CLINICAL TRIALS PROFILE FOR ZILEUTON

All Clinical Trials for ZILEUTON

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00098358 ↗	Study of Oral Zileuton in the Treatment of Moderate to Severe Facial Acne Vulgaris	Unknown status	Critical Therapeutics	Phase 2	2004-11-01	Tissue inflammation is a major component of the acne disease process. Leukotriene B4 (LTB4) is thought to be a major player in the development of tissue inflammation. Synthesis of LTB4 is controlled by the enzyme 5-lipoxygenase. Zileuton blocks the activity of 5-lipoxygenase. This study will test the safety and efficacy of zileuton in the treatment of facial acne.
NCT00070486 ↗	Carboplatin and Gemcitabine Combined With Celecoxib and/or Zileuton in Treating Patients With Advanced Non-Small Cell Lung Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2003-12-01	RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib and zileuton may stop the growth of tumor cells by stopping blood flow to the tumor and may block the enzymes necessary for tumor cell growth. Combining chemotherapy with celecoxib and/or zileuton may kill more tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of combining celecoxib and/or zileuton with carboplatin and gemcitabine in treating patients who have advanced non-small cell lung cancer.
NCT00070486 ↗	Carboplatin and Gemcitabine Combined With Celecoxib and/or Zileuton in Treating Patients With Advanced Non-Small Cell Lung Cancer	Completed	Alliance for Clinical Trials in Oncology	Phase 2	2003-12-01	RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib and zileuton may stop the growth of tumor cells by stopping blood flow to the tumor and may block the enzymes necessary for tumor cell growth. Combining chemotherapy with celecoxib and/or zileuton may kill more tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of combining celecoxib and/or zileuton with carboplatin and gemcitabine in treating patients who have advanced non-small cell lung cancer.
NCT00056004 ↗	Zileuton in Preventing Lung Cancer in Patients With Bronchial Dysplasia	Completed	National Cancer Institute (NCI)	Phase 2	2003-06-01	RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of zileuton may be an effective way to prevent lung cancer in patients who have bronchial dysplasia. PURPOSE: Randomized phase II trial to study the effectiveness of zileuton in preventing lung cancer in patients who have bronchial dysplasia.
NCT00056004 ↗	Zileuton in Preventing Lung Cancer in Patients With Bronchial Dysplasia	Completed	Barbara Ann Karmanos Cancer Institute	Phase 2	2003-06-01	RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of zileuton may be an effective way to prevent lung cancer in patients who have bronchial dysplasia. PURPOSE: Randomized phase II trial to study the effectiveness of zileuton in preventing lung cancer in patients who have bronchial dysplasia.
NCT00262405 ↗	Zileuton for the Treatment of Idiopathic Pulmonary Fibrosis	Completed	National Institutes of Health (NIH)	Phase 2	2001-01-01	Open label trial of zileuton compared to azathioprine/prednisone for patients with idiopathic pulmonary fibrosis. Study subjects will undergo a detailed clinical, radiographic, and physiologic assessment at baseline. Subjects will be monitored off treatment for three months for changes in symptoms and physiology. Subjects will then be randomized to six months of treatment with zileuton or azathioprine/prednisone. The primary endpoint of this trial is change in LTB4 levels in bronchoalveolar lavage fluid following six months of treatment. Secondary endpoints are progression free survival, change in dyspnea, change in quality of life, and change in physiology.

Clinical Trial Conditions for ZILEUTON

Condition Name

Condition Name for ZILEUTON
Intervention	Trials
Asthma	6
Lung Cancer	2
Chronic Myelogenous Leukemia	2
Tobacco Use Disorder	2

Condition MeSH

Condition MeSH for ZILEUTON
Intervention	Trials
Asthma	6
Pulmonary Fibrosis	2
Tobacco Use Disorder	2
Pulmonary Disease, Chronic Obstructive	2

Clinical Trial Locations for ZILEUTON

Trials by Country

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Trials by Country for ZILEUTON
Location	Trials
United States	75
Brazil	1
India	1

Trials by US State

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−

Trials by US State for ZILEUTON
Location	Trials
Massachusetts	9
California	6
Michigan	5
Minnesota	4
Maryland	4

Clinical Trial Progress for ZILEUTON

Clinical Trial Phase

Clinical Trial Phase for ZILEUTON
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	2
Phase 2	7

Clinical Trial Status

Clinical Trial Status for ZILEUTON
Clinical Trial Phase	Trials
Completed	14
Terminated	5
Unknown status	1

Clinical Trial Sponsors for ZILEUTON

Sponsor Name

Sponsor Name for ZILEUTON
Sponsor	Trials
National Cancer Institute (NCI)	4
Critical Therapeutics	4
University of Massachusetts, Worcester	2

Sponsor Type

Sponsor Type for ZILEUTON
Sponsor	Trials
Other	15
Industry	8
NIH	7

Zileuton: Clinical Trials, Market Analysis, and Projections

Introduction

Zileuton, a 5-lipoxygenase inhibitor, has been a significant player in the treatment of asthma and other inflammatory conditions since its FDA approval in 1996. This article delves into the clinical trials, market analysis, and future projections for zileuton, providing a comprehensive overview of its efficacy, safety, market dynamics, and future outlook.

