Pimozide

Evidence Level: L3 Predicted Indications: 10

Table of Contents

  1. Pimozide
    1. Pharmacist Assessment Report
    2. Pimozide: From Tourette Syndrome to Trichotillomania
    3. One-Sentence Summary
    4. Quick Overview
    5. Why is This Prediction Reasonable?
    6. Clinical Trial Evidence
    7. Literature Evidence
    8. India Market Information
    9. Safety Considerations
    10. Conclusion and Next Steps
    11. Disclaimer

Pharmacist Assessment Report

Pimozide: From Tourette Syndrome to Trichotillomania

One-Sentence Summary

Pimozide is a dopamine D2 antagonist antipsychotic, originally used to treat Tourette syndrome. The TxGNN model predicts it may be effective for trichotillomania (compulsive hair pulling). Support is limited: no registered clinical trials and 9 publications, mostly reviews, plus one small, dated augmentation study from 1992.

Quick Overview

Item Content
Original Indication Tourette syndrome
Predicted New Indication Trichotillomania
TxGNN Prediction Score 1.0000
Evidence Level L3
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. Pimozide is known to be a dopamine D2 receptor antagonist, and its efficacy in Tourette syndrome is established.

Trichotillomania and Tourette syndrome share features of repetitive, habit-like behaviour. Both are thought to involve dopaminergic dysregulation in cortico-striatal-thalamic circuits. A 1992 study (PMID 1532960) reported that low-dose pimozide added to serotonin reuptake inhibitors was helpful in trichotillomania. A dermatology review (PMID 15554735) also covers pimozide use in related psychodermatologic conditions.

However, the evidence is small-scale and dated. More recent evidence maps favour other approaches, such as SSRIs, N-acetylcysteine, olanzapine and behavioural therapy.

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

PMID Year Type Journal Key Findings
15554735 2004 Review Am J Clin Dermatol Comprehensive review of pimozide in dermatologic practice, including monosymptomatic hypochondriacal psychosis
36802832 2023 Evidence mapping / Review J Cutan Med Surg Maps RCT evidence for pharmacological treatment of primary psychodermatologic disorders
30446201 2018 Review Clin Dermatol Antipsychotic drugs in dermatology, acting through central and peripheral receptor effects
1532960 1992 Clinical study (small augmentation study) J Clin Psychiatry Low-dose pimozide augmentation of serotonin reuptake blockers in trichotillomania
27320510 2016 Review Tijdschr Psychiatr Treatment options for paediatric trichotillomania
10497682 1999 Review Ann Acad Med Singap Overview of trichotillomania as an under-diagnosed psychiatric condition
11475941 2001 Review CNS Drugs Psychogenic excoriation: clinical features and treatment approaches
10357517 1999 Case series J Child Adolesc Psychopharmacol Risperidone (not pimozide) added in SRI-resistant trichotillomania; notes earlier benefit of pimozide
10900563 2000 Review Int J Psychiatry Med Delusional parasitosis clinical profile (indirect relevance)

India Market Information

Authorization Number Product Name Dosage Form Approved Indication
182021 Pimolite 4mg Tablet Strip of 10 tablets Not stated
165606 Orap 4mg Tablet Strip of 10 tablets Not stated
134766 Mozep 2 Tablet Strip of 10 tablets Not stated
176959 Pimide 2mg Tablet Strip of 10 tablets Not stated
163388 Orap 2mg Tablet Strip of 10 tablets Not stated

All 20 licences are valid single-ingredient oral tablets. The five above are a selection.

Safety Considerations

  • Contraindications (model-derived associations from the TxGNN model (deep learning), not label text; these may reflect similarities the model learned between related diseases, not biological evidence): long QT syndrome (including familial), torsades de pointes, sudden cardiac arrest, heart conduction disease, epilepsy, kidney disease, liver disease, gallbladder disease, potassium deficiency, benign prostatic hyperplasia, glaucoma, neuroleptic malignant syndrome, neutropenia, agranulocytosis, leukopenia and related congenital neutropenias, female breast carcinoma, and Alzheimer disease.
  • Drug Interactions: 247 interactions were recorded. Major ones include hydrocortisone, amphotericin B (including the lipid complex), bupropion, aprepitant, morphine, lorcaserin, cimetidine, potassium citrate, clarithromycin, picosulfuric acid, and polyethylene glycol with electrolytes. Moderate ones include famotidine, epinephrine, hyoscyamine, loperamide, atropine, bisacodyl, glycopyrronium, and dicyclomine.

Please also refer to the package insert for label-based warnings and contraindications, which were not available for this report.

Conclusion and Next Steps

Decision: Hold

Rationale: Support for trichotillomania is limited to a small 1992 augmentation study and reviews, with no registered trials. Pimozide also carries QT-prolongation risk and a heavy interaction burden, while better-supported alternatives exist.

To proceed, the following is needed:

  • Package insert warnings and contraindications for the Indian-marketed products, which are required before safety screening
  • Detailed mechanism of action data
  • Modern controlled trial data for pimozide in trichotillomania, with a comparison against current options (SSRIs, N-acetylcysteine, olanzapine, behavioural therapy)
  • A cardiac (QT/ECG) monitoring and drug interaction management plan

    Disclaimer

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



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