 Lebanese American University Medical Center Unknown No outcome recorded
Phase 3 NCT05728632 Jan 2019 → Feb 2023 breast cancer, chemotherapy-induced toxicity, diffuse large B-cell lymphoma, left ventricular failure Giulio Stefanini Unknown No outcome recorded
Phase 3 NCT01648634 Feb 2012 → Jul 2021 Duchenne muscular dystrophy, cardiomyopathy, heart failure Assistance Publique - Hôpitaux de Paris Completed No outcome recorded
Phase 3 NCT01508026 Jan 2012 → Mar 2013 hypertensive disorder Forest Laboratories Completed No outcome recorded
Phase 3 NCT01415505 Aug 2011 → Jan 2013 essential hypertension Forest Laboratories Completed No outcome recorded
Phase 3 NCT01499134 Aug 2011 → Jun 2014 hypertensive disorder, peripheral arterial disease Thomas Jefferson University Completed No outcome recorded
Phase 3 NCT00683124 Jul 2008 → Jul 2013 Marfan syndrome Fondazione IRCCS Policlinico San Matteo di Pavia Unknown No outcome recorded
Phase 3 NCT00547300 Oct 2007 → Jan 2008 hypertensive disorder Forest Laboratories Terminated No outcome recorded
Phase 3 NCT00142584 Aug 2005 → Mar 2008 hypertensive disorder Mylan Bertek Pharmaceuticals Completed No outcome recorded
Phase 427 trials
Phase 4 NCT04432610 Jan → Dec 2030 Clinical Hospital Center Zemun Withdrawn No outcome recorded
Phase 4 NCT06249802 Jan 2025 → Jan 2029 expected brain aneurysm Jagiellonian University Not yet recruiting No outcome recorded
Phase 4 NCT06035978 Mar 2024 → Apr 2026 symptomatic heart failure University Hospital Ostrava Unknown No outcome recorded
Phase 4 NCT05585125 Feb 2024 → Jul 2026 overdue diastolic heart failure Weill Medical College of Cornell University Enrolling by invitation No outcome recorded
Phase 4 NCT05019027 Jan 2024 → Mar 2026 overdue amyloidosis, heart disorder Weill Medical College of Cornell University Enrolling by invitation No outcome recorded
Phase 4 NCT04769362 May 2021 → Jan 2026 overdue myocardial infarction Samsung Medical Center Recruiting No outcome recorded
Phase 4 NCT03778554 Dec 2018 → Apr 2025 overdue ST-elevation myocardial infarction Bispebjerg Hospital Active not recruiting No outcome recorded
Phase 4 NCT03596385 Oct 2018 → Jan 2025 myocardial infarction National Center for Cardiovascular Research Carlos III Completed No outcome recorded
Phase 4 NCT02817360 Feb 2016 → Dec 2025 overdue heart disorder, type 2 diabetes mellitus Martin Huelsmann Recruiting No outcome recorded
Phase 4 NCT03245996 Jun 2015 → Sep 2016 Tartu University Hospital Completed No outcome recorded
Phase not applicable9 trials
NCT07123506 Sep 2025 → Nov 2028 expected atrial fibrillation, atrial flutter, atrial septal defect Yonsei University Not yet recruiting No outcome recorded
NCT04513509 Oct 2020 → Jun 2022 atrial fibrillation National Taiwan University Hospital Completed No outcome recorded
NCT05328310 Jan 2019 → Dec 2022 hypertensive disorder Korea University Anam Hospital Unknown No outcome recorded
NCT02619526 Dec 2016 → Jul 2018 heart failure Dong-A University Unknown No outcome recorded
NCT01044693 Jan 2010 → Jul 2014 hypertensive disorder, pure autonomic failure Vanderbilt University Completed No outcome recorded
NCT01051947 Dec 2009 → May 2010 Creighton University Withdrawn No outcome recorded
NCT01056718 Nov 2009 → Nov 2013 hypertensive disorder Mercy Research Completed No outcome recorded
NCT00995072 Oct 2009 → Apr 2013 hypertensive disorder, sexual disorder East Coast Institute for Research Completed No outcome recorded
NCT00849810 Jan 2009 → Nov 2010 hypertensive disorder University of Mississippi Medical Center Terminated No outcome recorded
Also used as a comparator or background therapy in 45 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT02467400 Comparator Jul 2015 → Oct 2017 postmenopausal osteoporosis Mayo Clinic Completed No outcome recorded
Phase 22 trials
Phase 2 NCT04130438 Comparator Oct 2020 → Mar 2022 coronary artery intramyocardial course Stanford University Terminated No outcome recorded
Phase 2 NCT01522950 Comparator May 2010 → Oct 2016 hypertensive disorder University of Minnesota Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT01939990 Comparator Jan 2012 → Mar 2013 hypertensive disorder University of Chicago Withdrawn No outcome recorded
Phase 32 trials
Phase 3 NCT05170061 Comparator Feb 2013 → Sep 2014 hypertensive disorder State University of New York at Buffalo Completed No outcome recorded
Phase 3 NCT00648895 Comparator Nov 2007 → Jul 2009 hypertensive disorder Forest Laboratories Completed No outcome recorded
Phase 432 trials
Phase 4 NCT07513883 Background Mar 2026 → Sep 2028 expected heart failure Ziekenhuis Oost-Limburg Recruiting No outcome recorded
Phase 4 NCT07397481 Comparator Mar 2024 → Mar 2025 cirrhosis of liver, hypertensive disorder Kafrelsheikh University Completed No outcome recorded
Phase 4 NCT06104423 Comparator Oct 2023 → Feb 2024 hypertensive disorder Menarini International Operations Luxembourg SA Completed No outcome recorded
Phase 4 NCT05513937 Comparator May → Nov 2022 hypertensive disorder Menarini International Operations Luxembourg SA Completed No outcome recorded
Phase 4 NCT04845061 Comparator Oct → Dec 2021 chronic obstructive pulmonary disease Ain Shams University Unknown No outcome recorded
Phase not applicable7 trials
NCT07568574 Background Mar 2026 → May 2028 expected Enhanced Emirates Limited Enrolling by invitation No outcome recorded
NCT01996085 Comparator Jan 2013 → Jun 2016 hypertensive disorder Military Institute od Medicine National Research Institute Completed No outcome recorded
NCT01441570 Comparator Feb 2012 → Jul 2013 hypertensive disorder Brigham and Women's Hospital Terminated No outcome recorded
NCT01076140 Comparator Feb 2010 → Jan 2011 hypertensive disorder University of Mississippi Medical Center Withdrawn No outcome recorded
NCT00999752 Comparator Oct 2009 → Feb 2010 hypertensive disorder InVasc Therapeutics, Inc. Completed No outcome recorded

