Bicalutamide
| Evidence Level: L4 | Predicted Indications: 10 |
Table of Contents
Bicalutamide: From Androgen Receptor Blockade to Hypertrichosis
One-Sentence Summary
Bicalutamide is a nonsteroidal androgen receptor (AR) antagonist, which the literature describes as commonly used in prostate cancer. The TxGNN model predicts it may be useful for hypertrichosis (excess hair growth). Evidence is very thin: 0 clinical trials and 1 publication (a comment letter), so this remains a research question.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the Singapore licence records compiled for this report. The literature describes bicalutamide as an AR inhibitor commonly used in prostate cancer. |
| Predicted New Indication | Hypertrichosis |
| TxGNN Prediction Score | 99.69% |
| Evidence Level | L4 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 6 |
| Recommended Decision | Hold (Research Question) |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data is not available from the drug database. Based on known pharmacology, bicalutamide blocks the androgen receptor.
Androgen signalling drives the conversion of fine hair follicles into terminal (thick) hair. Blocking the AR could plausibly reduce androgen-dependent hair growth, which is the basis for the link to hypertrichosis.
The only supporting publication is a 2022 comment on a retrospective review of 35 patients, which reported that bicalutamide improved minoxidil-induced hypertrichosis in female pattern hair loss. This is indirect, secondary evidence. The original study's abstract was not available, so its design and size cannot be confirmed. The prediction also fits only androgen-dependent hair growth. It does not fit congenital forms such as Ambras syndrome, which are genetic rather than androgen-driven.
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. |
Singapore Market Information
All six registrations are valid, single-ingredient oral film-coated or plain tablets. Approved-indication text was not available in the data compiled for this report.
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| SIN11344P | CASODEX TABLET 150 mg | Tablet, film coated | Corden Pharma GmbH |
| SIN09772P | CASODEX TABLET 50 mg | Tablet, film coated | Corden Pharma GmbH |
| SIN15134P | BICALUTAMIDE STADA FILM COATED TABLET 50MG | Tablet, film coated | Kocak Farma Ilac ve Kimya Sanyi A.S. |
| SIN15695P | CALUMEX FILM-COATED TABLETS 50MG | Tablet, film coated | GENEPHARM S.A |
| SIN14145P | BICALOX TABLETS 50MG | Tablet, film coated | DOUGLAS MANUFACTURING LTD |
A sixth registration, SIN14824P (BICAMED 50, Hetero Labs Limited, plain tablet), is not shown.
Safety Considerations
- Disease associations from the knowledge graph (drug-disease contraindication edges, not package-insert text): liver disease, gallbladder disease, hyperglycaemia, diabetes mellitus, diabetic ketoacidosis, anaemia (including macrocytic anaemia), interstitial lung disease, and drug-induced liver injury.
- Drug interactions: 100 interactions were identified. The two Major ones are cisapride and dolasetron. Most of the others are Moderate, including famotidine, loperamide, aprepitant, clarithromycin, levofloxacin, granisetron, eliglustat, budesonide, and several laxatives (bisacodyl, lactulose, lactitol, magnesium salts, castor oil, mineral oil, glycerin). Metronidazole is Minor.
Please refer to the package insert for label warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The only evidence for hypertrichosis is one comment letter on a small retrospective study, with no registered trials. The mechanistic link (AR blockade reducing androgen-dependent hair growth) is plausible but unconfirmed. Safety signals, particularly liver-related ones, also need weighing for what is largely a non-life-threatening condition.
To proceed, the following is needed:
- The original retrospective study (35 patients) to assess its design, dose, and outcomes
- Controlled studies in androgen-dependent hypertrichosis or hirsutism
- Package-insert warnings and contraindications for Singapore products, plus the approved indication text
- A liver-safety monitoring plan for non-oncology use
- Detailed mechanism-of-action data
Note on other predictions: Among the other predicted indications, female breast carcinoma has the strongest support (L2). It has a Phase 2 trial (NCT03650894, bicalutamide with nivolumab and ipilimumab in metastatic HER2-negative breast cancer, n=30, active, not recruiting) and substantial preclinical and review literature on AR-positive triple-negative breast cancer. A single-arm phase II study of bicalutamide plus an aromatase inhibitor (PMID 31434793) showed no synergistic activity. That indication is more suitable for a separate evaluation, with AR-expression-based patient selection as the key guardrail.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.