CLINICAL TRIALS PROFILE FOR CLOFIBRATE

All Clinical Trials for CLOFIBRATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000482 ↗	Coronary Drug Project	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1965-04-01	To determine whether regular administration of lipid modifying drugs (clofibrate, nicotinic acid, estrogen, dextrothyroxine) to men with a documented myocardial infarction would result in significant reduction in total mortality over a five year period. Secondarily, to determine whether the degree to which these drugs changed serum lipids was correlated with any effect on mortality and morbidity rates; to gain further information on the long-term prognosis of myocardial infarction (by studying the control group as intensively as the treatment group); to acquire further experience and knowledge concerning the techniques and methodology of long-term clinical trials; to determine, in a substudy, the effectiveness of aspirin, a platelet inhibitor, in reducing recurrences of myocardial infarction.
NCT00000483 ↗	Coronary Drug Project Mortality Surveillance	Completed	National Heart, Lung, and Blood Institute (NHLBI)	N/A	1981-06-01	To determine whether there were any long term sequelae of the drugs used in the Coronary Drug Project (estrogens, dextrothyroxine, nicotinic acid, clofibrate).
NCT00238004 ↗	The Low HDL On Six Weeks Statin Therapy (LOW) Study	Unknown status	Craigavon Area Hospital	Phase 4	2005-11-01	Abnormal blood cholesterol levels increase the risk of developing, or dying from heart disease. It is well recognised that if "harmful" LDL cholesterol is high, and "protective" HDL cholesterol is low, this risk is increased. Drugs called statins are routinely used in patients with heart disease, are well tolerated, and decrease the harmful LDL cholesterol levels. However, statins only increase protective HDL cholesterol to a small extent. Some patients may thus benefit from additional medication to increase protective HDL-cholesterol further. One of the most effective drugs which can do this is nicotinic acid. This drug is well established having been available for over 30 years. Previous use has been limited by facial flushing in a large percentage of patients receiving the drug. However a new formulation called Niaspan is now available which is associated with much less flushing. Although many patients will have transient flushing, it is estimated that only 1 patient out of every 20 receiving the drug will have to discontinue treatment. We therefore propose, in patients with coronary artery disease and low HDL cholesterol despite being on a statin, to study the effect of Niaspan on HDL cholesterol and other lipid parameters, and to assess its tolerability.
NCT00311987 ↗	Study of 3,5-Diiodothyropropionic Acid (DITPA) in Hypercholesterolemic Patients	Terminated	Johns Hopkins University	Phase 1/Phase 2	2006-04-01	The natural thyroid hormones, thyroxine (T4) and triiodothyronine (T3), are known to have a cholesterol-lowering effect. Their pharmacologic use for this purpose is limited, however, by their actions on other organs, including the heart, bone, and brain, where there can be side effects of excessive thyroid hormone action. 3,5-diiodothyropropionic acid (DITPA) is a thyroid hormone analog with relative selectivity for a form of the thyroid hormone receptor expressed in the liver, where it regulates several aspects of lipid metabolism, including the clearance of low-density lipoprotein (LDL) cholesterol. This study is designed to determine whether DITPA is safe and effective in achieving LDL cholesterol levels that are consistent with the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guidelines in patients who have not achieved those levels on conventional therapy, due to drug-resistant disease, drug intolerance, or both. This is a single-center, randomized, double-blind, placebo-controlled study. Following a 4-week Pre-Randomization Phase with dietary counseling and a 2-week placebo run-in, eligible patients will be randomized (1:1:1) to receive DITPA (90 mg/day, 180 mg/day), or placebo for a total treatment duration of 12 weeks. Sixty (60) patients will be randomized to 1 of 3 treatment groups in a 1:1:1 ratio (i.e., 20 patients per treatment group): - DITPA at 90 mg/day (45 mg twice a day [BID] taken orally) - DITPA at 180 mg/day (90 mg BID taken orally) - Placebo (BID taken orally) Those patients randomized to receive DITPA at 90 mg/day will receive 45 mg/day for the first 2 weeks, followed by 90 mg/day for 10 weeks. Those patients randomized to receive DITPA at 180 mg/day will receive 45 mg/day for the first 2 weeks, followed by 90 mg/day for the next 2 weeks, and then 180 mg/day for 8 weeks.
NCT00983788 ↗	Effect of Bezafibrate on Muscle Metabolism in Patients With Fatty Acid Oxidation Defects	Completed	Groupe Hospitalier Pitie-Salpetriere	Phase 2	2009-10-01	The investigators propose to evaluate the effect of bezafibrate on metabolism during exercise in 22 adult patients affected with carnitine palmitoyltransferase II (CPTII) or very-long chain acyl-CoA-dehydrogenase (VLCAD) deficiencies. This study will be an 9-month, randomized, double-blind, placebo-controlled crossover trial. The trial will be conducted in two centers: Institut de Myologie, Pitié-Salpêtrière Hospital in France, and Rigshospitalet, University of Copenhagen, in Denmark. The main criteria for assessing the potential effect of this drug will be the fat oxidation rate studied during a moderate workload on cycle ergometer, after infusion of stable isotopes (palmitate and glucose tracers).

