Auranofin
| Evidence Level: L5 | Predicted Indications: 2 |
Table of Contents
- Auranofin
- Auranofin: From an Unrecorded Original Indication to Colobomatous Microphthalmia-Rhizomelic Dysplasia Syndrome
Auranofin: From an Unrecorded Original Indication to Colobomatous Microphthalmia-Rhizomelic Dysplasia Syndrome
One-Sentence Summary
Auranofin is an oral capsule marketed in the US under one NDA, but the Evidence Pack records no approved indication for it. The TxGNN model predicts it may be effective for colobomatous microphthalmia-rhizomelic dysplasia syndrome, a rare congenital malformation syndrome. This prediction has 0 clinical trials and 0 publications behind it, so it rests on the model score alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the available data |
| Predicted New Indication | Colobomatous microphthalmia-rhizomelic dysplasia syndrome |
| TxGNN Prediction Score | 99.56% |
| Evidence Level | L5 (model prediction only) |
| US Market Status | ✓ Marketed |
| Number of NDAs | 1 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. The only support for this prediction is the high TxGNN score (99.56%). No mechanistic link to the predicted disease can be established from the provided data.
Auranofin is generally known as a gold(I) compound with anti-inflammatory activity that inhibits thioredoxin reductase. This is background knowledge, not part of the Evidence Pack. The predicted disease is a rare congenital developmental malformation syndrome, and no plausible pathway connects this kind of drug to it.
A second prediction, brachydactyly-syndactyly syndrome (score 99.24%), is in the same position. It is also a congenital limb malformation with no clinical trials or literature. A drug acting on redox or inflammatory pathways has no evident reason to change a structural developmental phenotype. Both predictions may reflect knowledge-graph connectivity artifacts rather than real biology.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
US Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| NDA018689 | Auranofin (Coral Way Pharma, LLC) | Capsule (oral) | Not listed in the available data |
Safety Considerations
Please refer to the package insert for safety information. No drug-interaction records were found for this drug.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction has a very high model score but no clinical trials, no literature and no mechanism data. The predicted disease is a congenital structural malformation with no apparent pharmacological rationale. The evidence is Level L5 (model prediction only), which is not enough to justify investment.
To proceed, the following is needed:
- Package insert warnings and contraindications (blocking gap for safety screening)
- The approved indication text for NDA018689, to establish the original indication
- Mechanism of action data, for example from DrugBank, to test for any link to the predicted disease
- Any preclinical or case-level evidence connecting auranofin to the predicted disease
- A route-compatibility assessment, which is still pending
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.