Elacestrant
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Elacestrant: From ER-Positive Breast Cancer to Amenorrhea
One-Sentence Summary
Elacestrant is an oral selective estrogen receptor degrader (SERD), originally used for ER-positive, HER2-negative, ESR1-mutated advanced breast cancer. The TxGNN model predicts it may be effective for amenorrhea, but there are currently 0 clinical trials and 0 publications supporting this direction. The prediction rests on model output alone, and the direction of effect is unclear.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the Singapore licence text. Based on the drug's known profile: ER-positive, HER2-negative, ESR1-mutated advanced breast cancer |
| Predicted New Indication | Amenorrhea |
| TxGNN Prediction Score | 92.50% |
| Evidence Level | L5 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 2 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Based on known information, elacestrant is an oral SERD that binds and degrades the estrogen receptor (ER). Its efficacy is established in ER-positive, HER2-negative, ESR1-mutated advanced breast cancer, where ER signalling drives tumour growth.
The prediction likely reflects network proximity between elacestrant and estrogen-signalling and hypothalamic-pituitary-gonadal (HPG) axis genes. Blocking and degrading ER could disrupt HPG feedback and cause amenorrhea. That would be a pharmacological side effect rather than a therapeutic benefit, so the prediction may reflect an adverse effect rather than a treatment opportunity.
Other predicted indications (ranks 2-10) are also supported only by model output. They include bone Paget disease, multiple endocrine neoplasia, primary cutaneous T-cell lymphoma and seborrheic dermatitis. The mechanistic links for these are weak or speculative, and none has clinical trial or literature 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 |
|---|---|---|---|
| SIN17096P | ORSERDU Film-Coated Tablet 345 mg | Film-coated tablet | Not stated in licence data |
| SIN17097P | ORSERDU Film-Coated Tablet 86 mg | Film-coated tablet | Not stated in licence data |
Both licences are valid single-ingredient products (oral route), manufactured by Catalent Greenville, Inc.
Cytotoxicity
| Item | Content |
|---|---|
| Cytotoxicity Classification | Targeted therapy (endocrine therapy, SERD), not a conventional cytotoxic |
| Myelosuppression Risk | Please refer to the package insert warnings and precautions |
| Emetogenicity Classification | Please refer to the package insert warnings and precautions |
| Monitoring Items | Please refer to the package insert warnings and precautions (typically liver function and lipid profile are considered for endocrine therapies) |
| Handling Protection | Please refer to the package insert and local institutional handling policy |
Safety Considerations
Please refer to the package insert for safety information.
No drug-interaction records were found in the data compiled for this report.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction is supported only by the TxGNN model score (L5), with no clinical trials or publications. Elacestrant's ER-degrading mechanism suggests amenorrhea is more likely an adverse pharmacological effect than a therapeutic target. Safety data are also missing.
To proceed, the following is needed:
- The HSA package insert, to obtain warnings, contraindications and approved indication text (a blocking gap for safety screening)
- Mechanism of action data from DrugBank
- Clarification of whether amenorrhea would be a therapeutic benefit or an adverse effect
- Literature and trial searches for any preclinical or clinical evidence in the predicted indications
- A review of the lower-ranked predictions only if a credible mechanism emerges
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.