Sulpiride
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Sulpiride: From Schizophrenia to Retinal Dystrophy with or without Extraocular Anomalies
One-Sentence Summary
Sulpiride is a selective dopamine D2/D3 receptor antagonist, originally used to treat schizophrenia. The TxGNN model predicts it may be effective for retinal dystrophy with or without extraocular anomalies, but no clinical trials and only 2 preclinical publications (rat retina studies) currently support this direction, so it should be treated as a research question rather than a treatment candidate.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Schizophrenia (the Singapore licence record lists no indication text) |
| Predicted New Indication | Retinal dystrophy with or without extraocular anomalies |
| TxGNN Prediction Score | 99.95% |
| Evidence Level | L4 (preclinical only) |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 1 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Pharmacology data show that sulpiride is selective for the dopamine D2 and D3 receptors and has low affinity for D4. It also has recorded interactions with carbonic anhydrases (CA1, CA7, CA12).
The link to retinal disease is indirect. In animal models of retinitis pigmentosa, the retinal dopamine system appears to be dysfunctional. In the P23H rat model, D2-like antagonists, including sulpiride, appeared to improve the light responses of retinal ganglion cells. They did this by increasing light sensitivity and converting abnormal long-latency ON-center cells into OFF-center cells.
This gives mechanism-level plausibility only. These studies did not test sulpiride as a treatment for inherited retinal dystrophy. Altered dopaminergic signalling in the retina is not evidence that the disease itself is modified. The very high TxGNN score is a computational prediction and cannot replace clinical evidence.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 27788033 | 2016 | Preclinical (animal/ex vivo electrophysiology) | J Ocul Pharmacol Ther | Tested haloperidol and clozapine on retinal ganglion cell visual responses in a rat model of retinitis pigmentosa. Earlier work showed that the D2 antagonists sulpiride and eticlopride appeared to improve responses in this model. |
| 26717015 | 2015 | Preclinical (animal/ex vivo electrophysiology) | PLoS One | Examined D2-like receptor antagonists on retinal ganglion cell light responses in wild-type and P23H rat retinas, a retinitis pigmentosa model with dysfunctional dopaminergic signalling. |
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN09937P | DEVODIL 200 TABLET 200 mg (REMEDICA LTD) | Tablet (oral) | Not stated in the licence record |
Safety Considerations
- Drug Interactions / Pharmacological Targets: The interaction query returned 5 entries. These are pharmacological target interactions rather than drug–drug interactions, with no severity level assigned: dopamine D2 receptor, dopamine D3 receptor, and carbonic anhydrases 1, 7 and 12.
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The only support is two preclinical rat electrophysiology studies and a high model score. There are no clinical trials, and the studies did not test sulpiride as a disease-modifying treatment for inherited retinal dystrophy. The remaining nine predicted indications (for example hydranencephaly, Charcot-Marie-Tooth type 1G and X-linked myopia) have no supporting trials or literature and no plausible mechanistic link. Several myopia predictions may even point in the unfavourable direction, since D2 antagonism is not the protective direction for eye growth.
To proceed, the following is needed:
- Package insert warnings and contraindications from HSA (currently missing and blocking safety screening)
- Detailed mechanism of action data
- Preclinical studies testing sulpiride directly in inherited retinal dystrophy models, with functional and structural outcomes
- Assessment of whether systemic dosing is feasible, or whether an ocular route would be needed (route compatibility has not been assessed; only an oral tablet is registered in Singapore)
- A safety review for long-term use in the target population, since sulpiride is an antipsychotic
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.