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Last Updated: March 17, 2025

CLINICAL TRIALS PROFILE FOR FENOFIBRIC ACID


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All Clinical Trials for FENOFIBRIC ACID

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00839293 ↗ Comparison of Fenofibric Acid Bioavailability From ABT-335 Capsules Completed Abbott Phase 1 2009-02-01 The purpose of this study is to evaluate the safety and compare the bioavailability of fenofibric acid from 2 different dosage strengths of ABT-335.
NCT00808678 ↗ Comparison of the Bioavailability of Fenofibric Acid and Rosuvastatin From ABT-143 Relative to That From the Coadministration of ABT-335 (Fenofibric Acid) and Rosuvastatin Calcium Completed AstraZeneca Phase 1 2008-12-01 The purpose of this study is to evaluate the safety and compare the pharmacokinetic parameters from the fixed dose combination ABT-143 relative to that from the co-administration of the two monotherapies.
NCT00826358 ↗ Comparison of the Bioavailability of Fenofibric Acid and Rosuvastatin From 5/45 mg Strength of ABT-143 Relative to That From the Coadministration of ABT-335 (Fenofibric Acid) 45 mg and Rosuvastatin Calcium 5 mg Completed AstraZeneca Phase 1 2008-11-01 The purpose of this study is to evaluate the safety and compare the pharmacokinetic parameters from the fixed dose combination ABT-143 relative to that from the co-administration of the two monotherapies.
NCT00300430 ↗ Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia. Completed Abbott Phase 3 2006-09-01 The primary purpose of this study is to test the safety and the effects of using an investigational drug regimen; once daily ABT-335 (Investigational drug) administered in combination with once daily atorvastatin calcium, rosuvastatin calcium or simvastatin in patients with abnormal lipid levels in the blood.
NCT00300456 ↗ Evaluate Safety and Efficacy of ABT-335 in Combination With Simvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood Completed Abbott Phase 3 2006-03-01 The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335) + simvastatin combination therapy with ABT-335 and simvastatin monotherapy in subjects with multiple abnormal lipid levels in the blood.
NCT00300469 ↗ Evaluate Safety and Efficacy of ABT-335 in Combination With Atorvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood Completed Abbott Phase 3 2006-03-01 The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335) + atorvastatin combination therapy with ABT-335 and atorvastatin monotherapy in subjects with multiple abnormal lipid levels in the blood.
NCT00300482 ↗ Evaluate Safety and Efficacy of ABT-335 in Combination With Rosuvastatin Calcium in Subjects With Multiple Abnormal Lipid Levels in the Blood Completed Abbott Phase 3 2006-03-01 The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335) + rosuvastatin calcium combination therapy with ABT-335 and rosuvastatin calcium monotherapy in subjects with multiple abnormal lipid levels in the blood.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 7 of 7 entries

Clinical Trial Conditions for FENOFIBRIC ACID

Condition Name

125440024681012HealthyDyslipidemiaCoronary Heart DiseaseMixed Dyslipidemia[disabled in preview]
Condition Name for FENOFIBRIC ACID
Intervention Trials
Healthy 12
Dyslipidemia 5
Coronary Heart Disease 4
Mixed Dyslipidemia 4
[disabled in preview] 0
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Condition MeSH

55540-0.500.511.522.533.544.555.5DyslipidemiasCoronary Artery DiseaseMyocardial IschemiaCoronary Disease[disabled in preview]
Condition MeSH for FENOFIBRIC ACID
Intervention Trials
Dyslipidemias 5
Coronary Artery Disease 5
Myocardial Ischemia 5
Coronary Disease 4
[disabled in preview] 0
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Clinical Trial Locations for FENOFIBRIC ACID

Trials by Country

+
Trials by Country for FENOFIBRIC ACID
Location Trials
United States 13
Korea, Republic of 4
Brazil 1
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Trials by US State

+
Trials by US State for FENOFIBRIC ACID
Location Trials
Illinois 5
North Dakota 2
Florida 2
West Virginia 1
Maryland 1
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Clinical Trial Progress for FENOFIBRIC ACID

