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Drug ReportsOlmesartan
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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Events Timeline
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
urogenital diseasesD000091642
cardiovascular diseasesD002318
endocrine system diseasesD004700
Trade Name
FDA
EMA
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Drug Products
FDA
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 medoxomilANDA2025-05-30
amlodipine and olmesartan medoxomil amlodipine and olmesartan medoxomilANDA2025-03-26
amlodipine besylate and olmesartan medoxomilNew Drug Application2024-06-03
azorNew Drug Application2023-07-12
benicarNew Drug Application2025-09-23
benicar hctNew Drug Application2023-07-12
olmesartan medoxomilANDA2025-10-03
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideANDA2024-11-06
olmesartan medoxomil amlodipine and hydrochlorothiazideANDA2025-08-04
olmesartan medoxomil and amlodipine besylate and hydrochlorothiazideANDA2025-06-30
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Indications
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EMA
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Agency Specific
FDA
EMA
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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
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I10——1——1
Essential hypertensionD000075222—I10——1——1
Indications Phases 2
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Indications Phases 1
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Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameOlmesartan
INNolmesartan
Description
Olmesartan medoxomil is a member of biphenyls.
Classification
Small molecule
Drug classangiotensin II receptor antagonists
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CCCc1nc(C(C)(C)O)c(C(=O)O)n1Cc1ccc(-c2ccccc2-c2nnn[nH]2)cc1
Identifiers
PDB—
CAS-ID144689-24-7
RxCUI—
ChEMBL IDCHEMBL1516
ChEBI ID48416
PubChem CID130881
DrugBankDB00275
UNII ID8W1IQP3U10 (ChemIDplus, GSRS)
Target
Agency Approved
AGTR1
AGTR1
Organism
Homo sapiens
Gene name
AGTR1
Gene synonyms
AGTR1A, AGTR1B, AT2R1, AT2R1B
NCBI Gene ID
185
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
Q8TBK4
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
Total medical expenditures per year (USD, in millions)
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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
Total medical expenditures per year (USD, in millions)
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Tabular view
Trends
PubMed Central
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Additional graphs summarizing 6,456 documents
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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 amlodipine and 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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22,678 adverse events reported
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