Oxyphenbutazone

Evidence Level: L5 Predicted Indications: 1

Table of Contents

  1. Oxyphenbutazone
    1. Pharmacist Assessment Report
    2. Oxyphenbutazone: Colobomatous microphthalmia-rhizomelic dysplasia syndrome
    3. One-Sentence Summary
    4. Quick Overview
    5. Why is This Prediction Reasonable?
    6. Clinical Trial Evidence
    7. Literature Evidence
    8. India Market Information
    9. Safety Considerations
    10. Conclusion and Next Steps
    11. Disclaimer

Pharmacist Assessment Report

Oxyphenbutazone: Colobomatous microphthalmia-rhizomelic dysplasia syndrome

One-Sentence Summary

Oxyphenbutazone is an oral non-steroidal anti-inflammatory drug that is currently marketed in India. The TxGNN model predicts it may be relevant to colobomatous microphthalmia-rhizomelic dysplasia syndrome, but no clinical trials and no publications currently support this prediction, so it rests on the model score alone.

Quick Overview

Item Content
Original Indication Not recorded in the local data
Predicted New Indication Colobomatous microphthalmia-rhizomelic dysplasia syndrome
TxGNN Prediction Score 0.9907
Evidence Level L5
India Market Status Listed in a compiled Indian medicine price dataset (3 of 3) – CDSCO approval status is not included in this data
Number of Listed Products 3 (valid: 3)
Recommended Decision Hold

Why is This Prediction Reasonable?

Detailed mechanism of action data is not currently available for this drug. Oxyphenbutazone belongs to the pyrazolone-type NSAID class, which acts mainly by inhibiting cyclooxygenase enzymes and reducing prostaglandin-mediated inflammation.

The predicted condition is a rare developmental disorder involving eye malformations (coloboma, microphthalmia) and skeletal abnormalities (rhizomelic dysplasia). It is a structural, developmental condition, and cyclooxygenase inhibition has no plausible disease-modifying role in it. No mechanistic link is evident.

The high model score (0.9907) is therefore best treated as a computational output without biological or clinical support, and may well be an artifact of the model.

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
164045 Oxy Triactin 100mg Tablet (Pharmed Ltd) Strip of 10 tablets Not stated
85358 Flanil 100mg Tablet (Pan Pharmaceuticals Ltd) Strip of 10 tablets Not stated
204215 Sioril 100mg Tablet (Albert David Ltd) Strip of 10 tablets Not stated

All three licences are single-ingredient oral products and are currently valid.

Safety Considerations

Please refer to the package insert for safety information.

Conclusion and Next Steps

Decision: Hold

Rationale: The prediction has no supporting clinical trials or publications and no plausible mechanistic link between cyclooxygenase inhibition and this developmental syndrome. The evidence level is L5 (model prediction only).

To proceed, the following is needed:

  • Detailed mechanism of action data for the drug
  • A biological rationale connecting the drug’s pharmacology to the pathology of this syndrome
  • Preclinical or mechanistic studies that directly address this disease
  • Package insert warnings and contraindications for a safety review

Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.



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