Paliperidone
| Evidence Level: L5 | Predicted Indications: 9 |
Table of Contents
- Paliperidone
- Pharmacist Assessment Report
- Paliperidone: From Schizophrenia to Retinal Dystrophy with or without Extraocular Anomalies
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- India Market Information
- Safety Considerations
- Conclusion and Next Steps
- Disclaimer
Paliperidone: From Schizophrenia to Retinal Dystrophy with or without Extraocular Anomalies
One-Sentence Summary
Paliperidone is an antipsychotic originally used to treat schizophrenia and related psychotic disorders. The TxGNN model predicts it may be effective for retinal dystrophy with or without extraocular anomalies, but this is a model prediction only, with 0 clinical trials and 0 publications supporting it.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Schizophrenia (also psychotic disorder, schizophreniform disorder, schizoaffective disorder, mental disorder) |
| Predicted New Indication | Retinal dystrophy with or without extraocular anomalies |
| TxGNN Prediction Score | 0.9992 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (17 of 17) – CDSCO approval status is not included in this data |
| Number of Listed Products | 17 (valid: 17) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the data compiled for this report. Paliperidone is an atypical antipsychotic, the active metabolite of risperidone, and is generally understood to act through dopamine D2 and serotonin 5-HT2A receptor antagonism. Its efficacy in schizophrenia is established.
For retinal dystrophy, no plausible mechanistic link has been established. Retinal dystrophies are mostly genetic degenerative conditions, and nothing shows that D2/5-HT2A antagonism would slow or reverse them. The very high score (rank 1,886 in the model’s overall ranking) comes from the TxGNN model (deep learning) and may reflect similarities the model learned between related diseases, not biological evidence.
The other top-ranked predictions have the same weakness: X-linked and syndromic myopia, hydranencephaly, a congenital glycosylation disorder, Charcot-Marie-Tooth disease type 1G and others. None has any clinical or literature support.
- The three Phase 4 trials are only indirectly relevant. One is terminated with 5 patients, one has unknown status, and one concerns recovery-oriented programs.
- The two publications are general reviews.
- Clozapine remains the guideline-supported option for this population.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
India Market Information
Paliperidone is marketed in India, with 17 valid single-ingredient registrations and no cancelled ones. Main examples are below.
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| 182626 | Peridol-OD 1.5 Tablet | Extended-release tablet (strip of 10) | Consern Pharma Limited |
| 178539 | Paliris 3 Tablet ER | Extended-release tablet (strip of 14) | Sun Pharmaceutical Industries Ltd |
| 174553 | Palido-OD 3 Tablet ER | Extended-release tablet (strip of 10) | Torrent Pharmaceuticals Ltd |
| 177340 | Palip 6mg Tablet XR | Extended-release tablet (strip of 10) | Intas Pharmaceuticals Ltd |
| 108501 | Invega Sustenna 75mg Injection | Injection (vial of 1) | Janssen Pharmaceuticals |
Other registrations include further oral strengths (1.5 mg to 9 mg) and Invega Sustenna 100 mg and 150 mg injections.
Safety Considerations
- Disease conditions flagged as contraindications (from the model’s knowledge graph, not label text): long QT syndrome and torsades de pointes, orthostatic hypotension and other hypotensive disorders, myocardial infarction and coronary thrombosis, epilepsy, diabetes mellitus and diabetic ketoacidosis, hyperglycemia, hyperlipidemia, obesity disorders, neutropenia and agranulocytosis, impaired renal function, Crohn disease and inflammatory bowel disease, basal ganglia disease, potassium deficiency, and others.
- Drug Interactions: 235 interactions were identified. Major interactions include bupropion and morphine. Moderate interactions include antidiabetic agents (metformin, pioglitazone, canagliflozin, alogliptin, acarbose, chlorpropamide, albiglutide), anticholinergic agents (atropine, hyoscyamine, glycopyrronium), amphotericin B, epinephrine, hydrocortisone, famotidine, loperamide, bisacodyl and lorcaserin.
Please refer to the package insert for label warnings and contraindications, which were not available for this report.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction for retinal dystrophy rests only on a score from the TxGNN model (deep learning), which may reflect similarities the model learned between related diseases, not biological evidence. There are no trials or publications, and no plausible mechanistic link to paliperidone’s pharmacology. The evidence level is L5.
To proceed, the following is needed:
- Detailed mechanism of action data (MOA) and a testable biological hypothesis connecting paliperidone to retinal pathology
- Preclinical evidence (for example retinal cell or animal models) supporting benefit in retinal dystrophy
- Package insert warnings and contraindications from the India regulatory source
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.