Zyflo

Asthma, Asthma

Treatment

4 FDA approvals

20 Active Studies for Zyflo

What is Zyflo

Zileuton

The Generic name of this drug

Treatment Summary

Zileuton is a medication that helps reduce the symptoms of asthma. It works by blocking the formation of certain substances called leukotrienes, which cause inflammation, swelling, increased mucus production, and constriction of the airways in asthmatic patients. The drug is specifically designed to inhibit the enzyme 5-lipoxygenase, which is responsible for forming leukotrienes from arachidonic acid. Zileuton was previously available as an immediate release tablet in the US, but has since been withdrawn from the market.

Zyflo

is the brand name

image of different drug pills on a surface

Zyflo Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Zyflo

Zileuton

1996

14

Approved as Treatment by the FDA

Zileuton, also known as Zyflo, is approved by the FDA for 4 uses such as Asthma and Chronic Asthma .

Asthma

Chronic Asthma

Helps manage Chronic Asthma

Asthma

Helps manage Chronic Asthma

Asthma

Effectiveness

How Zyflo Affects Patients

Zileuton is a drug used to treat asthma. It works by blocking the leukotriene synthesis pathway, which is thought to contribute to asthma symptoms. It has been shown to reduce asthma symptoms caused by cold air in humans.

How Zyflo works in the body

Zileuton helps relieve symptoms of asthma by blocking the production of substances called leukotrienes. Leukotrienes cause inflammation and narrowing of the airways in asthmatic patients. Zileuton specifically targets 5-lipoxygenase, an enzyme that makes leukotrienes. By blocking the formation of these substances, Zileuton helps reduce inflammation, bronchial spasms, and other asthma symptoms. Both the R(+) and S(-) enantiomers of the drug have been shown to be effective in laboratory studies.

When to interrupt dosage

The suggested dosage of Zyflo is contingent upon the diagnosed condition. The measure, as stated in the table below, is subject to the mode of administration (e.g. Tablet - Oral or Tablet, extended release).

Condition

Dosage

Administration

Asthma

, 600.0 mg

Oral, Tablet, extended release, , Tablet, extended release - Oral, Tablet, multilayer, extended release, Tablet, multilayer, extended release - Oral, Tablet - Oral, Tablet, Tablet, film coated, Tablet, film coated - Oral

Asthma

, 600.0 mg

Oral, Tablet, extended release, , Tablet, extended release - Oral, Tablet, multilayer, extended release, Tablet, multilayer, extended release - Oral, Tablet - Oral, Tablet, Tablet, film coated, Tablet, film coated - Oral

Warnings

Zyflo Contraindications

Condition

Risk Level

Notes

Liver Failure, Acute

Do Not Combine

Pulse Frequency

Do Not Combine

There are 20 known major drug interactions with Zyflo.

Common Zyflo Drug Interactions

Drug Name

Risk Level

Description

Aminophylline

Major

The metabolism of Aminophylline can be decreased when combined with Zileuton.

Anagrelide

Major

The metabolism of Anagrelide can be decreased when combined with Zileuton.

Axitinib

Major

The metabolism of Axitinib can be decreased when combined with Zileuton.

Bendamustine

Major

The metabolism of Bendamustine can be decreased when combined with Zileuton.

Clomipramine

Major

The metabolism of Clomipramine can be decreased when combined with Zileuton.

Zyflo Toxicity & Overdose Risk

The lowest amount of zileuton that has been found to be lethal in mice is 500-4000mg/kg and in rats it is 300-1000mg/kg. This is much higher than the maximum recommended human daily dose.

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Zyflo Novel Uses: Which Conditions Have a Clinical Trial Featuring Zyflo?

A total of 147 active clinical trials are currently exploring the efficacy of Zyflo in providing relief from Asthma.

Condition

Clinical Trials

Trial Phases

Asthma

92 Actively Recruiting

Phase 1, Phase 4, Early Phase 1, Phase 2, Not Applicable, Phase 3

Asthma

1 Actively Recruiting

Phase 2

Zyflo Reviews: What are patients saying about Zyflo?

