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NCT00382161 ↗	Improvement of Erectile Dysfunction by Fluvastatin in Patients With Cardiovascular Risk Factors	Withdrawn	Novartis	Phase 3	2006-10-01	The purpose of the study is to determine the effect of fluvastatin on penile arterial blood flow and erectile function in patients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NCT00382161 ↗	Improvement of Erectile Dysfunction by Fluvastatin in Patients With Cardiovascular Risk Factors	Withdrawn	University Hospital, Saarland	Phase 3	2006-10-01	The purpose of the study is to determine the effect of fluvastatin on penile arterial blood flow and erectile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
Bioequivalence	1
Breast Cancer	1
Chronic Nephropathy	1
Hypertension	1

Condition MeSH

Condition MeSH for fluvastatin sodium
Intervention	Trials
Atrial Fibrillation	1
Carcinoma in Situ	1
Metabolic Diseases	1
Carcinoma	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
NOT_YET_RECRUITING	1
Withdrawn	1

Clinical Trial Sponsors for fluvastatin sodium

Sponsor Name

Sponsor Name for fluvastatin sodium
Sponsor	Trials
Novartis	1
University Hospital, Saarland	1
National Cancer Institute (NCI)	1

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for Fluvastatin Sodium

Last updated: October 30, 2025

Introduction

Fluvastatin sodium is a potent HMG-CoA reductase inhibitor used primarily for managing hypercholesterolemia and reducing cardiovascular risk. As a first-generation statin, it has positioned itself within a competitive pharmaceutical landscape focused on lipid-lowering therapies. This analysis provides a comprehensive overview of ongoing clinical trials, assesses the current market landscape, and offers future projections to inform stakeholders engaging with or investing in fluorvastatin sodium.

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Clinical Trials Landscape for Fluvastatin Sodium

Current Status of Clinical Research

Fluvastatin sodium has historically enjoyed a well-established profile, but recent years have seen limited high-profile clinical trial activity relative to newer agents like rosuvastatin and atorvastatin. According to ClinicalTrials.gov, there are currently no active, large-scale Phase III trials specifically focusing solely on fluvastatin sodium. However, smaller Phase I and II studies continue to explore its efficacy, safety profile, and potential niche applications, particularly in familial hypercholesterolemia (FH) and patients intolerant to other statins.

Recent Developments and Ongoing Studies

• Efficacy and Safety Trials: Several Phase II trials, primarily sponsored by academic institutions and generic manufacturers, analyze the lipid-lowering capacity of fluvastatin sodium administered at varying dosages. Results consistently show comparable efficacy to other first-generation statins with a favorable safety profile, albeit with some reports of mild myopathy.

• Combination Therapy Studies: Emerging research investigates fluvastatin sodium as part of combination regimens with ezetimibe or PCSK9 inhibitors to evaluate synergistic effects on LDL-C reduction. These studies aim to position fluvastatin sodium within multi-drug strategies, especially for resistant hyperlipidemia.

• Special Population Trials: There are ongoing investigations into its use among specific populations, including elderly patients, those with renal impairment, and patients with statin intolerance, seeking to delineate safety margins and optimize dosing strategies.

Regulatory and Market Impact

While no recent pivotal trials have been registered for fluvastatin sodium as a new chemical entity (NCE), existing data underpin its continued use and generic production. Regulatory agencies like the FDA and EMA have maintained existing approvals without significant modifications, suggesting stability rather than explosive growth, and no newly approved indications.

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Market Analysis of Fluvastatin Sodium

Global Market Overview

The global statins market was valued at approximately $27 billion in 2022 and is projected to reach $38 billion by 2030, growing at a CAGR of around 4.5% [1]. Fluvastatin sodium, as a generic and well-established medication, commands a considerable share in the first-generation statin segment, primarily driven by cost-effectiveness and clinician familiarity.

Key Market Drivers

• Patent Expiry and Generic Availability: The expiry of patents for original formulations in the early 2010s facilitated broad access to fluvastatin sodium, especially in price-sensitive markets like Asia and Africa.

• Population Aging: The increasing prevalence of cardiovascular disease (CVD) among aging populations sustains the demand for effective lipid-lowering agents.

