Summary
Indomethacin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Chronic Pancreatitis would be drug repurposing rather than first-in-human development. This does not mean it is approved for Chronic Pancreatitis. ClinicalTrials.gov lists 4 registered trials linking Indomethacin to Chronic Pancreatitis: 1 is currently recruiting; 3 have completed. The most advanced is Phase 4 (NCT02797067). It plans or enrolled 1370 participants. Registration activity spans 2016 to 2025. The literature layer holds 3 publications for this pair: 1 Cochrane review and 2 clinical trial publications. Publication years run from 2017 to 2025. 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 Chronic Pancreatitis ranks 50 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: Progressive exocrine and endocrine insufficiency; spontaneous improvement possible in alcoholic CP with sustained abstinence (30-40% pain improvement); structural damage (fibrosis, calcifications) is irreversible.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 41.5 (trials 12.5, literature 9.0, tier 15, approved bonus 5.0) |
| Registered trials | 4 total: 1 recruiting, 0 active / not yet recruiting, 3 completed, 0 other |
| Linked publications | 3 (2 clinical trial publications, 1 Cochrane review) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
| Linked via biomarker / target | ALDH2 |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT02797067 | Rectal Indomethacin to Prevent Post ESWL-pancreatitis 2016 | completed | Phase 4 | 1,370 |
| NCT04207060 | Trial of Indomethacin in Chronic Pancreatitis 2020 | completed | PHASE1, PHASE2 | 27 |
| NCT03609944 | SpHincterotomy for Acute Recurrent Pancreatitis 2018 | completed | Not applicable | 181 |
| NCT07202559 | Indometacin With or Without Aggressive Intravenous Hydration to Prevent Pancreatitis After Pancreatic Extracorporeal Shock Wave Lithotripsy 2025 | recruiting | Not applicable | 1,250 |
Published literature
- Clinical trial publication Oral Indomethacin for Chronic Pancreatitis: Results From the PAIR Randomized Placebo-Controlled TrialHan S, Vege SS, Hart PA et al. · Clinical and translational gastroenterology · 2025 · PMID 40622408
- Cochrane review Post-endoscopic retrograde cholangiopancreatography pancreatitis: A systematic review for prevention and treatmentPekgöz M · World journal of gastroenterology · 2019 · PMID 31413535
- Clinical trial publication Rectally administered indomethacin to prevent post-ESWL-pancreatitis (RIPEP): study protocol for a randomized controlled trialQian YY, Chen H, Tang XY et al. · Trials · 2017 · PMID 29096689
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 ALDH2. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Indomethacin approved for Chronic Pancreatitis?
Indomethacin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Chronic Pancreatitis would be drug repurposing rather than first-in-human development. This does not mean it is approved for Chronic Pancreatitis. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Indomethacin in clinical trials for Chronic Pancreatitis?
ClinicalTrials.gov lists 4 registered trials linking Indomethacin to Chronic Pancreatitis: 1 is currently recruiting; 3 have completed. The most advanced is Phase 4 (NCT02797067). It plans or enrolled 1370 participants. Registration activity spans 2016 to 2025.
What does the evidence show for Indomethacin in Chronic Pancreatitis?
Indomethacin has both completed registered trials and synthesis-level publications linked to Chronic Pancreatitis. 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 Open Targets and ChEMBL, in this case via the biomarker or target ALDH2. 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 2026-07-06. Page built 2026-10-07.