Valine
| Evidence Level: L4 | Predicted Indications: 10 |
Table of Contents
Valine: From an Unspecified Original Indication to Sclerosing Cholangitis
One-Sentence Summary
Valine is a branched-chain amino acid. The data compiled for this report list no approved indication for it, and its only U.S. record is a cancelled liquid product. The TxGNN model predicts it may be useful for sclerosing cholangitis, but there are 0 clinical trials and only 2 loosely related publications (a cohort study and a Mendelian randomization study), and neither tests valine as a treatment.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not available (the single U.S. record has no approved-indication text) |
| Predicted New Indication | Sclerosing cholangitis |
| TxGNN Prediction Score | 99.42% |
| Evidence Level | L4 |
| US Market Status | Cancelled only |
| Number of NDAs | 1 (cancelled) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Valine is an essential branched-chain amino acid (BCAA), a nutritional and metabolic building block rather than a drug with a defined target.
The link to sclerosing cholangitis is indirect. Altered plasma amino acid profiles, including tyrosine and BCAAs, have been reported in cholestatic liver disease. A Mendelian randomization study also associates blood metabolites and metabolic pathways with cholestatic liver diseases (primary biliary cholangitis and primary sclerosing cholangitis). These findings are associative or genetic-epidemiological. They do not show that giving valine would treat the disease. The high TxGNN score is a model output, and no interventional data exist.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 39015781 | 2024 | Mendelian randomization | Frontiers in Medicine | Investigates causal links between blood metabolites and the risk of primary biliary cholangitis and primary sclerosing cholangitis |
| 15790420 | 2005 | Cohort | BMC Gastroenterology | Examines amino acid abnormalities and the relation of plasma tyrosine to fatigue in primary biliary cirrhosis and primary sclerosing cholangitis |
Both papers are observational and none tests valine as an intervention.
US Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| Not available | L-Valine High (Professional Complementary Health Formulas) | Liquid | Not available (status: cancelled) |
Safety Considerations
Please refer to the package insert for safety information. No warnings, contraindications, or drug-interaction records were found in the data compiled for this report.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests on a high model score and indirect metabolic associations only. There are no clinical trials and no evidence that valine is therapeutic in sclerosing cholangitis. The drug has no active U.S. authorization, and the safety and mechanism data are incomplete.
To proceed, the following is needed:
- Mechanism of action data (for example from DrugBank) and a hypothesis for why valine would affect cholestatic liver disease
- Package insert warnings and contraindications to allow a safety screen
- Preclinical or early interventional evidence showing benefit in sclerosing cholangitis models or patients
- Clarification of the regulatory status and intended formulation, since the only U.S. record is cancelled
Other Predicted Indications (Brief Note)
The other top predictions do not change the decision.
- Hyperthyroidism: Observational links exist between BCAA levels and thyroid function. Most retrieved papers concern TSH receptor mutations and appear to be keyword matches on valine in mutation names. Evidence level L4, Hold.
- Angle-closure glaucoma, aqueous misdirection, traumatic glaucoma, neovascular glaucoma, glaucomatous optic disc atrophy, obsolete bundle branch block: Prediction only, with no relevant evidence (L5, Hold).
- Resistance to thyroid hormone (THRB mutation) and hyperthyroxinemia: The papers are genetic reports where valine appears only in mutation nomenclature. They give no therapeutic evidence (L5, Hold).
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.