Clinical Trial Conditions for CLOFIBRATE

Condition Name

Condition Name for CLOFIBRATE
Intervention	Trials
Cardiovascular Diseases	2
Myocardial Ischemia	2
Coronary Disease	2
Heart Diseases	2

Condition MeSH

Condition MeSH for CLOFIBRATE
Intervention	Trials
Coronary Artery Disease	3
Myocardial Ischemia	3
Heart Diseases	2
Coronary Disease	2

Clinical Trial Locations for CLOFIBRATE

Trials by Country

Trials by Country for CLOFIBRATE
Location	Trials
Mexico	1
United States	1
Brazil	1
United Kingdom	1
Canada	1

Trials by US State

Trials by US State for CLOFIBRATE
Location	Trials
Maryland	1

Clinical Trial Progress for CLOFIBRATE

Clinical Trial Phase

Clinical Trial Phase for CLOFIBRATE
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	2
Phase 3	2

Clinical Trial Status

Clinical Trial Status for CLOFIBRATE
Clinical Trial Phase	Trials
Completed	6
Unknown status	2
Terminated	1

Clinical Trial Sponsors for CLOFIBRATE

Sponsor Name

Sponsor Name for CLOFIBRATE
Sponsor	Trials
National Heart, Lung, and Blood Institute (NHLBI)	2
Centre for Addiction and Mental Health	1
Fundação de Amparo à Pesquisa do Estado de São Paulo	1

Sponsor Type

Sponsor Type for CLOFIBRATE
Sponsor	Trials
Other	9
NIH	2
Industry	1

Last updated: July 27, 2026

ofibrate Clinical Trials Update, Market Analysis, and Future Projections (2026)
Executive summary: Clofibrate is an older, off-patent lipid-lowering fibrate used for dyslipidemia and, in some markets, hypertriglyceridemia. The clinical-development pipeline is limited versus modern lipid therapies, with most activity shifting to formulation, safety surveillance, and evidence-generation rather than new phase 3 registration programs. Market growth is constrained by generic availability, guideline preference for statins and, when needed, add-on therapies with better outcome evidence, plus residual off-label use patterns. Near-term revenue is therefore expected to be stable to modestly declining globally, with the largest demand pockets in regions where older fibrates remain embedded in reimbursement and prescribing practice.

What is clofibrate’s current clinical trials status in 2026?

Answer: Clofibrate’s current clinical footprint is dominated by small studies and observational or formulation-focused work rather than large, registrational trials.

Phase-by-phase view

Registrational phase (Phase 2/3): Limited. Clofibrate has no clear, widely recognized late-stage program intended for new FDA approval or label expansion in major jurisdictions, given market maturity and existing generic supply.
Early clinical (Phase 1/2): Sparse. Any activity typically targets pharmacokinetics, tolerability, or comparative bioavailability between generic brands or alternative formulations.
Post-marketing and real-world evidence: Ongoing in some form, usually addressing safety signals and adherence patterns in dyslipidemia cohorts.

What are investigators studying?

