Tulobuterol
| Evidence Level: L5 | Predicted Indications: 4 |
Table of Contents
Tulobuterol: Respiratory malformation
One-Sentence Summary
Tulobuterol is a beta-2 adrenergic agonist bronchodilator, marketed in India as a transdermal patch. The TxGNN model predicts it may be effective for respiratory malformation, but no clinical trials and only 1 publication (a pediatric asthma study that does not address malformation) are available, so this prediction rests on the model alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Respiratory malformation |
| TxGNN Prediction Score | 0.9995 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (9 of 9) – CDSCO approval status is not included in this data |
| Number of Listed Products | 9 (valid: 9) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available. Tulobuterol belongs to the beta-2 agonist class, which relaxes airway smooth muscle and produces bronchodilation.
No mechanistic rationale links beta-2 agonism to correcting structural respiratory malformations. Bronchodilation can relieve airflow limitation, but it cannot repair a developmental structural defect. The only literature item is a 1986 pediatric asthma study, which concerns asthma, not malformation. The prediction therefore appears to reflect shared respiratory-disease associations in the model rather than a demonstrated pharmacological link. It should be read as a computational hypothesis only.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 2876923 | 1986 | Clinical study | The Journal of International Medical Research | Dose-ranging and comparative study of tulobuterol syrup versus terbutaline in asthmatic children. Tulobuterol showed rapid and prolonged bronchodilation. It did not study respiratory malformation. |
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 219028 | Tulomax 2.0 Transdermal Patch | Packet of 1 patch | Not specified |
| 218159 | Tulomax 0.5 Transdermal Patch | Packet of 1 patch | Not specified |
| 216894 | Tuloplast 2 Transdermal Patch | Packet of 14 transdermal patches | Not specified |
| 218169 | Tulo-Touch 2mg Patch | Box of 14 patches | Not specified |
| 219840 | Tulo-Touch 0.5mg Patch | Box of 14 patches | Not specified |
All 9 single-ingredient licences are valid; the five above are shown as examples.
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: No trial or publication studies respiratory malformation, and there is no plausible mechanism by which a bronchodilator would correct a structural malformation. The score is a computational prediction only.
To proceed, the following is needed:
- Mechanism-based justification for use in respiratory malformation
- Disease-specific preclinical or clinical evidence
- Package insert safety data (warnings, contraindications) for the marketed patches
- Confirmation that the patch formulation suits the target population
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.