Mosapride
| Evidence Level: L5 | Predicted Indications: 1 |
Table of Contents
Mosapride: From Gastrointestinal Motility Disorders to Insomnia
One-Sentence Summary
Mosapride is a 5-HT4 receptor agonist that speeds up gastric emptying and is used for gastrointestinal disorders in the countries where it is approved. The TxGNN model predicts it may be effective for insomnia, but no clinical trials and no publications currently support this direction. This is a model-only prediction at this stage.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the licence records. Pharmacology data describe use for gastrointestinal disorders (accelerating gastric emptying). |
| Predicted New Indication | Insomnia |
| TxGNN Prediction Score | 0.9987 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data |
| Number of Listed Products | at least 20 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the compiled records. Based on known pharmacology, mosapride is a selective 5-HT4 receptor agonist that promotes gastrointestinal motility. Its active metabolite also has some 5-HT3 antagonist activity.
No direct pathway from this mechanism to sleep regulation has been established in the data compiled for this report. A speculative link could involve the gut-brain axis or serotonergic modulation of sleep-wake circuits, but nothing here supports it.
The very high score (0.9987) reflects the model’s output only. It should be treated as a hypothesis to test, not as evidence of efficacy.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
India Market Information
Mosapride has 20 valid single-ingredient registrations in India, and none are cancelled. The licence records contain no approved indication text. Five representative authorisations are listed below.
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| 133728 | Moza 5 Tablet | Strip of 10 tablets | Intas Pharmaceuticals Ltd |
| 116482 | Kinetix 5mg Tablet | Strip of 10 tablets | Lupin Ltd |
| 146225 | Mozax 2.5mg Tablet | Strip of 10 tablets | Sun Pharmaceutical Industries Ltd |
| 145288 | Movaride 2.5mg Tablet | Strip of 10 tablets | Dr Reddy’s Laboratories Ltd |
| 141041 | Mosapid 5mg Tablet | Strip of 10 tablets | Cipla Ltd |
All products are oral. Most are tablets, and one product (Moza MPS Chewable Tablet) is a chewable tablet.
Safety Considerations
Please refer to the package insert for safety information.
The only interaction record is a pharmacology entry for the drug’s own target, the 5-HT4 receptor. It is not a drug-drug interaction and has no bearing on this indication.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests on a model score alone. There are no clinical trials or publications, no established mechanistic link to sleep, and the safety label data are missing.
To proceed, the following is needed:
- Package insert warnings and contraindications from the Indian regulator or manufacturers. This is a blocking gap for safety screening.
- Detailed mechanism of action data for mosapride.
- A literature and trial search, plus preclinical or mechanistic work, on serotonergic or gut-brain links to sleep.
- A comparison of mosapride’s pharmacology with that of existing insomnia treatments.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.