Where new studies appear, they usually cluster into:

• Bioequivalence and formulation performance (IR vs. modified-release versions if present in local product portfolios)
• Safety monitoring in fibrate-exposed populations, with emphasis on known class risks (gallbladder events, muscle toxicity in combination settings, and effects on liver enzymes)
• Adherence and treatment persistence in older fibrate users
• Therapeutic positioning in settings where fibrates remain used for high triglycerides, often as add-on when statins are insufficient

Which regulators approve and monitor clofibrate, and what are the practical implications?

Answer: Clofibrate is regulated as an established small molecule in multiple markets, with ongoing pharmacovigilance requirements rather than approval-pathway-driven innovation.

FDA and US market reality

In the US, most attention around clofibrate is tied to generic availability and label usage in hypertriglyceridemia/dyslipidemia rather than brand-led regulatory updates. Practical implications for market projections:

• Low regulatory friction for generics: manufacturing and filing paths are mature.
• Limited incentives for new clinical trials that require large outcomes datasets.

Other jurisdictions

Across EU and other jurisdictions, fibrates are largely legacy therapies. The main regulatory driver affecting commercial outcomes is not new approval but changes in reimbursement and guideline adoption.

How strong is the clofibrate patent estate, and how does that shape clinical activity?

Answer: Clofibrate is long off originator patent protection. This suppresses incentives for large trials designed to create new IP barriers.

Typical downstream effects of off-patent status

• Generic dominance limits returns on investment for new trials.
• Study sponsors pivot to lifecycle uses that can be executed with smaller datasets (bioequivalence/formulation, local safety surveillance).
• Lower likelihood of placebo-controlled outcomes trials because there is no clear commercial monopolization path.

What is the current market size and demand profile for clofibrate?

Answer: Clofibrate is a niche-within-lipid-therapy market relative to statins and newer agents. Demand depends on local prescribing patterns, reimbursement, and the clinical need for triglyceride lowering when alternatives are cost-restricted or unavailable.

Where demand concentrates

Market pull is usually strongest where:

• Fibrate-based regimens remain guideline-endorsed for hypertriglyceridemia
• Generic pricing is a key purchasing criterion
• Healthcare systems have inertia toward older lipid-lowering schedules
• Cardiovascular outcomes alternatives are limited by cost or access

Key demand drivers

• High triglyceride prevalence in populations with metabolic syndrome
• Cost containment (older generics win procurement tenders)
• Physician comfort with established fibrate safety workflows
• Combination practices when clinicians use fibrates with statins cautiously

Who are the main competitors to clofibrate in lipid-lowering therapy?

Answer: Competition comes from statins, newer triglyceride-lowering agents, and other fibrates (where available in local formularies).

Direct therapeutic substitutes

• Statins (first-line dyslipidemia)
• Other fibrates (often with better perceived tolerability or more contemporary evidence portfolios)
• Omega-3 triglyceride-lowering products (in markets where reimbursed)
• Emerging triglyceride therapies (only where adopted)

Competitive dynamic

• Brand premium is absent for clofibrate due to generics.
• Clinical differentiation is weak versus outcomes-biased alternatives.
• Usage is often relegated to patients with persistent hypertriglyceridemia or specific contraindication profiles.

How will clofibrate’s market evolve: 2026 to 2031 projections

Answer: The base case is a stable-to-modest decline global trajectory through 2031, with country-level dispersion driven by reimbursement policy and guideline adherence.

Projection logic (base case)

1. Generic erosion is ongoing: pricing pressure remains structural.
2. Therapeutic switching continues: clinicians favor statin-based care and modern add-ons where affordable.
3. No major new indications are likely without novel clinical development.
4. Safety and tolerability scrutiny can reduce persistence in some cohorts, especially where monitoring systems are strong and clinicians avoid fibrate combinations.

Scenario framework (directional)

• Base case (most likely): low-single-digit decline in units and/or value outside a few steady reimbursed markets.
• Downside case: faster substitution by modern triglyceride therapies and heightened prescribing restrictions.
• Upside case: persistent fibrate utilization in cost-constrained systems plus stable procurement volumes for generics.

What clinical and safety evidence most affects clofibrate utilization today?

Answer: Class safety considerations influence prescribing behavior more than brand-specific outcomes.

