Nebivolol

Overview

Nebivolol is a racemic mixture of 2 enantiomers where one is a beta adrenergic antagonist and the other acts as a cardiac stimulant without beta adrenergic activity. Treatment with nebivolol leads to a greater decrease in systolic and diastolic blood pressure than atenolol, propranolol, or pindolol. Nebivolol and other beta blockers are generally not first line therapies as many patients are first treated with thiazide diuretics. Nebivolol was granted FDA approval on 17 December 2007.

Indication

Nebivolol is indicated to treat hypertension.

Associated Conditions

Hypertension

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Efficacy of Targeted Medical Therapy in Angina and Nonobstructive Coronary Arteries	2024/05/22	NCT06424834	Phase 2	Recruiting	Stanford University
Beta-blockade in Unruptured Intracranial Aneurysm	2024/02/08	NCT06249802	Phase 4	Not yet recruiting	Jagiellonian University
Open-label inteRventional Clinical Trial to Assess Efficacy and Safety of the exteMporaneous combInation of Nebivolol and Ramipril in hypertenSIve pAtients	2023/10/27	NCT06104423	Phase 4	Completed	Menarini International Operations Luxembourg SA
Determination of Drug Levels for Pharmacotherapy of Heart Failure	2023/09/13	NCT06035978	Phase 4	Not yet recruiting	University Hospital Ostrava
Cardioprotective Effects of Nebivolol Versus Placebo in Patients Undergoing Chemotherapy With Anthracyclines	2023/02/15	NCT05728632	Phase 3	Active, not recruiting	Giulio Stefanini
Effectiveness and Safety of Combination of Nebivolol and Amlodipine in Hypertensive Patients Versus Each Monotherapy	2022/08/24	NCT05513937	Phase 4	Completed	Menarini International Operations Luxembourg SA
Effect of Different Antihypertensive Drugs on Central Blood Pressure	2022/04/14	NCT05328310	Not Applicable	Active, not recruiting	Korea University Anam Hospital
Effectiveness and Safety of Combination of Nebivolol and Zofenopril in Hypertensive patIents Versus Each Monotherapy	2022/02/25	NCT05257148	Phase 4	Completed	Menarini International Operations Luxembourg SA
24 Hour Ambulatory Cardiac Oxygen Consumption	2021/12/27	NCT05170061	Phase 3	Completed	State University of New York at Buffalo
Nebivolol 0.5, 1.0, or Timolol 0.5 Suspension Compared to Timolol 0.5 Solution to Treat Glaucoma/Ocular Hypertension	2021/06/02	NCT04910100	Phase 2	Completed	Betaliq, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Bystolic	Allergan, Inc.	0456-1410	ORAL	10 mg in 1 1	6/27/2023
Nebivolol	Bryant Ranch Prepack	63629-9423	ORAL	20 mg in 1 1	9/3/2021
Nebivolol	Macleods Pharmaceuticals Limited	33342-459	ORAL	10 mg in 1 1	4/8/2025
Nebivolol	ANI Pharmaceuticals, Inc.	62559-276	ORAL	5 mg in 1 1	9/17/2021
Nebivolol	Ascend Laboratories, LLC	67877-392	ORAL	5 mg in 1 1	7/13/2023
Nebivolol	A-S Medication Solutions	50090-5752	ORAL	5 mg in 1 1	4/13/2022
Nebivolol	Camber Pharmaceuticals, Inc.	31722-587	ORAL	10 mg in 1 1	1/31/2024
Nebivolol Hydrochloride	Unichem Pharmaceuticals (USA), Inc.	29300-375	ORAL	2.5 mg in 1 1	7/11/2023
nebivolol	Glenmark Pharmaceuticals Inc., USA	68462-618	ORAL	20 mg in 1 1	8/1/2023
nebivolol	Major Pharmaceuticals	0904-7189	ORAL	5 mg in 1 1	2/14/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
NEBIPRESS TABLETS 5MG	2nd Plant, Standard Chem. & Pharm. Co. Ltd.	SIN16976P	TABLET	5 mg	3/22/2024
NOXBETA TABLET 5 MG	BERLIN-CHEMIE AG (granulation), BERLIN-CHEMIE AG	SIN16486P	TABLET	5 mg	5/6/2022
NEBILET TABLET 5 mg	BERLIN-CHEMIE AG (granulation), Berlin-Chemie AG	SIN11728P	TABLET	5mg	11/19/2001
NEBIVOLOL STELLA TABLET 5MG	STELLAPHARM J.V. CO., LTD. - BRANCH 1	SIN16481P	TABLET	5 mg	5/4/2022
NEVOPRES TABLET 5MG	PT. Dexa Medica	SIN15958P	TABLET	5mg	6/16/2020
NEVODIO TABLET 5MG	PT. Dexa Medica	SIN16446P	TABLET	5mg	3/18/2022

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
NEBIVOLOL SCP nebivolol (as hydrochloride) 1.25 mg immediate release tablet blister pack	311726	Southern Cross Pharma Pty Ltd	Medicine	A	4/3/2020
LOBIVON nebivolol (as hydrochloride) 1.25 mg/5 mg composite starter titration tablet blister pack	149679	A Menarini Australia Pty Ltd	Medicine	A	6/26/2009
NEBIVOLOL SCP nebivolol (as hydrochloride) 10 mg immediate release tablet blister pack	311734	Southern Cross Pharma Pty Ltd	Medicine	A	4/3/2020
NEBIVOLOL VIATRIS nebivolol (as hydrochloride) 10 mg tablet blister pack	281796	Helix Pharmaceuticals Pty Ltd	Medicine	A	2/21/2018
NEBIVOLOL SANDOZ nebivolol (as hydrochloride) 10 mg immediate release tablet blister pack	311725	Southern Cross Pharma Pty Ltd	Medicine	A	4/3/2020
LOBIVON nebivolol (as hydrochloride) 5mg tablet blister pack	148883	A Menarini Australia Pty Ltd	Medicine	A	6/26/2009
NEBIVOLOL-RJIC nebivolol (as hydrochloride) 10 mg tablet blister pack	421911	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	11/16/2023
NEBIVOLOL-RJIC nebivolol (as hydrochloride) 1.25 mg tablet blister pack	421909	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	11/16/2023
NEBIVOLOL-WGR nebivolol (as hydrochloride) 10 mg tablet blister pack	421917	GM Pharma International Pty Ltd	Medicine	A	11/16/2023
NEBIVOLOL VIATRIS nebivolol (as hydrochloride) 1.25 mg tablet blister pack	281797	Helix Pharmaceuticals Pty Ltd	Medicine	A	2/21/2018

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
LOBIVON 5 MG COMPRIMIDOS	Menarini International Operations Luxembourg S.A.	1-21520	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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