Avalide, Aprovel(irbesartan)
Aprovel, Avalide, Avapro, CoAprovel, Karvea, Karvezide (irbesartan) is a small molecule pharmaceutical. Irbesartan was first approved as Aprovel on 1997-08-26. It is used to treat diabetic nephropathies, hypertension, and left ventricular dysfunction in the USA. It has been approved in Europe to treat hypertension. It is known to target type-1 angiotensin II receptor and hepatic sodium/bile acid cotransporter.
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Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| urogenital diseases | D000091642 |
| cardiovascular diseases | D002318 |
| endocrine system diseases | D004700 |
Trade Name
FDA
EMA
Avapro (generic drugs available since 2012-03-30)
CombinationsAvalide (generic drugs available since 2012-03-30)
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 |
|---|---|---|
| avalide | New Drug Application | 2021-11-16 |
| avapro | New Drug Application | 2021-01-12 |
| irbesartan and hydrochlorothiazide | ANDA | 2023-05-08 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| diabetic nephropathies | EFO_0000401 | D003928 | — |
| hypertension | EFO_0000537 | D006973 | I10 |
| left ventricular dysfunction | — | D018487 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
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
— C09CA04: Irbesartan
— C09D: Angiotensin ii receptor blockers (arbs), combinations
— C09DA: Angiotensin ii receptor blockers (arbs) and diuretics
— C09DA04: Irbesartan and diuretics
— C09DB: Angiotensin ii receptor blockers (arbs) and calcium channel blockers
— C09DB05: Irbesartan and amlodipine
— C09DX: Angiotensin ii receptor blockers (arbs), other combinations
— C09DX07: Irbesartan, amlodipine and hydrochlorothiazide
HCPCS
No data
Clinical
Clinical Trials
96 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 | 4 | 13 | 22 | 5 | 44 |
| Healthy volunteers/patients | — | 5 | — | — | 1 | 3 | 9 | ||
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | 1 | 4 | — | 5 |
| Diabetic nephropathies | D003928 | EFO_0000401 | 1 | 1 | 1 | 2 | — | 4 | |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | — | 3 | 1 | — | 4 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | 1 | — | 1 | 1 | 3 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | 1 | 2 | — | 3 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | — | — | — | 1 | 1 | 2 |
| Abdominal obesity | D056128 | HP_0001956 | — | — | — | 1 | — | 1 | |
| Renin-angiotensin system | D012084 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Essential hypertension | D000075222 | I10 | — | 1 | 2 | — | — | 3 | |
| Chronic renal insufficiency | D051436 | N18 | — | 1 | 1 | — | 1 | 3 | |
| Iga glomerulonephritis | D005922 | EFO_0004194 | — | — | 2 | — | — | 2 | |
| Focal segmental glomerulosclerosis | D005923 | EFO_0004236 | — | 1 | 1 | — | — | 2 | |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | 2 | — | — | 2 |
| Covid-19 | D000086382 | U07.1 | — | — | 1 | — | — | 1 | |
| Ehlers-danlos syndrome | D004535 | Orphanet_98249 | Q79.6 | — | — | 1 | — | — | 1 |
| Sepsis | D018805 | A41.9 | — | — | 1 | — | — | 1 | |
| Hyperlipidemias | D006949 | EFO_0003774 | E78.5 | — | — | 1 | — | — | 1 |
| Kidney transplantation | D016030 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Blood pressure | D001794 | EFO_0004325 | — | 1 | — | — | — | 1 | |
| Psychological stress | D013315 | — | 1 | — | — | — | 1 | ||
| Ebola hemorrhagic fever | D019142 | EFO_0007243 | A98.4 | 1 | 1 | — | — | — | 1 |
| Marfan syndrome | D008382 | Orphanet_558 | Q87.4 | — | 1 | — | — | — | 1 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| Morbid obesity | D009767 | EFO_0001074 | — | — | — | — | 1 | 1 | |
| Pregnancy-induced hypertension | D046110 | O13 | — | — | — | — | 1 | 1 | |
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | — | — | — | — | 1 | 1 |
| Insulin resistance | D007333 | EFO_0002614 | — | — | — | — | 1 | 1 | |
| Microcirculation | D008833 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | IRBESARTAN |
| INN | irbesartan |
| Description | Irbesartan is a biphenylyltetrazole that is an angiotensin II receptor antagonist used mainly for the treatment of hypertension. It has a role as an antihypertensive agent, an angiotensin receptor antagonist, an environmental contaminant and a xenobiotic. It is a biphenylyltetrazole and an azaspiro compound. |
| Classification | Small molecule |
| Drug class | angiotensin II receptor antagonists |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CCCCC1=NC2(CCCC2)C(=O)N1Cc1ccc(-c2ccccc2-c2nnn[nH]2)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 138402-11-6 |
| RxCUI | 83818 |
| ChEMBL ID | CHEMBL1513 |
| ChEBI ID | 5959 |
| PubChem CID | 3749 |
| DrugBank | DB01029 |
| UNII ID | J0E2756Z7N (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
AGTR1
AGTR1
SLC10A1
SLC10A1
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
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 8,231 documents
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Safety
Black-box Warning
Black-box warning for: Avalide, Avapro, Irbesartan and hydrochlorothiazide
Adverse Events
Top Adverse Reactions
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30,289 adverse events reported
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