Summary
Indomethacin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Systemic Lupus Erythematosus (SLE) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Systemic Lupus Erythematosus (SLE). No registered clinical trial in this database tests Indomethacin specifically in Systemic Lupus Erythematosus (SLE). The evidence below comes from published literature only, so any clinical signal has not yet been tested prospectively against this condition in a registered study. The literature layer holds 4 publications for this pair: 4 clinical trial publications. Publication years run from 1980 to 1997. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
The RepurpOS disease-intelligence file for Systemic Lupus Erythematosus ranks 276 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: Spontaneous drug-free remission: 2-10% in some cohorts over 5 years; disease-free survival in 15-20% at 20 years; renal lupus (LN) progression to ESRD in 10-20% within 20 years on standard care.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 28.0 (trials 0.0, literature 8.0, tier 15, approved bonus 5.0) |
| Registered trials | 0 total: 0 recruiting, 0 active / not yet recruiting, 0 completed, 0 other |
| Linked publications | 4 (4 clinical trial publications) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | ChEMBL |
| Linked via biomarker / target | ATRIP |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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
No registered trial links Indomethacin to Systemic Lupus Erythematosus (SLE) in the current OSMF trial extract.
Published literature
- Clinical trial publication Methotrexate in patients with moderate systemic lupus erythematosus (exclusion of renal and central nervous system disease)Gansauge S, Breitbart A, Rinaldi N et al. · Annals of the rheumatic diseases · 1997 · PMID 9227169
- Clinical trial publication Improvement of renal function with a selective thromboxane A2 synthetase inhibitor, DP-1904, in lupus nephritisYoshida T, Kameda H, Ichikawa Y et al. · The Journal of rheumatology · 1996 · PMID 8895147
- Clinical trial publication Refractory nephrotic syndrome in lupus nephritis: favorable response to indomethacin therapyEspinoza LR, Jara LJ, Martinez-Osuna P et al. · Lupus · 1993 · PMID 8485564
- Clinical trial publication Immunological effects of Biarison in the treatment of rheumatoid arthritis and systemic lupus erythematosus. A preliminary reportSkrifvars B, Nissilä M · Scandinavian journal of rheumatology · 1980 · PMID 7375869
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 ChEMBL, in this case via the biomarker or target ATRIP. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Indomethacin approved for Systemic Lupus Erythematosus (SLE)?
Indomethacin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Systemic Lupus Erythematosus (SLE) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Systemic Lupus Erythematosus (SLE). Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Indomethacin in clinical trials for Systemic Lupus Erythematosus (SLE)?
No registered clinical trial in this database tests Indomethacin specifically in Systemic Lupus Erythematosus (SLE). The evidence below comes from published literature only, so any clinical signal has not yet been tested prospectively against this condition in a registered study.
What does the evidence show for Indomethacin in Systemic Lupus Erythematosus (SLE)?
The record for Indomethacin in Systemic Lupus Erythematosus (SLE) rests on 4 publications without a registered trial. This is a lead for hypothesis generation, not evidence of efficacy. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in ChEMBL, in this case via the biomarker or target ATRIP. 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.