Ioversol

Evidence Level: L5 Predicted Indications: 10

Table of Contents

  1. Ioversol
  2. Ioversol: From Radiographic Contrast Imaging to Osteoarthritis Susceptibility
    1. One-Sentence Summary
    2. Quick Overview
    3. Why is This Prediction Reasonable?
    4. Clinical Trial Evidence
    5. Literature Evidence
    6. US Market Information
    7. Safety Considerations
    8. Conclusion and Next Steps
    9. Disclaimer

## Pharmacist Assessment Report

Ioversol: From Radiographic Contrast Imaging to Osteoarthritis Susceptibility

One-Sentence Summary

Ioversol is an iodinated radiographic contrast agent, marketed in the US as Optiray injection. The TxGNN model predicts it may be relevant to osteoarthritis susceptibility (score 99.67%), but this is a model prediction with 0 supporting clinical trials and 0 publications for that exact term. The related term osteoarthritis has 4 registered trials and 1 publication, but they test an embolization procedure, not ioversol as a treatment.


Quick Overview

Item Content
Original Indication Radiographic contrast imaging (the source record lists no approved indication text)
Predicted New Indication Osteoarthritis susceptibility
TxGNN Prediction Score 99.67%
Evidence Level L5 (model prediction only)
US Market Status ✓ Marketed
Number of NDAs 3 records (all under NDA019710)
Recommended Decision Hold

Why is This Prediction Reasonable?

Currently, detailed mechanism of action data is not available. Ioversol is an iodinated contrast agent used to make blood vessels and tissues visible on imaging. It is considered pharmacologically inert, with no known disease-modifying or genetic-susceptibility activity.

The evidence does not show a plausible mechanistic link between the original use (diagnostic imaging) and osteoarthritis. The high TxGNN score most likely reflects proximity in the knowledge graph, not a real biological effect. Other top predictions include rare skeletal dysplasias (brachyolmia, acromesomelic dysplasia) and alopecia, which also have no plausible mechanism.

The only indirect signal is on the related term osteoarthritis (rank 2, score 99.63%). Several trials study genicular artery embolization (GAE) for knee osteoarthritis. Ioversol may at most serve as the angiographic contrast agent during the procedure. The trials do not show it is the intervention, and some use Lipiodol (ethiodized oil), a different agent.


Clinical Trial Evidence

No trials are registered for “osteoarthritis susceptibility”. The trials below come from the related prediction “osteoarthritis”. They test embolization procedures, not ioversol.

Trial Number Phase Status Enrollment Key Findings
NCT06497140 Phase 3 Recruiting 130 Sham-controlled RCT of genicular artery embolization in symptomatic knee OA. The role of ioversol is not confirmed.
NCT06859164 Phase 2 Recruiting 50 Pilot sham-controlled GAE trial for knee OA pain (NIH-NIAMS funded). The role of ioversol is unclear.
NCT06611007 Phase 1/2 Recruiting 15 Safety of Lipiodol embolization in hand OA. Lipiodol is a different agent.
NCT04733092 Phase 1 Completed 22 Lipiodol emulsion embolization for inflammatory hypervascularization in knee pain. The agent is not ioversol.

Literature Evidence

None of the retrieved papers tests ioversol as a therapy for the predicted indication.

PMID Year Type Journal Key Findings
38102013 2024 Prospective clinical trial Diagn Interv Imaging LipioJoint-1: safety and efficacy of transient GAE with an ethiodized oil emulsion in knee OA. It is procedure-related and does not involve ioversol.
22195536 2012 Retrospective cohort Am J Med Safety of intravenous iodinated contrast in sickle cell disease. It concerns diagnostic use, not therapeutic benefit (rank 5, hemoglobinopathy).
23321839 2013 Case series / imaging review J Comput Assist Tomogr Craniofacial bone infarcts in sickle cell disease (rank 5, hemoglobinopathy). Imaging findings only.
40137121 2025 Computational study Metabolites In silico screen of PAD4 inhibitors for rheumatoid arthritis (rank 3). It does not involve ioversol.

US Market Information

Authorization Number Product Name Dosage Form Approved Indication
NDA019710 Optiray (Liebel-Flarsheim Company LLC) Injection Not specified in the source record

The record contains three identical entries for this NDA, shown once above. The route is injectable only.


Safety Considerations

Please refer to the package insert for safety information. No warnings, contraindications, or drug interaction data were retrieved.


Conclusion and Next Steps

Decision: Hold

Rationale: The prediction has no plausible mechanism and no direct clinical support. The only related trials study embolization procedures, and ioversol is not confirmed to be the intervention. The evidence stays at L5 for the top-ranked term, and at most L4 for the related osteoarthritis term.

To proceed, the following is needed:

  • Package insert warnings and contraindications (a blocking gap for safety screening)
  • Mechanism of action data
  • Confirmation of which contrast or embolic agent the GAE trials actually use, and whether ioversol plays any role
  • A biological rationale linking ioversol to osteoarthritis, if one exists

This report is for research reference only and does not constitute medical advice. Repurposing candidates require clinical validation before any application.

Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.



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