Summary
Indomethacin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Ankylosing Spondylitis / Axial Spondyloarthropathy would be drug repurposing rather than first-in-human development. This does not mean it is approved for Ankylosing Spondylitis / Axial Spondyloarthropathy. ClinicalTrials.gov lists 3 registered trials linking Indomethacin to Ankylosing Spondylitis / Axial Spondyloarthropathy: 1 is active or not yet recruiting; 1 has completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT07582146). The largest enrolment is 192 participants (NCT02183168). Registration activity spans 2001 to 2026. The literature layer holds 8 publications for this pair: 1 Cochrane review, 2 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 1990 to 2015. 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 Ankylosing Spondylitis ranks 151 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 structural damage (sacroiliac fusion, syndesmophytes) in majority without treatment; spontaneous radiographic remission essentially zero; ~10% achieve clinical remission without anti-inflammatory therapy.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 52.0 (trials 11.0, literature 21.0, tier 15, approved bonus 5.0) |
| Registered trials | 3 total: 0 recruiting, 1 active / not yet recruiting, 1 completed, 1 other |
| Linked publications | 8 (5 clinical trial publications, 2 randomised controlled 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 | ALOX5 |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT07582146 | Effectiveness and Safety of Acemetacin in Active Axial Spondyloarthritis: A Real-world Study 2026 | not yet recruiting | Phase 4 | 150 |
| NCT03473665 | Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis 2018 | terminated | Phase 4 | 9 |
| NCT02183168 | Evaluation of Efficacy and Safety of Meloxicam Suppository (15mg Daily) and Tablet (15 mg Daily) Compared to Indomethacin Suppository (50 mg Daily) in Patients With Ankylosing Spondylitis 2001 | completed | Phase 3 | 192 |
Published literature
- Cochrane review Non-steroidal anti-inflammatory drugs (NSAIDs) for axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis)Kroon FP, van der Burg LR, Ramiro S et al. · The Cochrane database of systematic reviews · 2015 · PMID 26186173
- Clinical trial publication Medication toxicity among patients with ankylosing spondylitisWard MM, Kuzis S · Arthritis and rheumatism · 2002 · PMID 12115151
- Clinical trial publication Efficacy of methotrexate in the treatment of ankylosing spondylitis: a three-year open studyBiasi D, Carletto A, Caramaschi P et al. · Clinical rheumatology · 2000 · PMID 10791621
- Clinical trial publication [Clinical and experimental study on treatment of ankylosing spondylitis]Lu S, Wang C, Yin Y · Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine · 1999 · PMID 11783210
- Clinical trial publication The efficacy and tolerability of aceclofenac in the treatment of patients with ankylosing spondylitis: a multicenter controlled clinical trial. Aceclofenac Indomethacin Study GroupBatlle-Gualda E, Figueroa M, Ivorra J et al. · The Journal of rheumatology · 1996 · PMID 8823693
- Clinical trial publication A comparative study of nabumetone and indomethacin in ankylosing spondylitisPalferman TG, Webley M · European journal of rheumatology and inflammation · 1991 · PMID 1365469
- Randomized controlled trial A 12-week double-blind study of the efficacy, safety and tolerance of pirazolac b.i.d. compared with indomethacin t.i.d. in patients with ankylosing spondylitisCarcassi C, La Nasa G, Perpignano G · Drugs under experimental and clinical research · 1990 · PMID 2198157
- Randomized controlled trial An overview of the efficacy of etodolac in arthritic disordersBacon PA · European journal of rheumatology and inflammation · 1990 · PMID 2146130
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 ALOX5. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Indomethacin approved for Ankylosing Spondylitis / Axial Spondyloarthropathy?
Indomethacin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Ankylosing Spondylitis / Axial Spondyloarthropathy would be drug repurposing rather than first-in-human development. This does not mean it is approved for Ankylosing Spondylitis / Axial Spondyloarthropathy. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Indomethacin in clinical trials for Ankylosing Spondylitis / Axial Spondyloarthropathy?
ClinicalTrials.gov lists 3 registered trials linking Indomethacin to Ankylosing Spondylitis / Axial Spondyloarthropathy: 1 is active or not yet recruiting; 1 has completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT07582146). The largest enrolment is 192 participants (NCT02183168). Registration activity spans 2001 to 2026.
What does the evidence show for Indomethacin in Ankylosing Spondylitis / Axial Spondyloarthropathy?
Indomethacin has both completed registered trials and synthesis-level publications linked to Ankylosing Spondylitis / Axial Spondyloarthropathy. 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 ALOX5. 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.