Raloxifene
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Raloxifene: From Postmenopausal Osteoporosis to Duodenal Ulcer
One-Sentence Summary
Raloxifene is a selective estrogen receptor modulator (SERM), originally used to treat and prevent postmenopausal osteoporosis. The TxGNN model predicts it may be effective for duodenal ulcer, but this is a computational prediction only, with 0 clinical trials and 0 publications currently supporting it.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Postmenopausal osteoporosis (the Singapore licence records contain no indication text) |
| Predicted New Indication | Duodenal ulcer |
| TxGNN Prediction Score | 99.72% |
| Evidence Level | L5 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 2 |
| 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. Its efficacy in postmenopausal osteoporosis is established, mainly through reducing bone resorption.
The data compiled for this report do not establish a plausible mechanistic link between estrogen receptor modulation and duodenal ulcer. The high score (99.72%) is a computational output only. Several of the other top predictions are also duodenal or gastrointestinal terms (duodenal obstruction, duodenogastric reflux), which suggests the prediction may reflect a knowledge-graph neighbourhood effect rather than true biological relevance. This prediction should be treated as a hypothesis only.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN14013P | Raloxon Film-coated Tablets 60 mg | Film-coated tablet | Not stated in the available records |
| SIN10872P | EVISTA Tablet 60 mg | Film-coated tablet | Not stated in the available records |
Safety Considerations
- Contraindications (from knowledge-graph associations, not label text): The knowledge graph links raloxifene with the following conditions: hypertension, liver disease, gallbladder disease, atrial fibrillation, hypertriglyceridemia, thrombophlebitis, coronary artery disease, stroke and cerebrovascular disorders (including cerebral infarction and transient ischaemic attack), pulmonary embolism, retinal artery occlusion, thrombophilia, impaired renal function, vertebrobasilar insufficiency and antiphospholipid syndrome. These should be verified against the official package insert.
- Drug Interactions: The interaction query returned 100 records, but all those listed have an unclassified severity level. Examples include calcitriol, pantoprazole, glimepiride, mesalazine, doxycycline, metformin, omeprazole, simvastatin and tetracycline. Clinical significance cannot be judged from the available data.
Please refer to the package insert for the official warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction is supported only by the model score, with no clinical trials, no relevant literature and no established mechanistic link. Official safety information from the package insert has also not been reviewed. Evidence is at the lowest level (L5).
To proceed, the following is needed:
- The HSA package insert, to obtain warnings, contraindications and approved indications
- Mechanism of action data (for example from DrugBank)
- A literature search and trial registry search specific to raloxifene and peptic or duodenal ulcer disease
- A biological rationale connecting estrogen receptor modulation to duodenal ulcer, or a decision to deprioritise this prediction
- A review of other predictions for stronger evidence. Pregnancy-associated osteoporosis has some literature, but it is not supportive, and raloxifene is contraindicated in pregnancy.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.