Bicalutamide clinical trials
Bicalutamide is named as an intervention in 17 current clinical trials in our Canada, Israel, Mexico, China, USA, France, Netherlands, Belgium, UK, Germany, Spain, Sweden, Poland, Czechia, Turkey, Brazil, South Korea, Taiwan, Italy, Switzerland and Norway registers. 8 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is NRG Oncology (3). The most-studied condition is Prostate Cancer.
Where Bicalutamide is approved
All regulators →Of the three regulators tracked here, the first to approve Bicalutamide was the US, on 4 Oct 1995. It is approved in 2 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Bicalutamide
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Bicalutamide works
All drug targets →- Androgen Receptor antagonist AntagonistTarget: AR androgen receptor✓ In ChEMBL and the Guide to Pharmacology
- COVID-19Phase 3
- Breast cancerPhase 3
- Lower urinary tract symptomPhase 3
- Prostate adenocarcinomaPhase 3
- CancerPhase 2/3
- Ovarian cancerPhase 2/3
- AdenocarcinomaPhase 2
- Fallopian tube carcinomaPhase 2
- Familial male-limited precocious pubertyPhase 2
- Malignant epithelial tumor of ovaryPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL409, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 2863, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Bicalutamide
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 8 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Bicalutamide
- ATC code
- L02BB03
- ChEMBL
- CHEMBL409
- DrugBank
- DB01128
- PubChem CID
- 2375
- CAS number
- 90357-06-5
- FDA UNII
- A0Z3NAU9DP
- Wikidata
- Q1988832
- Wikipedia
- Bicalutamide
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Bicalutamide
17 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Bicalutamide across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
8 single-substance products containing Bicalutamide on the HPRA medicines list.
- Bicalutamide 50 mg film-coated tabletsAccord Healthcare Ireland Ltd. · PA2315/079/001 · Marketed
- Bicalutamide Teva 50 mg film-coated tabletsTeva Pharma B.V. · PA0749/032/001 · Marketed
- Biluta 50 mg film-coated tabletsRowex Ltd · PA0711/100/001 · Marketed
- Casodex 50 mg film-coated tabletsLaboratoires Juvise Pharmaceuticals · PA23154/002/001 · Marketed
- Casodex 50 mg film-coated tabletsPCO Manufacturing Ltd. · PPA0465/144/001
Supply shortages
No entry for Bicalutamide in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Bicalutamide
21 conditionsAll 21 conditions
| Condition (as registered) | Trials |
|---|---|
| Prostate Cancer | 4 |
| Prostate Adenocarcinoma | 3 |
| Stage IVA Prostate Cancer AJCC v8 | 2 |
| Prostatic Neoplasms | 1 |
| Salivary Gland Carcinoma | 1 |
| Precision Therapy | 1 |
| Extramammary Paget Disease | 1 |
| Scrotum Disease | 1 |
| Metastatic Breast Cancer | 1 |
| Salivary Duct Carcinoma | 1 |
| Triple Negative Breast Neoplasms | 1 |
| Castration Levels of Testosterone | 1 |
| Metastatic Prostatic Adenocarcinoma | 1 |
| Stage IV Prostate Cancer AJCC v8 | 1 |
| Stage I Prostate Adenocarcinoma AJCC v7 | 1 |
| Stage II Prostate Adenocarcinoma AJCC v7 | 1 |
| Stage III Prostate Adenocarcinoma AJCC v7 | 1 |
| Non-Muscle Invasive Bladder Cancer | 1 |
| Stage III Prostate Cancer AJCC v8 | 1 |
| Breast Cancer | 1 |
| Metastasis | 1 |
Sponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| NRG Oncology | 3 |
| Aragon Pharmaceuticals, Inc | 1 |
| Alessa Therapeutics Inc | 1 |
| Peking Union Medical College | 1 |
| Fudan University | 1 |
| UNICANCER | 1 |
| Marco Lorenzo Bonu | 1 |
| Radboud University Medical Center | 1 |
| Universitaire Ziekenhuizen KU Leuven | 1 |
| SWOG Cancer Research Network | 1 |
| RTOG Foundation, Inc | 1 |
| Abdenour Nabid | 1 |
| CHU de Quebec-Universite Laval | 1 |
| Brigham and Women's Hospital | 1 |
| Icahn School of Medicine at Mount Sinai | 1 |
By country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Bicalutamide trials
How many clinical trials are testing Bicalutamide?
17 current trials in our Canada, Israel, Mexico, China, USA, France, Netherlands, Belgium, UK, Germany, Spain, Sweden, Poland, Czechia, Turkey, Brazil, South Korea, Taiwan, Italy, Switzerland and Norway registers name Bicalutamide (also registered as ICI 176) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Bicalutamide trials recruiting patients?
Yes. 8 of the 17 trials are recruiting: 1 with sites in Canada, 1 with sites in Israel, 1 with sites in Mexico, 2 with sites in China, 1 with sites in Netherlands, 1 with sites in Belgium, 1 with sites in Italy and 1 with sites in Switzerland. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Bicalutamide clinical trials?
NRG Oncology (3), Aragon Pharmaceuticals, Inc (1), Alessa Therapeutics Inc (1) and Peking Union Medical College (1), among 15 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Bicalutamide licensed in Ireland?
Yes. The HPRA medicines list includes 8 single-substance products containing Bicalutamide, for example Bicalutamide 50 mg film-coated tablets (Accord Healthcare Ireland Ltd.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Bicalutamide shortage?
Not in the lists we track: Bicalutamide has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Bicalutamide works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Bicalutamide works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Bicalutamide (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.