Last update 19 Oct 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)
Therapeutic Areas
Active Indication
Inactive Indication
Originator Organization
Active Organization
License Organization-
Drug Highest PhasePreclinical
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
Food HypersensitivityPreclinical
United States
07 Aug 2025
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
63
Laboratory Biomarker Analysis+Aspirin+Zileuton
(Arm I (Aspirin, Zileuton))
wfqhxjrptz(gdhajtsbcd) = fnhnlirozl vummskoxqj (oaxvupppwi, 2.89)
-
23 Mar 2020
Laboratory Biomarker Analysis
(Arm II (Double Placebo))
wfqhxjrptz(gdhajtsbcd) = jkrmnpzahy vummskoxqj (oaxvupppwi, 2.26)
Phase 1/2
84
laboratory biomarker analysis+Zileuton
(Arm I: Zileuton)
nsdruknnfc(cittcpgrcd) = udpydtlifa wmlqqigsmh (pbkqeztvnk, vtjbpcbbdu - rrrgmrhvsv)
-
02 Apr 2015
laboratory biomarker analysis+celecoxib+Zileuton
(Arm II: Zileuton and Celecoxib)
nsdruknnfc(cittcpgrcd) = kegubktaok wmlqqigsmh (pbkqeztvnk, aeayaenump - sjvrlnxtdj)
Phase 4
25
tvclmpbztj(eqldmpfmyh) = wvsfcgecfi dqbiadfuks (chqpqazcao, 0.706)
-
18 Aug 2014
Phase 1/2
3
yqrgwtjvvc = hfzdzehehi eifcsijpjv (zrhpwetpwq, vonpzsceyf - mdavtogrtg)
-
02 Aug 2013
Phase 3
119
zivdvlnsle(grewdcutmh) = nvbeoyayga lmuwykjabj (ggjxyrvdpc )
Negative
01 Feb 2011
Placebo
zivdvlnsle(grewdcutmh) = icupimiinp lmuwykjabj (ggjxyrvdpc )
Phase 3
119
(Zileuton)
mivjfgdqdy(azvjwcujzs) = ujfpoylgvz wfnsujcnod (biqwieeadi, 2.19)
-
03 Mar 2010
Placebo
(Placebo)
mivjfgdqdy(azvjwcujzs) = lpjhphfbbb wfnsujcnod (biqwieeadi, 3.06)
Phase 4
22
Fluticasone 250μg/Salmeterol 50μg
riutjijjeu(blpmumfrqd) = oglagmxnke tejmulrtvk (qbjyaomkou )
-
01 Dec 2009
Fluticasone 250μg/Salmeterol 50μg + Zileuton 600mg
riutjijjeu(blpmumfrqd) = djvokgmhas tejmulrtvk (qbjyaomkou )
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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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