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
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
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Hydrochlorothiazide
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Olmesartan medoxomil
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TRIBENZOR | Cosette Pharmaceuticals | N-200175 RX | 2010-07-23 | 5 products, RLD, RS |
Amlodipine besylate
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Olmesartan medoxomil
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| AZOR | Cosette Pharmaceuticals | N-022100 RX | 2007-09-26 | 4 products, RLD, RS |
Hydrochlorothiazide
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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 |
|---|---|---|
| amlodipine and olmesartan medoxomil | ANDA | 2024-08-15 |
| 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 | 2024-09-26 |
| olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide | ANDA | 2024-08-23 |
| olmesartan medoxomil and hydrochlorothiazide | ANDA | 2024-07-30 |
| olmesartan medoxomil, amlodipine and hydrochlorothiazide | ANDA | 2021-01-31 |
| olmesartan medoxomil, amlodipine and hydrochlorothiazide 20/5/12.5 mg | ANDA | 2017-03-16 |
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Indications
FDA
EMA
No data
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
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 | 8 | 45 | 35 | 18 | 106 |
| Essential hypertension | D000075222 | — | I10 | — | 2 | 29 | 8 | 4 | 43 |
| Healthy volunteers/patients | — | — | — | 16 | — | 1 | 1 | — | 18 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 1 | 4 | 3 | 1 | 9 |
| Dyslipidemias | D050171 | HP_0003119 | — | — | — | 2 | 2 | 2 | 6 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | 2 | 3 | 1 | 6 |
| Covid-19 | D000086382 | — | — | — | — | 2 | 2 | 1 | 5 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | 3 | 2 | — | 5 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | — | 3 | 2 | — | 5 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 2 | — | 2 | — | 4 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart failure | D006333 | HP_0001635 | I50 | — | — | 2 | — | 1 | 3 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | 1 | 2 | — | — | 3 |
| Hyperlipidemias | D006949 | HP_0003077 | E78.5 | — | — | 1 | — | 1 | 2 |
| Syndrome | D013577 | — | — | — | — | 2 | — | — | 2 |
| Proteinuria | D011507 | HP_0000093 | R80 | — | — | 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 |
| Hyperlipoproteinemias | D006951 | HP_0010980 | — | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ischemic stroke | D000083242 | — | — | — | 2 | — | — | — | 2 |
| Ischemia | D007511 | EFO_0000556 | — | — | 2 | — | — | — | 2 |
| Cerebral infarction | D002544 | — | I63 | — | 1 | — | — | — | 1 |
| Coronary disease | D003327 | — | — | — | 1 | — | — | — | 1 |
| Glomerulonephritis | D005921 | HP_0000099 | N05 | — | 1 | — | — | — | 1 |
| Chronic disease | D002908 | — | — | — | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Systolic heart failure | D054143 | EFO_1001207 | I50.20 | — | — | — | — | 1 | 1 |
| Frailty | D000073496 | — | R53.1 | — | — | — | — | 1 | 1 |
| Hyperaldosteronism | D006929 | HP_0011736 | E26 | — | — | — | — | 1 | 1 |
| Adenoma | D000236 | — | — | — | — | — | — | 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 |
| Sleep apnea syndromes | D012891 | HP_0010535 | G47.3 | — | — | — | — | 1 | 1 |
| Apnea | D001049 | HP_0002104 | R06.81 | — | — | — | — | 1 | 1 |
Show 10 more
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
No data
Variants
No data
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
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Amlodipine and olmesartan medoxomil, Amlodipine besylate and olmesartan medoxomil, Azor, Benicar, Benicar hct, Olmesartan medoxomil, Olmesartan medoxomil / amlodipine besylate / 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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25,267 adverse events reported
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