Selenium
| Evidence Level: L5 | Predicted Indications: 1 |
Table of Contents
Selenium: From Trace-Element Supplementation (Parenteral) to Sclerosing Cholangitis
One-Sentence Summary
Selenium is a trace element marketed in Singapore as an intravenous infusion concentrate (the registered indication text is not available in the data compiled for this report). The TxGNN model predicts it may be effective for sclerosing cholangitis, but there are 0 clinical trials and only 5 publications, all associative or preclinical, so this remains a computational prediction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the registration data (approved indication text is empty) |
| Predicted New Indication | Sclerosing cholangitis |
| TxGNN Prediction Score | 99.04% |
| Evidence Level | L5 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 1 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Based on known information, selenium is an essential trace element given by infusion, and its role in the body is well established, but the registered indication could not be confirmed from the data compiled for this report.
A plausible but unproven link exists through selenoproteins such as glutathione peroxidase and thioredoxin reductase. These enzymes counter oxidative stress and inflammation, which are believed to contribute to cholestatic liver injury. The available literature is associative: it reports hepatic copper and selenium retention in primary sclerosing cholangitis (PSC), poor dietary intake in PSC patients, and proteomic changes in mouse models of fibrosis. None of it tests selenium as a treatment.
The TxGNN score is very high, but it is a model output only and does not replace clinical evidence.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 9053974 | 1995 | Cohort | Scand J Gastroenterol | Trace-element metabolism studied in 32 PSC patients; hepatic retention of copper and selenium reported |
| 39601354 | 2025 | Cohort | Liver Int | Dietary intake of PSC patients compared with Nordic recommendations; poor fat-soluble vitamin intake and dietary quality |
| 29148959 | 2017 | Case report / cohort | JPEN J Parenter Enteral Nutr | Parenteral nutrition with a lipid emulsion in a patient with severe malabsorption, PSC and ulcerative colitis; discusses oxidative stress and antioxidant deficiency |
| 18941372 | 2008 | Review | Eur J Cancer Prev | Review of colorectal cancer chemoprevention agents; indirect relevance to PSC |
| 17109383 | 2006 | Preclinical (mouse) | Proteomics | Hepatic proteome changes in murine toxic fibrosis and sclerosing cholangitis models |
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN16847P | Selenium Aguettant Concentrate for Solution for Infusion 10 mcg/ml (Laboratoire Aguettant) | Infusion, solution concentrate | Not stated in the available registration data |
Safety Considerations
- Drug Interactions: Six interactions were identified. One is rated Major and five Moderate.
- Major: Dimercaprol
- Moderate: Levofloxacin, Triethylenetetramine, Deferiprone, Tolevamer, Eltrombopag
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests on a model score alone (Evidence Level L5). There are no clinical trials, and the literature is associative or preclinical, with nothing testing selenium as a treatment for sclerosing cholangitis. The registered indication and the mechanism of action are also not yet confirmed.
To proceed, the following is needed:
- Package insert warnings and contraindications from the Singapore regulator (HSA) for safety screening
- Mechanism of action data and the registered indication for this product
- Evidence that selenium status or supplementation affects disease course in sclerosing cholangitis (for example, mechanistic or interventional studies)
- Assessment of whether the intravenous route and dose suit a chronic liver indication
- Review of the Major interaction with dimercaprol and the Moderate interactions listed above
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.