Losartan
Cozaar, Hyzaar (losartan) is a small molecule pharmaceutical. Losartan was first approved as Cozaar on 1995-04-14. It is used to treat diabetic nephropathies, heart failure, hypertension, left ventricular dysfunction, and left ventricular hypertrophy in the USA. The pharmaceutical is active against type-1 angiotensin II receptor.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Cozaar (generic drugs available since 2010-01-06)
CombinationsHyzaar (generic drugs available since 2010-01-06)
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 |
|---|---|---|
| hyzaar | New Drug Application | 2022-06-01 |
| losartan potassium and hydrochlorothiazide | ANDA | 2024-01-11 |
| losartan potassium and hydrochlorothiazide | ANDA | 2024-01-31 |
| losartan potassium and hydrochlorothiazide losartan potassium hctz | ANDA | 2019-10-14 |
| losartan potassium-hydrochlorothiazide | ANDA | 2010-09-16 |
Indications
FDA
EMA
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
— C09CA01: Losartan
— C09D: Angiotensin ii receptor blockers (arbs), combinations
— C09DA: Angiotensin ii receptor blockers (arbs) and diuretics
— C09DA01: Losartan and diuretics
— C09DB: Angiotensin ii receptor blockers (arbs) and calcium channel blockers
— C09DB06: Losartan and amlodipine
HCPCS
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Clinical
Clinical Trials
424 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 | 14 | 21 | 45 | 53 | 21 | 150 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | 1 | 3 | 3 | 5 | 6 | 17 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 1 | 2 | 4 | 5 | 4 | 16 |
| Essential hypertension | D000075222 | — | I10 | 1 | 3 | 6 | 5 | — | 15 |
| Covid-19 | D000086382 | — | U07.1 | 1 | 6 | 5 | 3 | 1 | 14 |
| Proteinuria | D011507 | HP_0000093 | R80 | — | 1 | 3 | 3 | 5 | 12 |
| Chronic renal insufficiency | D051436 | — | N18 | — | 1 | 1 | 1 | 8 | 11 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | 1 | — | 2 | 3 | 2 | 8 |
| Iga glomerulonephritis | D005922 | EFO_0004194 | — | — | — | 1 | 4 | 2 | 7 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | — | 1 | 5 | 1 | 7 |
Show 50 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Marfan syndrome | D008382 | Orphanet_558 | Q87.4 | — | 2 | 7 | — | — | 9 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | 3 | 1 | — | — | 4 |
| Hyperlipidemias | D006949 | HP_0003077 | E78.5 | 1 | 1 | 1 | — | — | 3 |
| Pneumonia | D011014 | EFO_0003106 | — | — | 1 | 1 | — | — | 2 |
| Glioblastoma | D005909 | EFO_0000515 | — | — | 1 | 1 | — | — | 2 |
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | — | 2 | 1 | — | — | 2 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | — | — | 1 | — | 1 | 2 |
| Pulmonary fibrosis | D011658 | — | J84.10 | 1 | 2 | 1 | — | — | 2 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | — | 1 | — | 1 | 2 |
| Overweight | D050177 | — | E66.3 | 1 | 1 | 1 | — | — | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 3 | 4 | — | — | — | 7 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 1 | 3 | — | — | — | 4 |
| Neoplasms | D009369 | — | C80 | 1 | 2 | — | — | — | 3 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 1 | — | — | — | 3 |
| Morbid obesity | D009767 | EFO_0001074 | — | 1 | 1 | — | — | 2 | 3 |
| Aging | D000375 | GO_0007568 | R41.81 | 1 | 2 | — | — | 1 | 3 |
| Hypertrophic cardiomyopathy | D002312 | EFO_0000538 | I42.1 | — | 2 | — | — | 1 | 3 |
| Pancreatic ductal carcinoma | D021441 | — | — | 1 | 1 | — | — | — | 2 |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | 2 | — | — | — | 2 |
| Fibrosis | D005355 | — | — | 1 | 2 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 24 | — | — | — | 6 | 30 |
| Drug interactions | D004347 | — | — | 3 | — | — | — | — | 3 |
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | 1 | — | — | — | — | 1 |
| Osteosarcoma | D012516 | — | — | 1 | — | — | — | — | 1 |
| Myelodysplastic syndromes | D009190 | — | D46 | 1 | — | — | — | — | 1 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 1 | — | — | — | — | 1 |
| Hematologic neoplasms | D019337 | — | — | 1 | — | — | — | — | 1 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | — | — | — | — | 1 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | 1 | — | — | — | — | 1 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | — | — | 2 | 2 |
| Systolic heart failure | D054143 | EFO_1001207 | I50.20 | — | — | — | — | 1 | 1 |
| Frailty | D000073496 | — | R53.1 | — | — | — | — | 1 | 1 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | — | — | — | — | 1 | 1 |
| Memory | D008568 | — | — | — | — | — | — | 1 | 1 |
| Learning | D007858 | — | — | — | — | — | — | 1 | 1 |
| Lupus nephritis | D008181 | EFO_0005761 | — | — | — | — | — | 1 | 1 |
| Albuminuria | D000419 | EFO_0004285 | R80.9 | — | — | — | — | 1 | 1 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | — | — | — | 1 | 1 |
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | — | — | — | — | 1 | 1 |
Show 15 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Losartan |
| INN | losartan |
| Description | Losartan is a biphenylyltetrazole where a 1,1'-biphenyl group is attached at the 5-position and has an additional trisubstituted imidazol-1-ylmethyl group at the 4'-position It has a role as an antihypertensive agent, an angiotensin receptor antagonist, an endothelin receptor antagonist and an anti-arrhythmia drug. It is a biphenylyltetrazole and a member of imidazoles. It is a conjugate acid of a losartan(1-). |
| Classification | Small molecule |
| Drug class | angiotensin II receptor antagonists |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCCCc1nc(Cl)c(CO)n1Cc1ccc(-c2ccccc2-c2nnn[nH]2)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 114798-26-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL191 |
| ChEBI ID | 6541 |
| PubChem CID | 3961 |
| DrugBank | DB00678 |
| UNII ID | JMS50MPO89 (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
CYP2C9
CYP2C9
Organism
Homo sapiens
Gene name
CYP2C9
Gene synonyms
CYP2C10
NCBI Gene ID
Protein name
cytochrome P450 2C9
Protein synonyms
(R)-limonene 6-monooxygenase, (S)-limonene 6-monooxygenase, (S)-limonene 7-monooxygenase, Cholesterol 25-hydroxylase, CYPIIC9, cytochrome P-450 S-mephenytoin 4-hydroxylase, Cytochrome P-450MP, Cytochrome P450 MP-4, Cytochrome P450 MP-8, Cytochrome P450 PB-1, cytochrome P450, family 2, subfamily C, polypeptide 9, flavoprotein-linked monooxygenase, microsomal monooxygenase, S-mephenytoin 4-hydroxylase, xenobiotic monooxygenase
Uniprot ID
Mouse ortholog
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Variants
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Financial
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Estimated US medical usage
Losartan
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Hydrochlorothiazide
Total medical expenditures per year (USD, in millions)
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Losartan
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Hyzaar, Losartan potassium and hydrochlorothiazide, Losartan potassium and hydrochlorothiazide, Losartan potassium and hydrochlorothiazide losartan potassium hctz, Losartan potassium-hydrochlorothiazide
Adverse Events
Top Adverse Reactions
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92,876 adverse events reported
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