CLINICAL TRIALS PROFILE FOR FLUVASTATIN SODIUM

All Clinical Trials for fluvastatin sodium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00199927 ↗	Statins in Proteinuric Nephropathies	Completed	Mario Negri Institute for Pharmacological Research	Phase 3	2003-03-01	End stage renal disease (ESRD) is rapidly growing worldwide. Patients with ESRD have increased morbidity and mortality mostly because of a dramatic excess of cardiovascular disease. Thus, preventing or limiting the progression of chronic nephropathies, in addition to limit the incidence of ESRD, may also postpone death. Drugs that inhibit the renin angiotensin system, such as Angiotensin-Converting-Enzyme inhibitors (ACEi) and Angiotensin II receptor antagonists (ATA), are reno- and cardio-protective in the long-term. There are data that statins,in addition to limit cardiovascular events may have specific reno-protective properties. Thus we designed a study aimed to evaluate whether statins associated to ACEi and ATA may have an additional reno-protective effect. ESPLANADE is a multicenter, prospective, randomized, parallel group study in which, after 2 months treatment with ACEi and ATA, two groups of 90 patients, with or without type 2 diabetes, are randomized to 6 months Fluvastatin (40 or 80 mg/day) treatment YES or NO.Twenty Italian Nephrology Units are involved in the trial. The study is fully coordinated by the Clinical Research Center for Rare Disease Aldo e Cele Daccò, Villa Camozzi, Ranica.
NCT00382161 ↗	Improvement of Erectile Dysfunction by Fluvastatin in Patients With Cardiovascular Risk Factors	Withdrawn	Novartis	Phase 3	2006-10-01	The purpose of the study is to determine the effect of fluvastatin on penile arterial blood flow and erectile function in patients with arteriogenic ED and cardiovascular risk factors.
NCT00382161 ↗	Improvement of Erectile Dysfunction by Fluvastatin in Patients With Cardiovascular Risk Factors	Withdrawn	University Hospital, Saarland	Phase 3	2006-10-01	The purpose of the study is to determine the effect of fluvastatin on penile arterial blood flow and erectile function in patients with arteriogenic ED and cardiovascular risk factors.
NCT00416403 ↗	Effect of Fluvastatin on Biomarkers in Women Who Are Undergoing Surgery for Ductal Carcinoma In Situ or Stage I Breast Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2006-07-01	RATIONALE: Collecting samples of blood and tissue from patients with cancer to study in the laboratory may help doctors learn how fluvastatin effects biomarkers related to breast cancer. PURPOSE: This randomized phase II trial is studying how fluvastatin effects biomarkers in women undergoing surgery for ductal carcinoma in situ or stage I breast cancer.
NCT00416403 ↗	Effect of Fluvastatin on Biomarkers in Women Who Are Undergoing Surgery for Ductal Carcinoma In Situ or Stage I Breast Cancer	Completed	University of California, San Francisco	Phase 2	2006-07-01	RATIONALE: Collecting samples of blood and tissue from patients with cancer to study in the laboratory may help doctors learn how fluvastatin effects biomarkers related to breast cancer. PURPOSE: This randomized phase II trial is studying how fluvastatin effects biomarkers in women undergoing surgery for ductal carcinoma in situ or stage I breast cancer.
NCT01551173 ↗	Efficacy and Safety of Fluvastatin Sodium Extended Release Tablets 80 mg Once Daily in Chinese Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia	Completed	Novartis Pharmaceuticals	Phase 4	2012-01-01	This study is to demonstrate therapeutic comparability of Fluvastatin sodium Extended Release Tablets 80 mg QD and Fluvastatin sodium Immediate Release Capsules 40 mg BID in LDL-C lowering from baseline to week 12 (endpoint) in patients with primary hypercholesterolemia or mixed dyslipidemia at moderate or high CV risk who did not achieve their lipid goals when treated with Fluvastatin sodium Immediate Release Capsules 40 mg QD.

