Gepirone
| Evidence Level: L5 | Predicted Indications: 3 |
Table of Contents
Gepirone: From Depressive Disorders to Benign Paroxysmal Torticollis of Infancy
One-Sentence Summary
Gepirone is a 5-HT1A receptor partial agonist developed for depressive disorders, and it is currently marketed in the US as an extended-release tablet (EXXUA). The TxGNN model predicts it may be effective for benign paroxysmal torticollis of infancy. There are 0 clinical trials and 0 publications supporting this direction, so it is a model prediction only.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Depressive disorders (the licence records provided contain no indication text) |
| Predicted New Indication | Benign paroxysmal torticollis of infancy |
| TxGNN Prediction Score | 99.67% |
| Evidence Level | L5 |
| US Market Status | ✓ Marketed |
| Number of NDAs | 4 entries, all under NDA021164 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Gepirone is a 5-HT1A partial agonist, and this is the only mechanistic information available. Detailed mechanism-of-action data is not available in the Evidence Pack. Its established use is in adults.
Benign paroxysmal torticollis of infancy is considered a migraine equivalent and is often linked to CACNA1A channelopathy. The link to serotonergic modulation is therefore speculative. The high TxGNN score reflects a model pattern, not clinical evidence.
The population is infants, which sets a much higher safety bar. No paediatric data for gepirone was found.
Two other predictions for this drug have more support than this one:
- Agoraphobia: one 1993 open-label study in panic disorder.
- Postpartum depression: only general depression reviews.
Both are rated L4 and framed as research questions.
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 |
|---|---|---|---|
| NDA021164 | EXXUA (Aytu Therapeutics, LLC) | Tablet, extended release (oral) | Not provided in the source data |
The source lists four identical entries under this NDA. They are shown here as one row.
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests on the model score alone. There are no trials or literature, the mechanistic link is speculative, and the target population is infants, for whom the drug has no established use.
To proceed, the following is needed:
- Any preclinical or clinical evidence linking 5-HT1A modulation to this condition.
- Package insert warnings and contraindications, and detailed MOA data.
- Paediatric safety and dosing data.
- Consideration of the higher-evidence candidates (agoraphobia, postpartum depression) first.
This report is for research reference only and does not constitute medical advice. Repurposing candidates require clinical validation before any use.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.