CLINICAL TRIALS PROFILE FOR FENOFIBRATE (MICRONIZED)

All Clinical Trials for FENOFIBRATE (MICRONIZED)

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00359281 ↗	Pharmacokinetic Drug Interactions of AEGR-733 on Lipid-lowering Agents	Completed	Aegerion Pharmaceuticals, Inc.	Phase 2	2006-03-01	This phase II, open-label research study was conducted in 129 healthy volunteers. Each subject will be given one initial oral dose of one of 7 FDA-approved medications (probe drugs), followed by a 7 day period where subjects receive the study medication AEGR-733 at 10 or 60 mg. On study day 8 subjects will receive the second oral dose of the same probe drug that was given on day 1 and a last dose of AEGR-733 (total of 7 doses).Subjects will return in 1 week for a final safety visit. Each FDA- approved probe drug will be given to ten (10) or fifteen (15) subjects. Safety, pharmacokinetic and pharmacodynamic assessments will be performed.
NCT00309712 ↗	Diabetes and Combined Lipid Therapy Regimen (DIACOR) Study	Completed	Abbott	N/A	2002-08-01	The primary study hypothesis of this study is to determine whether there is a greater percentage of patients achieving a triglyceride level of <200 mg/dL with the combination of simvastatin 20 mg and fenofibrate 160mg than with either simvastatin 20 mg monotherapy or fenofibrate 160mg monotherapy.
NCT00309712 ↗	Diabetes and Combined Lipid Therapy Regimen (DIACOR) Study	Completed	Merck Sharp & Dohme Corp.	N/A	2002-08-01	The primary study hypothesis of this study is to determine whether there is a greater percentage of patients achieving a triglyceride level of <200 mg/dL with the combination of simvastatin 20 mg and fenofibrate 160mg than with either simvastatin 20 mg monotherapy or fenofibrate 160mg monotherapy.
NCT00309712 ↗	Diabetes and Combined Lipid Therapy Regimen (DIACOR) Study	Completed	Intermountain Health Care, Inc.	N/A	2002-08-01	The primary study hypothesis of this study is to determine whether there is a greater percentage of patients achieving a triglyceride level of <200 mg/dL with the combination of simvastatin 20 mg and fenofibrate 160mg than with either simvastatin 20 mg monotherapy or fenofibrate 160mg monotherapy.
NCT00422396 ↗	Effects of Micronized Fenofibrate on Fasting and Postprandial Lipoproteins, Inflammatory Mediators and Thrombosis	Completed	Abbott	N/A	2001-01-01	This is a randomized placebo controlled clinical trial designed to investigate the effects of micronized fenofibrate on fasting and postprandial lipoproteins, oxidized fatty acids and lipoproteins, inflammatory mediators and thrombotic factors among hypertriglyceridemic individuals with two or more other characteristics of the metabolic syndrome.
NCT00422396 ↗	Effects of Micronized Fenofibrate on Fasting and Postprandial Lipoproteins, Inflammatory Mediators and Thrombosis	Completed	University of Michigan	N/A	2001-01-01	This is a randomized placebo controlled clinical trial designed to investigate the effects of micronized fenofibrate on fasting and postprandial lipoproteins, oxidized fatty acids and lipoproteins, inflammatory mediators and thrombotic factors among hypertriglyceridemic individuals with two or more other characteristics of the metabolic syndrome.

Clinical Trial Conditions for FENOFIBRATE (MICRONIZED)

Condition Name

Condition Name for FENOFIBRATE (MICRONIZED)
Intervention	Trials
Healthy Male Volunteers	2
Dyslipidemia	1
Healthy	1
Hypertriglyceridemia With the Metabolic Syndrome	1

Condition MeSH

Condition MeSH for FENOFIBRATE (MICRONIZED)
Intervention	Trials
Dyslipidemias	2
Diabetes Mellitus	1
Thrombosis	1
Metabolic Syndrome X	1

Clinical Trial Locations for FENOFIBRATE (MICRONIZED)

Trials by Country

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−

Trials by Country for FENOFIBRATE (MICRONIZED)
Location	Trials
United States	3
Korea, Republic of	2
Greece	1

Trials by US State

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−

Trials by US State for FENOFIBRATE (MICRONIZED)
Location	Trials
Illinois	1
Pennsylvania	1
Utah	1

Clinical Trial Progress for FENOFIBRATE (MICRONIZED)

Clinical Trial Phase

Clinical Trial Phase for FENOFIBRATE (MICRONIZED)
Clinical Trial Phase	Trials
Phase 4	2
Phase 2	1
Phase 1	2

Clinical Trial Status

Clinical Trial Status for FENOFIBRATE (MICRONIZED)
Clinical Trial Phase	Trials
Completed	5
Unknown status	2

Clinical Trial Sponsors for FENOFIBRATE (MICRONIZED)

Sponsor Name

Sponsor Name for FENOFIBRATE (MICRONIZED)
Sponsor	Trials
Abbott	2
Hanlim Pharm. Co., Ltd.	2
Merck Sharp & Dohme Corp.	1

Sponsor Type

Sponsor Type for FENOFIBRATE (MICRONIZED)
Sponsor	Trials
Industry	6
Other	4

Fenofibrate (Micronized): Clinical Trials, Market Analysis, and Projections

Introduction

Fenofibrate, a fibric acid derivative, is widely used in the management of hyperlipidemias. The micronized formulation of fenofibrate has gained significant attention due to its improved bioavailability and efficacy. Here, we delve into the clinical trials, market analysis, and projections for micronized fenofibrate.