Safety elements that constrain growth

• Gallbladder-related events (monitoring and risk selection)
• Hepatic enzyme changes (lab monitoring)
• Myopathy/rhabdomyolysis risk, particularly when combined with other interacting agents
• Drug interaction burden in combination regimens

Real-world prescribing impact

• Physicians often use clofibrate selectively when triglyceride reduction is the primary objective.
• Treatment persistence is sensitive to routine lab monitoring capacity and local protocols.

What formulation and delivery improvements could matter commercially for clofibrate?

Answer: The main commercially relevant “innovation” is lifecycle reformulation: bioequivalence, stability, manufacturing consistency, and patient acceptability.

Most common improvement categories

• Tablet bioequivalence between generic suppliers
• Dose-splitting practicality (depending on strengths available)
• Packaging and shelf-life optimization for emerging-market distribution
• Local compliance specifications (pharmacopeial alignment)

Because clofibrate is off-patent, these changes rarely expand market size, but they can defend share against supply disruptions and poor-quality brand perception.

What generic entry risks exist for clofibrate products?

Answer: For established generic molecules, the primary risks are not patent barriers but manufacturing quality, supply reliability, and regulatory enforcement.

Main risk channels

• Lot failures / quality recalls that can temporarily remove products from distribution
• Regulatory inspections that delay manufacturing for specific sites
• Procurement contract dynamics favoring lowest-cost qualified suppliers
• Regional brand withdrawals leading to temporary demand swings

How does clofibrate compare with fenofibrate and gemfibrozil for market competitiveness?

Answer: In many formularies, other fibrates and newer agents capture a larger share depending on local guidance and perceived safety.

Comparison drivers

• Clinical positioning for hypertriglyceridemia
• Perceived tolerability and monitoring convenience
• Availability of strengths and dosing flexibility
• Local reimbursement and historical prescribing habits

Commercial consequence

Even if clofibrate remains the lowest-cost fibrate in some markets, share loss is likely where prescribers consolidate into better-known or more evidence-supported fibrates.

What historical clinical evidence continues to influence prescribing?

Answer: The legacy clinical record shapes risk tolerance, especially around outcomes and safety narratives for fibrate class therapies.

Practical effect on current utilization

• Clinicians may prefer statin-first strategies and reserve fibrates for triglyceride-focused goals.
• Where reimbursement ties access to guideline criteria, clofibrate utilization can contract quickly as protocols tighten.

Key market risks for investors and licensors considering clofibrate

Answer: The investment risk is primarily demand dilution and price erosion, not regulatory uncertainty.

Risk checklist

• Sustained price compression from multi-supplier generics
• Guideline-driven contraction where modern therapies gain coverage
• Safety-driven treatment interruption in populations needing close monitoring
• Competitive substitution to other fibrates and omega-3 based regimens
• Supply chain concentration in a commodity-like generic market

Key Takeaways

• Clinical pipeline: Mostly limited to smaller studies such as bioequivalence, formulation, and post-marketing evidence generation; no broad late-stage registration push.
• Market: Clofibrate is mature and generic-dominated, with growth constrained by guideline preference for statins and modern triglyceride options where reimbursed.
• Projections (2026-2031): Base case is stable to modest decline, with geographic variation tied to reimbursement and prescribing inertia.
• Business implication: Commercial strategy should focus on supply reliability, cost competitiveness, and lifecycle manufacturing quality rather than expecting label-expansion upside.

FAQs

1. Is clofibrate still used for hypertriglyceridemia in major countries?
2. Does clofibrate have any current FDA label expansion or new indication activity?
3. How does clofibrate’s safety monitoring compare with other fibrates in real-world practice?
4. What substitution pressures does clofibrate face from omega-3 and newer triglyceride therapies?
5. How do generic manufacturing and quality issues typically impact clofibrate availability and pricing?

References

1. Bloomberg sourced general medical and regulatory context.
2. American Diabetes Association Standards of Care (latest edition, fibrate and triglyceride management context).
3. ACC/AHA Cholesterol Guidelines (latest edition, triglyceride and fibrate positioning).
4. EMA and national medicines authority pharmacovigilance frameworks (context for post-marketing monitoring of legacy generics).