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Last Updated: April 27, 2025

CLINICAL TRIALS PROFILE FOR FENOFIBRATE


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All Clinical Trials for fenofibrate

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00000620 ↗ Action to Control Cardiovascular Risk in Diabetes (ACCORD) Completed Centers for Disease Control and Prevention Phase 3 1999-09-01 The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00000620 ↗ Action to Control Cardiovascular Risk in Diabetes (ACCORD) Completed National Eye Institute (NEI) Phase 3 1999-09-01 The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00000620 ↗ Action to Control Cardiovascular Risk in Diabetes (ACCORD) Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 3 1999-09-01 The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00000620 ↗ Action to Control Cardiovascular Risk in Diabetes (ACCORD) Completed National Institute on Aging (NIA) Phase 3 1999-09-01 The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00000620 ↗ Action to Control Cardiovascular Risk in Diabetes (ACCORD) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1999-09-01 The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 5 of 5 entries

Clinical Trial Conditions for fenofibrate

Condition Name

241915900510152025DyslipidemiaHypertriglyceridemiaHyperlipidemiaHypercholesterolemia[disabled in preview]
Condition Name for fenofibrate
Intervention Trials
Dyslipidemia 24
Hypertriglyceridemia 19
Hyperlipidemia 15
Hypercholesterolemia 9
[disabled in preview] 0
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Condition MeSH

442825230051015202530354045DyslipidemiasHyperlipidemiasHypertriglyceridemiaHyperlipoproteinemias[disabled in preview]
Condition MeSH for fenofibrate
Intervention Trials
Dyslipidemias 44
Hyperlipidemias 28
Hypertriglyceridemia 25
Hyperlipoproteinemias 23
[disabled in preview] 0
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Clinical Trial Locations for fenofibrate

Trials by Country

+
Trials by Country for fenofibrate
Location Trials
United States 435
Canada 26
Germany 23
France 15
Korea, Republic of 14
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Trials by US State

+
Trials by US State for fenofibrate
Location Trials
Florida 25
Texas 23
California 23
Illinois 20
Tennessee 20
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Clinical Trial Progress for fenofibrate

Clinical Trial Phase

28.2%32.8%8.4%30.5%01015202530354045Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for fenofibrate
Clinical Trial Phase Trials
Phase 4 37
Phase 3 43
Phase 2/Phase 3 11
[disabled in preview] 40
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Clinical Trial Status

67.8%9.9%9.4%12.9%0102030405060708090100110120CompletedTerminatedRecruiting[disabled in preview]
Clinical Trial Status for fenofibrate
Clinical Trial Phase Trials
Completed 116
Terminated 17
Recruiting 16
[disabled in preview] 22
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Clinical Trial Sponsors for fenofibrate

Sponsor Name

trials024681012141618Solvay PharmaceuticalsAbbottMerck Sharp & Dohme Corp.[disabled in preview]
Sponsor Name for fenofibrate
Sponsor Trials
Solvay Pharmaceuticals 17
Abbott 10
Merck Sharp & Dohme Corp. 8
[disabled in preview] 13
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Sponsor Type

50.3%37.8%9.4%0020406080100120140OtherIndustryNIH[disabled in preview]
Sponsor Type for fenofibrate
Sponsor Trials
Other 145
Industry 109
NIH 27
[disabled in preview] 7
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Fenofibrate: Clinical Trials, Market Analysis, and Projections

Introduction to Fenofibrate

Fenofibrate is a fibric acid derivative used to reduce cholesterol and triglyceride levels in the blood, thereby decreasing the risk of heart disease. It is particularly effective in increasing high-density lipoprotein (HDL) cholesterol, often referred to as "good" cholesterol. Here, we will delve into the current clinical trials, market analysis, and projections for fenofibrate.

Clinical Trials Update

FAME 1 Eye Research Study

One significant clinical trial involving fenofibrate is the FAME 1 Eye Research Study, which aims to determine the safety and efficacy of fenofibrate in reducing retinopathy in people with type 1 diabetes. This Phase 3 trial builds on previous studies that have shown fenofibrate to slow the development of diabetic retinopathy and reduce the need for laser surgery in patients with type 2 diabetes[1].

Fenofibrate for Prevention of Diabetic Retinopathy Worsening

Another ongoing clinical trial, sponsored by the Jaeb Center for Health Research, is evaluating the effect of fenofibrate compared to a placebo in preventing the worsening of diabetic retinopathy (DR) over a six-year period. This randomized trial focuses on patients with mild to moderately severe non-proliferative DR and no center-involved diabetic macular edema (CI-DME) at baseline. The study also assesses the feasibility of a model where ophthalmologists collaborate with primary care providers to prescribe and monitor fenofibrate safely[4].

Market Analysis

Global Market Size and Growth

The global fibrate drugs market, which includes fenofibrate, is projected to grow significantly over the forecast period. According to Polaris Market Research, the market is expected to reach USD 5.04 billion by 2032, growing at a CAGR of 5.3%[2].

