Haloperidol
| Evidence Level: L5 | Predicted Indications: 9 |
Table of Contents
- Haloperidol
- Pharmacist Assessment Report
- Haloperidol: Congenital disorder of glycosylation with defective fucosylation
- 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
Haloperidol: Congenital disorder of glycosylation with defective fucosylation
One-Sentence Summary
Haloperidol is a dopamine D2-blocking antipsychotic, originally used for psychotic disorders, schizophrenia and Tourette syndrome. The TxGNN model predicts it may be effective for congenital disorder of glycosylation with defective fucosylation, but no clinical trials and no publications currently support this prediction, so it rests on the model score alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Congenital disorder of glycosylation with defective fucosylation |
| TxGNN Prediction Score | 0.9991 |
| 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 |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the data compiled for this report. Haloperidol is generally understood as a high-affinity dopamine D2 receptor antagonist, and its efficacy in psychotic disorders is well established.
No plausible mechanistic link could be identified between D2 antagonism and defective fucosylation, a congenital metabolic disorder of protein glycosylation. The high score (0.9991) is a model output only. Haloperidol could at most offer symptomatic help for neuropsychiatric features, which would not be disease-modifying. This prediction should therefore be treated as a hypothesis with no supporting evidence.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
India Market Information
Haloperidol has 20 valid single-ingredient registrations in India, all oral tablets. The records compiled for this report do not include approved indication text. The five listed below are examples.
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| 105789 | Halodias DT 0.25 Tablet | Strip of 10 dispersible tablets | Matias Healthcare Pvt Ltd |
| 106385 | Halodyl 1.5mg Tablet | Strip of 10 tablets | Tas Med India Pvt Ltd |
| 70174 | Dolcin 1.5mg Tablet | Strip of 10 tablets | Cinerea Biotech Pvt Ltd |
| 142809 | Mindwel 5mg Tablet | Strip of 10 tablets | Ajanta Pharma Ltd |
| 104792 | Hexidol Plus 5 mg/2 mg Tablet | Strip of 10 tablets | Torrent Pharmaceuticals Ltd |
Safety Considerations
- Contraindication-related conditions (drug-disease associations compiled for this report, not label text):
- Cardiac and neurological: long QT syndrome (including familial), torsades de pointes, epilepsy, basal ganglia disease, neuroleptic malignant syndrome.
- Haematological: neutropenia, leukopenia, agranulocytosis and congenital neutropenia syndromes.
- Metabolic and other: liver disease, gallbladder disease, hypothyroidism, potassium deficiency, hypotensive disorder, female breast carcinoma.
- Drug Interactions: 303 interactions were recorded. Major-level examples include bupropion, morphine, clarithromycin and dolasetron. Moderate-level examples include famotidine, epinephrine, hydrocortisone, amphotericin B and several anticholinergics.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction has only a model score, with no clinical trials, no literature and no plausible mechanistic link to haloperidol’s D2 antagonism. The patient group is also vulnerable, and haloperidol carries QT, extrapyramidal and haematological risks, so there is no basis to proceed.
To proceed, the following is needed:
- Mechanistic or preclinical evidence linking haloperidol to the fucosylation pathway
- Detailed mechanism of action data (MOA)
- Package insert warnings and contraindications from the Indian regulator
- A safety plan covering QT prolongation, extrapyramidal symptoms and the high interaction burden
It has completed Phase 3 trials (for example NCT00129220, a haloperidol-controlled olanzapine trial) and network meta-analyses (2022, 2025), and carries an L1 rating and a “Proceed with Guardrails” recommendation. It is closer to established clinical use than to novel repurposing. It would be a more productive candidate for evaluation than the prediction in this report.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.