Nebivolol - PharmaKB

Nebivolol

Bystolic, Nebivolol, Vyduo (nebivolol) is a small molecule pharmaceutical. Nebivolol was first approved as Bystolic on 2007-12-17. It is used to treat malignant hypertension in the USA. It is known to target beta-3 adrenergic receptor, beta-2 adrenergic receptor, and beta-1 adrenergic receptor.

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Commercial

Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

YTD

Max

Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
cardiovascular diseases	D002318

Trade Name

FDA

EMA

Bystolic, Nebivolol (discontinued: Nebivolol)

Combinations

Vyduo (discontinued: Byvalson)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Nebivolol hydrochloride

Tradename	Company	Number	Date	Products
BYSTOLIC	Allergan	N-021742 RX	2007-12-17	4 products, RLD

Nebivolol hydrochloride

Valsartan

Tradename	Company	Number	Date	Products
BYVALSON	AbbVie	N-206302 DISCN	2016-06-03	1 products, RLD

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Labels

FDA

EMA

Brand Name	Status	Last Update
bystolic	New Drug Application	2024-08-23
nebivolol	ANDA	2025-09-24
nebivolol hydrochloride	ANDA	2023-07-11

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
malignant hypertension	EFO_1001031	D006974	—
heart failure	EFO_0003144	D006333	I50
diabetic nephropathies	EFO_0000401	D003928	—
hypertension	EFO_0000537	D006973	I10
left ventricular dysfunction	—	D018487	—

Agency Specific

FDA

EMA

No data

Patent Expiration

Patent	Expires	Flag	FDA Information
Nebivolol Hydrochloride / Valsartan, Byvalson, Abbvie
7838552	2027-10-04		U-185
7803838	2026-08-29	DP

ATC Codes

C: Cardiovascular system drugs

— C07: Beta-adrenergic blocking agents

— C07A: Beta blocking agents

— C07AB: Beta blocking agents, selective

— C07AB12: Nebivolol

— C07B: Beta blocking agents and thiazides

— C07BB: Beta blocking agents, selective, and thiazides

— C07BB12: Nebivolol and thiazides

— C07F: Beta blocking agents, other combinations

— C07FB: Beta blocking agents and calcium channel blockers

— C07FB12: Nebivolol and amlodipine

— C09: Agents acting on the renin-angiotensin system

— C09D: Angiotensin ii receptor blockers (arbs), combinations

— C09DX: Angiotensin ii receptor blockers (arbs), other combinations

— C09DX05: Valsartan and nebivolol

HCPCS

No data

Clinical

Clinical Trials

124 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hypertension	D006973	EFO_0000537	I10	—	—	—	1	—	1
Left ventricular hypertrophy	D017379	EFO_0003896	—	—	—	—	1	—	1
Blood pressure	D001794	EFO_0004325	—	—	—	—	1	—	1

Indications Phases 3

No data

Indications Phases 2

No data

Indications Phases 1

No data

Indications Without Phase

No data

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Nebivolol
INN	nebivolol
Description	2,2'-iminobis[1-(6-fluoro-3,4-dihydro-2H-chromen-2-yl)ethanol] is a member of the class of chromanes that is 2,2'-iminodiethanol in which one hydrogen attached to each hydroxy-bearing carbon is replaced by a 6-fluorochroman-2-yl group. It is an organofluorine compound, a secondary amino compound, a secondary alcohol, a diol and a member of chromanes.
Classification	Small molecule
Drug class	beta-blockers (propranolol type)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	OC(CNCC(O)C1CCc2cc(F)ccc2O1)C1CCc2cc(F)ccc2O1

Identifiers

PDB	—
CAS-ID	99200-09-6
RxCUI	—
ChEMBL ID	CHEMBL434394
ChEBI ID	64019
PubChem CID	71301
DrugBank	DB04861
UNII ID	030Y90569U (ChemIDplus, GSRS)

Target

Agency Approved

No data

Alternate

ADRB3

ADRB2

ADRB1

Organism

Homo sapiens

Gene name

ADRB3

Gene synonyms

ADRB3R, B3AR

NCBI Gene ID

155

Protein name

beta-3 adrenergic receptor

Protein synonyms

adrenergic, beta-3-, receptor, Beta-3 adrenoceptor, Beta-3 adrenoreceptor

Uniprot ID

Q4JFT4

Mouse ortholog

Adrb3 (11556)

beta-3 adrenergic receptor (Q9QZ98)

Variants

No data

Financial

Revenue by drug

€

₣

No data

Estimated US medical usage

Nebivolol

Total medical expenditures per year (USD, in millions)

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Number of persons purchased

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Number of purchases

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Refill frequency

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Price per prescription (USD)

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Trends

PubMed Central

Top Terms for Disease or Syndrome:

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Safety

Black-box Warning

No Black-box warning

Adverse Events

Top Adverse Reactions

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7,735 adverse events reported

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