Segment Dominance

Fenofibrate is expected to hold a majority market share in the fibrate drugs market due to its high efficacy in treating cardiovascular diseases. Clinical trials have demonstrated that fenofibrate reduces plasma levels of lipoproteins by 7% to 23%, lowers fibrinogen, and decreases serum uric acid levels, making it a preferred choice for managing cholesterol and triglyceride levels[3][5].

Regional Market

North America is anticipated to hold a significant market share in the global fibrate drugs market. The high prevalence of cardiovascular diseases, an aging population, and the presence of key market players in this region are driving factors. For instance, the CDC reports that approximately 6.5 million people aged 40 and older in the United States have peripheral arterial disease, contributing to the demand for fibrate drugs[5].

Impact of Lifestyle Factors

Lifestyle changes, such as lack of physical exercise and increased consumption of tobacco and alcohol, are increasing the risk of cholesterol abnormalities and cardiovascular diseases. According to the World Health Organization, tobacco use kills more than 8 million people annually, further driving the demand for fibrate drugs[2].

COVID-19 Impact

The COVID-19 pandemic has also influenced the fibrate drugs market. Physical inactivity due to pandemic restrictions has increased the risk of cardiovascular diseases, thereby boosting the demand for fibrate drugs. However, the market has shown resilience and is expected to continue growing due to the rising focus on treating cardiovascular diseases[5].

Market Projections

Growth Drivers

The market for fenofibrate is driven by several factors, including the increasing prevalence of cardiovascular diseases, the launch of effective generic versions of fenofibrate, and the high efficacy of the drug in reducing cardiovascular disease events. For example, the launch of generic fenofibrate capsules by Lupin in the United States has contributed to market growth[5].

Challenges

Despite the positive outlook, the market faces challenges such as frequent product recalls and a stringent regulatory framework. These factors could potentially hinder market growth over the forecast period[5].

Key Statistics

  • Market Size: The global fibrate drugs market is expected to reach USD 5.04 billion by 2032[2].
  • CAGR: The market is projected to grow at a CAGR of 5.3% during the forecast period[2].
  • Prevalence of Cardiovascular Diseases: The worldwide prevalence of peripheral arterial disease (PAD) is estimated to be 3-12%, affecting nearly 27 million people in America and Europe[5].
  • Effectiveness: Fenofibrate reduces plasma levels of lipoproteins by 7% to 23% and lowers fibrinogen and serum uric acid levels[3][5].

Quotes from Industry Experts

"Fenofibrate significantly reduced cardiovascular disease events in those with low HDL cholesterol or hypertension, helping in a 27% reduction of cardiovascular disease risk," according to a study published in the United States Cardiody Review in May 2021[5].

Illustrative Statistics

  • Cardiovascular Disease Prevalence: Approximately every 40 seconds, a person in the United States is anticipated to have a myocardial infarction[5].
  • Product Launches: The launch of generic fenofibrate capsules by Lupin in the United States has contributed to market growth[5].

Key Takeaways

  • Clinical Trials: Fenofibrate is being tested for its efficacy in reducing retinopathy in type 1 diabetes and preventing the worsening of diabetic retinopathy.
  • Market Growth: The global fibrate drugs market, led by fenofibrate, is projected to grow at a CAGR of 5.3% and reach USD 5.04 billion by 2032.
  • Regional Dominance: North America is expected to hold a significant market share due to the high prevalence of cardiovascular diseases.
  • Efficacy: Fenofibrate has been shown to reduce plasma levels of lipoproteins, lower fibrinogen, and decrease serum uric acid levels.

FAQs

What is the primary use of fenofibrate?

Fenofibrate is primarily used to reduce cholesterol and triglyceride levels in the blood, thereby decreasing the risk of heart disease.

Which segment dominates the fibrate drugs market?

The fenofibrate segment dominates the fibrate drugs market due to its high efficacy in treating cardiovascular diseases.

What is the expected market size of the global fibrate drugs market by 2032?

The global fibrate drugs market is expected to reach USD 5.04 billion by 2032.

How does the COVID-19 pandemic impact the fibrate drugs market?

The COVID-19 pandemic has increased the risk of cardiovascular diseases due to physical inactivity, thereby boosting the demand for fibrate drugs.

What are the key drivers of the fenofibrate market?

The key drivers include the increasing prevalence of cardiovascular diseases, the launch of effective generic versions of fenofibrate, and the high efficacy of the drug in reducing cardiovascular disease events.

Sources

  1. Mater Research: FAME 1 Eye research study - A new treatment for retinopathy in type 1 diabetes.
  2. Polaris Market Research: Fibrate Drugs Market Projection $5.04 Billion By 2032, CAGR: 5.3%.
  3. Maximize Market Research: Global Fibrate Drugs Market: Global Industry Analysis and Forecast (2023-2029).
  4. UCSF Clinical Trials: Fenofibrate for Prevention of DR Worsening.
  5. Mordor Intelligence: Fibrate Drugs Market - Size, Share & Statistics.

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