Selenium
| Evidence Level: L5 | Predicted Indications: 1 |
Table of Contents
Selenium: From an Unspecified Original Indication to Sclerosing Cholangitis
One-Sentence Summary
Selenium is an essential trace element, marketed in the US mainly as selenious acid injection (trace-element supplementation) and as a homeopathic pellet. The label-derived indication text was not available in the data compiled for this report. The TxGNN model predicts it may be effective for sclerosing cholangitis, but there are currently 0 clinical trials and only 5 publications, all observational, preclinical or indirect, so the evidence is very limited.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not available (approved indication text is empty in the compiled data) |
| Predicted New Indication | Sclerosing cholangitis |
| TxGNN Prediction Score | 99.04% |
| Evidence Level | L5 |
| US Market Status | Cancelled only (no currently valid licenses) |
| Number of NDAs | 3 authorizations in total (1 NDA, 1 ANDA, 1 unnumbered homeopathic product), all cancelled |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data is not available. Based on general knowledge, selenium is a cofactor of glutathione peroxidases and other selenoproteins. Antioxidant and anti-inflammatory effects on cholestatic liver injury are therefore plausible, but this has not been verified in the data compiled for this report.
The literature links selenium to primary sclerosing cholangitis (PSC) only as a matter of status. One 1995 study reported abnormal hepatic copper and selenium retention in PSC patients, and a 2025 study examined dietary intake in PSC. These are observational findings about selenium levels or intake. They do not show that giving selenium treats the disease. The very high TxGNN score (0.99) is a model output and has no supporting mechanistic or clinical confirmation here.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 9053974 | 1995 | Observational | Scand J Gastroenterol | Trace element metabolism in 32 PSC patients; hepatic copper and selenium retention observed |
| 39601354 | 2025 | Observational | Liver Int | Dietary survey in PSC; poor fat-soluble vitamin intake and dietary quality |
| 29148959 | 2017 | Clinical case | JPEN J Parenter Enteral Nutr | Parenteral nutrition lipid emulsion and GGT monitoring in a patient with PSC and ulcerative colitis; not selenium-specific |
| 18941372 | 2008 | Review | Eur J Cancer Prev | Colorectal cancer chemoprevention; only indirect relevance, likely via PSC-associated colorectal cancer risk |
| 17109383 | 2006 | Preclinical | Proteomics | Hepatic proteome changes in murine models of fibrogenesis and sclerosing cholangitis |
US Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| NDA209379 (cancelled) | Selenious Acid (American Regent) | Injection, solution | Not available |
| ANDA219629 (cancelled) | Selenious Acid (Gland Pharma) | Injection, solution | Not available |
| Not numbered (cancelled) | Selenium Metallicum (Hahnemann Laboratories) | Pellet | Not available |
Safety Considerations
Drug Interactions (6 interactions found; mostly moderate):
- Major: Dimercaprol
- Moderate: Levofloxacin, Triethylenetetramine, Deferiprone, Tolevamer, Eltrombopag
For other safety information, please refer to the package insert.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests only on a model score. There are no registered clinical trials, and the literature shows only altered selenium status in PSC, not a therapeutic effect. Selenium has no currently valid US license in the compiled data, and the original indication and safety labeling are not available.
To proceed, the following is needed:
- FDA package insert warnings and contraindications, which are currently missing and block safety screening
- Mechanism-of-action data (for example, from DrugBank) to assess a mechanistic link to sclerosing cholangitis
- Preclinical or early clinical evidence that selenium supplementation changes the course of cholestatic liver disease
- Confirmation of the current US regulatory and supply status, and of route and dosage-form compatibility
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.