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Drug ReportsNebivolol
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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Events Timeline
5D
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3M
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YTD
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2Y
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FDA approval date
EMA approval date
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Study first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
cardiovascular diseasesD002318
Trade Name
FDA
EMA
Bystolic, Nebivolol (discontinued: Nebivolol)
Combinations
Vyduo (discontinued: Byvalson)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Nebivolol hydrochloride
Tradename
Company
Number
Date
Products
BYSTOLICAllerganN-021742 RX2007-12-17
4 products, RLD
Nebivolol hydrochloride
+
Valsartan
Tradename
Company
Number
Date
Products
BYVALSONAbbVieN-206302 DISCN2016-06-03
1 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
bystolicNew Drug Application2024-08-23
nebivololANDA2025-03-17
nebivolol hydrochlorideANDA2023-07-11
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Nebivolol Hydrochloride / Valsartan, Byvalson, Abbvie
78385522027-10-04U-185
78038382026-08-29DP
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
122 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I10———1—1
Left ventricular hypertrophyD017379EFO_0003896————1—1
Blood pressureD001794EFO_0004325————1—1
HypertrophyD006984EFO_0002460————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 nameNebivolol
INNnebivolol
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 classbeta-blockers (propranolol type)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
OC(CNCC(O)C1CCc2cc(F)ccc2O1)C1CCc2cc(F)ccc2O1
Identifiers
PDB—
CAS-ID99200-09-6
RxCUI—
ChEMBL IDCHEMBL434394
ChEBI ID64019
PubChem CID71301
DrugBankDB04861
UNII ID030Y90569U (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
ADRB3
ADRB3
ADRB2
ADRB2
ADRB1
ADRB1
Organism
Homo sapiens
Gene name
ADRB3
Gene synonyms
ADRB3R, B3AR
NCBI Gene ID
Protein name
beta-3 adrenergic receptor
Protein synonyms
adrenergic, beta-3-, receptor, Beta-3 adrenoceptor, Beta-3 adrenoreceptor
Uniprot ID
Mouse ortholog
Adrb3 (11556)
beta-3 adrenergic receptor (Q9QZ98)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
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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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,669 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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7,583 adverse events reported
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