Fluvastatin
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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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| cardiovascular diseases | D002318 |
| nutritional and metabolic diseases | D009750 |
Trade Name
FDA
EMA
Fluvastatin, Lescol (discontinued: Fluvastatin, Lescol)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| fluvastatin | ANDA | 2024-07-25 |
| fluvastatin sodium | ANDA | 2024-09-16 |
| lescol | New Drug Application | 2023-12-13 |
| lescol lescol xl | 2007-01-09 | |
| lescol xl | New Drug Application | 2011-03-23 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hypercholesterolemia | — | D006937 | — |
| coronary artery disease | — | D003324 | I25.1 |
| hypertriglyceridemia | EFO_0004211 | D015228 | — |
| hyperlipoproteinemias | — | D006951 | — |
Agency Specific
FDA
EMA
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Patent Expiration
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HCPCS
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Clinical
Clinical Trials
74 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dyslipidemias | D050171 | — | — | — | — | 3 | 5 | — | 8 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | — | — | 4 | — | 4 |
| Hypercholesterolemia | D006937 | — | — | — | — | 2 | 2 | — | 4 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | 2 | — | 2 |
| Coronary disease | D003327 | — | — | — | — | — | 2 | — | 2 |
| Coronary artery disease | D003324 | — | I25.1 | — | — | — | 2 | — | 2 |
| Syndrome | D013577 | — | — | — | — | — | 2 | — | 2 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | — | 1 | — | 1 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | — | 1 | — | 1 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | — | — | 1 | — | — | 1 |
| Hyperlipoproteinemia type ii | D006938 | EFO_0004911 | E78.00 | — | — | 1 | — | — | 1 |
Indications Phases 2
No data
Indications Phases 1
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dyslipidemias | D050171 | — | — | — | — | — | — | 1 | 1 |
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 | — |
| CAS-ID | 93957-54-1 |
| RxCUI | — |
| 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
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Variants
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Financial
Revenue by drug
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Estimated US medical usage
Fluvastatin
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,249 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,586 adverse events reported
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