Drugs / Zileuton

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) ZYFLO — 1996-12-09 fda.gov ↗

Trials 15

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial · 1 missed
Phase 0 NCT01174056 Jul 2011 → Mar 2014 pneumonitis Washington University School of Medicine Completed Missed primary
Phase 13 trials
Phase 1 NCT02047149 Jan 2014 → Jun 2016 chronic myeloid leukemia University of Massachusetts, Worcester Terminated No outcome recorded Stop: Enrollment
Phase 1 NCT01136941 Sep 2010 → Apr 2013 sickle cell disease Children's Hospital Medical Center, Cincinnati Completed No outcome recorded
Phase 1 NCT01130688 Jan 2010 → Oct 2012 chronic myeloid leukemia University of Massachusetts, Worcester Terminated No outcome recorded Stop: Enrollment
Phase 1/23 trials
Phase 1/2 NCT01021215 May 2010 → Aug 2012 nicotine dependence National Cancer Institute (NCI) Completed No outcome recorded
Phase 1/2 NCT00467831 Apr 2007 → Nov 2012 Hermansky-Pudlak syndrome, oculocutaneous albinism, platelet storage pool deficiency, pulmonary fibrosis National Human Genome Research Institute (NHGRI) Terminated No outcome recorded Stop: Enrollment
Phase 1/2 NCT00299065 Jan → Jun 2006 asthma Critical Therapeutics Completed No outcome recorded
Phase 26 trials · 1 missed
Phase 2 NCT02348203 Jan 2016 → Feb 2019 nicotine dependence National Cancer Institute (NCI) Completed No outcome recorded
Phase 2 NCT00534625 Sep 2007 → Mar 2008 asthma Critical Therapeutics Completed No outcome recorded
Phase 2 NCT00098358 Nov 2004 → May 2005 acne Critical Therapeutics Unknown No outcome recorded
Phase 2 NCT00070486 Dec 2003 → Dec 2006 lung cancer Alliance for Clinical Trials in Oncology Completed Missed primary
Phase 2 NCT00056004 Jun 2003 → Sep 2006 head and neck cancer, lung cancer Barbara Ann Karmanos Cancer Institute Completed No outcome recorded
Phase 2 NCT00262405 Jan 2001 → May 2007 idiopathic pulmonary fibrosis University of Michigan Completed No outcome recorded
Phase 42 trials
Phase 4 NCT01805687 Mar → Jun 2013 asthma Cornerstone Therapeutics Inc. Completed No outcome recorded
Phase 4 NCT00486343 Jul 2007 → May 2008 asthma Critical Therapeutics Terminated No outcome recorded Stop: Enrollment
Comparator or background therapy4 trials
Phase 2 NCT00723021 Comparator Jul → Dec 2008 asthma Pfizer Completed No outcome recorded
Phase 3 NCT00493974 Comparator Mar 2007 → Dec 2008 chronic obstructive pulmonary disease University of Minnesota Terminated No outcome recorded Stop: Enrollment
Phase 4 NCT01125748 Background May 2010 → Aug 2013 allergic asthma Genentech, Inc. Completed Met primary
Phase 4 NCT00575861 Comparator Sep 2005 → Nov 2007 asthma Gelb, Arthur F., M.D. Completed No outcome recorded

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2019-11-08 Lupin Limited Regulatory Lupin receives US FDA approval for Zileuton Extended-Release Tablets lupin.com ↗

All press releases naming this drug 2 releases

DateIssuerRelease

Evidence & citations 12 cited values

Every value below carries the sentence it was read from. 21 sources stand behind the page.

FieldValueCited text
Known as zileuton “zileuton or other 5-lipoxygenase enzyme inhibitors” NCT01125748 ↗
18

NCT00262405 ↗

NCT01136941 ↗

NCT00534625 ↗

NCT00493974 ↗

NCT00467831 ↗

NCT00098358 ↗

NCT01021215 ↗

NCT01805687 ↗

NCT00070486 ↗

NCT01174056 ↗

Show 8 more sources

Known as A-64077 ChEMBL registry synonym — accepted as the source's own label CHEMBL93 ↗
Known as ABBOTT-64077 ChEMBL registry synonym — accepted as the source's own label CHEMBL93 ↗
Known as NSC-730712 ChEMBL registry synonym — accepted as the source's own label CHEMBL93 ↗
Known as NSC-759277 ChEMBL registry synonym — accepted as the source's own label CHEMBL93 ↗
Known as Zileuton CR “Zileuton CR tablets 2x600mg BID for 24 weeks” NCT00486343 ↗
Known as Zyflo ChEMBL registry synonym — accepted as the source's own label CHEMBL93 ↗
Known as Zyflo CR “Study to evaluate the bronchodilator effects of Zyflo CR in patients with chronic stable asthma.” NCT01805687 ↗
Action Inhibit “inhibitors of two eicosanoid pathways (cyclooxygenase-2 [COX-2], celecoxib and 5-lipoxygenase [5-LOX], zileuton) added to chemotherapy” PMID 18281656 ↗ Feb 2008
Modality Small molecule — CHEMBL93 ↗
Route Oral “receive oral zileuton” NCT00056004 ↗
Target ALOX5 “the arachidonate 5-lipoxygenase (5-LO) gene (Alox5) is a critical regulator for LSCs in BCR-ABL-induced CML (Chen Y et al. Loss of the Alox5 gene impairs leukemia stem cells...” NCT01130688 ↗