Summary
Zileuton has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Inflammatory Bowel Disease (Crohn's / UC) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Inflammatory Bowel Disease (Crohn's / UC). No registered clinical trial in this database tests Zileuton specifically in Inflammatory Bowel Disease (Crohn's / UC). The evidence below comes from published literature only, so any clinical signal has not yet been tested prospectively against this condition in a registered study. The literature layer holds 2 publications for this pair: 2 clinical trial publications. Publication years run from 1992 to 1997. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
The RepurpOS disease-intelligence file for Inflammatory Bowel Disease ranks 200 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Disease course unchanged in ~85% of patients at 10 years on standard care; ~23% (CD) and ~12% (UC) relapse within 12 months of thiopurine withdrawal in sustained remission.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 24.0 (trials 0.0, literature 4.0, tier 15, approved bonus 5.0) |
| Registered trials | 0 total: 0 recruiting, 0 active / not yet recruiting, 0 completed, 0 other |
| Linked publications | 2 (2 clinical trial publications) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | inhibitor; inhibitor |
| Data sources | DGIdb |
| Linked via biomarker / target | ALOX5 |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
No registered trial links Zileuton to Inflammatory Bowel Disease (Crohn's / UC) in the current OSMF trial extract.
Published literature
- Clinical trial publication A trial of zileuton versus mesalazine or placebo in the maintenance of remission of ulcerative colitis. The European Zileuton Study Group For Ulcerative ColitisHawkey CJ, Dube LM, Rountree LV et al. · Gastroenterology · 1997 · PMID 9041232
- Clinical trial publication 5-Lipoxygenase inhibitors for the treatment of inflammatory bowel diseaseRask-Madsen J, Bukhave K, Laursen LS et al. · Agents and actions · 1992 · PMID 1359745
Mechanism and notes
Recorded mechanism or class: inhibitor; inhibitor.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target ALOX5. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Zileuton approved for Inflammatory Bowel Disease (Crohn's / UC)?
Zileuton has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Inflammatory Bowel Disease (Crohn's / UC) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Inflammatory Bowel Disease (Crohn's / UC). Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Zileuton in clinical trials for Inflammatory Bowel Disease (Crohn's / UC)?
No registered clinical trial in this database tests Zileuton specifically in Inflammatory Bowel Disease (Crohn's / UC). The evidence below comes from published literature only, so any clinical signal has not yet been tested prospectively against this condition in a registered study.
What does the evidence show for Zileuton in Inflammatory Bowel Disease (Crohn's / UC)?
The record for Zileuton in Inflammatory Bowel Disease (Crohn's / UC) rests on 2 publications without a registered trial. This is a lead for hypothesis generation, not evidence of efficacy. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target ALOX5. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.