Atorvastatin
Atorvaliq, Caduet, Lipitor, Liptruzet (atorvastatin) is a small molecule pharmaceutical. Atorvastatin was first approved as Lipitor on 1996-12-17. It is used to treat coronary artery disease, hypercholesterolemia, hyperlipoproteinemias, and hypertriglyceridemia in the USA. The pharmaceutical is active against 3-hydroxy-3-methylglutaryl-Coenzyme A reductase.
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Commercial
Trade Name
FDA
EMA
Atorvaliq, Lipitor (generic drugs available since 2011-11-30)
CombinationsCaduet (generic drugs available since 2011-11-30, discontinued: Liptruzet)
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 |
---|---|---|
atorvaliq | New Drug Application | 2023-02-16 |
atorvastatin calcium | ANDA | 2023-06-16 |
caduet | New Drug Application | 2021-03-25 |
lipitor | New Drug Application | 2021-11-16 |
lypqozet | ANDA | 2021-01-14 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
coronary artery disease | — | D003324 | I25.1 |
hypercholesterolemia | HP_0003124 | D006937 | — |
hyperlipoproteinemias | — | D006951 | — |
hypertriglyceridemia | EFO_0004211 | D015228 | — |
Agency Specific
FDA
EMA
No data
ATC Codes
C: Cardiovascular system drugs
— C10: Lipid modifying agents
— C10A: Lipid modifying agents, plain
— C10AA: Hmg coa reductase inhibitors, plain lipid modifying drugs
— C10AA05: Atorvastatin
— C10B: Lipid modifying agents, combinations
— C10BA: Combinations of various lipid modifying agents
— C10BA05: Atorvastatin and ezetimibe
— C10BA08: Atorvastatin and omega-3 fatty acids
— C10BX: Lipid modifying agents in combination with other drugs
— C10BX03: Atorvastatin and amlodipine
— C10BX06: Atorvastatin, acetylsalicylic acid and ramipril
— C10BX08: Atorvastatin and acetylsalicylic acid
— C10BX11: Atorvastatin, amlodipine and perindopril
— C10BX12: Atorvastatin, acetylsalicylic acid and perindopril
— C10BX15: Atorvastatin and perindopril
— C10BX18: Atorvastatin, amlodipine and ramipril
HCPCS
No data
Clinical
Clinical Trials
825 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Hypercholesterolemia | D006937 | HP_0003124 | 7 | 17 | 59 | 39 | 8 | 130 | |
Dyslipidemias | D050171 | HP_0003119 | 6 | 11 | 25 | 27 | 3 | 72 | |
Hyperlipidemias | D006949 | EFO_0003774 | E78.5 | 10 | 10 | 27 | 8 | 2 | 55 |
Healthy volunteers/patients | — | 44 | 1 | — | 6 | 3 | 54 | ||
Coronary artery disease | D003324 | I25.1 | — | 2 | 10 | 23 | 10 | 45 | |
Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | 6 | 5 | 17 | 7 | 35 |
Hypertension | D006973 | EFO_0000537 | I10 | 5 | 2 | 6 | 15 | 4 | 32 |
Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 1 | — | 8 | 14 | 5 | 28 |
Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | 1 | 7 | 14 | 6 | 28 |
Coronary disease | D003327 | 1 | — | 8 | 11 | — | 20 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 9 | 1 | — | — | 11 |
Prostatic neoplasms | D011471 | C61 | 1 | 4 | 2 | — | 2 | 9 | |
Covid-19 | D000086382 | U07.1 | — | 2 | 5 | — | 2 | 8 | |
Hyperlipoproteinemia type ii | D006938 | EFO_0004911 | E78.00 | — | — | 6 | — | 1 | 7 |
Chronic periodontitis | D055113 | EFO_0006343 | K05.3 | — | 6 | 5 | — | — | 6 |
Hiv | D006678 | O98.7 | 1 | 2 | 1 | — | 1 | 5 | |
Subdural hematoma chronic | D020200 | — | 2 | 1 | — | 1 | 4 | ||
Myelodysplastic syndromes | D009190 | D46 | 1 | 2 | 1 | — | — | 4 | |
Myeloid leukemia acute | D015470 | C92.0 | 1 | 2 | 1 | — | — | 4 | |
Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | — | 3 | 1 | — | — | 4 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | 1 | 2 | — | — | 2 | 5 |
Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | 3 | 2 | — | — | — | 4 |
Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | 2 | — | — | 1 | 3 |
Cardiotoxicity | D066126 | EFO_1001482 | — | 3 | — | — | — | 3 | |
