Overview
Bicalutamide is an oral non-steroidal anti-androgen for prostate cancer. It is comprised of a racemic mixture that is a 50:50 composition of the (R)-bicalutamide and (S)-bicalutamide enantionmers. Bicalutamide binds to the androgen receptor.
Indication
Bicalutamide is indicated in combination with a luteinizing hormone-releasing hormone (LHRH) agonist for the treatment of Stage D2 metastatic carcinoma of the prostate.
Associated Conditions
- Metastatic stage D2 Prostatic carcinoma
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/10/21 | Phase 3 | Recruiting | |||
2024/07/30 | Phase 2 | Recruiting | |||
2024/07/15 | Phase 1 | Not yet recruiting | |||
2024/04/15 | Phase 2 | Recruiting | |||
2024/01/24 | Phase 1 | Recruiting | |||
2023/08/30 | Phase 2 | Withdrawn | CHU de Quebec-Universite Laval | ||
2023/08/07 | Phase 1 | Recruiting | |||
2022/12/12 | Not Applicable | Not yet recruiting | Royal College of Surgeons, Ireland | ||
2022/08/24 | Phase 2 | Recruiting | |||
2022/04/14 | Phase 2 | Recruiting | CHU de Quebec-Universite Laval |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Kremers Urban | 62175-132 | ORAL | 50 mg in 1 1 | 6/2/2009 | |
| Proficient Rx LP | 71205-577 | ORAL | 50 mg in 1 1 | 11/1/2022 | |
| Physicians Total Care, Inc. | 54868-4503 | ORAL | 50 mg in 1 1 | 1/27/2012 | |
| Physicians Total Care, Inc. | 54868-6133 | ORAL | 50 mg in 1 1 | 8/11/2010 | |
| ANI Pharmaceuticals, Inc. | 62559-890 | ORAL | 50 mg in 1 1 | 6/30/2020 | |
| Bryant Ranch Prepack | 63629-8308 | ORAL | 50 mg in 1 1 | 8/12/2019 | |
| Accord Healthcare Inc. | 16729-023 | ORAL | 50 mg in 1 1 | 1/16/2024 | |
| Golden State Medical Supply, Inc. | 60429-177 | ORAL | 50 mg in 1 1 | 2/22/2024 | |
| ANI Pharmaceuticals, Inc. | 62559-680 | ORAL | 50 mg in 1 1 | 8/30/2019 | |
| Sun Pharmaceutical Industries, Inc. | 47335-485 | ORAL | 50 mg in 1 1 | 11/1/2018 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| BICAMED 50 BICALUTAMIDE TABLETS 50mg | SIN14824P | TABLET | 50.000 mg | 8/4/2015 | |
| CALUMEX FILM-COATED TABLETS 50MG | SIN15695P | TABLET, FILM COATED | 50mg | 5/24/2019 | |
| BICALOX TABLETS 50MG | SIN14145P | TABLET, FILM COATED | 50MG | 5/8/2012 | |
| BICALUTAMIDE STADA FILM COATED TABLET 50MG | SIN15134P | TABLET, FILM COATED | 50mg | 12/12/2016 | |
| CASODEX TABLET 50 mg | SIN09772P | TABLET, FILM COATED | 50 mg | 5/16/1998 | |
| CASODEX TABLET 150 mg | SIN11344P | TABLET, FILM COATED | 150 mg | 7/8/2000 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Bicalutamide Tablets | 国药准字J20150050 | 化学药品 | 片剂 | 8/28/2019 | |
| Bicalutamide Tablets | 国药准字HJ20140720 | 化学药品 | 片剂 | 11/30/2023 | |
| Bicalutamide Tablets | 国药准字HJ20140719 | 化学药品 | 片剂 | 11/30/2023 | |
| Bicalutamide Tablets | 国药准字H20244241 | 化学药品 | 片剂 | 6/28/2024 | |
| Bicalutamide Tablets | 国药准字HJ20181036 | 化学药品 | 片剂 | 11/18/2022 | |
| Bicalutamide Tablets | 国药准字HJ20181035 | 化学药品 | 片剂 | 11/18/2022 | |
| Bicalutamide Tablets | 国药准字H20234422 | 化学药品 | 片剂 | 10/27/2023 | |
| Bicalutamide Tablets | 国药准字H20064085 | 化学药品 | 片剂 | 6/23/2021 | |
| Bicalutamide Tablets | 国药准字H20073877 | 化学药品 | 片剂 | 7/12/2022 | |
| Bicalutamide Tablets | 国药准字H20113535 | 化学药品 | 片剂 | 8/16/2021 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| HEXALIS TABLETS 150MG | N/A | N/A | N/A | 4/24/2025 | |
| HEXALIS TABLETS 50MG | N/A | N/A | N/A | 4/24/2025 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| COSAMIDE bicalutamide 50mg tablets bottle | 135219 | Medicine | A | 11/7/2007 | |
| BICALUTAMIDE SCP bicalutamide 50 mg tablets blister pack | 135852 | Medicine | A | 12/20/2007 | |
| BICALUTAMIDE AMEDA bicalutamide 50mg film-coated tablet blister pack | 273903 | Medicine | A | 7/20/2016 | |
| MPL-BICALUTAMIDE bicalutamide 50mg film-coated tablet blister pack | 226975 | Medicine | A | 9/26/2014 | |
| APO-BICALUTAMIDE bicalutamide 50mg film-coated tablet blister pack | 194683 | Medicine | A | 4/13/2012 | |
| BI ELIGARD CP (Eligard 3 month 22.5mg and MPL-Bicalutamide 50mg, 28 pack) | 238311 | Medicine | A | 5/24/2016 | |
| BI ELIGARD CP (Eligard 3 month 22.5mg and MPL-Bicalutamide 50mg, 84 pack) | 237652 | Medicine | A | 5/25/2016 | |
| BICALUTAMIDE ASTRON bicalutamide 50mg film-coated tablet blister pack | 273901 | Medicine | A | 7/20/2016 | |
| COSUDEX bicalutamide 50 mg tablet blister pack | 54639 | Medicine | A | 7/1/1996 | |
| COSUDEX bicalutamide 150 mg tablet blister pack | 77715 | Medicine | A | 8/6/2002 |
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