Risperidone

Evidence Level: L5

Predicted Indications: 4

Risperidone

Pharmacist Assessment Report

Risperidone: Gaze palsy, familial horizontal, with progressive scoliosis

One-Sentence Summary

Risperidone is an atypical antipsychotic that acts mainly by blocking dopamine D2 and serotonin 5-HT2A receptors. The TxGNN model predicts it may be relevant to familial horizontal gaze palsy with progressive scoliosis (gaze palsy, familial horizontal, with progressive scoliosis), with a score of 0.9976. There are currently no clinical trials and no publications supporting this prediction, so it is a model output only.

Quick Overview

Item	Content
Original Indication	Not recorded in the local data
Predicted New Indication	Gaze palsy, familial horizontal, with progressive scoliosis
TxGNN Prediction Score	0.9976
Evidence Level	L5
Australia Market Status	Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data
Number of PBS Items	1 (valid: 1)
Recommended Decision	Hold

Why is This Prediction Reasonable?

Detailed mechanism of action data is not available in the data compiled for this report. Risperidone is generally known as a D2/5-HT2A antagonist.

The predicted condition is an ultra-rare genetic disorder caused by ROBO3 mutations, which affect axon guidance in the brainstem. No plausible mechanistic link between risperidone’s receptor pharmacology and this pathology has been identified. The high TxGNN score reflects a model-based association only and should not be read as evidence of benefit.

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

Currently no related literature available.

Australia Market Information

ARTG Number	Product Name	Dosage Form	Approved Indication
ARTG 11869Q	APO-Risperidone	Tablet 0.5 mg (oral)	Not available in the data compiled for this report

At least one valid licence is on record (1 single-ingredient entry, valid). Available route: oral.

Safety Considerations

Drug Interactions (100 interactions in total, 20 shown in the data compiled for this report). Major-level interactions include:
- Bupropion
- Morphine
Moderate-level interactions include acarbose, famotidine, epinephrine, hydrocortisone, albiglutide, alogliptin, metformin, amphotericin B, hyoscyamine, loperamide, atropine, lorcaserin, bisacodyl, glycopyrronium, canagliflozin and clidinium. Ranitidine is a minor interaction.
Conditions flagged for caution or contraindication in the data compiled for this report (not taken from label text): orthostatic hypotension and other hypotensive disorders, multiple system atrophy, postural orthostatic tachycardia syndrome, epilepsy, liver disease and liver failure, gallbladder disease, diabetes mellitus, hyperglycaemia, diabetic ketoacidosis, neutropenia, agranulocytosis, hyperlipidaemia, obesity, stroke and cerebrovascular disorders, myocardial infarction and other cardiovascular or heart conduction disease, sudden cardiac arrest, female breast carcinoma, and haemoglobinopathy.

Please refer to the TGA-approved Product Information (PI) for warnings and contraindications.

Conclusion and Next Steps

Decision: Hold

Rationale: The prediction rests on a model score alone. No trials or publications address this disease, and no mechanistic rationale links risperidone to ROBO3-related gaze palsy with scoliosis.

To proceed, the following is needed:

Any preclinical or clinical study that directly examines risperidone in this condition
A defined mechanistic hypothesis linking risperidone’s pharmacology to ROBO3-related axon guidance
Detailed mechanism of action data
Review of the TGA-approved Product Information for safety information

Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.