Agomelatine
| Evidence Level: L5 | Predicted Indications: 7 |
Table of Contents
- Agomelatine
- Pharmacist Assessment Report
- Agomelatine: MT1/MT2 melatonergic agonist and 5-HT2C antagonist → benign paroxysmal torticollis of infancy
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- India Market Information
- Safety Considerations
- Conclusion and Next Steps
- Disclaimer
Agomelatine: MT1/MT2 melatonergic agonist and 5-HT2C antagonist → benign paroxysmal torticollis of infancy
One-Sentence Summary
Agomelatine is a melatonergic antidepressant that acts on MT1/MT2 receptors and blocks 5-HT2C receptors. The TxGNN model predicts it may be effective for benign paroxysmal torticollis of infancy, but no clinical trials and no publications were found for this disease, so the prediction rests on the model alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | benign paroxysmal torticollis of infancy |
| TxGNN Prediction Score | 0.9996 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (2 of 2) – CDSCO approval status is not included in this data |
| Number of Listed Products | 2 (valid: 2) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Agomelatine acts as an agonist at the melatonin MT1 and MT2 receptors and as an antagonist at the 5-HT2C receptor. The data compiled for this report also lists activity at the 5-HT2A and 5-HT2B receptors. Detailed mechanism-of-action data for the drug is not otherwise available.
For this prediction, no mechanistic rationale is evident. Benign paroxysmal torticollis of infancy is a childhood movement disorder that is often linked to variants in the CACNA1A gene (a calcium channel gene). It has no established connection to melatonergic or serotonergic signalling. The high score is a model output based on patterns in the data, and it is not supported by any biological or clinical finding. It 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
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 152176 | Noveltin Tablet | Strip of 10 tablets | Not recorded |
| 639 | Agoprex Tablet | Strip of 10 tablets | Not recorded |
Safety Considerations
Drug targets (pharmacology data): Agomelatine binds the 5-HT2A, 5-HT2B and 5-HT2C receptors and the MT1 and MT2 receptors. These are target activities, not recorded drug-drug interactions.
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction has a high model score but no supporting trials, literature or plausible mechanism, and the pathway to the disease (a channelopathy-associated paediatric condition) is not linked to agomelatine’s pharmacology. Evidence is at level L5.
To proceed, the following is needed:
- A mechanistic hypothesis linking melatonergic or 5-HT2C signalling to this condition
- Preclinical or case-based evidence in the disease
- Package insert warnings and contraindications from the local regulator
- Paediatric safety data, since the condition occurs in infants
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.