Betahistine Mesylate
| 證據等級: L5 | 預測適應症: 0 個 |
目錄
- Betahistine Mesylate
- Betahistine Mesylate: Preliminary Drug Repurposing Assessment (No Predicted Indication)
Betahistine Mesylate: Preliminary Drug Repurposing Assessment (No Predicted Indication)
One-Sentence Summary
Betahistine mesylate is a histamine analogue commonly used for the treatment of vertigo and Ménière’s disease, currently marketed in Malaysia with 1 registration. The TxGNN model has not generated any predicted new indications for this drug, and critical data gaps (mechanism of action, safety profile) remain unresolved, precluding further evaluation at this time.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not available (registration data incomplete) |
| Predicted New Indication | None — TxGNN produced no predictions |
| TxGNN Prediction Score | N/A |
| Evidence Level | N/A |
| Malaysia Market Status | ✓ Marketed (已上市) |
| Number of Registrations | 1 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
No prediction was generated by TxGNN for Betahistine Mesylate. This section therefore addresses the drug’s known pharmacology for context.
Betahistine is a structural analogue of histamine that acts as a weak H₁ receptor agonist and a potent H₃ receptor antagonist. By blocking presynaptic H₃ autoreceptors, it increases histamine turnover and release in the central nervous system, thereby improving microcirculation in the inner ear (stria vascularis) and modulating vestibular function. It is primarily prescribed for Ménière’s disease and associated vertigo symptoms.
The absence of a TxGNN prediction may be attributed to one or more factors: (1) the DrugBank ID was not successfully mapped (drugbank_id: null), preventing the drug from being placed in the knowledge graph; (2) betahistine mesylate (a specific salt form) may not be present as a distinct node in TxGNN’s underlying knowledge graph (which typically uses INN base forms); or (3) the drug’s pharmacological profile did not yield statistically significant repurposing candidates above the model’s confidence threshold. Resolving the DrugBank mapping is a prerequisite for any meaningful prediction.
Clinical Trial Evidence
Currently no related clinical trials identified, as no predicted indication was generated.
Literature Evidence
Currently no related literature identified, as no predicted indication was generated.
Malaysia Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| (Not available) | (Not available) | (Not available) | (Not available) |
Note: One registration is recorded in the database, but the licence details (authorization number, product name, dosage form, and approved indication) are incomplete. Please verify directly with the NPRA database.
Safety Considerations
Please refer to the package insert for safety information. Key warnings, contraindications, and drug interaction data are currently unavailable in this evidence pack (data gaps identified as blocking severity).
Conclusion and Next Steps
Decision: Hold
Rationale: TxGNN did not generate any repurposing predictions for Betahistine Mesylate, most likely due to a failed DrugBank ID mapping that prevented the drug from being incorporated into the knowledge graph. Without a valid prediction, no repurposing evaluation can proceed.
To proceed, the following is needed:
- Resolve DrugBank mapping — Query DrugBank using the base INN “betahistine” (DB06698) rather than the salt form “betahistine mesylate” to obtain a valid DrugBank ID and link the drug into the knowledge graph
- Re-run TxGNN prediction — Once the DrugBank ID is mapped, re-execute the KG and DL prediction pipelines to generate repurposing candidates
- Complete NPRA registration data — Retrieve full licence details (authorization number, product name, dosage form, approved indication) from the NPRA database
- Obtain safety profile — Download and parse the package insert to extract key warnings, contraindications, and drug interaction information (currently identified as a blocking data gap, DG001)
- Obtain mechanism of action data — Query DrugBank API for detailed MOA information (data gap DG002)
Disclaimer: This report is for research purposes only and does not constitute medical advice. Any drug repurposing candidates require clinical validation before application.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.