Risperidone
| Evidence Level: L5 | Predicted Indications: 6 |
Table of Contents
- Risperidone
- Risperidone: From Registered Antipsychotic (Indication Text Not Available) to Gaze Palsy, Familial Horizontal, with Progressive Scoliosis
Risperidone: From Registered Antipsychotic (Indication Text Not Available) to Gaze Palsy, Familial Horizontal, with Progressive Scoliosis
One-Sentence Summary
Risperidone is an atypical antipsychotic with 7 SAHPRA registrations, but the approved-indication text is not recorded in the supplied data. The TxGNN model predicts it may be effective for familial horizontal gaze palsy with progressive scoliosis (an ultra-rare ROBO3-related disorder), with 0 clinical trials and 0 publications supporting this prediction. It is a model-only signal with no plausible mechanistic link.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the SAHPRA records supplied |
| Predicted New Indication | Gaze palsy, familial horizontal, with progressive scoliosis |
| TxGNN Prediction Score | 99.76% |
| Evidence Level | L5 |
| South Africa Market Status | Marketed |
| Number of SAHPRA Registrations | 7 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the record. From general pharmacology, risperidone acts mainly by antagonising dopamine D2 and serotonin 5-HT2A receptors, and it is used for psychiatric conditions.
The predicted disease is a rare developmental disorder linked to ROBO3. It affects eye-movement pathways and the spine. Nothing in risperidone’s D2/5-HT2A pharmacology points to a role in this condition. The very high TxGNN score most likely reflects proximity in the knowledge graph rather than a therapeutic rationale. This prediction should be treated as a computational artefact unless independent evidence emerges.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
South Africa Market Information
Showing 5 of 7 registrations. The approved-indication text is not included in the supplied records.
| Registration Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| Reg. No. 46/2.6.5/0362 | Zoxadon ODT 0.5 mg | Orally disintegrating tablet | Not stated in supplied record |
| Reg. No. A40/2.6.5/0706 | Perizal | Tablet | Not stated in supplied record |
| Reg. No. 42/2.6.5/0792 | Risnia | Tablet | Not stated in supplied record |
| Reg. No. 44/2.6.5/0003 | Perida 0.5 mg | Tablet | Not stated in supplied record |
| Reg. No. 41/2.6.5/1056 | Rutra 1 mg/ml Solution | Oral solution | Not stated in supplied record |
Safety Considerations
Please refer to the SAHPRA-approved Professional Information (PI) for safety information. Report adverse drug reactions to SAHPRA.
Conclusion and Next Steps
Decision: Hold
Rationale: This prediction has no trials, no publications and no mechanistic rationale. The score reflects graph proximity only, so there is no basis to pursue it.
To proceed, the following is needed:
- An independent biological rationale linking risperidone to ROBO3-related pathways, and any supporting studies
- The SAHPRA Professional Information (PI), to confirm approved indications and safety data
- Mechanism of action data (MOA) from DrugBank
Other predictions in the same Evidence Pack that merit review instead:
| Predicted Indication | Evidence Level | Supporting Evidence | Pack Recommendation |
|---|---|---|---|
| Major affective disorder | L1 | Phase 3 RCTs in paediatric bipolar disorder (NCT00057681, NCT00221403) and several meta-analyses of antipsychotic augmentation in treatment-resistant depression | Proceed with Guardrails |
| Trichotillomania | L4 | Case reports and small case series (1997–2021) of risperidone added to SSRIs, with no RCT | Research Question |
| Phelan-McDermid syndrome | L4 | A review, a zebrafish study and a case study, with no controlled human data | Research Question |
Major affective disorder is likely already an approved use of risperidone, so it may not be true repurposing. The approved indications should be verified against the PI, and the sub-indication (bipolar mania, paediatric bipolar disorder or depression augmentation) should be specified. Any use would need metabolic, prolactin and extrapyramidal monitoring, with extra caution in children and older adults.
This report is for research reference only and does not constitute medical advice. Repurposing candidates require clinical validation before any clinical use.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.