Summary
Indomethacin 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). ClinicalTrials.gov lists 2 registered trials linking Indomethacin to Inflammatory Bowel Disease (Crohn's / UC): 1 has completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00473980). It plans or enrolled 28 participants. Registration activity spans 1998 to 2023. The literature layer holds 1 publication for this pair: 1 clinical trial publication. The dated items are from 1965. 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 | 27.5 (trials 5.5, literature 2.0, tier 15, approved bonus 5.0) |
| Registered trials | 2 total: 0 recruiting, 0 active / not yet recruiting, 1 completed, 1 other |
| Linked publications | 1 (1 clinical trial publication) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | ChEMBL |
| Linked via biomarker / target | ADAM17 |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT00473980 | Preoperative Non-steroidal Anti-inflammatory Drugs(NSAID) to Colorectal Cancer Patients 1998 | completed | Phase 4 | 28 |
| NCT05999708 | A First Time in Human Study to Evaluate the Safety and Tolerability of GSK4381406 in Healthy Participants 2023 | withdrawn | Phase 1 | — |
Published literature
- Clinical trial publication Indomethacin in the treatment of uveitis. A double-blind trialPerkins ES, MacFaul PA · Transactions of the ophthalmological societies of the United Kingdom · 1965 · PMID 5335698
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in ChEMBL, in this case via the biomarker or target ADAM17. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Indomethacin approved for Inflammatory Bowel Disease (Crohn's / UC)?
Indomethacin 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 Indomethacin in clinical trials for Inflammatory Bowel Disease (Crohn's / UC)?
ClinicalTrials.gov lists 2 registered trials linking Indomethacin to Inflammatory Bowel Disease (Crohn's / UC): 1 has completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00473980). It plans or enrolled 28 participants. Registration activity spans 1998 to 2023.
What does the evidence show for Indomethacin in Inflammatory Bowel Disease (Crohn's / UC)?
Indomethacin has 1 completed trial and 1 linked publication for Inflammatory Bowel Disease (Crohn's / UC). Completed trials may or may not have posted results; follow the NCT links to check. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in ChEMBL, in this case via the biomarker or target ADAM17. 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.