Clinical Trials and Efficacy

Early Clinical Trials

In the phase II/III clinical trials leading up to its FDA approval, zileuton was generally well tolerated, although some patients experienced elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels. A notable study involving 2458 patients with asthma who received zileuton 600mg four times daily, along with usual asthma care, highlighted that liver chemistry monitoring is crucial, especially during the first three months of treatment. This study found that 4.4% of patients on zileuton had ALT levels elevated to ≥3 times the upper limit of normal (ULN), with the majority of these elevations occurring within the first three months[1].

Comparative Studies

A randomized controlled trial compared zileuton with slowly absorbed theophylline in patients with chronic asthma. The study showed that zileuton, particularly at a dose of 400mg four times daily, resulted in significant improvements in forced expiratory volume in 1 second (FEV1) and symptom scores, comparable to or sometimes surpassing those of theophylline. Zileuton reduced asthmatic responses and decreased the generation of leukotriene B4, a key mediator in asthma[4].

Recent Studies

A clinical study examining the effects of aspirin and zileuton on biomarkers of tobacco smoke exposure and lung disease in smokers found significant changes in gene expression associated with lung health. The study indicated that the combination of aspirin and zileuton altered genes related to lung cancer, smoking, and lung disease, suggesting potential benefits beyond asthma treatment[3].

Safety Profile

Liver Chemistry Monitoring

The safety profile of zileuton is closely tied to liver chemistry monitoring. The majority of ALT level elevations occur within the first three months of treatment, and monitoring during this period is most effective in detecting these elevations. Patients who experienced mild to moderate ALT elevations were often able to continue zileuton therapy with resolution of the elevation. However, close monitoring is essential to prevent irreversible liver injury[1].

Demographic Variations

Women, especially those aged 65 and older, appear to be at a higher risk of elevated ALT levels compared to men. This demographic variation highlights the need for tailored monitoring strategies based on patient demographics[1].

Market Analysis

Global Market Trends

The global zileuton market is influenced by several factors, including the prevalence of respiratory disorders, advancements in pharmaceutical technology, and the impact of the COVID-19 pandemic. The pandemic has underscored the importance of respiratory health, potentially driving long-term growth in the zileuton market despite initial logistical challenges and production disruptions[2].

Market Segmentation

The market is segmented based on resin types, applications, and geographical regions. Zileuton is available in different resin forms, each catering to specific formulation requirements. The primary application remains the treatment of asthma and related respiratory disorders, although ongoing research explores its potential in other inflammatory conditions[2].

Regional Outlook

North America and Europe dominate the market share due to the high prevalence of respiratory disorders and robust pharmaceutical industries. Emerging economies in the Asia-Pacific region present lucrative opportunities for market expansion, driven by increasing healthcare expenditure and rising awareness about respiratory health[2].

Market Projections

Growth Drivers

The demand for effective respiratory medications like zileuton is expected to grow due to several key factors:

• Increasing pollution levels
• Aging populations
• Prevalence of respiratory diseases
• Ongoing research into novel formulations and expanded therapeutic indications[2].

Future Outlook

As the global healthcare landscape evolves, the zileuton market is poised for growth. Advancements in pharmaceutical technology and the exploration of new therapeutic uses are expected to fuel market expansion. The market is projected to see significant growth from 2024 to 2031, driven by the increasing need for effective respiratory treatments and the potential for zileuton to address other inflammatory conditions[2].

Conclusion

Zileuton has established itself as a valuable treatment option for asthma and other inflammatory conditions. The clinical trials have highlighted its efficacy and the importance of liver chemistry monitoring to ensure safety. The market analysis indicates a strong future outlook, driven by growing demand for respiratory medications and ongoing research into new applications.

Key Takeaways

• Zileuton is effective in managing asthma symptoms by inhibiting the 5-lipoxygenase pathway.
• Close liver chemistry monitoring, especially in the first three months, is crucial to prevent liver injury.
• The global market is driven by the prevalence of respiratory disorders and advancements in pharmaceutical technology.
• North America and Europe currently dominate the market, but emerging economies in Asia-Pacific offer significant growth opportunities.
• Future growth is expected due to increasing pollution, aging populations, and ongoing research into new therapeutic uses.

FAQs

What is zileuton and how does it work?

Zileuton is a 5-lipoxygenase inhibitor that disrupts the synthesis of leukotrienes, which are key mediators in inflammation and bronchoconstriction.

What are the common side effects of zileuton?

Common side effects include elevations in ALT and AST levels, which necessitate regular liver chemistry monitoring.

How does zileuton compare to other asthma treatments?

Zileuton has been shown to be as effective as, or in some cases more effective than, other treatments like theophylline in improving FEV1 and symptom scores.

What is the impact of the COVID-19 pandemic on the zileuton market?

The pandemic has underscored the importance of respiratory health, potentially driving long-term growth in the zileuton market despite initial logistical challenges.

What are the future prospects for the zileuton market?

The market is expected to grow due to increasing demand for respiratory medications, advancements in pharmaceutical technology, and the potential for zileuton to address other inflammatory conditions.

Sources

1. Clinical pattern of zileuton-associated liver injury: results of a 12-month open-label, safety surveillance study. PubMed.
2. Exploring the Global Zileuton Market: Trends, Analysis, and COVID-19 Impact Forecast (2024-2031). OpenPR.
3. Clinical Study of Aspirin and Zileuton on Biomarkers of Tobacco Smoke Exposure and Lung Disease. MDPI.
4. A Randomized Controlled Trial Comparing Zileuton With Theophylline in Patients With Chronic Asthma. JAMA Network.