Azilsartan
Edarbi, Edarbyclor (azilsartan) is a small molecule pharmaceutical. Azilsartan was first approved as Edarbi on 2011-02-25. It is used to treat hypertension in the USA. It has been approved in Europe to treat hypertension. It is known to target type-1 angiotensin II receptor.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| cardiovascular diseases | D002318 |
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| edarbi | New Drug Application | 2024-01-23 |
| edarbyclor | New Drug Application | 2024-02-01 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
ATC Codes
C: Cardiovascular system drugs
— C09: Agents acting on the renin-angiotensin system
— C09C: Angiotensin ii receptor blockers (arbs), plain
— C09CA: Angiotensin ii receptor blockers (arbs), plain
— C09CA09: Azilsartan medoxomil
— C09D: Angiotensin ii receptor blockers (arbs), combinations
— C09DA: Angiotensin ii receptor blockers (arbs) and diuretics
— C09DA09: Azilsartan medoxomil and diuretics
HCPCS
No data
Clinical
Clinical Trials
68 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 | 4 | 5 | 27 | 5 | 15 | 54 |
| Essential hypertension | D000075222 | — | I10 | — | 3 | 18 | 3 | 3 | 26 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | 2 | 4 | 2 | 1 | 8 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 1 | 3 | 2 | — | 5 |
| Stable angina | D060050 | — | I20.89 | — | — | — | 1 | 1 | 2 |
| Dyslipidemias | D050171 | HP_0003119 | — | — | — | — | 1 | — | 1 |
| Angina pectoris | D000787 | EFO_0003913 | I20 | — | — | — | 1 | — | 1 |
| Insulin resistance | D007333 | HP_0000855 | — | — | — | — | 1 | — | 1 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | — | — | — | 1 | — | 1 |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 3 | — | 1 | — | — | 4 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | 1 | 1 | — | 2 | 3 |
| Covid-19 | D000086382 | — | — | — | — | 1 | — | 1 | 2 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | 1 | — | 1 | 2 |
| Infections | D007239 | EFO_0000544 | — | — | — | 1 | — | — | 1 |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | — | 1 | — | — | 1 |
| Severe acute respiratory syndrome | D045169 | EFO_0000694 | J12.81 | — | — | 1 | — | — | 1 |
| Communicable diseases | D003141 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Therapeutic equivalency | D013810 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart failure | D006333 | HP_0001635 | I50 | — | — | — | — | 1 | 1 |
| Systolic heart failure | D054143 | EFO_1001207 | I50.20 | — | — | — | — | 1 | 1 |
| Frailty | D000073496 | — | R53.1 | — | — | — | — | 1 | 1 |
| Coronary artery disease | D003324 | — | I25.1 | — | — | — | — | 1 | 1 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | — | — | 1 | 1 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | — | — | 1 | 1 |
| Overweight | D050177 | — | E66.3 | — | — | — | — | 1 | 1 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | — | — | — | 1 | 1 |
| Proteinuria | D011507 | HP_0000093 | R80 | — | — | — | — | 1 | 1 |
| Blood pressure | D001794 | EFO_0004325 | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Azilsartan |
| INN | azilsartan |
| Description | Azilsartan is a benzimidazolecarboxylic acid that is benzimidazole-7-carboxylic acid substituted at position 2 by a methoxy group and at position 1 by a 2'-[(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl]methyl group. Used (as the prodrug, azilsartan medoxomil) for treatment of hypertension. It has a role as an angiotensin receptor antagonist and an antihypertensive agent. It is a benzimidazolecarboxylic acid, a 1,2,4-oxadiazole and an aromatic ether. |
| Classification | Small molecule |
| Drug class | angiotensin II receptor antagonists |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCOc1nc2cccc(C(=O)O)c2n1Cc1ccc(-c2ccccc2-c2noc(=O)[nH]2)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 147403-03-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL57242 |
| ChEBI ID | 68850 |
| PubChem CID | 135415867 |
| DrugBank | DB08822 |
| UNII ID | F9NUX55P23 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
AGTR1
AGTR1
Organism
Homo sapiens
Gene name
AGTR1
Gene synonyms
AGTR1A, AGTR1B, AT2R1, AT2R1B
NCBI Gene ID
Protein name
type-1 angiotensin II receptor
Protein synonyms
Angiotensin II type-1 receptor, AT1 receptor, AT1AR, AT1BR, type-1B angiotensin II receptor
Uniprot ID
Mouse ortholog
Agtr1b (11608)
type-1 angiotensin II receptor B (P29755)
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Azilsartan – Takeda
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Estimated US medical usage
Azilsartan
Total medical expenditures per year (USD, in millions)
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Price per prescription (USD)
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Azilsartan
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Chlorthalidone
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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Additional graphs summarizing 1,147 documents
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Safety
Black-box Warning
Black-box warning for: Edarbi, Edarbyclor
Adverse Events
Top Adverse Reactions
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1,665 adverse events reported
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