Zafirlukast
| Evidence Level: L5 | Predicted Indications: 1 |
Table of Contents
Zafirlukast: Bronchitis
One-Sentence Summary
Zafirlukast is a cysteinyl leukotriene receptor antagonist. The TxGNN model predicts it may be useful for bronchitis, but this rests on the model score alone: no clinical trials and no publications were found for this indication.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Bronchitis |
| TxGNN Prediction Score | 0.9993 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (1 of 1) – CDSCO approval status is not included in this data |
| Number of Listed Products | 1 (valid: 1) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Zafirlukast is known as a CysLT1 receptor antagonist. Cysteinyl leukotrienes contribute to airway inflammation, bronchoconstriction and mucus secretion, so a plausible mechanistic rationale exists for inflammatory bronchial conditions.
This reasoning remains hypothetical. Bronchitis is a heterogeneous condition (acute viral, chronic, eosinophilic), and the subtype the model refers to is not specified. The similarity to the drug’s current use has not yet been assessed, and route compatibility is also pending.
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 |
|---|---|---|---|
| 247909 | Zuvair 10mg Tablet (Dr Reddy’s Laboratories Ltd) | Strip of 10 tablets (oral) | Not stated in the licence record |
The product is a single-ingredient oral tablet and is currently valid.
Safety Considerations
- Drug Interactions: 376 interacting drugs were identified. Moderate-level interactions include aprepitant, acetylsalicylic acid, metronidazole, budesonide (including nasal), saxagliptin, eliglustat, naltrexone, nateglinide, nitisinone, repaglinide, rosuvastatin, simvastatin and tinidazole. Sibutramine is rated minor. Pantoprazole, mesalazine, morphine, metformin and omeprazole have an unrated (unknown) level.
Package insert warnings and contraindications were not available. Please refer to the package insert for further safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The only support for this prediction is the model score of 0.9993. There are no clinical trials or publications for bronchitis, so the evidence level is L5. The drug is marketed in India, but that does not support this new use.
To proceed, the following is needed:
- Clinical or observational evidence in a defined bronchitis subtype (e.g., chronic or eosinophilic)
- Mechanism of action data to support the link to bronchitis
- Package insert warnings and contraindications, to complete the safety review
- A review of the interacting drugs likely to be co-prescribed in this population
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.