Clinical Trial Phase

9.5%23.8%61.9%002468101214Phase 4Phase 3Phase 1[disabled in preview]
Clinical Trial Phase for FENOFIBRIC ACID
Clinical Trial Phase Trials
Phase 4 2
Phase 3 5
Phase 1 13
[disabled in preview] 1
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Clinical Trial Status

85.7%9.5%0024681012141618CompletedTerminatedUnknown status[disabled in preview]
Clinical Trial Status for FENOFIBRIC ACID
Clinical Trial Phase Trials
Completed 18
Terminated 2
Unknown status 1
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Clinical Trial Sponsors for FENOFIBRIC ACID

Sponsor Name

trials01122334455667AbbottMutual Pharmaceutical Company, Inc.AstraZeneca[disabled in preview]
Sponsor Name for FENOFIBRIC ACID
Sponsor Trials
Abbott 6
Mutual Pharmaceutical Company, Inc. 6
AstraZeneca 2
[disabled in preview] 4
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Sponsor Type

73.9%21.7%0024681012141618IndustryOtherNIH[disabled in preview]
Sponsor Type for FENOFIBRIC ACID
Sponsor Trials
Industry 17
Other 5
NIH 1
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Fenofibric Acid: Clinical Trials, Market Analysis, and Projections

Introduction to Fenofibric Acid

Fenofibric acid, a derivative of the fibrate class of drugs, is widely used to treat severe hypertriglyceridemia, primary hypercholesterolemia, and mixed dyslipidemia. It is marketed under the brand name Trilipix, among others, and is available in various generic formulations.

Clinical Trials and Safety Studies

Current and Ongoing Trials

One of the significant ongoing clinical trials is the Safety Study of Fenofibrate During Pregnancy. This study aims to evaluate the safety of fenofibrate in pregnant women with severe hypertriglyceridemia. The trial involves recruiting 200 pregnant women with triglyceride levels greater than 10 mM, who will be exposed to fenofibrate for more than one week. The study will compare pregnancy outcomes and infant physical growth between exposed and unexposed women. It will also assess the placental transfer and milk penetration of fenofibric acid[4].

Historical Trial Findings

Previous clinical trials have highlighted several key points about fenofibrate:

  • Liver Enzyme Elevations: Fenofibrate has been associated with increases in serum transaminases (AST and ALT). In a pooled analysis of 10 placebo-controlled trials, increases to more than three times the upper limit of normal of ALT occurred in 5.3% of patients taking fenofibrate compared to 1.1% of patients on placebo[1].
  • Thromboembolic Events: The FIELD trial and the Coronary Drug Project have shown higher rates of pulmonary embolus (PE) and deep vein thrombosis (DVT) in patients treated with fenofibrate compared to the placebo group[1].
  • Carcinogenic Potential: Animal studies have indicated an increased incidence of liver carcinomas, pancreatic carcinomas, and other tumors at doses significantly higher than the maximum recommended human dose (MRHD)[1].

Mechanism of Action and Clinical Effects

Fenofibric acid works by activating the peroxisome proliferator-activated receptor alpha (PPARα), which regulates the expression of genes involved in lipid metabolism. This activation leads to:

  • Reduced Triglycerides: By increasing the lipolysis and clearance of triglyceride-rich lipoproteins.
  • Increased HDL: By enhancing the production of apolipoprotein A-I, a major component of HDL cholesterol.
  • Decreased LDL: By reducing the production of apolipoprotein B, a component of LDL cholesterol.
  • Other Effects: Fenofibrate also reduces fibrinogen levels and serum uric acid levels, which can be beneficial in managing cardiovascular risk factors[3].

Market Analysis and Projections

Global Market Trends

The global fibrate drugs market, which includes fenofibric acid, is expected to grow significantly over the forecast period.

  • Market Size and Growth: The market was valued at US $2.84 billion from 2018 to 2022 and is projected to reach US $4 billion by 2029, with a Compound Annual Growth Rate (CAGR) of 5% from 2023 to 2029[3].
  • Segmentation: The market is segmented by drug type, distribution channel, and region. The fenofibrate segment, which includes fenofibric acid, dominated the market in 2022 and is expected to maintain a significant market share by 2029[3].

