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 acts as a serotonin, dopamine and alpha-adrenergic receptor antagonist. The TxGNN model predicts it may be relevant for retinal dystrophy with or without extraocular anomalies, but this is a computational prediction only: no clinical trials and no publications were found to support it.
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 |
| India Market Status | Listed in a compiled Indian medicine price dataset (7 of 7) – CDSCO approval status is not included in this data |
| Number of Listed Products | 7 (valid: 7) |
| 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 generally described as an antagonist at serotonin, dopamine and alpha-adrenergic receptors.
No mechanistic rationale linking this receptor pharmacology to the genetic drivers of inherited retinal dystrophy is supported by the data compiled for this report. The high TxGNN score (0.9977) reflects a model-based prediction and should not be read as evidence of benefit. Further work would have to start from basic biological questions, such as whether any of asenapine’s target receptors play a role in the affected retinal pathways.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 6374 | Asenapt 10 Sublingual tablet (Sun Pharmaceutical) | Strip of 10 sublingual tablets | Not stated in the licence record |
| 6563 | Asenapt 5 Sublingual tablet (Sun Pharmaceutical) | Strip of 10 sublingual tablets | Not stated in the licence record |
| 242555 | Welenuf 5mg Tablet (Torrent Pharmaceuticals) | Strip of 10 tablets | Not stated in the licence record |
| 8880 | Azin 10mg Tablet (Intas Pharmaceuticals) | Strip of 10 tablets | Not stated in the licence record |
| 12104 | Azin 5mg Tablet (Intas Pharmaceuticals) | Strip of 10 tablets | Not stated in the licence record |
All 7 registrations are single-ingredient products and currently valid; the table lists the first 5.
Safety Considerations
- Conditions flagged as contraindication-related in the reference data (not taken from label text): long QT syndrome, torsades de pointes, orthostatic hypotension, neutropenia, agranulocytosis, leukopenia, liver failure, epilepsy, diabetes mellitus, diabetic ketoacidosis, hyperglycemia, stroke and other cerebrovascular disorders, myocardial infarction, coronary artery disease, myocardial ischemia, and neuroleptic malignant syndrome.
- Drug Interactions: 238 interactions were recorded. Major-level examples include bupropion, morphine and cisapride. Moderate-level examples include metformin, pioglitazone, famotidine, epinephrine, atropine and clarithromycin.
Please also refer to the package insert for full safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests only on a model score. There are no clinical trials, no literature and no plausible mechanistic link, so the evidence level is L5.
To proceed, the following is needed:
- A mechanistic hypothesis connecting asenapine’s receptor pharmacology to the retinal dystrophy pathways
- Preclinical data in relevant retinal disease models
- Mechanism of action data and package insert warnings and contraindications
- A route and dosage-form assessment, since the available oral and sublingual forms may not suit an ocular indication
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.