Bicalutamide
| Evidence Level: L4 | Predicted Indications: 10 |
Table of Contents
Bicalutamide: Hypertrichosis (disease)
One-Sentence Summary
Bicalutamide is a nonsteroidal androgen receptor antagonist. The TxGNN model predicts it may be effective for hypertrichosis, with a score of 0.9969. Currently there are no registered clinical trials and only 1 publication (a 2022 comment letter on a retrospective review of 35 patients with minoxidil-induced hypertrichosis), so the evidence level is L4.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Hypertrichosis (disease) |
| TxGNN Prediction Score | 0.9969 |
| Evidence Level | L4 |
| Canada Market Status | Marketed (marketed DINs: 6 of 6) |
| Number of DINs | 6 (marketed: 6) |
| 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 pharmacology, bicalutamide is a nonsteroidal androgen receptor (AR) antagonist, which blocks androgen signalling in target tissues.
Hypertrichosis, particularly minoxidil-induced hypertrichosis in women, has an androgen-signalling component, so AR blockade is biologically plausible. The only supporting item is a comment on a retrospective review reporting that bicalutamide improved minoxidil-induced hypertrichosis in female pattern hair loss. This is indirect evidence: the review itself is not part of the data compiled, and a comment letter is not primary clinical evidence.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 35304167 | 2022 | Comment/Letter | Journal of the American Academy of Dermatology | Comment on a retrospective review of 35 patients in which bicalutamide improved minoxidil-induced hypertrichosis in female pattern hair loss; no abstract available |
Canada Market Information
| DIN | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 02270226 | TEVA-BICALUTAMIDE | Not recorded | Not recorded |
| 02519178 | BICALUTAMIDE | Not recorded | Not recorded |
| 02357216 | JAMP-BICALUTAMIDE | Not recorded | Not recorded |
| 02325985 | ACH-BICALUTAMIDE | Not recorded | Not recorded |
| 02275589 | PMS-BICALUTAMIDE | Not recorded | Not recorded |
Safety Considerations
- Drug Interactions: 100 interactions were found in the interaction databases. Examples include Major interactions with cisapride and dolasetron, and Moderate interactions with clarithromycin, levofloxacin, famotidine, loperamide, aprepitant, budesonide and granisetron, among others.
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction score is high (0.9969), but the only human evidence is an indirect comment letter on a small retrospective review, with no registered trials. The evidence level is L4, which supports treating this as a research question rather than a candidate for clinical use.
To proceed, the following is needed:
- Obtain the original retrospective review of 35 patients and assess its design, outcomes and safety data
- A prospective, controlled study of bicalutamide in hypertrichosis, especially minoxidil-induced hypertrichosis
- Detailed mechanism-of-action data
- Package insert warnings and contraindications, to assess safety in the target population
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.