Quetiapine

Evidence Level: L5

Predicted Indications: 10

Quetiapine

Pharmacist Assessment Report

Quetiapine: From Schizophrenia and Bipolar Disorder to retinal dystrophy with or without extraocular anomalies

One-Sentence Summary

Quetiapine is an atypical antipsychotic originally used to treat schizophrenia and bipolar disorder. The TxGNN model predicts it may be effective for retinal dystrophy with or without extraocular anomalies, but no clinical trials and no publications currently support this prediction, so it is a computational signal only.

Quick Overview

Item	Content
Original Indication	Schizophrenia; bipolar disorder (including manic bipolar affective disorder and major affective disorder). The Indian licence records list no indication text.
Predicted New Indication	Retinal dystrophy with or without extraocular anomalies
TxGNN Prediction Score	0.9957
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. Based on known information, quetiapine is an atypical antipsychotic. Its efficacy in schizophrenia and bipolar disorder is established. Its receptor pharmacology is generally described as dopamine D2 and serotonin 5-HT2A antagonism, with histamine H1 and alpha-1 adrenergic blockade.

Inherited retinal dystrophies are genetic degenerative conditions of the retina. From the data compiled for this report, no plausible mechanistic link can be established between quetiapine’s receptor pharmacology and the pathology of these conditions. The high score (rank 7,551 in the model’s overall ranking) comes from the TxGNN model (deep learning) and may reflect similarities the model learned between related diseases, not biological evidence. This prediction should be treated as a hypothesis only.

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

Currently no related literature available.

India Market Information

Quetiapine is marketed in India as single-ingredient oral tablets, in both immediate-release and sustained-release (SR) forms. There are 20 valid registrations and none cancelled. Five are shown below. The licence records contain no approved-indication text.

Authorization Number	Product Name	Dosage Form	Manufacturer
183101	Qtripil 50mg Tablet	Strip of 10 tablets	Arinna Lifescience Pvt Ltd
177775	Pine 50mg Tablet	Strip of 10 tablets	Suraksha Pharma Pvt Ltd
183623	Q-Zac 50 SR Tablet	Strip of 10 SR tablets	Dorris Pharmaceutical Pvt Ltd
182912	Quel 100 Tablet	Strip of 10 tablets	Ipca Laboratories Ltd
208161	Sera 200mg Tablet SR	Strip of 10 SR tablets	Curelogic Pharma

Safety Considerations

Disease-level contraindication signals (knowledge graph, not label text): Associations were found with the following conditions:
- Cardiovascular: hypertension, orthostatic hypotension, postural orthostatic tachycardia syndrome, multiple system atrophy, long QT syndrome (including familial), torsades de pointes, myocardial infarction.
- Neurological: epilepsy, basal ganglia disease, focal hand dystonia, blepharospasm.
- Metabolic and endocrine: diabetes mellitus, diabetic ketoacidosis, hyperglycemia, hypothyroidism (including myxedema and congenital hypothyroidism), potassium deficiency, hyperlipidemia (including familial), hypertriglyceridemia, obesity (including monogenic obesity).
- Haematological: neutropenia, agranulocytosis.
- Other: liver disease, gallbladder disease, female breast carcinoma.
Drug Interactions: 356 interactions were identified. The two Major interactions among those listed are bupropion and morphine. Other interactions are Moderate, including:
- Antidiabetic agents: acarbose, metformin, pioglitazone, alogliptin, canagliflozin, albiglutide, chlorpropamide.
- Anticholinergic agents: atropine, hyoscyamine, glycopyrronium, clidinium.
- Others: epinephrine, famotidine, loperamide, aprepitant, dexamethasone, lorcaserin, bisacodyl.

Please also refer to the package insert for label-based warnings and contraindications.

Conclusion and Next Steps

Decision: Hold

Rationale: The prediction rests on a model score alone, with no clinical trials, no literature and no identifiable mechanistic link. Quetiapine also carries notable cardiometabolic and haematological safety signals, which raise the bar for any new use.

For context, among the top 10 predicted indications, trichotillomania (score 0.9938) has the most supporting evidence. It has six publications, mostly case reports and reviews, including quetiapine-specific reports (PMIDs 19142421, 12405081). It has no registered trials and sits at L4, so it is a research question rather than an actionable indication. The other predictions, such as congenital glycosylation disorders, structural brain malformations and X-linked myopia, are also unsupported.

To proceed, the following is needed:

Mechanism of action data, to allow a mechanistic assessment
A literature and preclinical search specific to retinal dystrophy, to show any biological plausibility
Package insert warnings and contraindications from Indian regulatory sources, for safety screening
If a better-supported candidate is wanted, a more focused evaluation of trichotillomania, starting with a verified review of the case-level evidence
Disclaimer

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