Threonine
| Evidence Level: L5 | Predicted Indications: 1 |
Table of Contents
Threonine: From No Registered Indication to gastroparesis (disease)
One-Sentence Summary
Threonine is an essential amino acid, supplied in Australia as a component of the MMA/PA Anamix Junior oral powder, and no approved indication is recorded in the data compiled for this report. The TxGNN model predicts it may be relevant to gastroparesis, but this rests on a computational score alone, with 0 clinical trials and 0 publications currently supporting the prediction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded (the ARTG entry has no indication text) |
| Predicted New Indication | Gastroparesis |
| TxGNN Prediction Score | 0.9932 |
| Evidence Level | L5 |
| Australia Market Status | Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data |
| Number of PBS Items | 1 (valid: 1) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Threonine is an essential amino acid, and the data compiled for this report list no original indication for it. Its only registered Australian product is a specialised oral amino acid formulation, MMA/PA Anamix Junior.
The prediction is supported only by a high TxGNN model (deep learning) score, which is a computational inference and not clinical evidence. One plausible but unverified link is threonine’s role in gastrointestinal mucin synthesis and gut mucosal integrity. Another is amino acid-related modulation of gastric motility and gut hormone signalling. Neither is supported by the data supplied.
No direct pathway has been established between threonine and the pathophysiology of gastroparesis, which involves impaired gastric emptying from enteric neuropathy, loss of interstitial cells of Cajal, or autonomic dysfunction. The prediction should be treated as a hypothesis for investigation only.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ARTG 10730R | MMA/PA Anamix Junior | Sachets containing oral powder 18 g, 30 | Not stated |
The only available route is oral.
Safety Considerations
- Knowledge-graph contraindication signals: The TxGNN knowledge graph (PrimeKG) links threonine with contraindication edges for phenylketonuria and disorder of phenylalanine metabolism. These come from the graph and not from product label text, so they should be verified against official sources.
- No drug interaction records were found.
Please refer to the TGA-approved Product Information (PI) for warnings, contraindications and other safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The recommendation rests entirely on a model prediction score (L5), with no registered clinical trials, no publications, no mechanism data and no documented original indication. There is no basis yet to move forward.
To proceed, the following is needed:
- Mechanism of action data linking threonine to gastric motility or gastroparesis pathophysiology
- A systematic literature search, and preclinical or clinical studies in gastroparesis
- Approved indication and safety information from the Product Information for the Australian product
- Review of the phenylalanine-metabolism contraindication signals
- An assessment of route and formulation suitability, since the only Australian product is a specialised metabolic formulation
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.