L-Lysine
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
L-Lysine: From Amino Acid Nutrition to Gastroparesis
One-Sentence Summary
L-Lysine is an essential amino acid. In South Africa it appears in registered parenteral nutrition products, but the SAHPRA records provided state no approved indication. The TxGNN model predicts it may be relevant to gastroparesis, but this rests on the model alone: 0 clinical trials and 1 publication were found, and that publication does not test lysine.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the SAHPRA records provided |
| Predicted New Indication | Gastroparesis |
| TxGNN Prediction Score | 99.77% |
| Evidence Level | L5 |
| South Africa Market Status | Marketed |
| Number of SAHPRA Registrations | 6 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available for L-lysine. It is an essential amino acid used nutritionally, including in parenteral nutrition products. No approved indication is recorded in the material provided.
No established link between L-lysine and gastric motility could be identified. The high score (99.77%) is a graph-based prediction only and does not reflect biological or clinical evidence. Gastroparesis involves loss of interstitial cells of Cajal and enteric neurons, leading to delayed gastric emptying. Nothing in the available data connects lysine to that process.
Clinical Trial Evidence
Currently no related clinical trials registered. No ICTRP, SANCTR or PACTR entries were found for L-lysine in gastroparesis.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 29414870 | 2018 | Preclinical | Bioengineering (Basel) | Gelatin-alginate hydrogels delivering mesenchymal stem cells to the stomach lumen as a possible gastroparesis therapy. Lysine is not the tested intervention, so this does not support the prediction. |
South Africa Market Information
| Registration Number | Product Name | Dosage Form |
|---|---|---|
| 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 |
| Reg. No. 41/25/0757 | Nutriflex Lipid Peri 1875ml | TPN |
- Five of the six registrations are listed above. The records give no approved indication text.
- Adco-ipratropium and Extraneal are not obviously lysine-containing products. Their ingredient mapping should be verified before relying on this list.
Safety Considerations
- Drug Interactions: No interactions were found in the queried database (0 records).
Please refer to the SAHPRA-approved Professional Information (PI) for warnings and contraindications. Report adverse drug reactions to SAHPRA.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction is model-only (L5), with no trials, no supporting literature and no plausible mechanism. The other nine predicted indications in the pack are also Hold, at L5 except vitamin deficiency disorder at L4, and none has direct supporting evidence.
To proceed, the following is needed:
- SAHPRA package insert warnings and contraindications (currently blocking safety screening)
- Mechanism of action data for L-lysine
- Verification of ingredient mapping for the six SAHPRA registrations
- Any preclinical or clinical study testing L-lysine itself in gastric motility disorders
- Confirmation of the original approved indication and Essential Medicines List status
This report is for research reference only and does not constitute medical advice. Repurposing candidates require clinical validation before any use.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.