Evidence & citations 20 cited values

Every value below carries the sentence it was read from. 116 sources stand behind the page.

FieldValueCited text
Known as nebivolol “Randomisation will be stratified according to the type of AMI (ie, ST-segment-elevation MI or non-ST-segment-elevation MI), type of β-blocker (carvedilol, bisoprolol, nebivolol...” PMID 39645270 Aug 2024
110

“Other names: acebutolol, atenolol, betaxolol, bisoprolol, carvedilol, labetalol, metoprolol, metoprolol succinate, metoprolol tartrate, nadolol, nebivolol, propranolol,...” NCT05585125

“Other Names: * acebutolol * atenolol * betaxolol * bisoprolol * carvedilol * labetalol * metoprolol succinate * metoprolol tartrate * nadolol * nebivolol * penbutolol *...” NCT05019027

“Trade-mark: Nebilet® (Berlin-Chemie Menarini) INN: nebivolol Dosage and route of administration: 5 mg tablets, o.d. for oral administration” NCT00942487

“The beta-blockers used in this study are extended-release beta-blockers, specifically bisoprolol or nebivolol.” NCT07123506

“betablocker therapy chosen might be any of the following: atenolol bisoprolol carvedilol metoprolol nebivololNCT03596385

Nebivolol is a medication that has been recently approved by the FDA for the treatment of hypertension.” NCT01049009

“Cardio-selective beta-blocker, including carvedilol, bisoprolol, metoprolol or nebivololNCT04575675

“Study group: Nebivolol • Patients will start with a dose of 5 mg every 24 hours.” NCT06755801

