Asenapine
| Evidence Level: L5 | Predicted Indications: 9 |
Table of Contents
Asenapine: Retinal dystrophy with or without extraocular anomalies
One-Sentence Summary
Asenapine is an atypical antipsychotic originally used for bipolar I disorder (manic and mixed episodes) and schizophrenia. The TxGNN model predicts it may be effective for retinal dystrophy with or without extraocular anomalies. However, there are no clinical trials and no publications supporting this prediction, so it is a model output only.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Retinal dystrophy with or without extraocular anomalies |
| TxGNN Prediction Score | 0.9977 |
| Evidence Level | L5 |
| Australia Market Status | Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data |
| Number of PBS Items | 1 (valid: 1) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the data compiled for this report. Asenapine is known as an atypical antipsychotic that antagonises serotonin, dopamine, alpha-adrenergic and histamine receptors. Its efficacy in mania and schizophrenia is established.
No plausible mechanistic link to retinal dystrophy has been identified. Retinal dystrophies are largely genetic conditions affecting the retina, and asenapine’s receptor pharmacology has no known connection to those genetic causes. The high score (0.9977) comes from the TxGNN model (deep learning) and may reflect similarities the model learned between related diseases, not biological evidence.
It is essentially on-label or closely related to asenapine’s approved uses, so it is not a true repurposing candidate. Its evidence is summarised in the conclusion below.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ARTG 5140M | Saphris | Sublingual wafer 5 mg (as maleate) | Not stated in the data compiled; refer to the TGA Product Information |
Safety Considerations
Contraindication-related conditions (from the knowledge graph, not label text): The knowledge graph links asenapine to the following conditions. Key groups are:
- Cardiac: long QT syndrome (including familial), torsades de pointes, myocardial infarction, myocardial ischaemia, coronary artery disease
- Cerebrovascular: stroke, cerebral infarction, cerebrovascular disorder
- Blood: neutropenia, agranulocytosis, leukopenia, severe congenital neutropenia
- Metabolic: diabetes mellitus, diabetic ketoacidosis, hyperglycaemia, obesity, potassium deficiency
- Neurological and autonomic: epilepsy, neuroleptic malignant syndrome, orthostatic hypotension, postural orthostatic tachycardia syndrome, multiple system atrophy
- Hepatic: liver failure
Drug Interactions: The interaction query returned 100 interactions in total. The main ones listed are:
- Major: bupropion, morphine, cisapride
- Moderate (examples): metformin, pioglitazone, alogliptin, canagliflozin, acarbose, albiglutide (antidiabetic agents), famotidine, cimetidine, clarithromycin, epinephrine, atropine, hyoscyamine, loperamide, bisacodyl
For full safety information, please refer to the TGA-approved Product Information (PI).
Conclusion and Next Steps
Decision: Hold
Rationale:
- The retinal dystrophy prediction is supported only by a model score. There are no trials or publications, and no plausible mechanism links asenapine’s receptor antagonism to this largely genetic group of retinal diseases.
- It would be rated L1 and “Proceed with Guardrails”, but it largely restates existing indications.
To proceed, the following is needed:
- A biological rationale or preclinical data linking asenapine to retinal dystrophy pathways
- Detailed mechanism of action data
- Label-based warnings and contraindications from the TGA Product Information
- If the affective disorder direction is pursued, clarification of its scope (acute mania or mixed episodes versus bipolar depression or unipolar depression), plus monitoring of metabolic and extrapyramidal effects and a review of the high interaction burden
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.