Olmesartan
Amlodipine Besylate / Hydrochlorothiazide / Olmesartan Medoxomil, Amlodipine Besylate / Olmesartan Medoxomil, Azor, Benicar, Hydrochlorothiazide / Olmesartan Medoxomil, Olmesartan Medoxomil, Tribenzor (olmesartan) is a small molecule pharmaceutical. Olmesartan was first approved as Benicar on 2002-04-25. It is used to treat diabetic nephropathies, heart failure, hypertension, and left ventricular dysfunction in the USA. The pharmaceutical is active against type-1 angiotensin II receptor.
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Commercial
Therapeutic Areas
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Drug Products
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EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| amlodipine and olmesartan medoxomil | ANDA | 2025-05-30 |
| amlodipine and olmesartan medoxomil amlodipine and olmesartan medoxomil | ANDA | 2025-03-26 |
| amlodipine besylate and olmesartan medoxomil | New Drug Application | 2024-06-03 |
| azor | New Drug Application | 2023-07-12 |
| benicar | New Drug Application | 2023-07-12 |
| benicar hct | New Drug Application | 2023-07-12 |
| olmesartan medoxomil | ANDA | 2025-06-11 |
| olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide | ANDA | 2024-11-06 |
| olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide | ANDA | 2025-06-30 |
| olmesartan medoxomil and hydrochlorothiazide | ANDA | 2025-07-14 |
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Agency Specific
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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
— C09CA08: Olmesartan medoxomil
— C09D: Angiotensin ii receptor blockers (arbs), combinations
— C09DA: Angiotensin ii receptor blockers (arbs) and diuretics
— C09DA08: Olmesartan medoxomil and diuretics
— C09DB: Angiotensin ii receptor blockers (arbs) and calcium channel blockers
— C09DB02: Olmesartan medoxomil and amlodipine
— C09DX: Angiotensin ii receptor blockers (arbs), other combinations
— C09DX03: Olmesartan medoxomil, amlodipine and hydrochlorothiazide
HCPCS
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Clinical
Clinical Trials
159 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 | 1 | 11 | 13 | 2 | 27 |
| Essential hypertension | D000075222 | — | I10 | — | — | 7 | 2 | 1 | 10 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 1 | 1 | 1 | — | 3 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | 1 | 1 | — | 2 |
| Chronic renal insufficiency | D051436 | — | N18 | — | — | — | 1 | — | 1 |
| Albuminuria | D000419 | EFO_0004285 | R80.9 | — | — | — | 1 | — | 1 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | — | — | — | 1 | — | 1 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | — | — | 1 | — | 1 |
| Overweight | D050177 | — | E66.3 | — | — | — | 1 | — | 1 |
| Healthy volunteers/patients | — | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | 1 | 1 | — | — | 2 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | — | 1 | — | — | 1 |
| Proteinuria | D011507 | — | R80 | — | — | 1 | — | — | 1 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | 1 | — | — | 1 |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | — | 1 | — | — | 1 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | 1 | — | — | 1 |
| Cardiac arrhythmias | D001145 | EFO_0004269 | I49.9 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glomerulonephritis | D005921 | — | N05 | — | 1 | — | — | — | 1 |
| Chronic disease | D002908 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Exercise | D015444 | EFO_0000483 | — | — | — | — | — | 1 | 1 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | — | — | 1 | 1 |
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | — | — | — | — | 1 | 1 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Olmesartan |
| INN | olmesartan |
| Description | Olmesartan medoxomil is a member of biphenyls. |
| Classification | Small molecule |
| Drug class | angiotensin II receptor antagonists |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCCc1nc(C(C)(C)O)c(C(=O)O)n1Cc1ccc(-c2ccccc2-c2nnn[nH]2)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 144689-24-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1516 |
| ChEBI ID | 48416 |
| PubChem CID | 130881 |
| DrugBank | DB00275 |
| UNII ID | 8W1IQP3U10 (ChemIDplus, GSRS) |
Target
Agency Approved
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)
Alternate
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Variants
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Financial
Revenue by drug
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Estimated US medical usage
Olmesartan
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Amlodipine
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Hydrochlorothiazide
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Olmesartan
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Amlodipine
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Olmesartan
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Hydrochlorothiazide
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Olmesartan
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Safety
Black-box Warning
Black-box warning for: Amlodipine and olmesartan medoxomil, Amlodipine and olmesartan medoxomil amlodipine and olmesartan medoxomil, Amlodipine besylate and olmesartan medoxomil, Azor, Benicar, Benicar hct, Olmesartan medoxomil, Olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide, Olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide, Olmesartan medoxomil and hydrochlorothiazide, Olmesartan medoxomil, amlodipine and hydrochlorothiazide, Olmesartan medoxomil, amlodipine and hydrochlorothiazide 20/5/12.5 mg, Olmesartan medoxomil, amlodipine and hydrochlorothiazide 20/5/12.5 mg olmesartan medoxomil, amlodipine and hydrochlorothiazide 40/10/12.5 mg olmesa..., Olmesartan medoxomil-hydrochlorothiazide, Tribenzor
Adverse Events
Top Adverse Reactions
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22,432 adverse events reported
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