“Beta blocker: carvedilol, metroprolol, bisoprolol or nebivololNCT07513883

Nebivolol/Valsartan 5/80mg randomly assigned for 8 weeks” NCT03180593

nebivolol: 10mg/d → 5 mg/d → 2,5 mg/d → 1,25 mg/d stop” NCT02200822

Nebivolol 1.25-10mg o.d.” NCT00878384

Nebivolol 10mg/d” NCT02817360

nebivololNCT04767061

nebivololNCT04757584

NCT03635125

NCT01595516

NCT01508026

NCT01522950

NCT00142584

NCT01996085

NCT04910100

NCT04130438

NCT00785512

NCT01502787

NCT03245996

NCT02467400

NCT00744237

NCT07568574

NCT01665508

NCT00547300

NCT03655964

NCT04845061

NCT01218100

NCT00775671

NCT00223717

NCT02619526

NCT00999752

NCT01501929

NCT01041287

NCT01358409

NCT01230892

NCT00125853

NCT02710071

NCT01605370

NCT00734630

NCT06201611

NCT06035978

NCT00683124

NCT00200473

NCT04631536

NCT01157234

NCT03930433

NCT01415531

NCT00200460

NCT00200434

NCT00200421

NCT00673075

NCT00995072

NCT00648895

NCT07233499

NCT06249802

NCT06104423

NCT01415505

NCT04513509

NCT05170061

NCT00200499

NCT06248099

NCT01961323

NCT02053246

NCT01051947

NCT01771406

NCT00893984

NCT01044693

NCT00770861

NCT00295542

NCT00924833

NCT00829296

NCT01057251

NCT01248338

NCT00992056

NCT01395329

NCT01885988

NCT05328310

NCT02057328

NCT01939990

NCT01441570

NCT01202175

NCT01648634

NCT01679652

NCT01499134

NCT01920282

NCT03778554

NCT00158093

NCT04888728

NCT00999102

NCT05257148

NCT05728632

NCT00517725

NCT05513937

NCT06424834

NCT00849810

NCT07397481

NCT01206439

NCT01076140

NCT01056718

NCT04432610

NCT00145236

NCT00673790

NCT00145210

Known as Bystolic ChEMBL registry synonym — accepted as the source's own label CHEMBL434394
Known as Bystolic (nebivolol) “Bystolic® (nebivolol)” NCT00785512
Known as Hypoloc ChEMBL registry synonym — accepted as the source's own label CHEMBL434394
Known as Narbivolol ChEMBL registry synonym — accepted as the source's own label CHEMBL434394
Known as NEB “This is a Phase IV, interventional, multicenter, open-label, multinational study with 2 study periods (a Run-in period of 4 weeks and an Assessment period of 12 weeks) to...” NCT06104423
4

“The goal of this study was to assess whether nebivolol (NEB), a vasodilatory β(1)-selective blocker, is a safe and efficacious monotherapy for individuals with systolic stage...” PMID 23332366 Jan 2013

Nebivolol (NEB) in contrast to atenolol (ATE) may have a beneficial effect on endothelial function and may be more effective than ATE in preventing CVD.” PMID 29184167 Nov 2017

“We compared an angiotensin receptor blocker (valsartan; VAL), a beta-blocker (nebivolol; NEB) and the combination of NEB/VAL” PMID 26116459 Mar 2015

Nebivolol (NEB)” NCT00142584

Known as Nebilet “Nebivolol (Nebilet) tablet will be administered orally to patients according to their clinical condition and the decision of the attending physician.” NCT06035978
1

NCT00942487

Known as Nebivolol component of byvalson ChEMBL registry synonym — accepted as the source's own label CHEMBL434394
Known as Nebivolol hcl ChEMBL registry synonym — accepted as the source's own label CHEMBL434394
Known as NEBIVOLOL HYDROCHLORIDE ChEMBL registry synonym — accepted as the source's own label CHEMBL434394
Known as Nebivolol hydrochloride component of byvalson ChEMBL registry synonym — accepted as the source's own label CHEMBL434394
Known as Nebivolol is bystolic Nebivolol is bystolicNCT00849810
Known as R-067555 ChEMBL registry synonym — accepted as the source's own label CHEMBL434394
Known as R-65824 ChEMBL registry synonym — accepted as the source's own label CHEMBL434394
Known as RO67555 ChEMBL registry synonym — accepted as the source's own label CHEMBL434394
Action Inhibit “The third-generation beta-adrenergic blocker nebivolol retains the beta-adrenergic blocker effects” PMID 19430350 Apr 2009
2

“Beta-2 adrenergic receptor antagonist” CHEMBL434394

“Beta-1 adrenergic receptor antagonist” CHEMBL434394

Modality Other / unclassified “The third generation beta-blocker, nebivolol, has vasodilating properties in addition to beta-adrenergic blockade.” NCT01499134
Route Oral “nebivolol administered orally once daily” NCT00200499
Target ADRB1 “Beta-1 adrenergic receptor antagonist” CHEMBL434394
Target ADRB2 “Beta-2 adrenergic receptor antagonist” CHEMBL434394