Valine
| Evidence Level: L4 | Predicted Indications: 10 |
Table of Contents
Valine: From Amino Acid Nutritional Component to Sclerosing Cholangitis
One-Sentence Summary
Valine is an essential amino acid, used in South Africa as a component of parenteral nutrition and peritoneal dialysis solutions. The TxGNN model predicts it may be relevant to sclerosing cholangitis, but this rests on the model score alone. There are 0 clinical trials and only 2 indirect publications, and neither tests valine as a treatment.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Nutritional amino acid component in parenteral nutrition and peritoneal dialysis products (no approved indication text in the registry data) |
| Predicted New Indication | Sclerosing cholangitis |
| TxGNN Prediction Score | 99.42% |
| Evidence Level | L4 |
| South Africa Market Status | Marketed |
| Number of SAHPRA Registrations | 12 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Based on known information, valine is a branched-chain amino acid (BCAA) supplied in nutrition and dialysis formulations. Its role there is to supply amino acids, not to treat a specific disease.
Cholestatic liver diseases, including primary sclerosing cholangitis (PSC), are associated with altered amino acid metabolism. This includes BCAAs and aromatic amino acids. That association is the only plausible link to the prediction. The two available papers are indirect. One observational study looks at plasma tyrosine and fatigue in PBC and PSC. The other is a Mendelian randomization study of blood metabolites and cholestatic liver disease risk. Neither shows that giving valine improves any outcome.
The high score of 0.994 (model rank 3181) reflects a knowledge-graph association. It is not evidence of benefit, and the direction of any effect is unknown.
Clinical Trial Evidence
Currently no related clinical trials registered. No SANCTR or PACTR entries were found either.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 15790420 | 2005 | Cohort | BMC Gastroenterol | Examined amino acid patterns and their relation to fatigue in PBC and PSC. Focused on plasma tyrosine, not valine treatment. |
| 39015781 | 2024 | Mendelian randomization | Front Med | Tested causal links between blood metabolites and the risk of PBC and PSC. Shows association only, not therapeutic benefit. |
South Africa Market Information
The registry data has no approved indication text for these products, and no EML status information. The first 5 of 12 registrations are listed.
| Registration Number | Product Name | Dosage Form |
|---|---|---|
| Reg. No. 37/34/0243 | Nutrineal PD4 with 1.1% amino acids 2.5L | Infusion |
| Reg. No. 33/10.2.1/0271 | Adco-ipratropium (ni201) | Vial |
| Reg. No. 38/34/0172 | Extraneal 2L single bag | Infusion |
| Reg. No. 37/25.2/0503 | Oliclinomel N6 900E 2000ml | Infusion |
| Reg. No. 41/25/0757 | Nutriflex Lipid Peri | Infusion |
Adco-ipratropium is an ipratropium product and does not appear to contain valine. This entry may be a mapping error and should be checked against the SAHPRA record.
Safety Considerations
Please refer to the SAHPRA-approved Professional Information (PI) for safety information. Report adverse drug reactions to SAHPRA.
Conclusion and Next Steps
Decision: Hold
Rationale: There are no clinical trials, and the two publications are indirect and do not test valine as a therapy. The prediction is a knowledge-graph score without mechanistic support. The other top predictions (angle-closure glaucoma, hyperthyroidism and others) are also Hold. Their literature is mostly amino acid substitution notation in gene mutation reports, not valine treatment.
To proceed, the following is needed:
- SAHPRA package insert warnings and contraindications (blocking for safety screening)
- Mechanism of action data for valine
- Evidence that valine supplementation affects outcomes in sclerosing cholangitis, such as a pilot or interventional study
- Verification of the Adco-ipratropium registration mapping
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.