Quetiapine
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Quetiapine: From Bipolar Disorder and Schizophrenia to Trichotillomania
One-Sentence Summary
Quetiapine is an atypical antipsychotic, originally used to treat schizophrenia and bipolar disorder (including manic episodes). The TxGNN model’s top-ranked prediction is retinal dystrophy, but that prediction has no supporting evidence. The best-supported candidate in the data compiled for this report is Trichotillomania, with 0 clinical trials and 6 publications, all case reports or reviews. This report therefore covers the top-ranked prediction in the overview table, and discusses trichotillomania as the only candidate with any literature support.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Bipolar disorder, major affective disorder, manic bipolar affective disorder, schizophrenia (from the knowledge graph; no label indication text is available) |
| Predicted New Indication (TxGNN rank 1) | Retinal dystrophy with or without extraocular anomalies |
| TxGNN Prediction Score (rank 1) | 99.57% |
| Best-Supported Candidate | Trichotillomania (TxGNN score 99.38%, rank 8 of the top 10) |
| Evidence Level | L5 for the rank 1 prediction (L4 for trichotillomania) |
| US Market Status | Cancelled only (no currently valid licenses in the data compiled) |
| Number of NDAs/ANDAs | 9 (1 NDA, 8 ANDAs; all cancelled) |
| Recommended Decision | Hold (rank 1); trichotillomania is a research question only |
Why is This Prediction Reasonable?
Detailed mechanism of action data for quetiapine is not available in the data compiled for this report. Based on general pharmacology, quetiapine is an atypical antipsychotic that acts mainly through serotonin (5-HT2A) and dopamine (D2) receptor antagonism. This is general knowledge, not drawn from the supplied data.
Rank 1 (retinal dystrophy): No clinical trials or literature were found, and no plausible mechanism links quetiapine to retinal degeneration. The high score is a graph-based prediction only. The same holds for the other top-ranked predictions, such as congenital disorder of glycosylation, hydranencephaly, 17p13.3 microdeletion syndrome, polymicrogyria, X-linked myopia, syndromic myopia, and Charcot-Marie-Tooth type 1G. These are genetic or structural conditions that an antipsychotic is not expected to modify.
Trichotillomania (rank 8): This is an obsessive-compulsive-spectrum disorder, and atypical antipsychotics are sometimes used as augmentation in OCD-spectrum conditions, so the idea is plausible. The direction of effect is not clear-cut, though. One report in the literature describes quetiapine exacerbating obsessive-compulsive symptoms in a patient who also had trichotillomania.
Clinical Trial Evidence
Currently no related clinical trials registered, for either the rank 1 prediction or trichotillomania.
Literature Evidence
No literature is available for the rank 1 prediction. For trichotillomania, the following publications were found. All are Tier 3 evidence (case reports or reviews), and none is a controlled study.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 12405081 | 2002 | Review / Case report | Psychiatry | Overview of trichotillomania, with a case report of a favorable response to quetiapine in a 33-year-old woman |
| 19142421 | 2008 | Case report / Case series | Rev Bras Psiquiatr | Quetiapine for the treatment of trichotillomania (no abstract available) |
| 11212595 | 2001 | Case report / Review | J Psychiatry Neurosci | Quetiapine exacerbated obsessive-compulsive symptoms in a patient with OCD, trichotillomania and bipolar features; reviews antipsychotic-induced OCS |
| 20833945 | 2010 | Case report / Review | Psychosomatics | Treatment of recurrent Rapunzel syndrome and trichotillomania |
| 27840761 | 2016 | Case report | Case Rep Psychiatry | Trichotillomania as a manifestation of dementia |
| 38797877 | 2025 | Review | Int J Dermatol | Review of pharmacological treatment for trichotillomania and gaps in treatment education |
US Market Information
All nine US authorizations are cancelled. The data compiled for this report does not include approved-indication text.
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| NDA020639 | SEROQUEL (H2-Pharma) | Film-coated tablet | Not available |
| ANDA091388 | Quetiapine Fumarate (NorthStar Rx) | Film-coated tablet | Not available |
| ANDA201190 | Quetiapine Fumarate (Sun Pharmaceutical) | Film-coated tablet | Not available |
| ANDA207655 | Quetiapine Fumarate (Aurobindo) | Film-coated extended-release tablet | Not available |
| ANDA204203 | Quetiapine (Major Pharmaceuticals) | Film-coated extended-release tablet | Not available |
Safety Considerations
Package insert warnings and contraindications are not available in the data compiled for this report. Please refer to the package insert for safety information.
Contraindication-related conditions (knowledge graph, not label text): The knowledge graph links quetiapine to caution in the following groups of conditions:
- Cardiovascular: hypertension, orthostatic hypotension, long QT syndrome, torsades de pointes, myocardial infarction
- Neurological: epilepsy, basal ganglia disease, dystonia, blepharospasm
- Metabolic: diabetes mellitus, diabetic ketoacidosis, hyperglycemia, hyperlipidemia, hypertriglyceridemia, obesity, hypothyroidism, potassium deficiency
- Haematological: neutropenia, agranulocytosis
- Other: liver disease, gallbladder disease, female breast carcinoma
Drug interactions: 100 interactions were recorded. The main ones shown in the data are:
- Major: bupropion, morphine
- Moderate: antidiabetic agents (metformin, pioglitazone, acarbose, alogliptin, albiglutide, canagliflozin, chlorpropamide), anticholinergic agents (atropine, hyoscyamine, glycopyrronium, clidinium), epinephrine, famotidine, loperamide, aprepitant, dexamethasone, lorcaserin, bisacodyl
Conclusion and Next Steps
Decision: Hold
Rationale:
- The rank 1 prediction (retinal dystrophy) and the other top-ranked predictions have no trials, no literature, and no plausible mechanism. They are model outputs only (Evidence Level L5).
- Trichotillomania has a plausible mechanism and a few case reports, but no controlled trials. The evidence is mixed because quetiapine has also been reported to worsen obsessive-compulsive symptoms. It is best treated as a research question, not a candidate for advancement.
- Quetiapine has no currently valid US licenses in the data compiled, and the safety label data is missing.
To proceed, the following is needed:
- Quetiapine mechanism of action data (for example, from DrugBank)
- FDA package insert warnings and contraindications
- For trichotillomania: a systematic literature review and, if warranted, a controlled trial
- Confirmation of current US market status and approved indications
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.