Drugs / Bicalutamide
Bicalutamide
also known as
CASODEX · Bic · Bicalutamide(Casodex) · ICI176,334-1 · Bicalutamida · Calutide · CDX · Cosudex · +3 more
Other / unclassified targets AR, TMPRSS2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | CASODEX | — | 1997-12-12 | fda.gov ↗ |
| Approved | US (FDA) | CASODEX | — | 1995-10-04 | fda.gov ↗ |
Trials 104 · started per year
today
US approved 1995
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT03358563 | Jan 2018 → Aug 2021 | prostate cancer | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 0 | NCT01050842 | Feb 2010 → May 2012 | hormone-resistant prostate carcinoma, prostate adenocarcinoma | Mayo Clinic | Completed | No outcome recorded |
| Phase 113 trials | ||||||
| Phase 1 | NCT05521698 | Jun 2026 → Jun 2028 expected | non-invasive bladder urothelial carcinoma, urinary tract non-invasive transitional cell neoplasm | University of Wisconsin, Madison | Recruiting | No outcome recorded |
| Phase 1 | NCT06501911 | Apr → Jul 2025 | glioblastoma | University of Nebraska | Withdrawn | No outcome recorded |
| Phase 1 | NCT05979389 | Feb 2024 → Aug 2028 expected | fatty liver disease, polycystic ovary syndrome | University of California, San Francisco | Recruiting | No outcome recorded |
| Phase 1 | NCT04943536 | Dec 2021 → Apr 2027 expected | prostate adenocarcinoma | Alessa Therapeutics Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04284761 | Oct 2020 → May 2023 | prostate adenocarcinoma | Alessa Therapeutics Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03878524 | Apr → Dec 2020 | acute myeloid leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative, blast phase chronic myelogenous leukemia, BCR-ABL1 positive, castration-resistant prostate carcinoma +14 | OHSU Knight Cancer Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02064036 | Jun 2013 → Dec 2020 | prostate adenocarcinoma | University of California, Davis | Completed | No outcome recorded |
| Phase 1 | NCT01415791 | Aug → Sep 2011 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01416883 | Jul → Aug 2010 | — | AstraZeneca | Terminated | No outcome recorded |
| Phase 1 | NCT00960310 | Jun 2006 | hypertrichosis, prostate cancer | Sandoz | Completed | No outcome recorded |
| Phase 1 | NCT00972855 | Sep 2003 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 1 | NCT00973050 | Sep 2003 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 1 | NCT02911350 | May 2000 → Dec 2016 | prostate cancer | NYU Langone Health | Completed | No outcome recorded |
| Phase 1/27 trials | ||||||
| Phase 1/2 | NCT06222593 | Oct 2024 → Jul 2026 overdue | renal cell carcinoma | State University of New York at Buffalo | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05095207 | Sep 2021 → Jun 2027 expected | breast cancer, metastatic neoplasm | Icahn School of Medicine at Mount Sinai | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03587285 | Sep 2018 → Jul 2021 | prostate neoplasm | Guangzhou University of Traditional Chinese Medicine | Unknown | No outcome recorded |
| Phase 1/2 | NCT03090165 | May 2018 → Oct 2026 expected | triple-negative breast carcinoma | Kari Wisinski | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02605486 | Nov 2015 → Nov 2026 expected | breast cancer | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT00669162 | Aug 2012 → Aug 2016 | prostate cancer | University of Kansas Medical Center | Completed | No outcome recorded |
| Phase 1/2 | NCT00878436 | Jun 2009 → Mar 2015 | prostate cancer | NYU Langone Health | Completed | No outcome recorded |
| Phase 248 trials · 5 missed | ||||||
| Phase 2 | NCT07117851 | Aug 2025 → Dec 2027 expected | extramammary Paget disease, scrotal disorder | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT06365788 | Apr 2024 → Dec 2027 expected | triple-negative breast carcinoma | Universitaire Ziekenhuizen KU Leuven | Recruiting | No outcome recorded |
| Phase 2 | NCT06018116 | Nov 2023 → Jan 2024 | urothelial carcinoma | CHU de Quebec-Universite Laval | Withdrawn | No outcome recorded |
| Phase 2 | NCT06145308 | Aug 2023 → Jul 2028 expected | salivary gland carcinoma | Peking Union Medical College | Recruiting | No outcome recorded |
| Phase 2 | NCT05327647 | Jun 2022 → Sep 2026 overdue | urinary bladder carcinoma | CHU de Quebec-Universite Laval | Recruiting | No outcome recorded |
| Phase 2 | NCT05100472 | Oct 2021 → Oct 2026 expected | prostate cancer | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04025372 | Jun 2020 → Oct 2027 expected | prostate cancer | Brigham and Women's Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06727357 | Sep 2019 → Mar 2025 overdue | breast cancer | European Institute of Oncology | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03650894 | Apr 2019 → Mar 2023 overdue | breast carcinoma | Providence Health & Services | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03541928 | Aug 2018 → Jul 2023 | prostate cancer | The Methodist Hospital Research Institute | Unknown | No outcome recorded |
