Risperidone
| Evidence Level: L5 | Predicted Indications: 6 |
Table of Contents
- Risperidone
- Risperidone: From Schizophrenia and Bipolar Disorder to Familial Horizontal Gaze Palsy with Progressive Scoliosis
Risperidone: From Schizophrenia and Bipolar Disorder to Familial Horizontal Gaze Palsy with Progressive Scoliosis
One-Sentence Summary
Risperidone is an atypical antipsychotic originally used for schizophrenia, bipolar disorder and autism-related irritability. The TxGNN model predicts it may be effective for familial horizontal gaze palsy with progressive scoliosis, a rare genetic disorder. This prediction currently has 0 clinical trials and 0 publications behind it, so it rests on model output alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Schizophrenia, bipolar disorder (including mania), autism spectrum disorder (from the knowledge graph; the US license records contain no indication text) |
| Predicted New Indication | Gaze palsy, familial horizontal, with progressive scoliosis |
| TxGNN Prediction Score | 99.76% |
| Evidence Level | L5 |
| US Market Status | Cancelled only (no currently valid licenses) |
| Number of NDAs | 10 licenses in total (2 NDAs, 8 ANDAs), all cancelled |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Based on known information, risperidone is an atypical antipsychotic. Its efficacy in schizophrenia, bipolar disorder and autism-related irritability is established, and it is generally understood to act through dopamine D2 and serotonin 5-HT2A receptor antagonism.
The predicted condition is a rare genetic disorder (ROBO3-related) affecting eye movement and spine development. There is no plausible dopaminergic or serotonergic target that links it to risperidone. The high score (rank 6497 in the model’s ranking) therefore looks like a computational artefact rather than a real pharmacological signal. No mechanistic link is supported by the data compiled for this report.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
US Market Information
All 10 licenses are cancelled. Indication text is not recorded for any of them. The five listed below are the main ones.
| Authorization Number | Product Name | Dosage Form | Status |
|---|---|---|---|
| NDA021444 | RISPERDAL M-TAB (Janssen) | Orally disintegrating tablet | Cancelled |
| NDA213586 | UZEDY (Teva) | Extended-release injectable suspension | Cancelled |
| ANDA078707 | Risperidone (Westminster) | Film-coated tablet | Cancelled |
| ANDA079059 | Risperidone (Bryant Ranch Prepack) | Solution | Cancelled |
| ANDA077542 | Risperidone (Sun Pharmaceutical) | Orally disintegrating tablet | Cancelled |
Safety Considerations
Label warnings and contraindications were not available in the data compiled for this report. Please refer to the package insert for them.
- Contraindication signals from the knowledge graph (these are not label text): cardiovascular and cerebrovascular conditions (myocardial infarction, stroke, heart conduction disease, sudden cardiac arrest, orthostatic or hypotensive disorders), metabolic conditions (diabetes mellitus, diabetic ketoacidosis, hyperglycemia, hyperlipidemia, obesity), blood disorders (neutropenia, agranulocytosis), liver and gallbladder disease, epilepsy, and female breast carcinoma.
- Drug Interactions (100 interactions found; the main ones are shown):
- Major: bupropion, morphine.
- Moderate: metformin, acarbose, alogliptin, albiglutide, canagliflozin, epinephrine, hydrocortisone, amphotericin B, atropine, hyoscyamine, glycopyrronium, loperamide, lorcaserin, bisacodyl, clidinium, famotidine.
- Minor: ranitidine.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction has a very high model score but no clinical trials, no literature and no plausible mechanism. Evidence is at L5, and all US licenses for risperidone are currently cancelled.
To proceed, the following is needed:
- A mechanistic rationale linking risperidone to ROBO3-related gaze palsy, or preclinical data supporting one.
- Detailed mechanism of action data (MOA).
- Label warnings and contraindications from the FDA package insert.
- Clarification of the regulatory status, since all US licenses are cancelled.
- Consideration of other predictions for this drug, which have more support in the data compiled for this report:
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.