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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
Clinical
Drug
Target
Variants
Financial
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Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
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
Clinical Trials
70 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypercholesterolemiaD006937HP_0003124——176216
DyslipidemiasD050171HP_0003119———37111
HypertensionD006973EFO_0000537I10——15—6
Coronary diseaseD003327—————516
Coronary artery diseaseD003324—I25.1———415
Cardiovascular diseasesD002318HP_0001626———3115
AtherosclerosisD050197EFO_0003914I25.1——1124
Metabolic syndromeD024821EFO_0000195E88.810———4—4
SyndromeD013577———2—2—4
Myocardial ischemiaD017202EFO_1001375I20-I25———314
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hyperlipoproteinemia type iiD006938EFO_0004911E78.00——4——4
HypertriglyceridemiaD015228EFO_0004211———3——3
Chronic renal insufficiencyD051436—N18——1——1
ProteinuriaD011507HP_0000093R80——1——1
Erectile dysfunctionD007172EFO_0004234F52.21——1——1
Homozygous familial hypercholesterolemiaD000090542————1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hepatitis cD006526—B19.212——14
HepatitisD006505HP_0012115K75.912——14
Hepatitis aD006506EFO_0007305B15—2——13
Chronic hepatitis cD019698EFO_0004220B18.211———2
Chronic hepatitisD006521—K73.911———2
Hereditary nephritisD009394EFO_0004128Q87.81—1———1
HepacivirusD016174———1———1
InflammationD007249MP_0001845——1———1
AgingD000375GO_0007568R41.81—1———1
Prostatic neoplasmsD011471—C61—1———1
Show 8 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
GliomaD005910EFO_0000520—1————1
Healthy volunteers/patients———1————1
RecurrenceD012008——1————1
MelanomaD008545——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Acute kidney injuryD058186HP_0001919N17————11
HyperlipidemiasD006949HP_0003077E78.5————11
SchizophreniaD012559EFO_0000692F20————11
Muscular diseasesD009135HP_0003198G72.9————11
Epidemiology
Epidemiological information for investigational and approved indications
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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)
Image (chem structure or protein)Loading
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
$
€
£
â‚£
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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Number of purchases
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,464 adverse events reported
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