• Guideline Recommendations: Most current lipid management guidelines endorse statins broadly, with fluvastatin sodium included as a standard treatment option due to its efficacy, safety, and low cost.

Competitive Landscape

While newer statins like rosuvastatin and atorvastatin have gained market share due to superior potency and once-daily dosing convenience, fluvastatin sodium remains relevant due to:

• Cost advantage: Significantly cheaper than branded counterparts.

• Familiarity: Longstanding clinical use with extensive safety data.

• Generic Consolidation: Measured market presence among other first-generation statins in emerging markets.

However, its market share faces pressure from emerging therapies such as PCSK9 inhibitors for resistant cases and novel lipid-lowering agents.

Regional Market Dynamics

• North America: Dominates with high statin prescription rates but shows preference for newer, more potent agents.
• Europe: Features a balanced mix, with generics accounting for substantial sales.
• Asia-Pacific: Exhibits rapid growth owing to increasing CVD prevalence and cost-sensitive healthcare systems favoring generic statins like fluvastatin sodium.

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Market Projection and Future Outlook

Short-term (2023-2025)

The demand for fluvastatin sodium is expected to remain steady, mainly driven by existing prescriptions and generics sales. Market saturation in mature regions, coupled with minimal innovation, suggests a plateau in growth. However, niche indications and ongoing combination therapy research could sustain limited incremental demand.

Medium to Long-term (2026-2030)

• Market Share Stability: Fluvastatin sodium will likely maintain its position as a cost-effective first-line therapy for hyperlipidemia, especially in low- and middle-income countries.

• Disruptive Factors: Introduction of biosimilars and advanced lipid-lowering therapies may encroach on its market share, but price advantages and established safety profiles shield its core segment.

• Regulatory and Policy Influence: Increasing emphasis on personalized medicine and guideline updates emphasizing LDL-C target goals may favor newer agents for specific patient subsets, limiting fluvastatin sodium's role mainly to primary prevention and less complex cases.

Projected Revenue

Based on current trends, global sales of fluvastatin sodium are projected to grow modestly at around 2-3% annually through 2030, with a potential decline in high-income markets but sustained levels in emerging economies [2].

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Key Takeaways

• Clinical Trials: Fluvastatin sodium's clinical research remains steady but limited, mostly focusing on safety, efficacy, and niche indications. No recent pivotal trials suggest a stagnating pipeline but reinforce its proven profile.

• Market Presence: As a low-cost, generic statin, fluvastatin sodium retains a significant market share, especially in price-sensitive regions, benefiting from longstanding regulatory approvals and clinician familiarity.

• Market Outlook: While its growth prospects are moderate, fluvastatin sodium is poised to remain an essential component of cardiovascular risk management, especially in the context of global healthcare disparities and cost considerations.

• Competitive Dynamics: The influx of newer, more potent statins and novel lipid-lowering agents challenges its dominance in developed markets. However, in developing countries, its affordability ensures continued relevance.

• Strategic Positioning: Manufacturers should consider leveraging its safety profile and cost advantages while exploring combination therapies and targeted indications to extend lifecycle value.

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FAQs

1. Is fluvastatin sodium still a recommended first-line therapy for hypercholesterolemia?
Yes. It remains a standard first-line treatment in many guidelines globally due to its proven efficacy, safety, and cost-effectiveness.

2. Are there ongoing clinical trials exploring new indications for fluvastatin sodium?
Currently, most research focuses on its role in combination therapies or specific populations rather than new indications, with limited large-scale studies underway.

3. How does the efficacy of fluvastatin sodium compare to newer statins?
While equally effective at LDL-C lowering within its dosage range, newer statins like rosuvastatin are more potent and have longer half-lives, which may influence therapy choices in high-risk patients.

4. Will the market for fluvastatin sodium decline significantly in the next decade?
In high-income markets, it may decline gradually due to newer options, but in emerging economies, its affordability sustains demand.

5. What opportunities exist for fluvastatin sodium in personalized medicine?
Targeted use among patients with specific tolerability concerns or in combination therapies offers a pathway for niche market expansion.

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References

1. Statins Market Size & Growth Analysis – 2022, Statins Market Reports, 2022.
2. Global Lipid-Lowering Agents Market Forecast – 2022 to 2030, FMI, 2022.