Clinical Efficacy of Micronized Fenofibrate

Lipid-Modifying Profile

Micronized fenofibrate is characterized by its ability to decrease low-density lipoprotein (LDL) and total cholesterol levels, significantly reduce elevated plasma triglyceride levels, and increase high-density lipoprotein (HDL) cholesterol levels[3][4][5].

Comparative Studies

Clinical trials have shown that micronized fenofibrate is as effective as, or in some cases more effective than, other lipid-lowering agents such as simvastatin and pravastatin. For instance, micronized fenofibrate 200mg once daily produced greater improvements in triglyceride and HDL cholesterol levels compared to these statins[3][4].

Specific Patient Groups

Micronized fenofibrate has demonstrated particular efficacy in patients with hypertriglyceridaemia, including those with type 2 diabetes mellitus and dyslipidaemia. It has also shown benefits in patients with metabolic syndrome, HIV infection with protease inhibitor-induced hypertriglyceridaemia, and dyslipidaemia secondary to heart transplantation[4].

Long-Term Effects

Studies like the Diabetes Atherosclerosis Intervention Study (DAIS) have indicated that micronized fenofibrate reduces the progression of coronary atherosclerosis in patients with type 2 diabetes mellitus. However, long-term data on cardiovascular morbidity and mortality are still being evaluated in ongoing studies such as the FIELD study[4].

Safety and Tolerability

Adverse Events

Micronized fenofibrate is generally well tolerated, with gastrointestinal disorders being the most frequent adverse events. Rare elevations in serum transaminase and creatine phosphokinase levels have also been reported[3][4].

Drug Interactions

Concurrent use of micronized fenofibrate with hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors may increase the risk of myopathy and/or rhabdomyolysis, although recent data suggest that low-dose combinations with simvastatin or pravastatin are safe. It may also enhance the effect of oral anticoagulants[5].

Market Analysis

Global Fibrate Drugs Market

The global fibrate drugs market, which includes fenofibrates, is expected to grow at a Compound Annual Growth Rate (CAGR) of 5% from 2023 to 2029, reaching a market size of approximately $4 billion by 2029. The fenofibrates segment dominated the market in 2022 and is expected to maintain a significant market share[2].

Distribution Channels

The market is segmented by distribution channels, including hospitals, retail pharmacies, and online pharmacies. Hospital pharmacies currently command the largest share of the market, while online pharmacies are growing due to their convenience and accessibility[2].

Regional Presence

Large-scale production of fenofibrate in North America and Europe drives the market in these regions. Companies like Abbott dominate the market with significant revenues from branded fenofibrate products[2].

Market Projections

Growth Drivers

The increasing prevalence of dyslipidaemia and the need for effective lipid-lowering therapies are key drivers of the market. The convenience of once-daily dosing and the improved bioavailability of micronized fenofibrate also contribute to its market growth[2][3].

Competitive Landscape

The market is competitive, with several key players including Abbott. The report provides a detailed competitive analysis of these players based on product, price, financial position, product portfolio, growth strategies, and regional presence[2].

Key Takeaways

• Improved Bioavailability: Micronized fenofibrate has a 30% higher bioavailability compared to non-micronized formulations.
• Clinical Efficacy: It is effective in reducing LDL and total cholesterol, lowering triglycerides, and increasing HDL cholesterol.
• Specific Patient Benefits: Particular efficacy in patients with hypertriglyceridaemia, type 2 diabetes, and other specific conditions.
• Market Growth: The global fibrate drugs market, led by fenofibrates, is expected to grow at a CAGR of 5% until 2029.
• Safety and Tolerability: Generally well tolerated, with gastrointestinal disorders being the most common adverse events.

FAQs

What is the primary difference between micronized and non-micronized fenofibrate?

The primary difference is the particle size, with micronized fenofibrate having particles less than 10 microns, leading to increased bioavailability and improved absorption characteristics[1].

How does micronized fenofibrate compare to other lipid-lowering agents?

Micronized fenofibrate is as effective as, or in some cases more effective than, statins like simvastatin and pravastatin, particularly in reducing triglycerides and increasing HDL cholesterol[3][4].

What are the common adverse events associated with micronized fenofibrate?

The most frequent adverse events are gastrointestinal disorders, with rare elevations in serum transaminase and creatine phosphokinase levels also reported[3][4].

Can micronized fenofibrate be used in combination with other lipid-lowering drugs?

Yes, it can be used in combination with HMG-CoA reductase inhibitors, but this may increase the risk of myopathy and/or rhabdomyolysis. However, low-dose combinations are generally considered safe[5].

What is the expected market size of the global fibrate drugs market by 2029?

The global fibrate drugs market is expected to reach approximately $4 billion by 2029, growing at a CAGR of 5% from 2023 to 2029[2].

Sources

1. Micronized Versus Non-Micronized Fenofibrate - What's the Difference. MedEd101.
2. Fibrate Drugs Market: Global Industry Analysis and Forecast (2023-2029). Maximize Market Research.
3. Micronised fenofibrate: a review of its pharmacodynamic and pharmacokinetic properties, and therapeutic use in dyslipidaemia. PubMed.
4. Micronised fenofibrate: an updated review of its clinical efficacy in the management of dyslipidaemia. PubMed.
5. Micronized fenofibrate: a new fibric acid hypolipidemic agent. PubMed.