Granisetron
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Granisetron: From Antiemetic Use to Manic Bipolar Affective Disorder
One-Sentence Summary
Granisetron is a 5-HT3 receptor antagonist marketed in the US in injectable, oral and other forms. The TxGNN model predicts it may be effective for manic bipolar affective disorder, but no clinical trials and no publications currently support this prediction, so it remains a model prediction only.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the license records (granisetron is a 5-HT3 antagonist antiemetic) |
| Predicted New Indication | Manic bipolar affective disorder |
| TxGNN Prediction Score | 99.62% |
| Evidence Level | L5 |
| US Market Status | ✓ Marketed |
| Number of NDAs | 14 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the input. Based on general pharmacology, granisetron selectively blocks 5-HT3 receptors. Serotonin signaling is loosely relevant to mood regulation, which gives a modest theoretical basis for the prediction.
No trial or publication was found to test this link, so it is speculative. The high TxGNN score (0.996) is a model output, not clinical evidence. It should not be read as proof of efficacy.
Among the other top-ranked predictions, only Tourette syndrome and trichotillomania have a similarly modest serotonergic or neuro-circuit rationale. Several others (conjunctivitis, bronchitis, nephrogenic syndrome of inappropriate antidiuresis) have no plausible mechanistic link and are likely knowledge-graph artifacts. All ten predictions are at evidence level L5.
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 | Manufacturer |
|---|---|---|---|
| ANDA091136 | Granisetron Hydrochloride | Injection, solution | Mylan Institutional LLC |
| ANDA204238 | Granisetron Hydrochloride | Injection, solution | Eugia US LLC |
| ANDA219282 | Granisol | Solution | Intra-Sana Laboratories |
| ANDA078969 | Granisetron Hydrochloride | Tablet | Breckenridge Pharmaceutical, Inc. |
Across all 14 authorizations, available dosage forms also include film-coated tablets and a patch. The license records contain no approved-indication text.
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests only on a model score. There are no clinical trials or publications, and the mechanistic link to mania is weak and unverified.
To proceed, the following is needed:
- Package insert warnings and contraindications for safety screening
- Detailed mechanism of action (MOA) data, for example from DrugBank
- A systematic literature and trial search for 5-HT3 antagonists in bipolar mania
- A check of route compatibility (available formulations vs. what the new indication would require)
- Preclinical or early clinical data that support the indication
This report is for research reference only and does not constitute medical advice. Repurposing candidates require clinical validation before any application.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.