Sulpiride

Evidence Level: L5

Predicted Indications: 9

Sulpiride

Pharmacist Assessment Report

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 so far only 2 preclinical publications and no clinical trials support this direction.

Quick Overview

Item	Content
Original Indication	Schizophrenia
Predicted New Indication	Retinal dystrophy with or without extraocular anomalies
TxGNN Prediction Score	0.9995
Evidence Level	L5
India Market Status	Listed in a compiled Indian medicine price dataset (3 of 3) – CDSCO approval status is not included in this data
Number of Listed Products	3 (valid: 3)
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, however, show that sulpiride is selective for the dopamine D2 and D3 receptors, with low affinity for the D4 receptor. It is used for schizophrenia, depression, anxiety and behavioural problems in children.

Dopamine D2-like receptors modulate the light responses of retinal ganglion cells. In animal models of retinitis pigmentosa, the retinal dopamine system appears to be dysfunctional. In the P23H rat model, D2 antagonists such as sulpiride and eticlopride appeared to improve visual responses. They did so by increasing the light sensitivity of retinal ganglion cells and converting abnormal ON-center cells into OFF-center cells.

This evidence is indirect. It concerns retinal signalling and does not show that sulpiride slows or treats photoreceptor degeneration. The very high TxGNN score is a computational prediction and is not corroborated by clinical data.

Eight other predictions (for example hydranencephaly, Charcot-Marie-Tooth type 1G and several myopia subtypes) have no trials or literature and no identifiable mechanistic link. For the myopia entries, a D2 antagonist would be expected to act unfavourably or neutrally, because dopamine agonists are the agents that inhibit myopia progression. They are not pursued here.

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

PMID	Year	Type	Journal	Key Findings
27788033	2016	Preclinical (animal electrophysiology)	J Ocul Pharmacol Ther	Tested whether the antipsychotics haloperidol and clozapine affect retinal ganglion cell visual responses in a rat model of retinitis pigmentosa, building on earlier findings that D2 antagonists such as sulpiride improve these responses
26717015	2015	Preclinical (animal electrophysiology)	PLoS One	Examined the effects of D2-like receptor antagonists on retinal ganglion cell light responses in wild-type and P23H rat retinas, a model of retinitis pigmentosa with dysfunctional retinal dopamine signalling

India Market Information

Authorization Number	Product Name	Dosage Form	Approved Indication
207900	Stride 400mg Tablet	Strip of 10 tablets	Not stated
201138	Stride 100mg Tablet	Strip of 10 tablets	Not stated
207168	Stride 200mg Tablet	Strip of 10 tablets	Not stated

All three registrations are valid single-ingredient oral products from VGR Bio Lab.

Safety Considerations

Drug Interactions: The pharmacology data list sulpiride’s targets: dopamine D2 and D3 receptors, plus carbonic anhydrase 1, 7 and 12. No drug–drug interaction entries with severity levels were returned.

Please refer to the package insert for warnings and contraindications. These could not be obtained for this report.

Conclusion and Next Steps

Decision: Hold

Rationale: The only support is two indirect preclinical electrophysiology studies in a rat model. There are no clinical trials, and the TxGNN score is not corroborated by clinical data. This is a research question, not a candidate ready for development. Package insert safety data are also missing.

To proceed, the following is needed:

Preclinical studies showing that sulpiride protects photoreceptors or slows degeneration, not only that it changes ganglion cell responses
Detailed mechanism-of-action data
India package insert warnings and contraindications, to allow safety screening
A safety assessment for chronic use in a retinal disease population, including the known central nervous system effects of a D2 antagonist
Clarification of which retinal dystrophy subtypes, if any, are plausible targets
Disclaimer

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