Drugs / Nebivolol
last change 11 days ago re-read 8 days ago

Nebivolol

Other / unclassified

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 · Korea University Anam Hospital · Menarini Group · University of California, San Diego
+98 more · 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 · Berlin-Chemie Menarini · 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 65 · started per year

today
US approved 2007
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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 · 1 missed
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 Missed primary
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 316 trials · 2 met primary
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 Met primary
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 Met primary
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 · 4 met primary · 2 missed
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 Met primary
Phase 4 NCT03778554 Dec 2018 → Apr 2025 overdue ST-elevation myocardial infarction Bispebjerg Hospital Active not recruiting Met primary
Phase 4 NCT03596385 Oct 2018 → Jan 2025 myocardial infarction National Center for Cardiovascular Research Carlos III Completed Missed primary
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 · 1 met primary
— 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 Met primary
— 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 Stop: Enrollment
Comparator or background therapy45 trials
Phase 0 NCT02467400 Comparator Jul 2015 → Oct 2017 postmenopausal osteoporosis Mayo Clinic Completed No outcome recorded
Phase 2 NCT04130438 Comparator Oct 2020 → Mar 2022 coronary artery intramyocardial course Stanford University Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT01522950 Comparator May 2010 → Oct 2016 hypertensive disorder University of Minnesota Completed No outcome recorded
Phase 2/3 NCT01939990 Comparator Jan 2012 → Mar 2013 hypertensive disorder University of Chicago Withdrawn No outcome recorded Stop: Business
Phase 3 NCT05170061 Comparator Feb 2013 → Sep 2014 hypertensive disorder State University of New York at Buffalo Completed No outcome recorded

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 114 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
109

“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 ↗

“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 nebivolol” NCT03596385 ↗

“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 nebivolol” NCT04575675 ↗

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

“Beta blocker: carvedilol, metroprolol, bisoprolol or nebivolol” NCT07513883 ↗

“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 ↗

Show 99 more sources

Known as Bystolic (nebivolol) “Bystolic® (nebivolol)” NCT00785512 ↗
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 ↗
Known as Nebivolol is bystolic “Nebivolol is bystolic” NCT00849810 ↗
Action Inhibit “The third-generation beta-adrenergic blocker nebivolol retains the beta-adrenergic blocker effects” PMID 19430350 ↗ Apr 2009
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 ↗