Isoleucine
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Isoleucine: From Parenteral Nutrition Amino Acid to Gastroparesis
One-Sentence Summary
Isoleucine is an essential branched-chain amino acid, used in Singapore as a component of parenteral (intravenous) nutrition and amino acid infusion products. The TxGNN model predicts it may be effective for gastroparesis, but no clinical trials and no supporting publications were found for this prediction, so it rests on model output alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not available (the approved indication text is blank in all registrations; products are amino acid infusion/nutrition formulations) |
| Predicted New Indication | Gastroparesis |
| TxGNN Prediction Score | 99.32% |
| 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, isoleucine is a branched-chain amino acid supplied as a component of amino acid infusions and combined parenteral nutrition products. Its established role is nutritional support, not treatment of a specific disease.
Amino acids can influence gastric motility and accommodation, so a link to gastroparesis is conceivable. However, the data compiled for this report contain no trials or publications supporting this, and no direct link to gastroparesis is established. The high score should therefore be read as a hypothesis generated by the model, not as evidence of efficacy.
Other predictions in the top 10 (for example dyspepsia, sclerosing cholangitis, renal tubular acidosis, potassium deficiency) are also supported only by indirect or tangential literature, and several (obsolete vitamin D deficiency, congenital prothrombin deficiency, hypophosphatemic rickets) have no plausible mechanistic link in the data.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available for gastroparesis.
For context, the closest related predicted indication, dyspepsia (rank 4, evidence level L4), has only indirect literature:
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 27558952 | 2016 | Preclinical (animal) | J Smooth Muscle Res | Evaluated the effects of straight-chain, hydroxylated and branched-chain amino acids on gastric adaptive relaxation in rats |
| 26743458 | 2016 | Cohort | Sci Rep | NMR metabonomics used to identify potential biomarkers of functional dyspepsia (biomarker study, not an intervention) |
| 19854601 | 2010 | Cohort | J Pharm Biomed Anal | Plasma metabolic profiles of 6 functional dyspepsia patients vs 6 controls, and the effect of acupuncture |
Singapore Market Information
Approved indication text is blank in the registration records. Five of the 19 authorizations are listed:
| 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 |
All 19 registrations are valid single-ingredient licences. Dosage forms include infusion solutions, injections, emulsions and a sterile peritoneal dialysis solution (NUTRINEAL PD4).
Safety Considerations
- Disease associations flagged in the knowledge graph (not label text): The TxGNN knowledge graph lists contraindication links between isoleucine and several conditions, including kidney disease (chronic kidney disease, chronic renal failure, end-stage renal failure), hypercalcemia and related conditions (humoral hypercalcemia of malignancy, sarcoidosis, nephrocalcinosis), nephrolithiasis, heart disease and cardiovascular disease, digitalis poisoning, ventricular fibrillation, and phenylketonuria / disorders of phenylalanine metabolism. These are model-derived associations and must be checked against the product labels.
Please refer to the package insert for further safety information, including warnings, contraindications and drug interactions.
Conclusion and Next Steps
Decision: Hold
Rationale: The gastroparesis prediction has a high model score but no clinical trials, no literature, and no supported mechanism (evidence level L5). Isoleucine is also used as a nutritional component rather than as a stand-alone therapy, and the knowledge graph flags renal and cardiac conditions of concern.
To proceed, the following is needed:
- Package insert warnings and contraindications from HSA, which are currently missing and block safety screening
- Mechanism of action data (for example from DrugBank)
- Approved indication text for the Singapore registrations
- A systematic literature search on branched-chain amino acids and gastric emptying or motility in gastroparesis
- Preclinical or early clinical studies to test the hypothesis
- Assessment of route and formulation compatibility, since current products are intravenous nutrition formulations
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.