Summary
Sulindac 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ClinicalTrials.gov lists 8 registered trials linking Sulindac to Colorectal Cancer: 3 have completed; 5 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT00118365). It plans or enrolled 375 participants. Registration activity spans 1996 to 2013. The literature layer holds 10 publications for this pair: 1 Cochrane review, 2 meta-analyses, 2 systematic reviews and 5 clinical trial publications. Publication years run from 2004 to 2024. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
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 | 69.5 (trials 20.5, literature 29.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 3 completed, 5 other |
| Linked publications | 10 (5 clinical trial publications, 2 meta-analyses, 2 systematic reviews, 1 Cochrane review) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | DGIdb |
| Linked via biomarker / target | APC |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00118365 | Eflornithine and Sulindac in Preventing Colorectal Cancer in Patients With Colon Polyps 1998 | completed | Phase 3 | 375 |
| NCT01483144 | Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis (FAP) 2013 | completed | Phase 3 | 171 |
| NCT01245816 | A Trial of Low Dose Sulindac Combined With Eflornithine in Patients With Familial Adenomatous Polyposis (FAP) 2011 | withdrawn | Phase 3 | — |
| NCT01187901 | A Clinical Trial of COX and EGFR Inhibition in Familial Polyposis Patients 2010 | completed | Phase 2 | 92 |
| NCT00062023 | Comparison of Sulindac, Aspirin, and Ursodiol in Preventing Colorectal Cancer 2003 | terminated | Phase 2 | 12 |
| NCT01856322 | Surgery Plus Sulindac or Surgery Alone for Advanced Colorectal Cancer 2013 | terminated | Phase 2 | 3 |
| NCT00319007 | Influence of Sulindac and Probiotics on the Development of Pouch Adenomas in Patients With Familial Adenomatous Polyposis 2006 | status unknown | Phase 2 | 30 |
| NCT00003365 | Sulindac and Plant Compounds in Preventing Colon Cancer 1996 | terminated | Not applicable | — |
Published literature
- Cochrane review Preventive effects of chemical drugs on recurrence of colorectal adenomas: systematic review and Bayesian network meta-analysisTan S, Ou Y, Yang Y et al. · European journal of gastroenterology & hepatology · 2024 · PMID 37942763
- Systematic review Eflornithine for chemoprevention in the high-risk population of colorectal cancer: a systematic review and meta-analysis with trial sequential analysisYang L, Wang Y, Hu S et al. · Frontiers in oncology · 2023 · PMID 38033490
- Meta-analysis The efficacy of chemopreventive agents on the incidence of colorectal adenomas: A systematic review and network meta-analysisHeer E, Ruan Y, Mah B et al. · Preventive medicine · 2022 · PMID 35878711
- Clinical trial publication Efficacy and safety of eflornithine (CPP-1X)/sulindac combination therapy versus each as monotherapy in patients with familial adenomatous polyposis (FAP): design and rationale of a randomized, double-blind, Phase III trialBurke CA, Dekker E, Samadder NJ et al. · BMC gastroenterology · 2016 · PMID 27480131
- Clinical trial publication Role of obesity in a randomized placebo-controlled trial of difluoromethylornithine (DFMO) + sulindac for the prevention of sporadic colorectal adenomasZell JA, Lin BS, Madson N et al. · Cancer causes & control : CCC · 2012 · PMID 22907422
- Clinical trial publication Randomized double-blind trial of sulindac and etodolac to eradicate aberrant crypt foci and to prevent sporadic colorectal polypsTakayama T, Nagashima H, Maeda M et al. · Clinical cancer research : an official journal of the American Association for Cancer Research · 2011 · PMID 21385928
- Clinical trial publication Randomized phase II trial of sulindac, atorvastatin, and prebiotic dietary fiber for colorectal cancer chemopreventionLimburg PJ, Mahoney MR, Ziegler KL et al. · Cancer prevention research (Philadelphia, Pa.) · 2011 · PMID 21209397
- Clinical trial publication Sulindac treatment in hereditary non-polyposis colorectal cancerRijcken FE, Hollema H, van der Zee AG et al. · European journal of cancer (Oxford, England : 1990) · 2007 · PMID 17434727
- Meta-analysis [Non-steroidal anti-inflammatory agents for chemoprevention of colorectal polyps: a meta-analysis]Wang YP, Wang Q, Gan T et al. · Zhonghua nei ke za zhi · 2004 · PMID 14990012
- Systematic review Nonsteroidal anti-inflammatory drugs and aspirin for the prevention of colorectal adenomas and cancer: a systematic reviewAsano TK, McLeod RS · Diseases of the colon and rectum · 2004 · PMID 15054679
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 DGIdb, in this case via the biomarker or target APC. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Sulindac approved for Colorectal Cancer?
Sulindac 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 Sulindac in clinical trials for Colorectal Cancer?
ClinicalTrials.gov lists 8 registered trials linking Sulindac to Colorectal Cancer: 3 have completed; 5 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT00118365). It plans or enrolled 375 participants. Registration activity spans 1996 to 2013.
What does the evidence show for Sulindac in Colorectal Cancer?
Sulindac has both completed registered trials and synthesis-level publications linked to Colorectal Cancer. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. 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 APC. 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.