CLINICAL TRIALS PROFILE FOR FENOFIBRATE

All Clinical Trials for FENOFIBRATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00006412 ↗	Safety and Effectiveness of Fenofibrate and Pravastatin in HIV-Positive Patients With Abnormal Blood Lipids	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	The purpose of this study is to compare the safety and effectiveness of fenofibrate and pravastatin in treating HIV-positive patients who have abnormal levels of fat (lipids) in the blood. Increased lipids in the blood associated with HIV infection and anti-HIV drugs is a growing problem. The drugs used in this study are known to reduce certain lipids, but little is known about their safety and effectiveness. This study will see if one of the drugs is safer and more effective than the other, or if combining the drugs is the safest and most effective way to lower lipids. This study has been changed. On June 26, 2001, this study was reviewed by the Data and Safety Monitoring Board (DSMB). The DSMB is an independent board monitoring the progress of the study. The review showed that neither pravastatin nor fenofibrate alone were effective in reaching all the cholesterol and triglyceride goals. There were no safety concerns. It is not known if the combination of fenofibrate and pravastatin is effective and safe. Therefore, it is important to continue this study.
NCT00076518 ↗	The Effect of Fish Oil Plus Fenofibrate on Triglyceride Levels in People Taking Highly Active Antiretroviral Therapy (HAART)	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	The purpose of this study is to determine the effectiveness of fish oil supplements combined with the drug fenofibrate in treating elevated triglyceride levels in people taking anti-HIV drugs. The participants in this study will have shown no response to fish oil supplements or fenofibrate alone.

Clinical Trial Conditions for FENOFIBRATE

Condition Name

Condition Name for FENOFIBRATE
Intervention	Trials
Dyslipidemia	24
Hypertriglyceridemia	19
Hyperlipidemia	15
Hypercholesterolemia	9

Condition MeSH

Condition MeSH for FENOFIBRATE
Intervention	Trials
Dyslipidemias	44
Hyperlipidemias	28
Hypertriglyceridemia	25
Hyperlipoproteinemias	23

Clinical Trial Locations for FENOFIBRATE

Trials by Country

Trials by Country for FENOFIBRATE
Location	Trials
United States	436
Canada	26
Germany	23
China	17
France	15

Trials by US State

Trials by US State for FENOFIBRATE
Location	Trials
Florida	25
Texas	23
California	23
Illinois	20
Tennessee	20

Clinical Trial Progress for FENOFIBRATE

Clinical Trial Phase

Clinical Trial Phase for FENOFIBRATE
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	3
PHASE2	5

Clinical Trial Status

Clinical Trial Status for FENOFIBRATE
Clinical Trial Phase	Trials
Completed	118
Recruiting	21
Terminated	17

Clinical Trial Sponsors for FENOFIBRATE

Sponsor Name

Sponsor Name for FENOFIBRATE
Sponsor	Trials
Solvay Pharmaceuticals	17
Abbott	10
Xijing Hospital of Digestive Diseases	9

Sponsor Type

Sponsor Type for FENOFIBRATE
Sponsor	Trials
Other	157
Industry	109
NIH	27

FENOFIBRATE: Clinical Trials Update and Market Projection

Last updated: April 26, 2026

What is fenofibrate and what indications matter commercially?

Fenofibrate is a lipid-modifying agent used to treat dyslipidemia. Commercial relevance is concentrated in two therapeutic areas:

• Hypertriglyceridemia: reduces elevated triglycerides.
• Mixed dyslipidemia (where triglycerides and LDL cholesterol are both abnormal).

In current practice, fenofibrate is positioned primarily as a triglyceride-lowering therapy within lipid management guidelines, with extensive generic penetration across key markets.

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What is the clinical-trials landscape for fenofibrate right now?

Fenofibrate is an established small molecule with broad generic availability. In 2025, trial activity is dominated by:

• Bioequivalence (BE) / formulation studies for generic and branded line extensions.
• Comparative effectiveness work in routine-care settings (often observational rather than registrational).
• Cardiometabolic risk studies that use fenofibrate as background therapy rather than as a standalone investigational product.

Regulatory endpoints and trial types

• Most ongoing interventional work is not expected to generate new labeling on a global basis because the active ingredient is off-patent in most jurisdictions.
• New approvals tend to come from new salts, formulations, or extended-release technologies, paired with BE and sometimes real-world evidence.

Trial activity pattern (what to expect)

Across registries, fenofibrate study volume is typically steady but skewed toward:

• Short-duration BE trials (often weeks).
• Pharmacokinetic (PK) and tolerability cohorts.
• Device-adjacent or regimen-adjacent studies (background lipid therapy comparisons).

Because fenofibrate is widely available, sponsors typically seek incremental value through:

• Differentiated release profiles
• Reduced pill burden (where applicable)
• Target population compliance improvements (dose timing and tolerability)

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Which fenofibrate formulations are commercially salient?

The market is supplied through multiple branded/generic formulations that historically include:

• Micronized fenofibrate
• Fenofibrate tablets (various dose strengths)
• Fenofibrate extended-release capsules/tablets (where available by region)

Commercial differentiation today is driven less by efficacy and more by:

• Dose frequency
• Formulation tolerability
• Generic substitution economics

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Why does patent status shape the clinical and commercial outlook?

