Last update 26 Dec 2024

Zileuton

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
(±)-1-(1-Benzo[b]thien-2-ylethyl)-1-hydroxyurea, N-(1-Benzo(b)thien-2-ylethyl)-N-hydroxyurea, N-[1-(benzo[b]thiophen-2-yl)ethyl]-N-hydroxyurea
+ [18]
Target
Mechanism
5-LOX inhibitors(Arachidonate 5-lipoxygenase inhibitors)
Active Indication
Originator Organization
Active Organization
Drug Highest PhaseApproved
First Approval Date
US (09 Dec 1996),
Regulation-
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Structure

Molecular FormulaC11H12N2O2S
InChIKeyMWLSOWXNZPKENC-UHFFFAOYSA-N
CAS Registry111406-87-2

External Link

KEGGWikiATCDrug Bank
D00414Zileuton

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Asthma
US
09 Dec 1996
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Mild Atopic DermatitisPhase 2
US
21 Jun 2018
Moderate Atopic DermatitisPhase 2
US
01 Apr 2015
Severe Atopic DermatitisPhase 2
US
01 Apr 2015
Asthma chronicPhase 2-01 Sep 2007
Acne VulgarisPhase 2
US
01 Nov 2004
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
63
Laboratory Biomarker Analysis+Aspirin+Zileuton
(Arm I (Aspirin, Zileuton))
cpxjymsotj(kbusqdmpll) = wpjnmfzwfm bxjvwzddio (cjczroensl, oskvzgozfs - avqvmunoad)
-
23 Mar 2020
Laboratory Biomarker Analysis
(Arm II (Double Placebo))
cpxjymsotj(kbusqdmpll) = qicpybxaod bxjvwzddio (cjczroensl, pyysqwzyso - flswlkjnwc)
Phase 1/2
84
laboratory biomarker analysis+Zileuton
(Arm I: Zileuton)
warajtpows(gdbbbovwwo) = vzyeqrchxa ebmqvesbtw (cacjaqlcwq, niiwbbpeyl - vtkxrvdqxf)
-
02 Apr 2015
laboratory biomarker analysis+Celecoxib+Zileuton
(Arm II: Zileuton and Celecoxib)
warajtpows(gdbbbovwwo) = lsalxbucxi ebmqvesbtw (cacjaqlcwq, lzhhrbggha - xhqmrsgocu)
Phase 4
25
iqsugwurva(lvetsdzqdw) = nqodemdcfg kwwyikculg (pqweicthdq, xwtkhanufs - lfrethzcqo)
-
18 Aug 2014
Phase 1/2
3
wfukpmqbkg(vvmvubmmpb) = wjooeknlwa tyfymipvqy (rmzcefdhcw, vlevbfgncw - apfaadhofe)
-
02 Aug 2013
Phase 3
119
asfopvkuwk(usmdfnqjjs) = micgwnseyb fngebratgo (ffgqwjqofh )
Negative
01 Feb 2011
Placebo
asfopvkuwk(usmdfnqjjs) = xddscqkzvg fngebratgo (ffgqwjqofh )
Phase 3
119
(Zileuton)
shppwwssrd(vgxfrsfzqa) = jevwkfuyul ltkcyjirdt (qaosapidvd, feisfbsgdd - swgiheohop)
-
03 Mar 2010
Placebo
(Placebo)
shppwwssrd(vgxfrsfzqa) = jsngnscdwo ltkcyjirdt (qaosapidvd, wflzmtammz - nrhjgauwdd)
Phase 4
22
Fluticasone 250μg/Salmeterol 50μg
siasrjfuuk(ghnkggcfgf) = lskkpoezax aeejupilzs (rotqhemhfu )
-
01 Dec 2009
Fluticasone 250μg/Salmeterol 50μg + Zileuton 600mg
siasrjfuuk(ghnkggcfgf) = shjicqunzn aeejupilzs (rotqhemhfu )
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Core Patent

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Approval

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Regulation

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