Tofisopam
| Evidence Level: L5 | Predicted Indications: 1 |
Table of Contents
Tofisopam: From Unspecified Original Indication to Insomnia
One-Sentence Summary
Tofisopam’s original approved indication is not documented in the available data, and detailed mechanism-of-action information has not yet been retrieved. The TxGNN model predicts it may be effective for Insomnia, but this prediction is currently not supported by any registered clinical trials or literature.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not documented in available data |
| Predicted New Indication | Insomnia |
| TxGNN Prediction Score | 99.16% |
| Evidence Level | L5 |
| India Market Status | Not Marketed |
| Number of Registrations | 0 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Based on the available information, Tofisopam’s original indication has also not been documented in this evidence pack, so the pharmacological relationship between its historical use and the predicted new indication (Insomnia) cannot yet be assessed.
Without MOA data or a confirmed original indication, no mechanistic rationale can be constructed at this time. This prediction currently rests solely on the TxGNN knowledge-graph model’s statistical association and has no corroborating clinical, literature, or mechanistic support.
Clinical Trial Evidence
Currently no related clinical trials registered
Literature Evidence
Currently no related literature available
India Market Information
Tofisopam is currently not marketed in India, and no registration records are available.
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction is based solely on a TxGNN model score (L5 evidence level), with no clinical trials, no literature support, no confirmed mechanism of action, and no original indication on record. There is insufficient basis to advance this candidate.
To proceed, the following is needed:
- Mechanism of action (MOA) data from DrugBank (DG002)
- Product label warnings/contraindications from the relevant regulatory agency (DG001) — currently blocking for safety pre-assessment
- Confirmation of the drug’s original approved indication(s)
- Independent literature or clinical trial evidence linking Tofisopam to insomnia treatment
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.