Fenofibrate is an older, off-patent active ingredient. That changes what counts as “progress”:

• Clinical trials rarely aim for new primary approvals of the active ingredient.
• Most trial runs support access and manufacturability (BE and formulation continuity).
• Market share is driven by pricing, distribution, and payer formularies, not new clinical differentiation.

Business impact

• Without fresh patent protection on the active ingredient, the value chain favors manufacturers who can sustain:
  • supply reliability,
  • low-cost manufacturing,
  • payer contracting,
  • and fast BE-to-market execution.

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What does the market for fenofibrate look like by demand drivers?

Core demand drivers

• Prevalence of hypertriglyceridemia and mixed dyslipidemia
• Clinician prescribing to reduce triglycerides in patients at risk of dyslipidemic complications
• Insurance coverage and generic affordability (high sensitivity to price)

Key market constraints

• Switch to alternative triglyceride therapies in some systems, especially where reimbursement favors newer agents or combinations.
• Guideline adherence and lipid panel monitoring cycles.
• Safety monitoring expectations (lipid and liver parameter oversight, renal function screening in practice).

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How are pricing and competition playing out?

Fenofibrate is exposed to classic generic-market forces:

• Multiple manufacturers
• Repeated price resets after new generic entries
• Margin pressure tied to tender cycles and payer negotiations

Competitive advantage typically tracks to:

• lowest landed cost,
• consistent supply,
• and documentation that enables rapid formulary uptake (BE package quality and dossier strength).

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What is a practical market projection framework for fenofibrate through 2030?

Given fenofibrate’s established status and generic saturation, the dominant projection mechanics are:

• Volume stability to mild growth from baseline dyslipidemia prevalence and aging demographics
• Value contraction as ASP (average selling price) trends downward with ongoing generic competition
• Limited value upside except in regions with slower generic penetration or favorable formulary positions

Directional projection (not a single-point forecast)

• Global volume: expected flat to low single-digit growth through 2030.
• Global value: expected low to mid single-digit decline through 2030, driven by price erosion and competitive intensity.

Scenario table

Scenario	Volume trend (2030 vs 2024)	Price trend	Market value trend	Primary drivers
Baseline	+0% to +5%	-3% to -6% CAGR pressure	-2% to -4% CAGR	Generic competition, payer swaps, tender resets
Upside	+5% to +10%	-2% to -4%	-1% to +2% CAGR	Higher adherence and formulary stickiness in TG-heavy patients
Downside	-1% to +2%	-4% to -8%	-4% to -7% CAGR	Faster switching to newer TG agents, aggressive payer cost pressure

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What investment conclusions follow from this clinical and market profile?

1) What will win commercially

• Manufacturing scale and reliability
• Low-cost BE-to-market execution
• Strong payer contracting and tender response
• Formulation continuity that reduces stockouts and improves switching friction

2) What is unlikely to create step-change value

• Conventional phase 2/3 programs for fenofibrate as a new active ingredient
• Incremental PK studies without a clear access story
• Trials that do not translate into label expansions (rare for off-patent active ingredients)

3) Where “clinical updates” still matter

Even when new labels are unlikely, clinical activity can still move markets through:

• formulation approvals that enable replacement or substitution,
• real-world safety observations that affect payer restrictions, and
• regional guideline updates that change preferred triglyceride management options.

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Key Takeaways

• Fenofibrate’s clinical-trial activity is predominantly formulation and bioequivalence driven, with limited probability of label-changing new approvals on a global scale.
• Market growth is constrained by generic saturation; value declines are expected to outpace volume growth through 2030.
• Commercial winners focus on cost, supply reliability, and payer access, not novel clinical differentiation.
• Projection outlook is flat-to-slightly up volume with value pressure from ongoing price competition.

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FAQs

1) Will new phase 3 trials for fenofibrate likely expand indications?

Not on the same scale as earlier registrational programs. Off-patent status shifts sponsors toward BE, PK, tolerability, and access-focused studies.

2) What is the main market risk to fenofibrate revenue?

Aggressive payer cost pressure and clinician switching toward newer triglyceride-lowering options where reimbursement favors alternatives.

3) What drives fenofibrate demand most strongly?

Patient populations with hypertriglyceridemia and mixed dyslipidemia, plus clinician adherence to routine lipid monitoring and treatment protocols.

4) How can market share shift even without new labels?

Through tender cycles, formulary updates, substitution dynamics, and differences in formulation availability (immediate vs extended release) and supply reliability.

5) What would constitute a meaningful positive catalyst?

A regulatory or reimbursement shift that improves access (formulary inclusion, tender wins, or region-specific guideline changes), rather than a new active-ingredient breakthrough.

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References

[1] U.S. National Library of Medicine. ClinicalTrials.gov. https://clinicaltrials.gov/
[2] U.S. Food and Drug Administration. Drug Trials Snapshots (where available for marketed products). https://www.fda.gov/
[3] OECD/WHO datasets and related sources for dyslipidemia prevalence and aging demographics (background demand drivers). https://www.oecd.org/