Elafibranor
| Evidence Level: L5 | Predicted Indications: 1 |
Table of Contents
Elafibranor: From Primary Biliary Cholangitis to Amenorrhea
One-Sentence Summary
Elafibranor is an oral dual PPAR-alpha/delta agonist marketed in the US as IQIRVO. The Evidence Pack does not record its original indication, but public labeling lists primary biliary cholangitis (PBC). The TxGNN model predicts it may be effective for amenorrhea, but this rests on a computational prediction alone, with 0 clinical trials and 0 publications currently supporting it.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the Evidence Pack (public labeling lists primary biliary cholangitis) |
| Predicted New Indication | Amenorrhea |
| TxGNN Prediction Score | 99.86% |
| Evidence Level | L5 |
| US Market Status | ✓ Marketed |
| Number of NDAs | 1 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the Evidence Pack. Elafibranor is a dual PPAR-alpha/delta agonist. PPAR signaling has been studied in ovarian steroidogenesis, folliculogenesis, and metabolic or insulin-related reproductive disorders such as PCOS. This may be the basis of the link in the knowledge graph.
This link is only a hypothesis. No mechanistic pathway from elafibranor to amenorrhea can be verified from the available data. Amenorrhea is a symptom with many distinct causes (hypothalamic, pituitary, ovarian, uterine), and the prediction does not say which one is targeted.
A high model score is not clinical evidence. It may reflect graph topology or hub-node bias. No safety or reproductive-endocrine data are available to weigh risk against benefit in reproductive-age women.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
US Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| NDA218860 | IQIRVO (Ipsen Biopharmaceuticals, Inc.) | Tablet, film coated (oral) | Not listed in the source record |
Safety Considerations
Please refer to the package insert for safety information. No drug interaction records were found.
Conclusion and Next Steps
Decision: Hold
Rationale: The only support is a computational prediction (L5), with no trials, no literature, and no verifiable mechanism linking the drug to amenorrhea. The prediction is also non-specific about the type of amenorrhea, and no safety data are available for reproductive-age women.
To proceed, the following is needed:
- The FDA package insert (warnings, contraindications, approved indication), which currently blocks safety screening
- Mechanism of action data, for example from DrugBank
- Preclinical or mechanistic studies of PPAR-alpha/delta signaling in the reproductive axis
- A defined amenorrhea subtype (for example hypothalamic vs. ovarian) to make the hypothesis testable
- A reproductive-endocrine safety review, including pregnancy and contraception considerations
This report is for research reference only and does not constitute medical advice. Repurposing candidates require clinical validation before any application.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.