Clinical Trial Conditions for fluvastatin sodium

Condition Name

Condition Name for fluvastatin sodium
Intervention	Trials
Hypertension	1
Impotence	1
Lipid Metabolism Disorders	1
Proteinuria	1

Condition MeSH

Condition MeSH for fluvastatin sodium
Intervention	Trials
Erectile Dysfunction	1
Dyslipidemias	1
Proteinuria	1
Carcinoma, Intraductal, Noninfiltrating	1

Clinical Trial Locations for fluvastatin sodium

Trials by Country

Trials by Country for fluvastatin sodium
Location	Trials
Italy	7
United States	4
Germany	1
Brazil	1
China	1

Trials by US State

Trials by US State for fluvastatin sodium
Location	Trials
New York	1
Massachusetts	1
Illinois	1
California	1

Clinical Trial Progress for fluvastatin sodium

Clinical Trial Phase

Clinical Trial Phase for fluvastatin sodium
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	2
Phase 3	2

Clinical Trial Status

Clinical Trial Status for fluvastatin sodium
Clinical Trial Phase	Trials
Completed	4
Withdrawn	1
NOT_YET_RECRUITING	1

Clinical Trial Sponsors for fluvastatin sodium

Sponsor Name

Sponsor Name for fluvastatin sodium
Sponsor	Trials
Federal University of São Paulo	1
Shenzhen Salubris Pharmaceuticals Co., Ltd.	1
Mario Negri Institute for Pharmacological Research	1

Sponsor Type

Sponsor Type for fluvastatin sodium
Sponsor	Trials
Other	5
Industry	3
NIH	1

Last updated: May 4, 2026

Fluvastatin Sodium (Brand: Lescol) — Clinical Trials Update and Market Projection

What is fluvastatin sodium, and how is it positioned commercially?

Fluvastatin sodium is an HMG-CoA reductase inhibitor (statin) used for lipid management, with clinical use anchored in primary and secondary prevention of atherosclerotic cardiovascular disease. Market positioning is shaped by (1) class-level substitution by newer statins and combination therapies, (2) long-standing guideline inclusion, and (3) patent aging dynamics that keep generic supply dominant in most markets.

Product archetype

• Small-molecule statin, oral
• Market reality: off-patent origin and generic penetration in major jurisdictions (US/EU/other high-income markets)
• Competitive set: other statins (atorvastatin, rosuvastatin, simvastatin, pravastatin) and combination regimens (statin + ezetimibe)

What clinical trials are active or relevant for fluvastatin sodium?

No complete, current, and authoritative “active trials list” can be produced from the information available in this chat. A reliable trials update requires live registry pulls (e.g., ClinicalTrials.gov, EU CTR, WHO ICTRP) with trial statuses, end dates, and results. Without that, any “update” would be incomplete.

Clinical evidence base (context only)

Fluvastatin sodium’s clinical development history is mature and primarily anchored in completed outcomes work from earlier eras. For investment-grade decisioning, the current question is not “does it work,” but “what new label expansions, novel formulations, or new indications are under execution.” That cannot be validated here.

What is the current market structure for fluvastatin sodium?

Supply and pricing structure

• Fluvastatin sodium is widely available as generic in many markets.
• Generic competition compresses net pricing and limits upside unless a differentiated dosage form, combination, or indication expansion exists.

Demand drivers

• Guideline use for LDL lowering and CV risk management
• Patient-level persistence is constrained by tolerability and LDL targets (driving switching to higher potency statins in many settings)
• Ongoing payer pressure pushes use toward lower-cost generics

Market analysis and projection (high-level, class-driven)

A precise fluvastatin sodium forecast requires:

• jurisdiction-by-jurisdiction sales
• unit volume and average selling price trends
• channel mix (retail vs institutional)
• competitor switching rates and payer formulary movement
• date-stamped evidence of any new approvals or exclusivity events affecting fluvastatin-specific share

That data is not present in the input. Under the operating constraints, producing a complete and accurate projection is not possible.

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Key Takeaways

• Fluvastatin sodium is a mature, off-patent statin with market dynamics dominated by generics and class-level competition.
• A current, accurate clinical trials update cannot be generated without live registry status data.
• A complete market projection for fluvastatin sodium cannot be produced without market sizing inputs by geography, pricing, and formulary dynamics.

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FAQs

1. Is fluvastatin sodium still under patent protection in major markets?
   In practice, fluvastatin origin IP is largely aged; generics dominate, but patent status is jurisdiction-specific and requires a live dossier check.

2. Are there new indications in fluvastatin sodium’s clinical pipeline?
   A verified pipeline requires current registry interrogation; no validated updates are available in this chat.

3. How does fluvastatin compete against newer statins?
   Competition is primarily potency and dosing convenience driven; higher potency statins often capture incremental LDL target patients.

4. What would be the biggest upside lever for fluvastatin sodium?
   A differentiated formulation, combination product exclusivity, or a new label with payer-supported positioning.

5. How are market forecasts typically built for off-patent statins?
   By combining generic price trend, formulary share, switch rates to competitors, and LDL target adherence, with geography-specific adjustments.

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References

No sources were provided in the prompt, and no external registry or market datasets were supplied for citation.