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Fluvastatin

Phase 4FDA approved

Dyslipidemia | Small molecule | Cardiovascular |Novartis AG|Trials Updated: Feb 23, 2017

Fluvastatin development status

FDA approval on record Mar 8, 1999 as Lescol
Approval holderNovartis
ApplicationNDA020261
Highest phase Phase 4 (NCT00171275)
Phase scored for NVSPhase 3
Registered trials 15 across 5 sponsors since Jul 2005

Fluvastatin target and mechanism

Molecular targetHMGCR
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials3
Total Enrollment492

FDA Designations

No designations recorded

Fluvastatin clinical trials

Fluvastatin · 3 trials · 4 indications

Phase 3 3
NCT00136799Efficacy and Safety of Fluvastatin in Different Doses in Adults With Mixed Dyslipidemia or Primary HypercholesterolemiaMixed Dyslipidemia
COMPLETED325 Analytics
NCT00171288Efficacy and Safety Study of Fluvastatin and Ezetimibe Combined Versus Fluvastatin AloneDyslipidemia
COMPLETED83 Analytics
NCT00171236Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial HypercholesterolemiaHeterozygous Familial Hypercholesterolemia
COMPLETED84 Analytics
PHASE3COMPLETED
Efficacy and Safety of Fluvastatin in Different Doses in Adults With Mixed Dyslipidemia or Primary Hypercholesterolemia
Mixed DyslipidemiaUnlock trial analytics
PHASE3COMPLETED
Efficacy and Safety Study of Fluvastatin and Ezetimibe Combined Versus Fluvastatin Alone
DyslipidemiaUnlock trial analytics
PHASE3COMPLETED
Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia
Heterozygous Familial HypercholesterolemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Percent change from baseline in low density lipoprotein cholesterol after 12 weeks
Change from baseline in low density lipoprotein cholesterol after 12 weeks

Secondary Endpoints

Percent change from baseline in total cholesterol after 12 weeks
Percent change from baseline in high density lipoprotein cholesterol after 12 weeks
Percent change from baseline in total triglycerides after 12 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
FluvastatinDRUG -
fluvastatin, ezetimibeDRUG -
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Mixed dyslipidemia * Primary hypercholesterolemia Exclusion Criteria: * Pregnant or lactating women * Age \> 18 years Other protocol-defined inclusion and exclusion criteria may apply.

Countries:ChinaSpainSwitzerland
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Frequently asked questions about Fluvastatin

What is fluvastatin?

Fluvastatin is a small molecule HMGCR inhibitor developed by Novartis AG (ticker NVS). It is being studied in Phase 3 clinical development for dyslipidemia, heterozygous familial hypercholesterolemia, and mixed dyslipidemia. It is an investigational therapy in the cardiovascular therapeutic area.

What is fluvastatin used for?

Fluvastatin is being evaluated for the treatment of dyslipidemia, heterozygous familial hypercholesterolemia, and mixed dyslipidemia. These are lipid disorders characterized by abnormal cholesterol levels. The clinical program includes adult and pediatric populations, with trials conducted in Spain, Switzerland, and China.

What does fluvastatin target?

Fluvastatin targets HMGCR, also known as HMG-CoA reductase. It acts as an inhibitor of this enzyme, which is the rate-limiting step in cholesterol biosynthesis. By inhibiting HMGCR, fluvastatin reduces cholesterol production in the body.

Who makes fluvastatin?

Fluvastatin is developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the clinical development program for fluvastatin in dyslipidemia and related lipid disorders.

What phase is fluvastatin in?

Fluvastatin is in Phase 3 clinical development. All three registered trials are Phase 3 studies, and all have completed. The program has enrolled a total of 325 participants across the trials, which were conducted in Spain, Switzerland, and China.

What clinical trials is fluvastatin in?

Fluvastatin has been studied in three completed Phase 3 trials: NCT00171288, which compared fluvastatin plus ezetimibe versus fluvastatin alone in dyslipidemia; NCT00171236, in children with heterozygous familial hypercholesterolemia; and NCT00136799, which evaluated different fluvastatin doses in adults with mixed dyslipidemia or primary hypercholesterolemia.

Is fluvastatin the same as ezetimibe?

No, fluvastatin and ezetimibe are different compounds. Fluvastatin is an HMGCR inhibitor, while ezetimibe is a separate cholesterol-lowering agent. One Phase 3 trial, NCT00171288, evaluated fluvastatin and ezetimibe in combination compared with fluvastatin alone in patients with dyslipidemia.