Avalide, Aprovel(irbesartan)
Aprovel, Avalide, Avapro, CoAprovel, Hydrochlorothiazide / Irbesartan, Ifirmacombi, Ifirmasta, Irbesartan, Irbesartan / Hydrochlorothiazide, 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.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Avapro, Irbesartan (discontinued: Avapro, Irbesartan)
CombinationsAvalide, Irbesartan hydrochlorothiazide (discontinued: Avalide, Irbesartan hydrochlorothiazide)
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 | 2025-08-11 |
| avapro | New Drug Application | 2025-08-11 |
| irbesartan | ANDA | 2025-10-02 |
| irbesartan and hydrochlorothiazide | ANDA | 2025-09-09 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
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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
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Clinical
Clinical Trials
136 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 | 7 | 12 | — | 19 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | 1 | 1 | — | 2 |
| Albuminuria | D000419 | EFO_0004285 | R80.9 | — | — | 1 | 1 | — | 2 |
| Dyslipidemias | D050171 | — | — | — | — | — | 1 | — | 1 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | — | — | — | 1 | — | 1 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | — | 1 | — | 1 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | — | — | 1 | — | 1 |
| Syndrome | D013577 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | — | 5 | — | — | 5 |
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | — | 2 | — | — | 2 |
| Cardiomegaly | D006332 | EFO_0002503 | I51.7 | — | 1 | 1 | — | — | 1 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | 1 | — | — | 1 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | 1 | — | — | 1 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | 1 | — | — | 1 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 1 | — | — | 1 |
| Cardiac arrhythmias | D001145 | EFO_0004269 | I49.9 | — | — | 1 | — | — | 1 |
| Hypercholesterolemia | D006937 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
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Indications Phases 1
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Indications Without Phase
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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 | — |
| ChEMBL ID | CHEMBL1513 |
| ChEBI ID | 5959 |
| PubChem CID | 3749 |
| DrugBank | DB01029 |
| UNII ID | J0E2756Z7N (ChemIDplus, GSRS) |
Target
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Variants
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Financial
Revenue by drug
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Estimated US medical usage
Irbesartan
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Hydrochlorothiazide
Total medical expenditures per year (USD, in millions)
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Irbesartan
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Trends
PubMed Central
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Additional graphs summarizing 10,395 documents
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Safety
Black-box Warning
Black-box warning for: Avalide, Avapro, Irbesartan, Irbesartan and hydrochlorothiazide
Adverse Events
Top Adverse Reactions
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19,649 adverse events reported
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