Prochlorperazine
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
- Prochlorperazine
- Pharmacist Assessment Report
- Prochlorperazine: From Schizophrenia to retinal dystrophy with or without extraocular anomalies (Top TxGNN Prediction, No Supporting Evidence)
- 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
Prochlorperazine: From Schizophrenia to retinal dystrophy with or without extraocular anomalies (Top TxGNN Prediction, No Supporting Evidence)
One-Sentence Summary
Prochlorperazine is a phenothiazine dopamine D2 antagonist, originally used for schizophrenia (and widely marketed in India as 5 mg tablets). The TxGNN model’s top-ranked prediction is retinal dystrophy with or without extraocular anomalies, but there are 0 clinical trials and 0 publications supporting it. The only prediction with any literature is manic bipolar affective disorder (7 publications, mostly old case reports and general reviews, no trials), which is the more biologically plausible direction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Schizophrenia (the India licence records contain no indication text) |
| Predicted New Indication | Retinal dystrophy with or without extraocular anomalies |
| TxGNN Prediction Score | 1.0000 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data |
| Number of Listed Products | at least 20 |
| Recommended Decision | Hold |
For comparison, the only prediction with literature is manic bipolar affective disorder (score 0.9998, Evidence Level L4, flagged as a research question rather than a go decision).
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the data compiled for this report. Prochlorperazine is known as a phenothiazine D2 dopamine receptor antagonist, and its efficacy in schizophrenia and in nausea, vomiting and agitation is established.
Retinal dystrophy with or without extraocular anomalies (top-ranked prediction): No mechanistic link has been identified. Inherited retinal degeneration is a genetic condition, and a D2 antagonist has no plausible disease-modifying pathway. The very high score comes from the TxGNN model (deep learning) and may reflect similarities the model learned between related diseases, not biological evidence. The same holds for the other top-ranked predictions: hydranencephaly, congenital disorder of glycosylation with defective fucosylation, X-linked myopia, Charcot-Marie-Tooth disease type 1G, perisylvian polymicrogyria, syndromic myopia, female-limited X-linked myopia 26, and atypical glycine encephalopathy. All have no trials, no literature and no plausible mechanism.
Manic bipolar affective disorder: This is biologically plausible. D2 antagonism underlies the antipsychotic efficacy seen in acute mania, and prochlorperazine is already used for psychosis and agitation. However, newer antipsychotics are the standard of care, so the incremental value of prochlorperazine is unclear.
Clinical Trial Evidence
Currently no related clinical trials registered, for the top-ranked prediction or for manic bipolar affective disorder.
Literature Evidence
No literature is available for the top-ranked prediction (retinal dystrophy). The publications below were retrieved for the manic bipolar affective disorder prediction. All are low-tier evidence.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 19461391 | 2009 | Review | J Psychiatr Pract | Use and safety of antipsychotic drugs during pregnancy |
| 26819726 | 2015 | Pharmacovigilance cohort | J Pharm Health Care Sci | Hyperglycaemic adverse events after antipsychotic use in FAERS reports |
| 13617778 | 1959 | Case report | Ann Med Psychol | Confusional dream-like attack caused by prochlorperazine in a mild manic-depressive patient |
| 14233737 | 1964 | Survey/case series | Am J Psychiatry | Electroshock therapy combined with phenothiazines and reserpine |
| 14222730 | 1964 | Case series | L’Encephale | Psychodysleptic manifestations during treatment with psycholeptics |
| 14242542 | 1965 | Review | Obstet Gynecol | Approach to severe puerperal psychological disorders |
| 14062306 | 1963 | Review | Tunisie Med | Emergency management of agitation in general practice |
India Market Information
There are 20 valid single-ingredient licences, all oral tablets and none cancelled. The licence records contain no approved-indication text. Main authorisations:
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 176671 | Prochlor 5mg Tablet (Hema Laboratories) | Strip of 10 tablets | Not stated |
| 199519 | Stemetil MD Tablet (Abbott) | Strip of 15 MD tablets | Not stated |
| 241810 | Westel 5mg Tablet (Key West Medicines) | Strip of 10 tablets | Not stated |
| 233491 | Vometil 5mg Tablet MD (Cipla) | Strip of 10 MD tablets | Not stated |
| 322 | Acuvert Tablet (Abbott) | Strip of 9 tablets | Not stated |
Safety Considerations
Package insert warnings and contraindications were not available. The following come from the model’s knowledge graph and from interaction databases, not from label text.
- Disease contraindications (knowledge graph): cardiovascular (hypertension, orthostatic hypotension, long QT syndrome, torsades de pointes, coronary artery disease, myocardial infarction); neurological (epilepsy, basal ganglia disease, multiple system atrophy, focal dystonia, blepharospasm); haematological (neutropenia, agranulocytosis, thrombocytopenia); metabolic and organ (hyperglycaemia, obesity, kidney disease, liver disease, gallbladder disease, gastric ulcer); others (benign prostatic hyperplasia, substance abuse/dependence, female breast carcinoma).
- Drug interactions: 368 interactions were recorded. Major ones include bupropion and potassium citrate. Moderate ones include antidiabetic agents (metformin, pioglitazone, acarbose, alogliptin, canagliflozin, chlorpropamide, albiglutide), anticholinergics (atropine, hyoscyamine, glycopyrronium), morphine, epinephrine, clarithromycin, famotidine, loperamide, lorcaserin, and laxatives (bisacodyl, picosulfuric acid).
- Pharmacovigilance data (PMID 26819726) associate antipsychotics with hyperglycaemic events.
Conclusion and Next Steps
Decision: Hold
Rationale: The top-ranked predictions, including retinal dystrophy, have only a model score behind them, with no trials, no literature and no plausible mechanism. Manic bipolar affective disorder is plausible but supported only by old, low-quality reports, and better-established antipsychotics already exist. It could be kept as a research question, not a development candidate.
To proceed, the following is needed:
- Package insert warnings and contraindications from the India regulator, a blocking gap for safety screening
- Detailed mechanism of action data from DrugBank
- For manic bipolar disorder: a systematic review or controlled data comparing prochlorperazine with current standard antipsychotics
- A cardiovascular, QT and metabolic safety review given the knowledge-graph contraindications
- No further work on the rare genetic disease predictions unless new biological evidence emerges
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.