Zileuton

Generic Name: Zileuton

Brand Names: Zyflo

Drug Type: Small Molecule

Chemical Formula: C_₁₁H_₁₂N_₂O_₂S

CAS Number: 111406-87-2

Unique Ingredient Identifier: V1L22WVE2S

Background: Leukotrienes are substances that induce numerous biological effects including augmentation of neutrophil and eosinophil migration, neutrophil and monocyte aggregation, leukocyte adhesion, increased capillary permeability, and smooth muscle contraction. These effects contribute to inflammation, edema, mucus secretion, and bronchoconstriction in the airways of...

Indication: For the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older.

Associated Conditions: Asthma, Chronic Asthma

Associated Therapies: -

Clinical Trials

Aspirin and Zileuton and Biomarker Expression in Nasal Tissue of Current Smokers

Phase 2

Completed

Conditions: Tobacco Use Disorder

Interventions: Drug: Aspirin
Other: Laboratory Biomarker Analysis
Other: Placebo Administration
Drug: Zileuton

First Posted Date: 2015-01-28

Last Posted Date: 2022-06-02

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 63

Registration Number: NCT02348203

Locations: 🇺🇸
Banner University Medical Center - Tucson, Tucson, Arizona, United States
🇺🇸
Boston University School of Medicine, Boston, Massachusetts, United States

Evaluation of Rosiglitazone Anti-inflammatory Effect With FDG-PET Imaging

Early Phase 1

Completed

Conditions: Lung Inflammation

Interventions: Drug: Zileuton placebo
Drug: Zileuton
Drug: Pioglitazone placebo
Drug: Pioglitazone

First Posted Date: 2010-08-03

Last Posted Date: 2014-04-23

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 39

Registration Number: NCT01174056

Locations: 🇺🇸
Washington University / Barnes Jewish Hospital, St. Louis, Missouri, United States

Trial of Zileuton CR in Children and Adults With Sickle Cell Disease

Phase 1

Completed

Conditions: Sickle Cell Disease

Interventions: Drug: Zileuton

First Posted Date: 2010-06-04

Last Posted Date: 2014-06-18

Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Target Recruit Count: 9

Registration Number: NCT01136941

Locations: 🇺🇸
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

Safety of Zileuton (Zyflo) in Combination With Imatinib Mesylate (Gleevec) in CML.

Phase 1

Terminated

Conditions: Chronic Myelogenous Leukemia

Interventions: Drug: Zileuton

First Posted Date: 2010-05-26

Last Posted Date: 2015-05-27

Lead Sponsor: University of Massachusetts, Worcester

Target Recruit Count: 2

Registration Number: NCT01130688

Locations: 🇺🇸
University of Massachusetts Medical School, Worcester, Massachusetts, United States

Zileuton With or Without Celecoxib As Chemopreventive Agents in Smokers

Phase 1

Completed

Conditions: Tobacco Use Disorder

Interventions: Drug: Zileuton
Drug: Celecoxib
Other: laboratory biomarker analysis

First Posted Date: 2009-11-26

Last Posted Date: 2015-04-02

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 84

Registration Number: NCT01021215

Locations: 🇺🇸
MD Anderson Cancer Center - Consortium Lead Organzation, Houston, Texas, United States
🇺🇸
Weill Cornell Medical College in New York City, Cornell University, New York, New York, United States

PF-04191834 Single Dose Bronchodilatory Study In Asthma.

Phase 2

Completed

Conditions: Asthma

Interventions: Drug: PF-04191834
Drug: zileuton
Drug: Placebo

First Posted Date: 2008-07-28

Last Posted Date: 2013-02-01

Lead Sponsor: Pfizer

Target Recruit Count: 15

Registration Number: NCT00723021

Locations: 🇺🇸
Pfizer Investigational Site, Omaha, Nebraska, United States

Zileuton and Exhaled Nitric Oxide in Asthmatics

Phase 4

Completed

Conditions: Asthma

Interventions: Drug: zileuton

First Posted Date: 2007-12-18

Last Posted Date: 2007-12-20

Lead Sponsor: Gelb, Arthur F., M.D.

Target Recruit Count: 19

Registration Number: NCT00575861

Locations: 🇺🇸
Arthur F Gelb Medical Corporation, Lakewood, California, United States

Assessment of PFT, Safety, and PK of Zileuton Injection in Asthma Patients

Phase 2

Completed

Conditions: Asthma

Interventions: Drug: zileuton
Drug: placebo

First Posted Date: 2007-09-26

Last Posted Date: 2008-03-21

Lead Sponsor: Critical Therapeutics

Target Recruit Count: 36

Registration Number: NCT00534625

Zileuton to Treat Adults With Chronic Obstructive Pulmonary Disease (The LEUKO Study)

Phase 3

Terminated

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Drug: Placebo
Drug: Zileuton

First Posted Date: 2007-06-29

Last Posted Date: 2019-11-18

Lead Sponsor: University of Minnesota

Target Recruit Count: 119

Registration Number: NCT00493974

Locations: 🇺🇸
University of Pittsburgh Emphysema Research Center, Pittsburgh, Pennsylvania, United States
🇺🇸
HealthPartners Research Foundation, Minneapolis, Minnesota, United States
🇺🇸
University of California San Francisco-Airway Clinical Research Center, San Francisco, California, United States

and more 11 locations

Pilot Study of a Multi-Drug Regimen for Severe Pulmonary Fibrosis in Hermansky-Pudlak Syndrome

Phase 1

Terminated

Conditions: Hermansky-Pudlak Syndrome (HPS)
Pulmonary Fibrosis
Oculocutaneous Albinism
Platelet Storage Pool Deficiency
Metabolic Disease

Interventions: Drug: Losartan
Drug: Zileuton
Drug: N-Acetylcysteine
Drug: Pravastatin
Drug: Erythromycin

First Posted Date: 2007-05-01

Last Posted Date: 2013-08-02

Lead Sponsor: National Human Genome Research Institute (NHGRI)

Target Recruit Count: 3

Registration Number: NCT00467831

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

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