Ulipristal
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Ulipristal: From Emergency Contraception to Rheumatoid Arthritis
One-Sentence Summary
Ulipristal is a selective progesterone receptor modulator, marketed in Singapore as a 30 mg tablet (ELLA). The TxGNN model predicts it may be effective for rheumatoid arthritis, but no clinical trials and no publications currently support this direction, so this is a computational prediction only.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the Singapore license record |
| Predicted New Indication | Rheumatoid arthritis |
| TxGNN Prediction Score | 90.31% |
| Evidence Level | L5 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 1 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the data compiled for this report. Ulipristal is generally known as a selective progesterone receptor modulator with some glucocorticoid receptor antagonism. A theoretical link to inflammatory modulation therefore exists, but it is speculative.
The original approved indication is not recorded in the Singapore license text, so the relationship between the original and new indication cannot be assessed from the available data. Glucocorticoid receptor antagonism could even work against an anti-inflammatory effect, so the direction of any benefit is uncertain.
The TxGNN score (90.31%) reflects patterns in a knowledge graph, not clinical findings. Other top-ranked predictions include tendinitis, fibromyalgia, myositis fibrosa and several rare bleeding or congenital disorders. Most of these have no identifiable mechanistic link to ulipristal. Two of them (myositis fibrosa and idiopathic granulomatous myositis) share an identical score, which suggests a shared graph neighbourhood rather than independent support.
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 |
|---|---|---|---|
| SIN13979P | ELLA TABLET 30MG (manufacturer: CENEXI) | Tablet (oral) | Not stated in the license record |
Safety Considerations
- Drug Interactions: 70 interacting drugs were identified. Examples from the interactions compiled for this report:
- Major: Edoxaban
- Moderate: Loperamide, Naldemedine, Rifaximin, Troglitazone, Deferasirox, Apixaban, Betrixaban, Rivaroxaban, Ticagrelor, Lusutrombopag, Fostamatinib, Artesunate
- Minor: Aprepitant, Clarithromycin, Naloxegol, Miconazole, Prucalopride, Clotrimazole, Fidaxomicin
- Pregnancy: Use in pregnancy is a concern for developmental-type predictions such as brachydactyly-syndactyly syndrome.
Please refer to the package insert for warnings and contraindications, as these were not available for this report.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests only on a computational score. No clinical trials or publications support ulipristal in rheumatoid arthritis, and the mechanistic link is speculative and may even run in the wrong direction. Evidence is at the lowest level (L5).
To proceed, the following is needed:
- Package insert warnings and contraindications from HSA, to allow safety screening
- Detailed mechanism of action data (for example from DrugBank)
- The original approved indication, to assess similarity to the predicted one
- A literature and trial search for ulipristal or progesterone receptor modulators in rheumatoid arthritis and inflammatory conditions
- Preclinical or mechanistic evidence that supports an anti-inflammatory effect in rheumatoid arthritis
- Route and dosing compatibility assessment for the new indication
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.