Bicalutamide

Evidence Level: L4

Predicted Indications: 10

Bicalutamide

Pharmacist Assessment Report

Bicalutamide: 多毛症 (hypertrichosis (disease))

One-Sentence Summary

Bicalutamide is a nonsteroidal androgen receptor antagonist. The TxGNN model predicts it may be useful for hypertrichosis (disease), with no registered clinical trials and 1 publication (a 2022 comment letter) currently linked to this direction. The evidence level is L4.

Quick Overview

Item	Content
Original Indication	Not recorded in the local data
Predicted New Indication	多毛症 (hypertrichosis (disease))
TxGNN Prediction Score	0.9969
Evidence Level	L4
Australia Market Status	Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data
Number of PBS Items	1 (valid: 1)
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 its known drug class, bicalutamide is a nonsteroidal androgen receptor (AR) antagonist.

Androgen signalling drives hair growth in androgen-sensitive follicles, so blocking the AR could plausibly reduce androgen-dependent hair growth. This is the mechanistic basis for the model’s prediction.

The only supporting literature is a 2022 comment on a retrospective review of 35 patients, in which bicalutamide improved minoxidil-induced hypertrichosis in female pattern hair loss. That review itself is not among the records compiled for this report, so the evidence is indirect and secondary. It has not been confirmed in a controlled trial.

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 reporting that bicalutamide improved minoxidil-induced hypertrichosis in female pattern hair loss. No abstract available.

Australia Market Information

ARTG Number	Product Name	Dosage Form	Approved Indication
ARTG 8094B	Cosudex	Tablet 50 mg	Not recorded in the local data

The drug is marketed in Australia with 1 valid single-ingredient licence.

Cytotoxicity

Item	Content
Cytotoxicity Classification	Targeted hormonal therapy (non-cytotoxic anti-androgen)
Myelosuppression Risk	Please refer to the Product Information (PI) warnings and precautions
Emetogenicity Classification	Please refer to the Product Information (PI) warnings and precautions
Monitoring Items	Please refer to the PI; liver function monitoring is commonly considered
Handling Protection	Please refer to the PI

Safety Considerations

Drug Interactions: 100 interactions are recorded. Examples include:
- Major: cisapride, dolasetron
- Moderate: clarithromycin, levofloxacin, granisetron, aprepitant, famotidine, loperamide, budesonide, eliglustat
- Minor: metronidazole
Conditions flagged as contraindication-related in the compiled data (not label text): liver disease, drug-induced liver injury, gallbladder disease, hyperglycaemia, diabetes mellitus, diabetic ketoacidosis, anaemia, macrocytic anaemia, interstitial lung disease.

Please refer to the TGA-approved Product Information (PI) for full safety information.

Conclusion and Next Steps

Decision: Hold

Rationale: The only human evidence is a comment letter on a small retrospective review, and there are no registered trials. The mechanistic rationale is plausible but unconfirmed, so the evidence level is L4.

To proceed, the following is needed:

Retrieval and appraisal of the source retrospective review of 35 patients
Controlled clinical data on bicalutamide for hypertrichosis
Detailed mechanism of action data
TGA Product Information warnings and contraindications for safety screening, especially liver function monitoring
Assessment of safety in the intended population, including women, given the drug’s anti-androgen effects

Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.