Summary
Indomethacin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Colorectal Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Colorectal Cancer. ClinicalTrials.gov lists 6 registered trials linking Indomethacin to Colorectal Cancer: 1 is currently recruiting; 3 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT02958566). The largest enrolment is 274 participants (NCT06837831). Registration activity spans 1997 to 2026. The literature layer holds 2 publications for this pair: 2 clinical trial publications. Publication years run from 2008 to 2010. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
The RepurpOS disease-intelligence file for Colorectal Cancer ranks 1212 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: Essentially zero; 5-year survival stage I: ~90% (resectable); stage IV: ~15% overall, ~20-30% with modern therapy and liver metastasis resection.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 40.5 (trials 16.5, literature 4.0, tier 15, approved bonus 5.0) |
| Registered trials | 6 total: 1 recruiting, 0 active / not yet recruiting, 3 completed, 2 other |
| Linked publications | 2 (2 clinical trial publications) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
| Linked via biomarker / target | ABL1 |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
| NCT02958566 | Multimodal Narcotic Limited Perioperative Pain Control With Colorectal Surgery 2017 | status unknown | Phase 4 | 80 |
| NCT01719926 | Phase I Platinum Based Chemotherapy Plus Indomethacin 2012 | completed | Phase 1 | 13 |
| NCT05782608 | IV Ibuprofen vs Ketorolac in Post Operative Pain in Colorectal Cancer Surgeries in Obese Patient 2023 | completed | Not applicable | 50 |
| NCT06837831 | Mepilex Lite Dressings for the Treatment of Acute Radiation Dermatitis of Anal Canal Skin 2026 | recruiting | Not applicable | 274 |
| NCT00002796 | Phase I-II Study of Fluorouracil in Combination With Phenylbutyrate in Advanced Colorectal Cancer 1997 | terminated | PHASE1, PHASE2 | 46 |
Published literature
- Clinical trial publication Receptor and enzyme expression for prostanoid metabolism in colorectal cancer related to tumor tissue PGE2Gustafsson A, Andersson M, Lagerstedt K et al. · International journal of oncology · 2010 · PMID 20043083
- Clinical trial publication Preoperative treatment with a non-steroidal anti-inflammatory drug (NSAID) increases tumor tissue infiltration of seemingly activated immune cells in colorectal cancerLönnroth C, Andersson M, Arvidsson A et al. · Cancer immunity · 2008 · PMID 18307280
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 Open Targets and ChEMBL, in this case via the biomarker or target ABL1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Indomethacin approved for Colorectal Cancer?
Indomethacin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Colorectal Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Colorectal Cancer. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Indomethacin in clinical trials for Colorectal Cancer?
ClinicalTrials.gov lists 6 registered trials linking Indomethacin to Colorectal Cancer: 1 is currently recruiting; 3 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT02958566). The largest enrolment is 274 participants (NCT06837831). Registration activity spans 1997 to 2026.
What does the evidence show for Indomethacin in Colorectal Cancer?
Indomethacin has 3 completed trials and 2 linked publications for Colorectal Cancer. 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 Open Targets and ChEMBL, in this case via the biomarker or target ABL1. 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.