| Phase 2 | NCT03141671 | Nov 2017 → Apr 2025 | prostate cancer | Dana-Farber Cancer Institute | Unknown | No outcome recorded |
| Phase 2 | NCT03147196 | Jun 2017 → Jun 2022 | prostate adenocarcinoma | Mayo Clinic | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03043807 | Feb 2017 → Oct 2022 | prostate cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 2 | NCT02716974 | Jun 2016 → Apr 2022 | prostate cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 2 | NCT02697032 | Feb 2016 → Nov 2019 | breast cancer | University Medical Center Groningen | Completed | No outcome recorded |
| Phase 2 | NCT02910050 | Jan 2016 → Sep 2018 | breast cancer | Xu fei | Unknown | Missed primary |
| Phase 2 | NCT02614859 | Dec 2015 → Jan 2020 | prostate cancer | Fox Chase Cancer Center | Completed | Missed primary |
| Phase 2 | NCT01969578 | Sep 2015 → Aug 2023 | salivary gland cancer | European Organisation for Research and Treatment of Cancer - EORTC | Completed | No outcome recorded |
| Phase 2 | NCT02348281 | Jan → Dec 2015 | breast cancer | Fudan University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02353988 | Jan 2015 → Jan 2017 | breast cancer | Jinling Hospital, China | Unknown | No outcome recorded |
| Phase 2 | NCT02299999 | Apr 2014 → Dec 2022 overdue | breast cancer | UNICANCER | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02146937 | Mar 2014 → Mar 2015 | prostatic adenoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01674270 | Aug 2012 → Dec 2014 | prostate cancer | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 2 | NCT01251861 | Mar 2011 → Jul 2018 | prostate carcinoma | National Cancer Institute (NCI) | Completed | Missed primary |
| Phase 2 | NCT00814788 | Dec 2008 → Dec 2015 | prostate cancer | University of California, Davis | Completed | No outcome recorded |
| Phase 2 | NCT00771017 | Jul 2008 → ? | prostate cancer | Eastern Cooperative Oncology Group | Withdrawn | No outcome recorded |
| Phase 2 | NCT00658697 | Jun 2008 → Sep 2014 | prostate cancer | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT00528866 | Apr 2008 → Dec 2013 | prostate cancer | Radiation Therapy Oncology Group | Completed | No outcome recorded |
| Phase 2 | NCT00630344 | Feb 2008 → May 2012 | prostate cancer | Dana-Farber Cancer Institute | Completed | Missed primary |
| Phase 2 | NCT00589472 | Nov 2007 → Jun 2010 | prostate adenocarcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT00486642 | Sep 2007 → Aug 2015 | hormone-resistant prostate carcinoma | National Cancer Institute (NCI) | Completed | Missed primary |
| Phase 2 | NCT00468715 | Mar 2007 → Jun 2021 | breast cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00544830 | Jul 2006 → Mar 2011 overdue | prostate adenocarcinoma | City of Hope Medical Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT00349557 | Apr 2006 → ? | prostate cancer | Benaroya Research Institute | Completed | No outcome recorded |
| Phase 2 | NCT00348998 | Apr 2006 → ? | prostate cancer | Virginia Mason Hospital/Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT00554086 | Nov 2005 → Sep 2009 | prostate cancer | Canadian Urology Research Consortium | Completed | No outcome recorded |
| Phase 2 | NCT00094328 | Nov 2004 → May 2008 | precocious puberty | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT00103376 | Oct 2004 → Oct 2009 | prostate cancer | Medical University of South Carolina | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00165399 | Mar 2004 → Dec 2005 | prostate adenocarcinoma | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT00637871 | Nov 2002 → Jun 2005 | gynecomastia disorder, prostate cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT00418080 | Apr 2002 → Dec 2006 | prostate cancer | University of L'Aquila | Completed | No outcome recorded |
| Phase 2 | NCT00028769 | Dec 2001 → Jun 2010 | prostate cancer | SWOG Cancer Research Network | Completed | No outcome recorded |
| Phase 2 | NCT00086736 | Nov 2001 → Nov 2003 | prostate cancer | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 2 | NCT00586898 | Jul 2001 → Mar 2009 | cancer, prostate disorder | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT01250717 | Jan 2001 → May 2011 | prostate cancer | Beth Israel Deaconess Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT00012090 | Sep 2000 → Apr 2004 | fallopian tube carcinoma, ovarian carcinoma, peritoneal carcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00006359 | Sep 2000 → Oct 2007 | prostate cancer | Alliance for Clinical Trials in Oncology | Completed | No outcome recorded |
