Summary
Omeprazole 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 2 registered trials linking Omeprazole to Ankylosing Spondylitis / Axial Spondyloarthropathy: 1 has completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT03473665). The largest enrolment is 400 participants (NCT00367211). Registration activity spans 2006 to 2018. The literature layer holds 1 publication for this pair: 1 clinical trial publication. The dated items are from 2008. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
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 | 29.0 (trials 7.0, literature 2.0, tier 15, approved bonus 5.0) |
| Registered trials | 2 total: 0 recruiting, 0 active / not yet recruiting, 1 completed, 1 other |
| Linked publications | 1 (1 clinical trial publication) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | inhibitor |
| Data sources | DGIdb |
| Linked via biomarker / target | ATP4B |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT03473665 | Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis 2018 | terminated | Phase 4 | 9 |
| 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 |
Published literature
- Clinical trial publication Population pharmacokinetics of infliximab in patients with ankylosing spondylitisXu Z, Seitz K, Fasanmade A et al. · Journal of clinical pharmacology · 2008 · PMID 18401017
Mechanism and notes
Recorded mechanism or class: inhibitor.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target ATP4B. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Omeprazole approved for Ankylosing Spondylitis / Axial Spondyloarthropathy?
Omeprazole 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 Omeprazole in clinical trials for Ankylosing Spondylitis / Axial Spondyloarthropathy?
ClinicalTrials.gov lists 2 registered trials linking Omeprazole to Ankylosing Spondylitis / Axial Spondyloarthropathy: 1 has completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT03473665). The largest enrolment is 400 participants (NCT00367211). Registration activity spans 2006 to 2018.
What does the evidence show for Omeprazole in Ankylosing Spondylitis / Axial Spondyloarthropathy?
Omeprazole has 1 completed trial and 1 linked publication for Ankylosing Spondylitis / Axial Spondyloarthropathy. 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 DGIdb, in this case via the biomarker or target ATP4B. 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.