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 | 2024-08-20 |
| avapro | New Drug Application | 2024-08-20 |
| irbesartan | ANDA | 2024-10-04 |
| irbesartan and hydrochlorothiazide | ANDA | 2024-10-01 |
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 | 2 | 5 | 18 | 31 | 15 | 70 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 2 | 7 | 3 | 6 | 2 | 18 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | 2 | 4 | 2 | 4 | 1 | 11 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 1 | 1 | 1 | 7 | — | 9 |
| Healthy volunteers/patients | — | — | — | 5 | — | — | 1 | 3 | 9 |
| Essential hypertension | D000075222 | — | I10 | 1 | 1 | 3 | 1 | 2 | 8 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | 1 | — | 2 | 4 | 7 |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | — | 5 | 2 | — | 7 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | — | 1 | 3 | 2 | 6 |
| Covid-19 | D000086382 | — | — | — | — | 2 | 2 | 1 | 5 |
Show 33 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Iga glomerulonephritis | D005922 | EFO_0004194 | — | — | 1 | 2 | — | — | 3 |
| Focal segmental glomerulosclerosis | D005923 | EFO_0004236 | — | — | 2 | 1 | — | — | 3 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | — | 2 | — | 1 | 3 |
| Cardiac arrhythmias | D001145 | EFO_0004269 | I49.9 | — | — | 1 | — | 1 | 2 |
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | — | 2 | — | — | 2 |
| Infections | D007239 | EFO_0000544 | — | — | — | 1 | — | — | 1 |
| Severe acute respiratory syndrome | D045169 | EFO_0000694 | J12.81 | — | — | 1 | — | — | 1 |
| Communicable diseases | D003141 | — | — | — | — | 1 | — | — | 1 |
| Pneumonia | D011014 | EFO_0003106 | — | — | — | 1 | — | — | 1 |
| Ehlers-danlos syndrome | D004535 | Orphanet_98249 | Q79.6 | — | — | 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 | — | — | 2 | — | — | — | 2 |
| Psychological stress | D013315 | — | — | — | 1 | — | — | — | 1 |
| Ebola hemorrhagic fever | D019142 | EFO_0007243 | A98.4 | 1 | 1 | — | — | — | 1 |
| Virus diseases | D014777 | — | B34 | 1 | 1 | — | — | — | 1 |
| Marfan syndrome | D008382 | Orphanet_558 | Q87.4 | — | 1 | — | — | — | 1 |
| Arachnodactyly | D054119 | — | — | — | 1 | — | — | — | 1 |
| Vasculitis | D014657 | HP_0002633 | — | — | 1 | — | — | — | 1 |
| Anti-neutrophil cytoplasmic antibody-associated vasculitis | D056648 | — | I77.82 | — | 1 | — | — | — | 1 |
| Ischemic stroke | D000083242 | — | — | — | 1 | — | — | — | 1 |
| Cerebrovascular disorders | D002561 | EFO_0003763 | I60-I69 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Therapeutic equivalency | D013810 | — | — | 2 | — | — | — | — | 2 |
| Disease | D004194 | EFO_0000408 | R69 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | — | — | — | — | 2 | 2 |
| Systolic heart failure | D054143 | EFO_1001207 | I50.20 | — | — | — | — | 1 | 1 |
| Frailty | D000073496 | — | R53.1 | — | — | — | — | 1 | 1 |
| Morbid obesity | D009767 | EFO_0001074 | — | — | — | — | — | 1 | 1 |
| Pregnancy-induced hypertension | D046110 | — | O13 | — | — | — | — | 1 | 1 |
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | — | — | — | — | 1 | 1 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | — | — | — | 1 | 1 |
| Microcirculation | D008833 | — | — | — | — | — | — | 1 | 1 |
| Left ventricular dysfunction | D018487 | — | — | — | — | — | — | 1 | 1 |
| Sleep apnea syndromes | D012891 | HP_0010535 | G47.3 | — | — | — | — | 1 | 1 |
Show 6 more
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) |
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Financial
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Estimated US medical usage
Irbesartan
+
Hydrochlorothiazide
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Irbesartan
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PubMed Central
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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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19,290 adverse events reported
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