5

Patient Review

8/3/2020

Zyflo for Late Onset Asthma

At 73, I'm quite active for my age. I can attribute a lot of that to Zyflo and its ability to help me breathe more deeply. That being said, it is rather pricey and the generic brand works just as well.

5

Patient Review

4/3/2009

Zyflo for Late Onset Asthma

This medication has made a world of difference for my COPD. I haven't found anything that works better.

5

Patient Review

3/17/2008

Zyflo for Asthma Prevention

I can breathe again. So much better than Singlair ever was.

5

Patient Review

5/16/2008

Zyflo for Allergic Asthma

Allergist changed my prescription to this and it helped a lot more. I can finally breathe properly and don't have headaches anymore.

5

Patient Review

10/5/2013

Zyflo for Allergic Asthma

Z has been a total game-changer for me and my asthma. I was using corticosteroids to manage it before, but this medication is much more effective.

5

Patient Review

10/16/2007

Zyflo for Asthma Prevention

This medication has improved my quality of life by allowing me to breathe more easily.

4.3

Patient Review

1/13/2010

Zyflo for Allergic Asthma

I was very surprised when my monthly pharmacy bill went up $22, especially since I am on Social Security Disability and don't have a lot of extra money. I wish there was a generic option.

4.3

Patient Review

3/26/2008

Zyflo for Late Onset Asthma

This medication works well to control my asthma, but I have noticed some side effects like yellowing of the eyes, fatigue, and muscle aches.

4

Patient Review

4/19/2010

Zyflo for Late Onset Asthma

I did experience some lightheadedness after taking the medication, but it was not severe and it went away quickly.

4

Patient Review

10/3/2007

Zyflo for Asthma Prevention

This medication is a big improvement from Singular, which was my previous prescription. The only downside is that I have to remember to take it four times per day.

3.7

Patient Review

10/4/2007

Zyflo for Allergic Asthma

Zyflo CR is much easier to use and I haven't had any side-effects.

3.3

Patient Review

10/27/2007

Zyflo for Late Onset Asthma

I switched from Singulair to Zyflo about a year ago, and I believe the medication is more effective than Singulair. The main problem is that it is hard to take -- I have to take one pill every six hours. I often forget to take it, or simply sleep through a dose. The medication is also expensive.

2

Patient Review

2/12/2013

Zyflo for Asthma Prevention

These drugs really disturbed my stomach and now my eyes feel gritty all day. My asthma is better, but I don't know if it's worth feeling this lousy constantly.
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Patient Q&A Section about zyflo

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What type of drug is Zyflo?

"This is a prescription medication for the treatment of asthma symptoms that comes in tablet form. It may be used alone or in conjunction with other drugs and is part of a class of drugs called 5-Lipoxygenase Inhibitors. Its safety and effectiveness in children under 12 years of age have not been established."

Answered by AI

What are the side effects of Zyflo?

"The side effects of this medication may include nausea, an upset stomach, diarrhea, trouble sleeping, or cold symptoms (a stuffy nose, sinus pain, sneezing, or a sore throat). Other potential side effects include a headache, weakness, or muscle pain."

Answered by AI

What is Zyflo used for?

"Zileuton is a medication used to help control and prevent asthma symptoms, such as wheezing and shortness of breath. Controlling these symptoms allows you to keep up with your usual activities and decreases the amount of time you miss from work or school. You need to use this medication consistently to get the best results."

Answered by AI

Is there a generic for Zyflo?

"At this time, there is no FDA-approved generic form of Zyflo available in the United States. Be aware that some online pharmacies may attempt to sell a counterfeit or fake version of this drug. These medications may be dangerous and potentially unsafe."

Answered by AI

Clinical Trials for Zyflo

Have you considered Zyflo clinical trials?

We made a collection of clinical trials featuring Zyflo, we think they might fit your search criteria.
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Image of Allergy Immunology Associates in Mayfield Heights, United States.

