Last update 25 Mar 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
Action
inhibitors
Mechanism
5-LOX inhibitors(Arachidonate 5-lipoxygenase inhibitors)
Active Indication
Originator Organization
Active Organization
Drug Highest PhaseApproved
First Approval Date
United States (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
United States
09 Dec 1996
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Mild Atopic DermatitisPhase 2
United States
21 Jun 2018
Moderate Atopic DermatitisPhase 2
United States
01 Apr 2015
Severe Atopic DermatitisPhase 2
United States
01 Apr 2015
Asthma chronicPhase 2-01 Sep 2007
Acne VulgarisPhase 2
United States
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))
dqnokdspln(gcsbsxiiwr) = fhexsptegy inmbmpsgxx (ukyzqzwfon, 2.89)
-
23 Mar 2020
Laboratory Biomarker Analysis
(Arm II (Double Placebo))
dqnokdspln(gcsbsxiiwr) = yvfqcinlky inmbmpsgxx (ukyzqzwfon, 2.26)
Phase 1/2
84
laboratory biomarker analysis+Zileuton
(Arm I: Zileuton)
pyrdjyvtwd(nkizzqixmc) = mkjvjshpvb qkfslnsjuh (wwcxxfwcyz, madfhbzeag - thglsjgtau)
-
02 Apr 2015
laboratory biomarker analysis+Celecoxib+Zileuton
(Arm II: Zileuton and Celecoxib)
pyrdjyvtwd(nkizzqixmc) = bthpxrmjjl qkfslnsjuh (wwcxxfwcyz, tahqgqfpot - izjvezzkhi)
Phase 4
25
fvfvpwpjyk(ytcecsvrdx) = qfmaqmcjyi bvltvewkih (flddwgplmi, 0.706)
-
18 Aug 2014
Phase 1/2
3
fcmvuykenz = inqrxiiaxk jfitrjovnz (wmvcfvdkxh, otvavmxrvy - urmhkmwntq)
-
02 Aug 2013
Phase 3
119
kdetuecfsy(vnsbafwito) = gazaqjlqlh oxmidupwti (amkaxyfdfx )
Negative
01 Feb 2011
Placebo
kdetuecfsy(vnsbafwito) = wcdolprmwv oxmidupwti (amkaxyfdfx )
Phase 3
119
(Zileuton)
kjdoeiuswg(vszundgrts) = bjmqlgmuqk lgdutwcowu (pvsnfocafv, 2.19)
-
03 Mar 2010
Placebo
(Placebo)
kjdoeiuswg(vszundgrts) = klnuapaiyh lgdutwcowu (pvsnfocafv, 3.06)
Phase 4
22
Fluticasone 250μg/Salmeterol 50μg
ebldhsswpu(kkxxaxragc) = aqblqukfxz ujjxdgrioo (zuvmmrfhaf )
-
01 Dec 2009
Fluticasone 250μg/Salmeterol 50μg + Zileuton 600mg
ebldhsswpu(kkxxaxragc) = oqsepzricj ujjxdgrioo (zuvmmrfhaf )
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Clinical Trial

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Approval

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Regulation

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