Serine
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
- Serine
- Serine: From Amino Acid Component of Parenteral Nutrition and Dialysis Products to Familial Visceral Myopathy
Serine: From Amino Acid Component of Parenteral Nutrition and Dialysis Products to Familial Visceral Myopathy
One-Sentence Summary
Serine is an amino acid that appears as a component in several South African parenteral nutrition and peritoneal dialysis products. The TxGNN model predicts it may be effective for Familial Visceral Myopathy, a rare genetic smooth-muscle disorder of the gut. This prediction currently has no clinical trials and no publications supporting it, so it rests on the model score alone.
Quick Overview
| Item | Content |
|---|---|
| Predicted New Indication | Familial visceral myopathy |
| TxGNN Prediction Score | 99.99% |
| Evidence Level | L5 (model prediction only) |
| South Africa Market Status | Marketed |
| Number of SAHPRA Registrations | 11 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Based on known information, serine is a component of amino acid infusion products and other multi-ingredient formulations, and it serves as a nutritional building block rather than a targeted therapy. No approved indication text was provided for the local registrations, so its original therapeutic role cannot be stated more precisely.
The evidence review found no established biological link between serine supplementation and familial visceral myopathy. This condition is a genetic smooth-muscle disorder, commonly ACTG2-related. The very high score (99.99%) most likely reflects the drug’s position in the knowledge graph rather than a real mechanistic relationship. Other top predictions are also gut motility disorders (intestinal obstruction, pseudo-obstruction and related conditions), which points to a shared knowledge-graph neighbourhood. Such clusters can produce high scores without any clinical support.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
South Africa Market Information
Serine has 11 SAHPRA registrations. The 5 main ones are listed below. Approved indication text is not available for these products.
| 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. 52/25/0739 | Numeta G13E | Infusion |
All registered forms are vials or infusions, and no oral form was identified. Route compatibility with the predicted indication has not been assessed.
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 prediction is supported only by a model score, with no relevant trials or literature and no plausible mechanism. The other predicted indications are at the same evidence level (L5). Retrieved records for them were mostly keyword-matched noise. For example, papers on the serine protease PRSS56 in glaucoma do not concern the amino acid serine.
To proceed, the following is needed:
- Mechanism of action data, to test whether any biologically credible link to visceral smooth-muscle disease exists
- The SAHPRA Professional Information (PI) for safety, contraindications and approved indications
- A relevant preclinical or clinical signal, such as a disease-model study, before any further evaluation
- Assessment of route and formulation compatibility, since current registrations are all parenteral
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.