Ioversol

證據等級: L5

預測適應症: 10 個

Ioversol: From Diagnostic Imaging to Osteoarthritis

One-Sentence Summary

Ioversol is a water-soluble, non-ionic iodinated contrast medium used exclusively as a diagnostic imaging agent for radiographic procedures including CT, angiography, and urography — it carries no approved therapeutic indications. The TxGNN model's top-ranked prediction is osteoarthritis susceptibility (99.67%), though this represents a genetic predisposition phenotype rather than a directly druggable condition; the more clinically relevant Rank 2 prediction is osteoarthritis (99.63%), supported by 4 clinical trials and 1 publication — however, all of these investigate Lipiodol-based genicular artery embolization, not Ioversol's direct therapeutic activity.

Quick Overview

Item	Content
Original Indication	Diagnostic imaging contrast enhancement (radiographic/CT procedures)
Predicted New Indication	Osteoarthritis Susceptibility (Rank 1) / Osteoarthritis (Rank 2)
TxGNN Prediction Score	99.67% (Rank 1) / 99.63% (Rank 2)
Evidence Level	L5 (Rank 1) / L4 (Rank 2)
Singapore Market Status	✗ Not marketed
Number of Registrations	0
Recommended Decision	Hold

Why is This Prediction Reasonable?

Currently, detailed mechanism of action data is not available in the Evidence Pack. Based on established pharmacology, Ioversol is a water-soluble, non-ionic, low-osmolar iodinated contrast medium whose sole clinical function is diagnostic imaging — it enhances X-ray attenuation via its high iodine content to provide contrast in CT scans, angiography, and other radiographic procedures. It carries no anti-inflammatory, chondroprotective, analgesic, or immunomodulatory properties of any kind.

The top-ranked TxGNN prediction, osteoarthritis susceptibility, represents a genetic predisposition phenotype driven by variants in genes such as GDF5 and ALDH1A2 — this is not a pharmacologically targetable disease state but rather a heritable trait. Ioversol has no gene-modifying or epigenetic regulatory mechanism, and the high prediction score most likely reflects short-distance proximity to the osteoarthritis node within the TxGNN knowledge graph topology rather than a genuine mechanistic prediction.

The Rank 2 prediction, osteoarthritis, has a marginally more plausible contextual connection: iodinated contrast media are used as procedural adjuncts during genicular artery embolization (GAE), an emerging interventional therapy for knee OA pain that targets synovial neovascularization. However, all current GAE clinical trials use Lipiodol (ethiodized oil) — an oil-based emulsion with dual embolic and contrast properties — which is chemically and mechanistically distinct from Ioversol's water-soluble, non-embolic formulation. In any GAE procedure, Ioversol's role would be inert vessel visualization only, not therapeutic contribution.

Clinical Trial Evidence

⚠️ Important note: The top-ranked prediction (osteoarthritis susceptibility, Rank 1) has no registered clinical trials. The four trials below are associated with the Rank 2 prediction (osteoarthritis) and involve genicular artery embolization — however, all use Lipiodol or ethiodized oil as the investigational embolization agent, not Ioversol itself.

Trial Number	Phase	Status	Enrollment	Key Findings
NCT04733092	Phase 1	Completed	22	Safety and efficacy of Lipiodol emulsion embolization for inflammatory hypervascularization in knee OA and periarticular pain; first-in-man pain relief validation
NCT06497140	Phase 3	Recruiting	130	Multicenter randomized sham-controlled RCT of GAE using ethiodized oil-based emulsion for symptomatic knee OA; currently the highest-quality trial design in the GAE field
NCT06611007	Phase 1/2	Recruiting	15	Pilot study evaluating safety and efficacy of Lipiodol® arterial embolization for symptomatic digital (hand) OA refractory to conventional treatment
NCT06859164	Phase 2	Recruiting	50	NIH-NIAMS funded pilot sham-controlled RCT of GAE for symptomatic knee OA; assessing enrollment feasibility and pain reduction (KOOS pain subscore) at 3 months

Literature Evidence

⚠️ Important note: The top-ranked prediction (osteoarthritis susceptibility, Rank 1) has no supporting literature. The publication below is associated with the Rank 2 prediction (osteoarthritis) but evaluates Lipiodol-based embolization — not Ioversol as a therapeutic agent.

PMID	Year	Type	Journal	Key Findings
38102013	2024	Phase 1 RCT	Diagnostic and Interventional Imaging	LipioJoint-1 trial: evaluated safety and efficacy of transient genicular artery embolization using an ethiodized oil-based emulsion for knee OA; demonstrated proof-of-concept for GAE as an OA pain intervention

Singapore Market Information

Ioversol currently has no HSA registrations in Singapore and is not marketed. No authorized product table can be generated.

Safety Considerations

No Singapore-registered package insert is available. Please refer to the international prescribing information (Optiray®, Guerbet) for full safety data.

The following considerations are relevant for iodinated contrast media as a class:

Renal toxicity: Risk of contrast-induced acute kidney injury; pre-procedure renal function assessment (eGFR) and adequate hydration are standard practice
Hypersensitivity reactions: Anaphylactoid reactions are possible; emergency management protocols should be in place at administration sites
Hemoglobinopathy patients: Available safety data (PMID 22195536) indicate that modern low- and iso-osmolar iodinated contrast agents show less in vitro erythrocyte sickling compared to older ionic agents, though clinical monitoring in patients with sickle cell disease remains warranted

Conclusion and Next Steps

Decision: Hold

Rationale: Ioversol is a diagnostic imaging agent with no established therapeutic mechanism for osteoarthritis, joint disease, or any of the other TxGNN-predicted conditions. The high prediction scores for osteoarthritis susceptibility and osteoarthritis most likely reflect knowledge graph topology artifacts (proximity to the OA node cluster) rather than genuine biological plausibility. All available clinical evidence pertains to Lipiodol-based GAE — a chemically and mechanistically distinct intervention that cannot be extrapolated to support Ioversol repurposing.

To proceed, the following would be needed:

A credible mechanistic hypothesis explaining how a non-embolic, water-soluble contrast agent could exert therapeutic benefit in OA independent of its imaging role
In vitro or preclinical evidence for any direct pharmacological activity on joint tissue, synovium, or inflammatory pathways
KG graph analysis to determine whether the high TxGNN scores represent a genuine biological signal or an artifact of osteoarthritis node centrality in the graph
If the broader goal is to evaluate GAE as an OA intervention, the relevant investigational product is Lipiodol or microparticle-based embolic agents — not Ioversol
Disclaimer

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