Losartan
Cozaar, Hyzaar, Losartan Potassium (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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Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cozaar | New Drug Application | 2024-06-27 |
| hyzaar | New Drug Application | 2023-03-17 |
| losartan | ANDA | 2018-02-15 |
| losartan pot/hctz | ANDA | 2019-08-02 |
| losartan potassium | ANDA | 2024-10-28 |
| losartan potassium and hydrochlorothiazide | ANDA | 2024-05-06 |
| losartan potassium and hydrochlorothiazide | ANDA | 2024-11-04 |
| losartan potassium and hydrochlorothiazide losartan potassium hctz | ANDA | 2019-10-14 |
| losartan potassium losartan potassium | ANDA | 2023-01-07 |
| losartan potassium losortan potassium | ANDA | 2023-08-24 |
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Agency Specific
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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
— 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
435 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 | 16 | 24 | 61 | 58 | 28 | 182 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 3 | 7 | 8 | 15 | 16 | 49 |
| Essential hypertension | D000075222 | — | I10 | 2 | 6 | 27 | 6 | 1 | 41 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | 1 | 4 | 3 | 7 | 7 | 21 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 2 | 3 | 4 | 6 | 4 | 18 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | 1 | 2 | 3 | 9 | 3 | 18 |
| Covid-19 | D000086382 | — | — | 1 | 7 | 7 | 3 | 1 | 17 |
| Chronic renal insufficiency | D051436 | — | N18 | 2 | 1 | 2 | 2 | 9 | 16 |
| Syndrome | D013577 | — | — | 3 | 4 | 7 | 2 | — | 15 |
| Proteinuria | D011507 | HP_0000093 | R80 | — | 2 | 3 | 4 | 6 | 15 |
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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 |
| Arachnodactyly | D054119 | — | — | — | 2 | 7 | — | — | 9 |
| Nephritis | D009393 | — | N05 | — | 1 | 2 | — | 1 | 4 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | 3 | 1 | — | — | 4 |
| Pulmonary fibrosis | D011658 | — | — | 1 | 2 | 1 | — | 2 | 4 |
| Hyperlipidemias | D006949 | HP_0003077 | E78.5 | 1 | 1 | 1 | — | — | 3 |
| Pneumonia | D011014 | EFO_0003106 | — | — | 1 | 1 | — | — | 2 |
| Acute kidney injury | D058186 | HP_0001919 | N17 | — | 1 | 1 | — | 1 | 2 |
| Glioblastoma | D005909 | EFO_0000515 | — | — | 1 | 1 | — | — | 2 |
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | — | 2 | 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 | 5 | — | — | 1 | 9 |
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | 1 | 3 | — | — | 2 | 5 |
| Neoplasms | D009369 | — | C80 | 2 | 2 | — | — | — | 4 |
| Adenocarcinoma | D000230 | — | — | 3 | 1 | — | — | — | 4 |
| Aging | D000375 | GO_0007568 | R41.81 | 1 | 2 | — | — | 2 | 4 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 1 | 3 | — | — | — | 4 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 1 | — | — | — | 3 |
| Morbid obesity | D009767 | EFO_0001074 | — | 1 | 1 | — | — | 2 | 3 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 1 | 2 | — | — | — | 3 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | 1 | — | — | 2 | 3 |
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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 | — | — | — | 8 | 32 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 2 | — | — | — | 2 | 4 |
| Recurrence | D012008 | — | — | 2 | — | — | — | 1 | 3 |
| Drug interactions | D004347 | — | — | 3 | — | — | — | — | 3 |
| Carcinoma | D002277 | — | C80.0 | 2 | — | — | — | — | 2 |
| Pure autonomic failure | D054970 | — | — | 2 | — | — | — | — | 2 |
| Arteriovenous fistula | D001164 | — | Q27.3 | 1 | — | — | — | 1 | 2 |
| Fistula | D005402 | — | — | 1 | — | — | — | 1 | 2 |
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | 1 | — | — | — | — | 1 |
| Osteosarcoma | D012516 | — | — | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Albuminuria | D000419 | EFO_0004285 | R80.9 | — | — | — | — | 2 | 2 |
| Systolic heart failure | D054143 | EFO_1001207 | I50.20 | — | — | — | — | 1 | 1 |
| Frailty | D000073496 | — | R53.1 | — | — | — | — | 1 | 1 |
| Urologic diseases | D014570 | — | N39.9 | — | — | — | — | 1 | 1 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34.0 | — | — | — | — | 1 | 1 |
| Localized scleroderma | D012594 | EFO_1001361 | L94.0 | — | — | — | — | 1 | 1 |
| Diffuse scleroderma | D045743 | EFO_0000404 | — | — | — | — | — | 1 | 1 |
| Memory | D008568 | — | — | — | — | — | — | 1 | 1 |
| Learning | D007858 | — | — | — | — | — | — | 1 | 1 |
| Lupus nephritis | D008181 | EFO_0005761 | — | — | — | — | — | 1 | 1 |
Show 27 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
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Safety
Black-box Warning
Black-box warning for: Cozaar, Hyzaar, Losartan, Losartan potassium, Losartan potassium and hydrochlorothiazide, Losartan potassium and hydrochlorothiazide, Losartan potassium and hydrochlorothiazide losartan potassium hctz, Losartan potassium losartan potassium, Losartan potassium losortan potassium, Losartan potassium tablets, 100 mg, Losartan potassium tablets, 100 mg losartan potassium tablets, 25 mg losartan potassium tablets, 50 mg, Losartan potassium tablets, 25 mg, Losartan potassium tablets, 25 mg losartan potassium tablets, 50 mg, Losartan potassium tablets, 50 mg, Losartan potassium-hydrochlorothiazide, Losartan potatssium, Losatan potassium, Losortan potassium
Adverse Events
Top Adverse Reactions
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130,841 adverse events reported
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