L-Lysine
| 證據等級: L5 | 預測適應症: 10 個 |
目錄
L-Lysine: From Unregistered Indication to Gastroparesis (Predicted)
One-Sentence Summary
L-Lysine has no registered original indication in the available data and is not currently marketed in South Africa. The TxGNN model predicts a possible link to Gastroparesis, with a very high prediction score (99.77%), but this is supported by 0 clinical trials and only 1 literature citation, which itself appears unrelated to L-Lysine’s known biology.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not available — no approved/registered indication on file |
| Predicted New Indication | Gastroparesis |
| TxGNN Prediction Score | 99.77% |
| Evidence Level | L5 |
| South Africa Market Status | Not Marketed |
| Number of SAHPRA Registrations | 0 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data for L-Lysine is currently not available. Based on the evidence collected, the TxGNN model assigns a very high prediction score (99.77%, global rank 1,612) linking L-Lysine to gastroparesis. However, the single literature record retrieved for this pairing does not describe any lysine-related mechanism at all — it discusses delivery of mesenchymal stem cells via a gelatin-alginate hydrogel to the stomach as a regenerative therapy for gastroparesis, a topic and mechanism unrelated to L-Lysine itself. This is most likely a keyword co-occurrence artefact rather than genuine supporting evidence.
L-Lysine also has no registered original indication in this evidence pack, and it is not registered with SAHPRA (0 licenses). Without a defined original indication or a documented mechanism of action, no plausible pharmacological bridge between L-Lysine and gastroparesis can currently be established from the available data. The high TxGNN score should therefore be interpreted as a computational signal only, not as evidence of clinical plausibility.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 29414870 | 2018 | Preclinical | Bioengineering (Basel, Switzerland) | Describes delivery of mesenchymal stem cells via gelatin-alginate hydrogel to the stomach lumen to regenerate interstitial cells of Cajal/enteric neurons in gastroparesis. Does not investigate L-Lysine and is likely a keyword-match artefact rather than direct evidence for this drug-disease pair. |
South Africa Market Information
Currently no SAHPRA registrations on file for L-Lysine.
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: The TxGNN score is high, but there is no clinical trial support and the sole literature citation does not actually relate to L-Lysine’s pharmacology — evidence level is L5 (model prediction only). Combined with the absence of MOA data and zero SAHPRA registrations, there is currently no basis to advance this candidate.
To proceed, the following is needed:
- Documented mechanism of action for L-Lysine (DrugBank or equivalent) — currently a High-severity data gap
- PI-level safety warnings/contraindications from the relevant regulatory authority — currently a Blocking data gap
- A targeted, verified literature/trial search specifically for “L-Lysine AND gastroparesis” to confirm whether the one retrieved citation is relevant or a false match
- As a secondary note: candidate #6 in this evidence pack (“vitamin deficiency disorder,” evidence level L4, 3 clinical trials) has comparatively stronger supporting evidence than the top-ranked gastroparesis prediction and may warrant separate review
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.