Drugs / Zileuton
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | ZYFLO | — | 1996-12-09 | fda.gov ↗ |
Trials 15 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT01174056 | Jul 2011 → Mar 2014 | pneumonitis | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 13 trials | ||||||
| Phase 1 | NCT02047149 | Jan 2014 → Jun 2016 | chronic myeloid leukemia | University of Massachusetts, Worcester | Terminated | No outcome recorded |
| 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 |
| 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 |
| Phase 1/2 | NCT00299065 | Jan → Jun 2006 | asthma | Critical Therapeutics | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| 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 | No outcome recorded |
| 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 |
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT00723021 Comparator | Jul → Dec 2008 | asthma | Pfizer | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT00493974 Comparator | Mar 2007 → Dec 2008 | chronic obstructive pulmonary disease | University of Minnesota | Terminated | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT01125748 Background | May 2010 → Aug 2013 | allergic asthma | Genentech, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00575861 Comparator | Sep 2005 → Nov 2007 | asthma | Gelb, Arthur F., M.D. | Completed | No outcome recorded |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 21 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | zileuton | “zileuton or other 5-lipoxygenase enzyme inhibitors” NCT01125748 ↗ |
| 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 ↗ |