Bicalutamide
| Evidence Level: L4 | Predicted Indications: 10 |
Table of Contents
Bicalutamide: Hypertrichosis (disease)
One-Sentence Summary
Bicalutamide is a nonsteroidal androgen receptor antagonist that is currently marketed in India. The TxGNN model predicts it may be useful for Hypertrichosis. The supporting evidence is thin: 0 clinical trials and 1 publication, a commentary letter on a retrospective review of 35 patients.
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 |
| India Market Status | Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data |
| Number of Listed Products | at least 20 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data are not available in the data compiled for this report. Bicalutamide is, however, known as a nonsteroidal androgen receptor (AR) antagonist. Androgen signalling drives hair follicle activity, so blocking the AR could plausibly reduce androgen-dependent hair growth.
The one publication in the data is a commentary on a retrospective review of 35 patients. That review, as its title indicates, reported bicalutamide improving minoxidil-induced hypertrichosis in female pattern hair loss. This suggests some clinical experience exists, but the review itself is not part of the data compiled here. The commentary is not primary evidence.
The mechanistic argument is therefore reasonable but unproven. It rests on a small retrospective observation in one specific setting, minoxidil-induced hair growth. It does not show benefit across hypertrichosis in general.
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 | Commentary on a retrospective review of 35 patients, which reported that bicalutamide improved minoxidil-induced hypertrichosis in female pattern hair loss. No abstract is available. |
India Market Information
Bicalutamide is marketed in India as single-ingredient oral tablets. All 20 licences in the data are valid, and none are cancelled. The records may be partial. Five main licences are shown below.
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| 29956 | Bicalon 50mg Tablet | Strip of 10 tablets | Celon Laboratories Ltd |
| 101427 | Guncef 50mg Tablet | Strip of 10 tablets | Oster Remedies |
| 217737 | Tabi Tablet | Strip of 10 tablets | Dr Reddy’s Laboratories Ltd |
| 40823 | Caludec 50mg Tablet | Strip of 10 tablets | Samarth Life Sciences Pvt Ltd |
| 34259 | Caluran 50 CP Tablet | Bottle of 30 tablets | Sun Pharmaceutical Industries Ltd |
Safety Considerations
- Drug Interactions: 389 interactions are recorded. Two are classed as Major:
- Cisapride
- Dolasetron
Most others are Moderate, for example famotidine, loperamide, aprepitant, clarithromycin, levofloxacin and granisetron. Metronidazole is Minor.
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The only human evidence is a commentary letter on a small retrospective review. There are no registered clinical trials. The score of 0.9969 is a model output and is not evidence of efficacy. The AR-blockade rationale is plausible, but it is not yet supported by prospective data.
To proceed, the following is needed:
- The primary retrospective review (35 patients) and any other clinical reports of bicalutamide in hypertrichosis, to assess effect size and the patient setting
- A prospective, controlled study in a defined hypertrichosis population
- Detailed mechanism-of-action data
- Package insert warnings and contraindications, including a safety plan for the relevant population (for example women of reproductive potential)
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.