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Drug ReportsFluvastatin
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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Novartis Pharmaceuticals
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Commercial
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Drug
Target
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Financial
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Safety
Events Timeline
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YTD
1Y
2Y
5Y
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
cardiovascular diseasesD002318
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Fluvastatin, Lescol (discontinued: Fluvastatin, Lescol)
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 XLSandozN-021192 RX2000-10-06
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
fluvastatinANDA2024-07-25
fluvastatin sodiumANDA2024-09-16
lescolNew Drug Application2023-12-13
lescol lescol xl2007-01-09
lescol xlNew Drug Application2011-03-23
Agency Specific
FDA
EMA
No data
Patent Expiration
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
C10AA04: Fluvastatin
HCPCS
No data
Clinical
No data
Drug
General
Drug common nameFluvastatin
INNfluvastatin
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 classenzyme inhibitors: antihyperlipidemics (HMG-CoA inhibitors)
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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-ID93957-54-1
RxCUI
ChEMBL IDCHEMBL2220442
ChEBI ID38562
PubChem CID446155
DrugBankDB01095
UNII ID4L066368AS (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
No data
Financial
Revenue by drug
$
£
No data
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
No data
Safety
Black-box Warning
No Black-box warning
Adverse Events
0 adverse events reported
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