Iodixanol
| Evidence Level: L5 | Predicted Indications: 3 |
Table of Contents
Iodixanol: From Iodinated Contrast Agent to Osteoarthritis Susceptibility
One-Sentence Summary
Iodixanol is an iodinated, non-ionic contrast agent used in diagnostic imaging, and it is marketed in the US as an injectable solution. The TxGNN model predicts it may be relevant to Osteoarthritis Susceptibility, but this is a computational prediction only, with 0 clinical trials and 0 publications supporting it.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not listed in the available US license records (Iodixanol is an iodinated contrast agent) |
| Predicted New Indication | Osteoarthritis susceptibility |
| TxGNN Prediction Score | 99.16% |
| Evidence Level | L5 |
| US Market Status | ✓ Marketed |
| Number of NDAs | 4 license records (2 unique: NDA020351 and ANDA214271) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Iodixanol is an iodinated, non-ionic contrast agent. It has no known disease-modifying pharmacology, so no mechanistic link to osteoarthritis susceptibility can be identified.
“Susceptibility” describes a genetic-risk phenotype rather than a clinical condition that can be treated. The high score (99.16%) most likely reflects a co-occurrence signal in the knowledge graph, not a therapeutic relationship.
Iodixanol does appear in osteoarthritis research, but as a diagnostic and experimental probe. For example, it is used as a CT contrast agent to study solute diffusion through cartilage. That is a different use from treating the disease.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available for osteoarthritis susceptibility.
For the closely related prediction osteoarthritis (score 99.07%), 7 papers were retrieved, but they do not support a treatment effect:
- They use iodinated contrast agents as imaging or diffusion probes. Examples are cartilage solute transport (PMID 27793406, 28063646) and photon-counting CT (PMID 40155520).
- One in vitro study found that iodine contrast agents did not affect platelet-rich plasma function (PMID 30374787).
- All are preclinical, computational or ex vivo studies, with no clinical efficacy data.
US Market Information
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| NDA020351 | Visipaque | Injection, solution | GE Healthcare Inc. |
| ANDA214271 | Iodixanol | Injection, solution | Fresenius Kabi USA, LLC |
The source data lists each of these two licenses twice, which accounts for the 4 records. Approved indication text is not available in the records.
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests on a model score alone. There are no clinical trials, the literature covers only diagnostic or experimental use, and there is no plausible therapeutic mechanism. “Osteoarthritis susceptibility” is also not a treatable clinical indication.
To proceed, the following is needed:
- Mechanism of action data for iodixanol (DrugBank)
- The US package insert, including warnings and contraindications, so that safety screening can begin
- Clarification of whether the intended use is therapeutic or diagnostic (for example, cartilage imaging in osteoarthritis). A diagnostic use would need a different evaluation path.
- Any preclinical or clinical evidence of a therapeutic effect in osteoarthritis. None currently exists.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.