Summary
Indomethacin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Osteoarthritis would be drug repurposing rather than first-in-human development. This does not mean it is approved for Osteoarthritis. ClinicalTrials.gov lists 8 registered trials linking Indomethacin to Osteoarthritis: 1 is currently recruiting; 5 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT02638831). It plans or enrolled 240 participants. Registration activity spans 2007 to 2023. The literature layer holds 14 publications for this pair: 5 Cochrane reviews, 3 meta-analyses, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 1993 to 2021. 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 Osteoarthritis ranks 302 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: Structural progression is essentially universal over 10+ years without intervention; pain fluctuates but functional decline is the expected trajectory; no disease-modifying therapy exists as of 2024.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 77.5 (trials 27.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 1 recruiting, 0 active / not yet recruiting, 5 completed, 2 other |
| Linked publications | 14 (5 Cochrane reviews, 5 clinical trial publications, 3 meta-analyses, 1 randomised controlled trial publication) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
| Linked via biomarker / target | ALDH1A2 |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00562627 | Efficacy of Multimodal Peri- and Intraarticular Drug Injections in Total Knee Arthroplasty 2007 | completed | Phase 4 | 102 |
| NCT02638831 | Ketorol Gel in Gonarthrosis and Low Back Pain 2013 | completed | Phase 4 | 240 |
| NCT02765815 | A Comparison of Exparel Local Anesthetic in Total Knee Arthroplasty (TKA) Patients 2016 | withdrawn | Phase 4 | — |
| NCT03119038 | Efficacy of Intraoperative Injections on Postoperative Pain Control During Total Hip Replacement 2016 | withdrawn | Phase 4 | — |
| NCT05992883 | NSAID Injection Versus Corticosteroid Injection for Basilar Thumb Arthritis 2023 | recruiting | Phase 3 | 240 |
| NCT02860949 | Multimodal Drug Infiltration in Total Knee Arthroplasty: Is Posterior Capsular Infiltration Worth the Risk? 2014 | completed | Phase 2 | 90 |
| NCT02700451 | Post-op Acetaminophen vs NSAID Use on Lumbar Spinal Fusion Outcomes 2016 | completed | Not applicable | 178 |
| NCT01042093 | Efficacy of Multimodal Perioperative Analgesia With Periarticular Drug Injection in Total Knee Arthroplasty(TKA) 2010 | completed | Not applicable | 160 |
Published literature
- Clinical trial publication Effect and usability of anti-inflammatory drug plasters for knee osteoarthritis: A crossover, double-blind, repeated measures, randomized controlled trialTanabe H, Doi T, Akai M et al. · Journal of orthopaedic science : official journal of the Japanese Orthopaedic Association · 2021 · PMID 32773325
- Cochrane review Topical analgesics for acute and chronic pain in adults - an overview of Cochrane ReviewsDerry S, Wiffen PJ, Kalso EA et al. · The Cochrane database of systematic reviews · 2017 · PMID 28497473
- Clinical trial publication Prompt analgesic effect of antihistaminic diphenhydramine ointment on bone-joint-muscle pain as assessed by skin impedanceFujita T, Ohue M, Fujii Y et al. · Pharmacology · 2013 · PMID 24008505
- Clinical trial publication [Clinical study on the prevention of heterotopic ossification after total hip arthroplasty by Xiaozhong Zhitong]Liu HP, Li YJ, Wang CX et al. · Zhongguo gu shang = China journal of orthopaedics and traumatology · 2011 · PMID 22097138
- Clinical trial publication [Randomized, double blind, multicentre, parallel group study to compare efficacy and safety of acemetacin and indometacin in patients with activated osteoarthrosis of the knee]Gallacchi G, Hodinka L · Praxis · 2009 · PMID 19513973
- Clinical trial publication The chondroprotective effect of selective COX-2 inhibition in osteoarthritis: ex vivo evaluation of human cartilage tissue after in vivo treatmentde Boer TN, Huisman AM, Polak AA et al. · Osteoarthritis and cartilage · 2009 · PMID 18926729
- Cochrane review WITHDRAWN: Analgesia and non-aspirin, non-steroidal anti-inflammatory drugs for osteoarthritis of the hipTowheed TE, Hochberg MC, Shea BJ et al. · The Cochrane database of systematic reviews · 2007 · PMID 17636642
- Cochrane review WITHDRAWN: Non-aspirin, non-steroidal anti-inflammatory drugs for treating osteoarthritis of the kneeWatson M, Brookes ST, Faulkner A et al. · The Cochrane database of systematic reviews · 2007 · PMID 17636601
- Randomized controlled trial A double-blind, randomized, controlled parallel group study evaluating the efficacy and safety of acemetacin for the management of osteoarthritisChou CT, Tsai YY · International journal of clinical pharmacology research · 2002 · PMID 12395912
- Cochrane review Analgesia and non-aspirin, non-steroidal anti-inflammatory drugs for osteoarthritis of the hipTowheed T, Shea B, Wells G et al. · The Cochrane database of systematic reviews · 2000 · PMID 10796384
- Cochrane review Non-aspirin, non-steroidal anti-inflammatory drugs for osteoarthritis of the kneeWatson MC, Brookes ST, Kirwan JR et al. · The Cochrane database of systematic reviews · 2000 · PMID 10796306
- Meta-analysis Quantitative systematic review of topically applied non-steroidal anti-inflammatory drugsMoore RA, Tramèr MR, Carroll D et al. · BMJ (Clinical research ed.) · 1998 · PMID 9487165
- Meta-analysis A systematic review of randomized controlled trials of pharmacological therapy in osteoarthritis of the hipTowheed TE, Hochberg MC · The Journal of rheumatology · 1997 · PMID 9034996
- Meta-analysis A study to determine the efficacy and safety of tenoxicam versus piroxicam, diclofenac and indomethacin in patients with osteoarthritis: a meta-analysisRiedemann PJ, Bersinic S, Cuddy LJ et al. · The Journal of rheumatology · 1993 · PMID 8014938
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 ALDH1A2. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Indomethacin approved for Osteoarthritis?
Indomethacin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Osteoarthritis would be drug repurposing rather than first-in-human development. This does not mean it is approved for Osteoarthritis. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Indomethacin in clinical trials for Osteoarthritis?
ClinicalTrials.gov lists 8 registered trials linking Indomethacin to Osteoarthritis: 1 is currently recruiting; 5 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT02638831). It plans or enrolled 240 participants. Registration activity spans 2007 to 2023.
What does the evidence show for Indomethacin in Osteoarthritis?
Indomethacin has both completed registered trials and synthesis-level publications linked to Osteoarthritis. 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 ALDH1A2. 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.