Fenofibric Acid Market Specifics

The fenofibric acid market is thriving due to several factors:

  • Increasing Demand: The growing prevalence of dyslipidemia and the need for effective lipid-lowering therapies drive the demand for fenofibric acid.
  • Generic Availability: The availability of generic versions of fenofibric acid from multiple manufacturers, such as AbbVie, Actavis, Alembic, and others, has increased accessibility and reduced costs, contributing to market growth[2].
  • CAGR Projection: The global fenofibric acid market is expected to expand at a CAGR of +4% over the forecast period from 2019 to 2025[5].

Distribution and Availability

Fenofibric acid is available in various formulations, including delayed-release capsules.

  • Brand and Generic Options: It is marketed under the brand name Trilipix and is also available in generic forms from several manufacturers, including AbbVie, Actavis, Alembic, Aurobindo Pharma, and others[2].
  • Strengths: The drug is available in strengths of 45 mg and 135 mg fenofibric acid equivalent[2].

Side Effects and Safety Considerations

While fenofibric acid is generally well-tolerated, it has several notable side effects and safety considerations:

  • Liver Enzyme Elevations: As mentioned, fenofibrate can cause significant increases in liver enzymes, necessitating regular monitoring and potential discontinuation if levels persist above three times the normal limit[1].
  • Thromboembolic Events: There is an increased risk of pulmonary embolus and deep vein thrombosis associated with fenofibrate therapy[1].
  • Carcinogenic Potential: Animal studies have shown an increased incidence of certain tumors, although the clinical significance in humans is not fully established[1].

Patient Resources and Professional Guidelines

For patients and healthcare professionals, it is crucial to be aware of the following:

  • Dosage Information: Fenofibric acid should be taken as directed, usually once daily with a meal, to minimize gastrointestinal side effects[2].
  • Pregnancy and Lactation: The safety of fenofibrate during pregnancy is being evaluated in ongoing studies. However, it is generally recommended to use caution and consider alternative treatments if possible[4].
  • Interactions: Patients should be aware of potential interactions with other medications and inform their healthcare providers about all medications they are taking[2].

Key Takeaways

  • Clinical Trials: Ongoing studies are evaluating the safety of fenofibrate in pregnant women and its long-term effects.
  • Mechanism of Action: Fenofibric acid works by activating PPARα, leading to improved lipid profiles.
  • Market Growth: The global fibrate drugs market, including fenofibric acid, is expected to grow significantly over the next few years.
  • Safety Considerations: Regular monitoring of liver enzymes and awareness of thromboembolic risks are crucial.
  • Availability: Fenofibric acid is available in both brand and generic forms, enhancing accessibility.

FAQs

What is fenofibric acid used for?

Fenofibric acid is used to treat severe hypertriglyceridemia, primary hypercholesterolemia, and mixed dyslipidemia.

What are the common side effects of fenofibric acid?

Common side effects include liver enzyme elevations, gastrointestinal issues, and an increased risk of thromboembolic events.

Is fenofibric acid safe during pregnancy?

The safety of fenofibrate during pregnancy is currently being evaluated in clinical trials. It is generally recommended to use caution and consider alternative treatments if possible.

How does fenofibric acid work?

Fenofibric acid works by activating the peroxisome proliferator-activated receptor alpha (PPARα), which regulates genes involved in lipid metabolism.

What is the market outlook for fenofibric acid?

The global fenofibric acid market is expected to grow at a CAGR of +4% from 2019 to 2025, driven by increasing demand and the availability of generic formulations.

Can fenofibric acid cause cancer?

Animal studies have shown an increased incidence of certain tumors at doses significantly higher than the maximum recommended human dose. However, the clinical significance in humans is not fully established.

Sources

  1. DrugBank: Fenofibric acid: Uses, Interactions, Mechanism of Action.
  2. Drugs.com: Generic Trilipix Availability.
  3. Maximize Market Research: Global Fibrate Drugs Market: Industry Analysis and Forecast.
  4. CenterWatch: Safety Study of Fenofibrate During Pregnancy.
  5. OpenPR: Find out why Fenofibric Acid Market is thriving by 2025 with top.

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