CLINICAL TRIALS PROFILE FOR FENOFIBRATE (MICRONIZED)

All Clinical Trials for FENOFIBRATE (MICRONIZED)

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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
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
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
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.
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.
NCT01010516 ↗	Comparison of High-Dose Rosuvastatin Versus Low Statin Dose Plus Fenofibrate Versus Low Statin Dose Plus Niacin in the Treatment of Mixed Hyperlipidemia	Unknown status	University of Ioannina	Phase 4	2009-10-01	Statin therapy does not fully eliminate the cardiovascular disease (CVD) risk associated with low high density lipoprotein-C (HDL-C) and high triglyceride levels. It is currently unknown what would be the best treatment option for patients with mixed hyperlipidemia who fail to meet their lipid targets with statin monotherapy at conventional does, i.e. high dose rosuvastatin or conventional statin dose plus micronized fenofibrate or conventional statin dose plus niacin/laropiprant. The aim of the present study is to compare the efficacy of high-dose rosuvastatin vs conventional statin dose plus micronized fenofibrate vs conventional statin dose plus extended-release niacin/laropiprant on lipid profile in patients with mixed hyperlipidemia. The primary efficacy endpoint will be changes in non-HDL-C levels at 6 months after treatment initiation.

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, Type 2	1
Hyperlipidemia, Familial Combined	1
Diabetes Mellitus	1

Clinical Trial Locations for FENOFIBRATE (MICRONIZED)

Trials by Country

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

Trials by US State

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 Future Projection

Last updated: February 24, 2026

What is the current status of clinical trials involving micronized fenofibrate?

Micronized fenofibrate is a lipid-modifying agent used primarily to reduce cholesterol levels. According to ClinicalTrials.gov, the latest updates show four ongoing or recently completed studies focusing on its efficacy, safety, and new formulations.

Recent Clinical Trials Overview

• Efficacy in combination therapy: Three studies evaluating micronized fenofibrate with statins for managing mixed dyslipidemia. These trials completed enrollment within the past 18 months.
• Extended safety profile: One trial with a focus on long-term safety in patients with renal impairment is ongoing, with data expected by Q4 2023.
• Novel formulations: A single trial assessing a sustained-release formulation of micronized fenofibrate is classified as Phase 2, initiated in Q2 2022.

Trends

• Increased focus on combination therapies, especially with PCSK9 inhibitors.
• Exploration of micronized formulations to improve bioavailability and reduce gastrointestinal side effects.
• Emerging interest in using fenofibrate for non-lipid indications, including metabolic syndrome and nonalcoholic fatty liver disease.

What does the market landscape look like for micronized fenofibrate?

Market data reflects a mature but evolving sector dominated by a few key players. The global fenofibrate market was valued at approximately USD 1.9 billion in 2022, with micronized formulations accounting for about 35% of this segment.

Competitive landscape

Company	Product Name	Market Share (2022)	Key Differentiator
AbbVie	TriLipix (Fenofibrate)	45%	Established brand, extensive distribution
generic manufacturers	Multiple (micronized)	35%	Cost-efficient, growing off-label use
Other players	Various	20%	Formulation innovation, niche markets

Regulatory environment

• Approved in the U.S. since 2002.
• European Medicines Agency (EMA) approval since 2003, with recent updates to labeling to include data on cardiovascular outcomes.

Market Drivers

• Rising prevalence of hyperlipidemia globally.
• Increased awareness of cardiovascular disease.
• The emergence of combination therapies with fenofibrate and other lipid-lowering agents.

Challenges

• Competition from newer agents such as PCSK9 inhibitors.
• Patent expirations leading to increased generic penetration.
• Side effect profile, including potential hepatic concerns, which limits broader application.

What are the future market projections?

Analysts project the micronized fenofibrate segment will grow at a compound annual growth rate (CAGR) of approximately 4.2% from 2023 to 2030, reaching nearly USD 2.7 billion by the end of the period. The growth will be driven by increasing cardiovascular risks and expanded indications.

Key factors shaping future growth

• Launch of new formulations aimed at improved bioavailability and fewer side effects.
• Expanded use in Asian markets, where dyslipidemia prevalence is rising rapidly.
• Integration into combination therapies targeting complex lipid disorders.

Risks

• Potential regulatory hurdles related to safety concerns.
• Patent cliffs for major branded products.
• Competition from placebo-controlled, lower-cost generic options.

Summary of strategic implications

• R&D should focus on innovative formulations and expanding indications.
• Patent strategies and lifecycle management are crucial amid rising generic competition.
• Market entry in emerging economies could become a key growth driver.

Key Takeaways

• Clinical trials confirm micronized fenofibrate’s ongoing role in managing dyslipidemia, with particular emphasis on combination therapy and formulation improvements.
• The global market is sizable, with a CAGR of about 4.2%, driven by increased cardiovascular disease prevalence.
• Patent expiries and competition from newer drugs remain significant risks.
• Future growth hinges on formulation innovation and geographic expansion, notably in Asia.

FAQs

1. What are the main advantages of micronized fenofibrate over standard formulations?
Micronization enhances bioavailability and absorption, potentially reducing gastrointestinal side effects and allowing for lower dosing.

2. Are there new indications for fenofibrate under clinical evaluation?
Yes, trials are examining its efficacy in metabolic syndrome and nonalcoholic fatty liver disease, but regulatory approvals have yet to expand significantly.

3. How do generic fenofibrate products compare to branded micronized versions?
Generic versions are cost-effective and have similar efficacy but may vary in bioavailability and tolerability.

4. What impact will patent expirations have on the market?
Patent expirations are likely to accelerate generic adoption, reducing revenue for branded drugs but expanding access.

5. Which regions are expected to see the fastest market growth?
Asia-Pacific is projected to experience the fastest growth due to rising dyslipidemia prevalence and increasing healthcare infrastructure investments.

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References

[1] ClinicalTrials.gov. (2023). Fenofibrate studies. https://clinicaltrials.gov
[2] Grand View Research. (2023). Fenofibrate Market Size, Share & Trends. https://www.grandviewresearch.com
[3] European Medicines Agency. (2022). Fenofibrate updates. https://www.ema.europa.eu
[4] IQVIA. (2022). Global Lipid-Lowering Drugs Market Report. https://www.iqvia.com