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
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| cardiovascular diseases | D002318 |
Trade Name
FDA
EMA
Bystolic, Nebivolol (discontinued: Nebivolol)
CombinationsVyduo (discontinued: Byvalson)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| bystolic | New Drug Application | 2024-08-23 |
| nebivolol | ANDA | 2026-06-09 |
| nebivolol hydrochloride | ANDA | 2023-07-11 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
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
128 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 | 2 | 6 | 16 | 35 | 17 | 74 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | 2 | 11 | 5 | 18 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | — | 5 | — | 5 |
| Diastolic heart failure | D054144 | EFO_1000899 | I50.30 | — | — | — | 4 | — | 4 |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | — | — | 1 | 3 | 4 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | — | — | — | 1 | 2 | 3 |
| Prehypertension | D058246 | — | — | — | — | — | 3 | — | 3 |
| Coronary artery disease | D003324 | — | I25.1 | — | 1 | 1 | 2 | — | 3 |
| Left ventricular dysfunction | D018487 | — | — | — | — | 2 | 1 | — | 3 |
| Blood pressure | D001794 | EFO_0004325 | — | — | — | — | 1 | 1 | 2 |
Show 36 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | — | U07.1 | — | — | 1 | — | 1 | 2 |
| Myocardial bridging | D054084 | — | — | — | 2 | 1 | — | — | 2 |
| Ventricular dysfunction | D018754 | — | — | — | — | 2 | — | — | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | 1 | — | — | 2 |
| Marfan syndrome | D008382 | Orphanet_558 | Q87.4 | — | — | 1 | — | — | 1 |
| Camurati-engelmann syndrome | D003966 | Orphanet_1328 | Q78.3 | — | — | 1 | — | — | 1 |
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | — | — | 1 | — | — | 1 |
| Duchenne muscular dystrophy | D020388 | EFO_0000429 | — | — | — | 1 | — | — | 1 |
| Peripheral arterial disease | D058729 | EFO_0004265 | — | — | — | 1 | — | — | 1 |
| Peripheral vascular diseases | D016491 | EFO_0003875 | I73.9 | — | — | 1 | — | — | 1 |
Show 7 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Essential hypertension | D000075222 | — | I10 | — | 1 | — | — | 1 | 2 |
| Ischemic stroke | D000083242 | — | — | — | 1 | — | — | — | 1 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 1 | — | — | — | 1 |
| Ischemia | D007511 | EFO_0000556 | — | — | 1 | — | — | — | 1 |
| Ocular hypertension | D009798 | EFO_1001069 | H40.0 | — | 1 | — | — | — | 1 |
| Glaucoma | D005901 | EFO_0000516 | H40 | — | 1 | — | — | — | 1 |
| Open-angle glaucoma | D005902 | EFO_0004190 | H40.1 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 4 | — | — | — | — | 4 |
| Pure autonomic failure | D054970 | — | — | 1 | — | — | — | 1 | 2 |
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | 1 | — | — | — | — | 1 |
| Fatty liver | D005234 | EFO_0003934 | — | 1 | — | — | — | — | 1 |
| Idiopathic pulmonary fibrosis | D054990 | — | J84.112 | 1 | — | — | — | — | 1 |
| Pulmonary fibrosis | D011658 | — | J84.10 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic renal insufficiency | D051436 | — | N18 | — | — | — | — | 1 | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | — | — | 1 | 1 |
| Exercise test | D005080 | EFO_0004328 | — | — | — | — | — | 1 | 1 |
| Renal insufficiency | D051437 | — | N19 | — | — | — | — | 1 | 1 |
| Kidney transplantation | D016030 | — | — | — | — | — | — | 1 | 1 |
| Hot flashes | D019584 | — | — | — | — | — | — | 1 | 1 |
| Heart rate | D006339 | EFO_0004326 | — | — | — | — | — | 1 | 1 |
| Sexual arousal | D000083942 | — | — | — | — | — | — | 1 | 1 |
| Systolic murmurs | D054160 | — | R01.1 | — | — | — | — | 1 | 1 |
| Multiple system atrophy | D019578 | — | — | — | — | — | — | 1 | 1 |
Show 7 more
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
ADRB3
ADRB2
ADRB2
ADRB1
ADRB1
Variants
No data
Financial
Revenue by drug
$
€
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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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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 5,775 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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8,104 adverse events reported
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