Mucocutaneous lymph node syndrome | D009080 | EFO_0004246 | M30.3 | 2 | 2 | — | — | — | 3 |
Balloon angioplasty coronary | D015906 | EFO_0003951 | — | 2 | — | — | 1 | 3 | |
Triple negative breast neoplasms | D064726 | — | 2 | — | — | — | 2 | ||
Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | 2 | — | — | — | 2 | |
Colorectal neoplasms | D015179 | — | 1 | — | — | 1 | 2 | ||
Adenocarcinoma | D000230 | 1 | 1 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 1 | — | — | — | 1 | 2 |
Pharmacokinetics | D010599 | 2 | — | — | — | — | 2 | ||
Infections | D007239 | EFO_0000544 | 1 | — | — | — | 1 | 2 | |
Hereditary nonpolyposis colorectal neoplasms | D003123 | EFO_0007354 | 1 | — | — | — | — | 1 | |
Autonomic nervous system diseases | D001342 | EFO_0009532 | G90 | 1 | — | — | — | — | 1 |
Lipodystrophy | D008060 | E88.1 | 1 | — | — | — | — | 1 | |
Hiv seronegativity | D018023 | 1 | — | — | — | — | 1 | ||
Epilepsy | D004827 | EFO_0000474 | G40.9 | 1 | — | — | — | — | 1 |
Sleep wake disorders | D012893 | G47 | 1 | — | — | — | — | 1 | |
Drug interactions | D004347 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Percutaneous coronary intervention | D062645 | — | — | — | — | 2 | 2 | ||
Asymptomatic diseases | D058070 | — | — | — | — | 2 | 2 | ||
Diastolic heart failure | D054144 | EFO_1000899 | I50.30 | — | — | — | — | 2 | 2 |
Coronary occlusion | D054059 | I21 | — | — | — | — | 1 | 1 | |
Proteinuria | D011507 | HP_0000093 | R80 | — | — | — | — | 1 | 1 |
Inborn genetic diseases | D030342 | EFO_0000508 | — | — | — | — | 1 | 1 | |
Hypoalphalipoproteinemias | D052456 | E78.6 | — | — | — | — | 1 | 1 | |
Delirium | D003693 | R41.0 | — | — | — | — | 1 | 1 | |
Altitude sickness | D000532 | EFO_1000782 | T70.29 | — | — | — | — | 1 | 1 |
Cancer pain | D000072716 | G89.3 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | ATORVASTATIN |
INN | atorvastatin |
Description | Atorvastatin is a dihydroxy monocarboxylic acid that is a member of the drug class known as statins, used primarily for lowering blood cholesterol and for preventing cardiovascular diseases. It has a role as an environmental contaminant and a xenobiotic. It is an aromatic amide, a member of monofluorobenzenes, a statin (synthetic), a dihydroxy monocarboxylic acid and a member of pyrroles. It is functionally related to a heptanoic acid. It is a conjugate acid of an atorvastatin(1-). |
Classification | Small molecule |
Drug class | enzyme inhibitors: antihyperlipidemics (HMG-CoA inhibitors) |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O |
Identifiers
PDB | 1HWK |
CAS-ID | 134523-00-5 |
RxCUI | 83367 |
ChEMBL ID | CHEMBL1487 |
ChEBI ID | 39548 |
PubChem CID | 60823 |
DrugBank | DB01076 |
UNII ID | A0JWA85V8F (ChemIDplus, GSRS) |
Target
Agency Approved
HMGCR
HMGCR
Organism
Homo sapiens
Gene name
HMGCR
Gene synonyms
NCBI Gene ID
Protein name
3-hydroxy-3-methylglutaryl-Coenzyme A reductase
Protein synonyms
3-hydroxy-3-methylglutaryl CoA reductase (NADPH), HMG-CoA reductase, hydroxymethylglutaryl-CoA reductase
Uniprot ID
Mouse ortholog
Hmgcr (15357)
3-hydroxy-3-methylglutaryl-coenzyme A reductase (Q5U4I2)
Alternate
No data
Variants
Clinical Variant
Identifier | Target mutation | Effect | Evaluation | Status |
---|---|---|---|---|
VCV000037346 | SLCO1B1, 521T>C, Val174Ala | drug response | 2022-02-15 | 1A |
VCV000017848 | APOE, 526C>T, Arg176Cys | drug response | 2021-03-24 | 2B |
Financial
Lipitor - Viatris
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Lipitor - Pfizer
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Caduet - Pfizer
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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33,308 adverse events reported
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