Summary
Indomethacin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Obstructive Sleep Apnoea (OSA) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Obstructive Sleep Apnoea (OSA). ClinicalTrials.gov lists 4 registered trials linking Indomethacin to Obstructive Sleep Apnoea (OSA): 3 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT05074056). It plans or enrolled 142 participants. Registration activity spans 2011 to 2022. No published literature item is linked to Indomethacin and Obstructive Sleep Apnoea (OSA) in the OSMF database yet, so the record rests on registry entries alone. Registry entries describe intent to study, not outcomes.
The RepurpOS disease-intelligence file for Obstructive Sleep Apnea 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: Spontaneous resolution without intervention rare; weight loss of 10-15% reduces AHI by 25-50% in obese patients; mild OSA may resolve with weight loss; moderate-severe OSA essentially irreversible without intervention.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 32.5 (trials 12.5, literature 0.0, tier 15, approved bonus 5.0) |
| Registered trials | 4 total: 0 recruiting, 0 active / not yet recruiting, 3 completed, 1 other |
| Linked publications | 0 |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT05074056 | Ketorolac on Postoperative Pain Reduction in Pediatric Patients with Adenotonsillectomy 2022 | completed | Phase 4 | 142 |
| NCT03467750 | Effect of Ketorolac on Post Adenotonsillectomy Pain 2018 | completed | Phase 4 | 63 |
| NCT01280006 | Effect of Selective and Nonselective Cyclooxygenase Enzyme Inhibition on Arterial Blood Pressure and Cerebral Blood Flow With Exposure to Intermittent Hypoxia in Humans 2011 | completed | PHASE1, PHASE2 | 12 |
| NCT04483427 | Multimodal Postoperative Analgesia Following OSA Surgery 2020 | status unknown | Not applicable | 30 |
Published literature
No publication is linked to this pair yet.
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 Obstructive Sleep Apnoea (OSA)?
Indomethacin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Obstructive Sleep Apnoea (OSA) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Obstructive Sleep Apnoea (OSA). Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Indomethacin in clinical trials for Obstructive Sleep Apnoea (OSA)?
ClinicalTrials.gov lists 4 registered trials linking Indomethacin to Obstructive Sleep Apnoea (OSA): 3 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT05074056). It plans or enrolled 142 participants. Registration activity spans 2011 to 2022.
What does the evidence show for Indomethacin in Obstructive Sleep Apnoea (OSA)?
Indomethacin has 3 completed registered trials for Obstructive Sleep Apnoea (OSA) but no linked publication, which usually means results are unpublished, pending, or not yet matched to this record. 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 2026-07-06. Page built 2026-10-07.