Osteopathic Manipulative Treatment for Asthma

18 - 60
All Sexes
Mayfield Heights, OH

Asthma is a common respiratory condition that can be difficult to control despite the use of medications such as inhalers, oral steroids or even injectable medications. Osteopathic Manipulative Treatment (OMT) is a hands-on technique used to improve the chest structure and function and may help in improving breathing. Previous research showed that OMT in asthma patients, can improve the movement of the ribs and improve the "peak flow" which is the maximum rate at which a person can exhale air after taking a deep breath. However, no studies have evaluated the impact of OMT on lung inflammation. This single-site research study at University Hospitals aims to evaluate whether Osteopathic Manipulative Treatment (OMT) can reduce lung inflammation and improve breathing and lung function in adult patients with asthma. The lung function will be evaluated by Spirometry which is a test that measures how much air you can breathe in and out of your lungs, as well as how quickly and easily you can exhale air. The lung inflammation will be measured using a device that can detect how much you are breathing out Nitric Oxide which is a gas produced by inflamed cells in the lungs, this test is called: Fractional exhaled Nitric Oxide or FeNO. Approximately 100 participants will be enrolled.

Waitlist Available
Has No Placebo

Allergy Immunology Associates

Nancy Wasserbauer-Kingston, DO

Image of DARTNet Institute in Aurora, United States.

Inhaled Corticosteroids + Azithromycin for Asthma

13 - 75
All Sexes
Aurora, CO

While asthma therapy is becoming more individualized based on asthma phenotypes, more research is needed to tailor newer therapies to individuals. Inhaled corticosteroid (ICS) medications are the foundation of care for all individuals with persistent asthma. But ICS use is not without possible long term side effects. This study will compare two currently available approaches to reduce AEX in primary care patients: (1) use of inhaled corticosteroids (ICS) as part of rescue therapy, also known as MART (Maintenance And Reliever Therapy) or PARTICS (Patient Activated Reliever Trigger Inhaled Corticosteriods) therapy - either of these therapies will be called Rescue-Inhaled Corticosteroids or R-ICS pronounced "Ricks," and (2) use of azithromycin (AZ) as a preventive therapy. These treatments will be studied both individually and in combination.

Phase 4
Recruiting

DARTNet Institute (+12 Sites)

Wilson D Pace, MD, FAAFP

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PF-07275315 for Asthma

18 - 70
All Sexes
Mobile, AL

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07275315) for the potential treatment of moderate-to-severe asthma. Asthma is a condition that makes it challenging to breathe, which negatively impacts the quality of life and functioning of people who are affected. This study is seeking participants who: * Are 18 to 70 years old * Have had moderate-to-severe asthma for at least 12 months that is not well controlled * Have been taking their regular maintenance treatment(s) for asthma over the last 12 months All participants will receive PF-07275315 or a placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. PF-07275315 or placebo will be given as multiple shots in the clinic over the course of 12 weeks. We will compare the experiences of people receiving PF-07275315 to those of the people who do not. This will help us determine if PF-07275315 is safe and effective. Participants will be involved in this study for about 9.5 months. During this time, they will have 10 visits at the study clinic.

Phase 2
Recruiting

Velocity Clinical Research, Mobile (+10 Sites)

Pfizer CT.gov Call Center

Pfizer

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Corticosteroids for Asthma

18+
All Sexes
Hamilton, Canada

Most individuals with asthma can effectively manage their symptoms and maintain normal lung function using inhaled medications, unfortunately, there is a subset of asthma sufferers whose symptoms, lung function, and risk of asthma attacks remain unimproved despite conventional inhaled medications. There could be several reasons for this. One possibility is that inhaled medications fail to reach the intended areas within the lungs, due to structural abnormalities within the airways themselves. Much like road conditions or closures can impede the speed and efficiency of vehicle travel, factors such as airway narrowing or mucus blockages, which are common in asthma, can obstruct the passage of inhaled medications through the airways. Our team has now optimized advanced medical imaging techniques, including magnetic resonance imaging (MRI) and computed tomography (CT), required to investigate this. This study will use these imaging methods to visually assess and measure individual patients' airways and determine whether abnormal airway structures impact how well they respond to inhaled and orally delivered medications. We anticipate finding that abnormal airway structures make inhaled medications less effective, but that they do not affect the response to oral medications.

Phase 4
Recruiting

St. Joseph's Healthcare Hamilton (+1 Sites)

Have you considered Zyflo clinical trials?

We made a collection of clinical trials featuring Zyflo, we think they might fit your search criteria.
Go to Trials