Sorbitol
| Evidence Level: L5 | Predicted Indications: 1 |
Table of Contents
Sorbitol: From an Osmotic Agent and Excipient to Exercise-Induced Malignant Hyperthermia
One-Sentence Summary
Sorbitol is a sugar alcohol used as an osmotic agent, sweetener and excipient, and no approved indication is recorded in the US regulatory data compiled for this report. The TxGNN model predicts it may be relevant to exercise-induced malignant hyperthermia, but 0 clinical trials and 0 publications currently support this direction. The prediction is a computational hypothesis only.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded (approved indication text is empty in all licenses) |
| Predicted New Indication | Exercise-induced malignant hyperthermia |
| TxGNN Prediction Score | 99.40% |
| Evidence Level | L5 |
| US Market Status | Cancelled only |
| Number of NDAs | 3 (all cancelled) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Sorbitol is known as a sugar alcohol used as an osmotic agent, sweetener and excipient. No therapeutic mechanism relevant to the predicted indication is documented in the data compiled for this report.
Malignant hyperthermia and exertional heat illness involve dysregulated calcium release in skeletal muscle (for example through RYR1) and hypermetabolism. No plausible pharmacological connection between sorbitol and these pathways is evident from the available information.
The high score (0.994) most likely reflects network proximity or shared neighbors in the knowledge graph rather than a biological rationale. The prediction should be treated as a hypothesis to examine, not as supporting evidence.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
US Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| NDA017863 | Sorbitol (Baxter Healthcare Corporation) | Irrigant | Not recorded (status: cancelled) |
| M007 | GeriCare Sorbitol Solution (GERI-CARE Pharmaceuticals) | Liquid | Not recorded (status: cancelled) |
| nan | Plaque identifying (Shenzhen Yagao Technology Co., Ltd.) | Powder, dentifrice | Not recorded (status: cancelled) |
Safety Considerations
- Disease-level contraindication signal (knowledge graph, not label text): active peptic ulcer disease.
- Drug Interactions (2 found):
- Tolevamer: Major
- Lamivudine: Moderate
Package insert warnings and contraindications were not available for this report. Please refer to the package insert for complete safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests only on a knowledge-graph score, with no clinical trials, no literature, no documented mechanism, and no plausible pharmacological link to the proposed indication. All US authorizations are cancelled, and package insert safety data are missing.
To proceed, the following is needed:
- Mechanism of action data for sorbitol, and a justification of any link to calcium-release dysregulation in skeletal muscle
- Preclinical or mechanistic studies supporting the prediction
- FDA package insert warnings and contraindications
- Route and formulation compatibility assessment for the proposed indication
- Review of the Major interaction with tolevamer and the peptic ulcer contraindication signal
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.