Asenapine
| Evidence Level: L5 | Predicted Indications: 9 |
Table of Contents
Asenapine: Retinal dystrophy with or without extraocular anomalies
One-Sentence Summary
Asenapine is an antipsychotic that blocks serotonin, dopamine, adrenergic and histamine receptors, and it is marketed in Canada under the brand name SAPHRIS. The TxGNN model predicts it may be effective for retinal dystrophy with or without extraocular anomalies, with a score of 0.9977. Currently there are no clinical trials and no publications supporting this direction, so it is a computational prediction 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 |
| Canada Market Status | Marketed (marketed DINs: 2 of 2) |
| Number of DINs | 2 (marketed: 2) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Based on known pharmacology, asenapine is a receptor antagonist acting on serotonin, dopamine, adrenergic and histamine receptors.
No plausible mechanistic link to inherited retinal degeneration was identified. The high TxGNN score is a computational result only. Nothing in the data compiled for this report shows that blocking these receptors would affect the causes of inherited retinal dystrophy. The prediction should be treated as a hypothesis, not a supported use.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
Canada Market Information
| DIN | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 02374803 | SAPHRIS | Not specified | Not specified in the data compiled |
| 02374811 | SAPHRIS | Not specified | Not specified in the data compiled |
Safety Considerations
- Drug Interactions: Interaction screening returned 100 records. Major-level interactions among those listed include bupropion, morphine and cisapride. Moderate-level interactions include acarbose, famotidine, epinephrine, albiglutide, alogliptin, metformin, pioglitazone, hyoscyamine, loperamide, atropine, cimetidine and clarithromycin, among others. Antidiabetic agents appear repeatedly, which suggests blood glucose monitoring when co-prescribed.
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: There are no clinical trials or publications for this disease, and no mechanistic link was identified between asenapine’s receptor pharmacology and inherited retinal dystrophy. The evidence level is L5 (model prediction only).
To proceed, the following is needed:
- Preclinical or mechanistic evidence linking asenapine’s targets to retinal degeneration
- Detailed mechanism of action data
- Package insert warnings and contraindications from Health Canada
- A safety assessment for the target population, particularly given the QT, metabolic and cardiovascular cautions typical of this drug class
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.