Summary
Naproxen Sodium 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 4 registered trials linking Naproxen Sodium to Ankylosing Spondylitis / Axial Spondyloarthropathy: 3 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT01208207). It plans or enrolled 1015 participants. Registration activity spans 2006 to 2015. No published literature item is linked to Naproxen Sodium and Ankylosing Spondylitis / Axial Spondyloarthropathy 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 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 | 34.0 (trials 14.0, 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 |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00844805 | Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1) 2009 | completed | Phase 3 | 158 |
| NCT01208207 | A Two-Part 26-Week Study of Etoricoxib as Treatment for Ankylosing Spondylitis (AS) (MK-0663-108) 2010 | completed | Phase 3 | 1,015 |
| NCT00367211 | Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers. 2006 | completed | Phase 3 | 400 |
| NCT02293681 | An Observational Study of Infliximab in Participants Suffering From Ankylosing Spondylitis With Hip Involvement 2015 | terminated | Not applicable | 76 |
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. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Naproxen Sodium approved for Ankylosing Spondylitis / Axial Spondyloarthropathy?
Naproxen Sodium 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 Naproxen Sodium in clinical trials for Ankylosing Spondylitis / Axial Spondyloarthropathy?
ClinicalTrials.gov lists 4 registered trials linking Naproxen Sodium to Ankylosing Spondylitis / Axial Spondyloarthropathy: 3 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT01208207). It plans or enrolled 1015 participants. Registration activity spans 2006 to 2015.
What does the evidence show for Naproxen Sodium in Ankylosing Spondylitis / Axial Spondyloarthropathy?
Naproxen Sodium has 3 completed registered trials for Ankylosing Spondylitis / Axial Spondyloarthropathy 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. 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.