Alanine
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Alanine: From Nutritional Amino Acid Supplementation to Gastroparesis
One-Sentence Summary
Alanine is an amino acid used as a component of parenteral nutrition and amino acid infusion products. The TxGNN model predicts it may be effective for gastroparesis, but this rests on a graph-based prediction alone: no clinical trials are registered and none of the 3 retrieved publications studies alanine as a treatment for the condition.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the Singapore licence records (used in parenteral nutrition and amino acid infusion products) |
| Predicted New Indication | Gastroparesis |
| TxGNN Prediction Score | 99.37% |
| Evidence Level | L5 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 19 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Based on known information, alanine is a component of multi-amino-acid infusion and parenteral nutrition products, where it serves as a nutritional substrate. No specific pharmacological action on gastric motility is documented in the data compiled for this report.
The relationship between the original use (nutritional support) and gastroparesis (delayed gastric emptying) is not supported by the data. The three retrieved papers concern hepatic and gastrointestinal complications of end-stage renal disease and diabetes. They do not study alanine or gastric motility. The high TxGNN score is a graph-based statistical signal only, and no credible mechanistic link was identified.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 10926110 | 2000 | Review | Advances in Renal Replacement Therapy | Reviews GI and hepatic disorders in end-stage renal disease; notes gastroparesis is more common in chronic renal failure. Does not study alanine. |
| 26315331 | 2016 | Review | Diabetic Medicine | Describes diabetic hepatosclerosis as a possible microvascular complication of diabetes. Not related to alanine. |
| 33763324 | 2021 | Case report | Cureus | Glycogen hepatopathy in a type 1 diabetic patient who also had gastroparesis. Not related to alanine therapy. |
Singapore Market Information
All 19 licences are valid single-ingredient registrations; the approved indication text is not available in the licence records. Five main authorisations:
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN16337P | AMINOVEN Solution for Infusion 15% | Infusion, solution | Not stated |
| SIN11682P | AMINOVEN Solution for Infusion 5% | Injection | Not stated |
| SIN11829P | AMINOVEN Solution for Infusion 10% | Injection | Not stated |
| SIN06299P | NEPHROSTERIL for Intravenous Infusion | Injection | Not stated |
| SIN08352P | AMINOPLASMAL-15% Infusion | Injection | Not stated |
Other registered products include Trophamine, Nutrineal PD4, Vaminolact, Aminoplasmal B.Braun 10% E, OliClinomel, SmofKabiven (several variants) and Nutriflex Omega (several variants).
Safety Considerations
The TxGNN knowledge graph (not label text) links alanine to contraindication edges for the following conditions:
- Renal: kidney disease, chronic kidney disease, chronic renal failure syndrome, end stage renal failure, nephrolithiasis, nephrocalcinosis, acute urate nephropathy, pyoureter
- Calcium and phosphorus disorders: hypercalcemia, humoral hypercalcemia of malignancy, sarcoidosis, phosphorus metabolism disease
- Cardiac: heart disease, cardiovascular disease, digitalis poisoning, ventricular fibrillation
- Metabolic: phenylketonuria, disorder of phenylalanine metabolism
These are graph-derived signals and must be verified against the product labels. No drug-interaction records were found. For label-based safety information, please refer to the package insert.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests only on a model score. There are no clinical trials, the retrieved literature does not evaluate alanine for gastroparesis, and no mechanistic link was identified. Alanine is also an amino acid nutrient with no established prokinetic action, and the knowledge graph flags several renal and metabolic contraindications.
To proceed, the following is needed:
- Mechanism of action data and a plausible biological link between alanine and gastric motility
- Package insert warnings and contraindications for the Singapore-registered products
- Preclinical or early clinical data on alanine in gastroparesis
- Assessment of route and formulation suitability, since current products are intravenous nutrition solutions
- Review of the other nine predicted indications; only renal tubular acidosis and postmenopausal osteoporosis have indirect (L4) physiological or observational evidence, and all remain at Hold
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.