Summary
Indomethacin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Asthma would be drug repurposing rather than first-in-human development. This does not mean it is approved for Asthma. ClinicalTrials.gov lists 1 registered trial linking Indomethacin to Asthma: 1 has completed. The most advanced is Phase 1 (NCT01733485). It plans or enrolled 50 participants. Registered activity dates to 2011. The literature layer holds 6 publications for this pair: 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 1997 to 2000. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
The RepurpOS disease-intelligence file for Asthma ranks 642 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: 26% of childhood-onset asthma in clinical remission by adulthood; <20% adult-onset achieves sustained remission; 65% long-term remission in mild-moderate vs 16% in severe.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 36.0 (trials 3.0, literature 13.0, tier 15, approved bonus 5.0) |
| Registered trials | 1 total: 0 recruiting, 0 active / not yet recruiting, 1 completed, 0 other |
| Linked publications | 6 (5 clinical trial publications, 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 | ADORA1 |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT01733485 | Electrophilic Fatty Acid Derivatives in Asthma 2011 | completed | Phase 1 | 50 |
Published literature
- Clinical trial publication Effect of inhaled indomethacin in asthmatic patients taking high doses of inhaled corticosteroidsTamaoki J, Nakata J, Nishimura K et al. · The Journal of allergy and clinical immunology · 2000 · PMID 10856147
- Clinical trial publication Allergen-induced synthesis of F(2)-isoprostanes in atopic asthmatics. Evidence for oxidant stressDworski R, Murray JJ, Roberts LJ 2nd et al. · American journal of respiratory and critical care medicine · 1999 · PMID 10588611
- Clinical trial publication Different effects of inhaled aspirinlike drugs on allergen-induced early and late asthmatic responsesSestini P, Refini RM, Pieroni MG et al. · American journal of respiratory and critical care medicine · 1999 · PMID 10194170
- Clinical trial publication Inhibitory effect of indomethacin on tachyphylaxis in response to acetaldehyde-induced bronchoconstriction in patients with asthmaFujimura M, Myou S, Kamio Y et al. · The Journal of allergy and clinical immunology · 1997 · PMID 9155828
- Clinical trial publication Effect of inhaled frusemide and oral indomethacin on the airway response to hypertonic saline challenge in asthmatic subjectsRodwell LT, Anderson SD, Spring J et al. · Thorax · 1997 · PMID 9039247
- Randomized controlled trial Effect of inhaled indomethacin on exercise-induced bronchoconstriction in children with asthmaShimizu T, Mochizuki H, Shigeta M et al. · American journal of respiratory and critical care medicine · 1997 · PMID 9001307
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 ADORA1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Indomethacin approved for Asthma?
Indomethacin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Asthma would be drug repurposing rather than first-in-human development. This does not mean it is approved for Asthma. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Indomethacin in clinical trials for Asthma?
ClinicalTrials.gov lists 1 registered trial linking Indomethacin to Asthma: 1 has completed. The most advanced is Phase 1 (NCT01733485). It plans or enrolled 50 participants. Registered activity dates to 2011.
What does the evidence show for Indomethacin in Asthma?
Indomethacin has 1 completed trial and 6 linked publications for Asthma. Completed trials may or may not have posted results; follow the NCT links to check. 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 ADORA1. 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.