Tipiracil
| Evidence Level: L5 | Predicted Indications: 9 |
Table of Contents
Tipiracil: Cecum villous adenoma
One-Sentence Summary
Tipiracil is a thymidine phosphorylase inhibitor that is marketed in combination with trifluridine to protect trifluridine from breakdown. The TxGNN model predicts it may be relevant to cecum villous adenoma, with a score of 0.9999, but no clinical trials and no publications currently support this direction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Cecum villous adenoma |
| TxGNN Prediction Score | 0.9999 |
| 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?
Tipiracil inhibits thymidine phosphorylase, the enzyme that rapidly degrades trifluridine. In the trifluridine/tipiracil combination, this raises trifluridine exposure and supports its cytotoxic effect. Tipiracil has no known direct antitumour effect on its own. Detailed mechanism-of-action data are not otherwise available in the data compiled for this report.
The predicted link is mainly anatomical: a villous adenoma of the cecum is a benign precursor lesion in the same organ as the colorectal cancers treated with the combination. No clinical, preclinical or literature evidence supports a benefit. There is also little rationale for cytotoxic therapy in a benign lesion that can usually be removed endoscopically. The prediction should therefore be seen as a hypothesis only.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available for cecum villous adenoma.
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 228143 | Tipanat 8.19mg/20mg Tablet (Natco Pharma Ltd) | Bottle of 20 tablets (oral) | Not specified in the data compiled for this report |
Safety Considerations
- Drug Interactions: 14 interaction records were compiled. Thirteen are rated Moderate, including cimetidine, tafenoquine, ketoconazole, brigatinib, crizotinib, encorafenib, ethinylestradiol, lenvatinib, medroxyprogesterone acetate, megestrol acetate, ribociclib, rucaparib and vandetanib. One further record links tipiracil to the SARS-CoV-2 non-structural protein 15 target in a pharmacology database; it has no severity rating and is not a clinical interaction.
Package insert warnings and contraindications are not available in the data compiled for this report. Please refer to the package insert for further safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests on the model score alone. There are no trials or publications on this disease, so the evidence level is L5. A benign, resectable lesion also gives little reason to expose patients to a cytotoxic combination.
To proceed, the following is needed:
- Preclinical or clinical data showing activity of tipiracil-containing therapy in cecal villous adenoma
- Detailed mechanism-of-action data
- Package insert warnings and contraindications for the Indian product
- A risk-benefit assessment against standard endoscopic management
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.