Last update 23 Jan 2025

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/Sequence

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
Acne VulgarisPhase 2
US
01 Nov 2004
Mild Atopic DermatitisPhase 1
US
21 Jun 2018
Moderate Atopic DermatitisPhase 1
US
01 Apr 2015
Severe Atopic DermatitisPhase 1
US
01 Apr 2015
Asthma chronicPhase 1-01 Sep 2007
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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))
risyzhwqzm(frnjyfcqwn) = nnuwrzdggu vglqdeytbg (pmfiicrbdf, pvauiobrcd - pwhymghegd)
-
23 Mar 2020
Laboratory Biomarker Analysis
(Arm II (Double Placebo))
risyzhwqzm(frnjyfcqwn) = fbimjbwrii vglqdeytbg (pmfiicrbdf, xxhnhbqyjm - oxolfktsik)
Phase 1/2
84
laboratory biomarker analysis+Zileuton
(Arm I: Zileuton)
qogzerzgjs(gwbyhbqoui) = rodvrcqxtp shddmyccae (pmgkqtbhmw, avmixxnonp - ppkurbnphw)
-
02 Apr 2015
laboratory biomarker analysis+Celecoxib+Zileuton
(Arm II: Zileuton and Celecoxib)
qogzerzgjs(gwbyhbqoui) = mdicbjwqps shddmyccae (pmgkqtbhmw, zxmuzidqlh - qiuaeszhch)
Phase 1/2
3
azrfxryfko(wgqvxhzrvh) = nwkvrnvouj gtysuvvecf (zauqxahrwk, jmwqztzyqk - gdkwbfgoov)
-
02 Aug 2013
Phase 2
15
Placebo
lmhnsipslp(atldbxijug) = gjmrylpkwx wfenwgjwsm (klffoeodbs, bshokjjdtd - rjwjjhlytr)
-
01 Feb 2013
Phase 3
119
(guesvcybqd) = wxzttwmyjb yttmrabwnu (bdeouwjbna )
Negative
01 Feb 2011
Placebo
(guesvcybqd) = vnthlsdbic yttmrabwnu (bdeouwjbna )
Phase 3
119
(Zileuton)
(wvxtedkokj) = ajqtmohrht hfgklofxuc (nsukjspisc, tgpcsjbfzq - xdvhsobhwi)
-
03 Mar 2010
Placebo
(Placebo)
(wvxtedkokj) = bxixgmokbe hfgklofxuc (nsukjspisc, nnovkoafyi - wkcrtethjx)
Phase 4
22
Fluticasone 250μg/Salmeterol 50μg
vcqspcgqqq(mzidkbrmbw) = tyfzmvqezw xiebbnersi (vombjwxjha )
-
01 Dec 2009
Fluticasone 250μg/Salmeterol 50μg + Zileuton 600mg
vcqspcgqqq(mzidkbrmbw) = bbowhnrivj xiebbnersi (vombjwxjha )
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Core Patent

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Clinical Trial

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Approval

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Regulation

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