Olmesartan
Azor, Benicar, 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
Therapeutic Area | MeSH |
---|---|
urogenital diseases | D000091642 |
cardiovascular diseases | D002318 |
endocrine system diseases | D004700 |
Trade Name
FDA
EMA
Benicar (generic drugs available since 2016-10-26)
CombinationsAzor, Benicar, Tribenzor (generic drugs available since 2016-10-26)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Amlodipine besylate
+
Hydrochlorothiazide
+
Olmesartan medoxomil
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
TRIBENZOR | Cosette Pharmaceuticals | N-200175 RX | 2010-07-23 | 5 products, RLD, RS |
Amlodipine besylate
+
Olmesartan medoxomil
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
AZOR | Cosette Pharmaceuticals | N-022100 RX | 2007-09-26 | 4 products, RLD, RS |
Hydrochlorothiazide
+
Olmesartan medoxomil
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
BENICAR HCT | Cosette Pharmaceuticals | N-021532 RX | 2003-06-05 | 3 products, RLD, RS |
Olmesartan medoxomil
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
BENICAR | Cosette Pharmaceuticals | N-021286 RX | 2002-04-25 | 3 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
azor | New Drug Application | 2022-06-17 |
benicar | New Drug Application | 2022-06-20 |
olmesartan medoxomil | ANDA | 2023-06-20 |
tribenzor | New Drug Application | 2022-06-17 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
diabetic nephropathies | EFO_0000401 | D003928 | — |
heart failure | EFO_0003144 | D006333 | I50 |
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
— 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
No data
Clinical
Clinical Trials
126 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 | 15 | 25 | 10 | 57 |
Essential hypertension | D000075222 | I10 | — | 1 | 22 | 5 | 2 | 30 | |
Healthy volunteers/patients | — | 12 | — | 1 | 1 | — | 14 | ||
Dyslipidemias | D050171 | HP_0003119 | — | — | 2 | 2 | 2 | 6 | |
Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | 3 | 2 | — | 5 |
Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | — | — | 2 | 1 | — | 3 |
Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 1 | 2 | — | 3 |
Peripheral arterial disease | D058729 | EFO_0004265 | — | — | — | 1 | — | 1 | |
Coronary artery disease | D003324 | I25.1 | — | — | — | 1 | — | 1 | |
Drug interactions | D004347 | — | — | — | 1 | — | 1 |
Show 4 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Diabetic nephropathies | D003928 | EFO_0000401 | — | 1 | 2 | — | — | 3 | |
Hyperlipidemias | D006949 | EFO_0003774 | E78.5 | — | — | 1 | — | 1 | 2 |
Heart failure | D006333 | EFO_0003144 | I50 | — | — | 2 | — | — | 2 |
Proteinuria | D011507 | HP_0000093 | R80 | — | — | 2 | — | — | 2 |
Covid-19 | D000086382 | U07.1 | — | — | 1 | — | — | 1 | |
Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | — | 1 | — | — | 1 |
Retinal diseases | D012164 | HP_0000479 | H35.9 | — | — | 1 | — | — | 1 |
Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | 1 | — | — | 1 |
Renal insufficiency | D051437 | HP_0000083 | N19 | — | — | 1 | — | — | 1 |
Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | — | 1 | — | — | 1 |
Show 2 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Ischemic stroke | D000083242 | — | 2 | — | — | — | 2 | ||
Coronary disease | D003327 | — | 1 | — | — | — | 1 | ||
Glomerulonephritis | D005921 | N05 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Therapeutic equivalency | D013810 | 2 | — | — | — | — | 2 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Hyperaldosteronism | D006929 | HP_0011736 | E26 | — | — | — | — | 1 | 1 |
Ambulatory blood pressure monitoring | D018660 | — | — | — | — | 1 | 1 | ||
Vascular stiffness | D059289 | — | — | — | — | 1 | 1 | ||
Exercise | D015444 | EFO_0000483 | — | — | — | — | 1 | 1 | |
Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | — | — | — | — | 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 is a biphenylyltetrazole. It has a role as an antihypertensive agent and an angiotensin receptor antagonist. |
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 | 321064 |
ChEMBL ID | CHEMBL1516 |
ChEBI ID | 48416 |
PubChem CID | 158781 |
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
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 5,490 documents
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Safety
Black-box Warning
Black-box warning for: Azor, Benicar, Olmesartan medoxomil, Tribenzor
Adverse Events
Top Adverse Reactions
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22,667 adverse events reported
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