Azilsartan kamedoxomil
Edarbi, Edarbyclor (azilsartan kamedoxomil) is a small molecule pharmaceutical. Azilsartan kamedoxomil 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.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| cardiovascular diseases | D002318 |
Trade Name
FDA
EMA
Edarbi (discontinued: Azilsartan medoxomil)
CombinationsEdarbyclor
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 |
|---|---|---|
| edarbi | New Drug Application | 2024-01-23 |
| edarbyclor | New Drug Application | 2024-02-01 |
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 kamedoxomil |
| INN | azilsartan medoxomil |
| 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)OCc3oc(=O)oc3C)c2n1Cc1ccc(-c2ccccc2-c2noc(=O)[n-]2)cc1.[K+] |
Identifiers
| PDB | — |
| CAS-ID | 863031-24-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2103795 |
| ChEBI ID | 68847 |
| PubChem CID | 135415867 |
| DrugBank | DB08822 |
| UNII ID | LL0G25K7I2 (ChemIDplus, GSRS) |
Target
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Variants
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Financial
No data
Trends
PubMed Central
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Additional graphs summarizing 285 documents
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Safety
Black-box Warning
Black-box warning for: Edarbi, Edarbyclor
Adverse Events
Top Adverse Reactions
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1,789 adverse events reported
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