Alosetron
| Evidence Level: L5 | Predicted Indications: 6 |
Table of Contents
Alosetron: From Severe Irritable Bowel Syndrome to Migraine Disorder
One-Sentence Summary
Alosetron is a 5-HT3 receptor antagonist. The Evidence Pack does not record its original indication; the US label is understood to cover severe diarrhea-predominant irritable bowel syndrome (IBS-D) in women. The TxGNN model predicts it may be effective for migraine disorder. There are currently 0 clinical trials and 0 publications supporting this direction, so it is a model prediction only.
Quick Overview
| Item | Content |
|---|---|
| Predicted New Indication | Migraine disorder |
| TxGNN Prediction Score | 99.64% |
| Evidence Level | L5 (model prediction only) |
| US Market Status | ✓ Marketed |
| Number of NDAs | 11 (all generic ANDA authorizations) |
| Recommended Decision | Hold |
The approved indication text in the US authorization records is empty, so the original indication is not listed in this table.
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the Evidence Pack. Alosetron is known as a 5-HT3 receptor antagonist, and serotonergic signaling is loosely implicated in migraine. This is only a general, class-level rationale. No alosetron-specific evidence supports it.
The link between the original indication (a gut disorder) and migraine is weak. No similarity analysis has been completed, and the graph score does not by itself imply a shared mechanism. Other top predictions from the same model, such as leprosy and nephrogenic syndrome of inappropriate antidiuresis, have no plausible 5-HT3 link. They are likely knowledge-graph artifacts. Migraine with brainstem aura scores 99.52%, but it likely inherits its score from the parent migraine node and has no subtype-specific rationale.
The drug’s boxed warning (ischemic colitis and serious complications of constipation) is also a poor fit for a chronic, non-life-threatening condition like migraine.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available for migraine disorder.
The related prediction “headache disorder” (rank 5) has one indirect source, a 2004 review of 5-HT3 receptor antagonists (PMID 15515406). It supports class-level plausibility only. It is not alosetron-specific, and headache is a commonly reported adverse event in this drug class.
US Market Information
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| ANDA206647 | Alosetron Hydrochloride | Tablet, film coated | Amneal Pharmaceuticals LLC |
| ANDA206647 | Alosetron Hydrochloride | Tablet, film coated | AvKARE |
| ANDA213614 | Alosetron | Tablet | Lifestar Pharma LLC |
| ANDA211621 | Alosetron Hydrochloride | Tablet | Eywa Pharma Inc |
All products are oral tablets. The pack lists 11 authorizations in total; the table shows the 4 distinct entries provided.
Safety Considerations
- Key Warnings: Per the Evidence Pack’s rationale notes, the drug carries a boxed warning for ischemic colitis and serious complications of constipation. The full package insert has not been parsed.
No drug-interaction records were found.
Conclusion and Next Steps
Decision: Hold
Rationale: The migraine prediction has a high model score but no trials, no literature, and no drug-specific mechanistic support. The boxed-warning risk profile is a poor fit for a chronic, non-life-threatening indication.
To proceed, the following is needed:
- Complete FDA package insert warnings and contraindications (a blocking gap for safety screening)
- Detailed mechanism of action data from DrugBank
- Any preclinical or clinical evidence of 5-HT3 antagonism in migraine that is specific to alosetron
- Original indication text from the US authorization records
- A benefit-risk assessment against the boxed warning
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.