Raloxifene
| Evidence Level: L5 | Predicted Indications: 4 |
Table of Contents
Raloxifene: Duodenal ulcer (disease)
One-Sentence Summary
Raloxifene was originally used to treat postmenopausal osteoporosis and osteoporosis. The TxGNN model predicts it may be effective for duodenal ulcer, but there are currently 0 clinical trials and 0 publications supporting this direction. The prediction rests on the model score alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Duodenal ulcer (disease) |
| TxGNN Prediction Score | 0.9972 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (14 of 14) – CDSCO approval status is not included in this data |
| Number of Listed Products | 14 (valid: 14) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Based on known information, raloxifene is a selective estrogen receptor modulator (SERM) with tissue-selective estrogen agonist and antagonist activity in bone, breast and uterus. Its efficacy in postmenopausal osteoporosis is established.
A link to duodenal ulcer is speculative. One could imagine a gastroprotective effect through estrogen receptor signalling in the gastric or duodenal mucosa, but nothing in the data compiled for this report establishes it. The high score (0.9972) is a model prediction only.
Other top-ranked predictions are also weak. Hypoalphalipoproteinemia (0.9965) has a plausible lipid-metabolism connection, but raloxifene lowers LDL cholesterol and has little or no effect on HDL, so correcting low HDL is not expected. Duodenal obstruction (0.9964) is largely a structural condition that a SERM is unlikely to address. Duodenogastric reflux (0.9959) is a motility disorder with no known raloxifene action. These scores come from the TxGNN model (deep learning) and may reflect similarities the model learned between related duodenal diseases, not biological evidence.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
India Market Information
Raloxifene has 14 valid single-ingredient registrations in India and none cancelled. The approved-indication text is not recorded for any of them. The main authorizations are:
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 47098 | Ceost 60mg Tablet (Comed Chemicals Ltd) | Strip of 10 tablets | Not recorded |
| 185019 | Ralista Tablet (Cipla Ltd) | Strip of 10 tablets | Not recorded |
| 189807 | Ruftuf 60mg Tablet (Ajanta Pharma Ltd) | Strip of 10 tablets | Not recorded |
| 80048 | Esserm 60mg Tablet (Torrent Pharmaceuticals Ltd) | Strip of 10 tablets | Not recorded |
| 85592 | Femoral 60mg Tablet (Duckbill Drugs Pvt Ltd) | Strip of 14 tablets | Not recorded |
All products are oral tablets.
Safety Considerations
- Contraindications (from knowledge-graph drug-disease edges, not label text): hypertension and hypertensive disorder, liver disease, gallbladder disease, atrial fibrillation, hypertriglyceridemia, thrombophlebitis, coronary artery disease, stroke and cerebrovascular disorders, ischemic stroke susceptibility, cerebral infarction, pulmonary embolism, retinal artery occlusion, thrombophilia, impaired renal function, transient ischemic attack, vertebrobasilar insufficiency, antiphospholipid syndrome. The recurring theme is cardiovascular and thromboembolic risk, along with liver, gallbladder and kidney conditions.
- Drug Interactions: 129 interactions were identified, but severity levels are unclassified. Examples include calcitriol, pantoprazole, omeprazole, lansoprazole, glimepiride, metformin, rosiglitazone, simvastatin, doxycycline, tetracycline, morphine and sucralfate. Clinical significance would need to be reviewed individually.
Please also refer to the package insert for label warnings, which were not available for this report.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests on model score alone (L5), with no clinical trials or literature, and no credible mechanistic link to duodenal ulcer. The contraindication profile, with its cardiovascular and thromboembolic concerns, adds caution. The other top-ranked predictions are no better supported.
To proceed, the following is needed:
- Package insert warnings and contraindications from the India regulator or manufacturers (currently a blocking gap for safety screening)
- Mechanism of action data (for example from DrugBank) to test for a link to duodenal ulcer
- Preclinical or observational evidence on raloxifene and gastroduodenal mucosal effects
- Classification of drug-interaction severity for the 129 identified interactions
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.