Fluvastatin
Lescol (fluvastatin) is a small molecule pharmaceutical. Fluvastatin was first approved as Lescol on 1993-12-31. 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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Novartis Pharmaceuticals
Commercial
Trade Name
FDA
EMA
Lescol (generic drugs available since 2012-04-11)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fluvastatin sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LESCOL XL | Novartis | N-021192 RX | 2000-10-06 | 1 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| fluvastatin | ANDA | 2023-02-23 |
| lescol | New Drug Application | 2020-09-25 |
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
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
48 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 | — | — | 4 | 3 | 1 | 8 | |
| Dyslipidemias | D050171 | HP_0003119 | — | — | 1 | 4 | — | 5 | |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | 1 | 3 | — | 4 |
| Coronary disease | D003327 | — | — | — | 3 | — | 3 | ||
| Kidney transplantation | D016030 | — | 1 | 1 | 2 | — | 3 | ||
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | — | — | 1 | 1 | 2 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | — | 1 | 1 | 2 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | 1 | 1 | 2 |
| Drug interactions | D004347 | — | — | — | 1 | 1 | 2 | ||
| Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | — | — | — | 2 | — | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 1 | — | 1 | 2 |
| Proteinuria | D011507 | HP_0000093 | R80 | — | — | 1 | — | — | 1 |
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | — | — | 1 | — | — | 1 |
| Hyperlipoproteinemia type ii | D006938 | EFO_0004911 | E78.00 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatitis c | D006526 | B19.2 | — | 1 | — | — | 1 | 2 | |
| Hereditary nephritis | D009394 | EFO_0004128 | Q87.81 | — | 1 | — | — | — | 1 |
| Hepacivirus | D016174 | — | 1 | — | — | — | 1 | ||
| Inflammation | D007249 | — | 1 | — | — | — | 1 | ||
| Aging | D000375 | GO_0007568 | R41.81 | — | 1 | — | — | — | 1 |
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | — | 1 | — | — | — | 1 |
| Prostatic neoplasms | D011471 | C61 | — | 1 | — | — | — | 1 | |
| Antiphospholipid syndrome | D016736 | EFO_0002689 | D68.61 | — | 1 | — | — | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glioma | D005910 | EFO_0000520 | 1 | — | — | — | — | 1 | |
| Healthy volunteers/patients | — | 1 | — | — | — | — | 1 | ||
| Melanoma | D008545 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | FLUVASTATIN |
| INN | fluvastatin |
| Description | (3R,5S)-fluvastatin is a (6E)-7-[3-(4-fluorophenyl)-1-(propan-2-yl)-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoic acid diastereoisomer in which the stereocentres beta- and delta- to the carboxy group have R and S configuration, respectively. The drug fluvastatin is an equimolar mixture of this compound and its enantiomer. It is a (6E)-7-[3-(4-fluorophenyl)-1-(propan-2-yl)-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoic acid and a statin (synthetic). It is a conjugate acid of a (3R,5S)-fluvastatin(1-). It is an enantiomer of a (3S,5R)-fluvastatin. |
| Classification | Small molecule |
| Drug class | enzyme inhibitors: antihyperlipidemics (HMG-CoA inhibitors) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CC(C)n1c(/C=C/C(O)CC(O)CC(=O)O)c(-c2ccc(F)cc2)c2ccccc21 |
Identifiers
| PDB | 1HWI |
| CAS-ID | 93957-54-1 |
| RxCUI | 41127 |
| ChEMBL ID | CHEMBL2220442 |
| ChEBI ID | 38562 |
| PubChem CID | 446155 |
| DrugBank | DB01095 |
| UNII ID | 4L066368AS (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 |
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 7,841 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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38,270 adverse events reported
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