| Phase 2 | NCT00684905 | Apr 2000 → Oct 2005 | prostate cancer | Mayo Clinic | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT03458221 | Jan 2023 → Oct 2026 expected | ovarian cancer | Gynaecologisch Oncologisch Centrum Zuid | Recruiting | No outcome recorded |
| Phase 2/3 | NCT00421694 | — | prostate cancer | University of L'Aquila | Completed | No outcome recorded |
| Phase 322 trials · 5 met primary · 5 missed | ||||||
| Phase 3 | NCT05019846 | Sep 2021 → Dec 2025 overdue | prostate cancer | Marco Lorenzo Bonu | Recruiting | No outcome recorded |
| Phase 3 | NCT04509999 | Oct 2020 → Jun 2021 | COVID-19 | University of Florida | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03009981 | Mar 2017 → Jun 2025 | prostate cancer | Alliance Foundation Trials, LLC. | Completed | Met primary |
| Phase 3 | NCT03055312 | Dec 2016 → Nov 2020 | triple-negative breast carcinoma | Sun Yat-sen University | Terminated | No outcome recorded |
| Phase 3 | NCT01368588 | Jul 2011 → Apr 2025 overdue | prostate cancer | Radiation Therapy Oncology Group | Active not recruiting | Missed primary |
| Phase 3 | NCT00936390 | Sep 2009 → Oct 2020 | prostate cancer | Radiation Therapy Oncology Group | Completed | Missed primary |
| Phase 3 | NCT00567580 | Feb 2008 → Jul 2018 | prostate cancer | Radiation Therapy Oncology Group | Unknown | Met primary |
| Phase 3 | NCT00541047 | Nov 2007 → Jul 2022 | prostate cancer, sexual disorder | University College, London | Completed | Mixed |
| Phase 3 | NCT02382094 | Jun 2005 → Apr 2009 | prostate cancer | Karolinska University Hospital | Completed | No outcome recorded |
| Phase 3 | NCT00067015 | May 2003 → Oct 2004 | prostate cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 3 | NCT00023829 | Aug 2001 → Jun 2004 | prostate cancer | Radiation Therapy Oncology Group | Completed | No outcome recorded |
| Phase 3 | NCT00021450 | Apr 2001 → Apr 2008 | prostate cancer | European Organisation for Research and Treatment of Cancer - EORTC | Completed | Met primary |
| Phase 3 | NCT00014586 | Jan 2001 → Feb 2003 | prostate cancer | European Organisation for Research and Treatment of Cancer - EORTC | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00223145 | Dec 2000 → Dec 2026 expected | prostate cancer | Abdenour Nabid | Active not recruiting | Met primary |
| Phase 3 | NCT00223171 | Oct 2000 → Dec 2026 expected | prostate cancer | University of Sherbrooke | Active not recruiting | No outcome recorded |
| Phase 3 | NCT00005044 | Feb 2000 → Sep 2012 | prostate cancer | Radiation Therapy Oncology Group | Completed | Missed primary |
| Phase 3 | NCT00002874 | Feb 1998 → Aug 2015 | prostate cancer | Radiation Therapy Oncology Group | Completed | Met primary |
| Phase 3 | NCT00003026 | Apr 1997 → Sep 2001 | prostate cancer | European Organisation for Research and Treatment of Cancer - EORTC | Completed | Missed primary |
| Phase 3 | NCT00002855 | Aug 1996 → Jun 2005 | prostate cancer | M.D. Anderson Cancer Center | Completed | Missed primary |
| Phase 3 | NCT00657904 | Aug 1995 → Jul 2008 | prostate cancer | AstraZeneca | Completed | Mixed |
| Phase 3 | NCT00002651 | May 1995 → Jun 2013 | prostate cancer | SWOG Cancer Research Network | Completed | No outcome recorded |
| Phase 3 | NCT00846976 | Dec 1994 → Jun 2013 | prostate cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT03971110 | Jan 2021 → Nov 2022 | prostate cancer | AstraZeneca | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT04248621 | Jan 2020 → Apr 2022 | prostate neoplasm | Wonju Severance Christian Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT00293696 | Oct 2004 → Nov 2006 | prostate cancer | Tampere University | Completed | No outcome recorded |
| Phase 4 | NCT00255268 | Aug 2004 → ? | metastatic prostate carcinoma | AstraZeneca | Withdrawn | No outcome recorded |
| Phase 4 | NCT00590213 | Jun 2003 → ? | prostate cancer | AstraZeneca | Completed | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT05746806 | Mar 2023 → Nov 2027 expected | prostate carcinoma | Insel Gruppe AG, University Hospital Bern | Active not recruiting | No outcome recorded |
| — | NCT05647356 | Jan 2023 → Apr 2025 | metabolic disease, polycystic ovary syndrome | Royal College of Surgeons, Ireland | Unknown | No outcome recorded |
| — | NCT04220398 | Jan 2020 → Dec 2022 | chemotherapy-induced toxicity, prostate carcinoma | RenJi Hospital | Unknown | No outcome recorded |
| — | NCT01342367 | Dec 2010 → May 2020 overdue | prostate cancer | University of Chicago | Active not recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT00636259 | — | prostate adenocarcinoma | AstraZeneca | No longer available | No outcome recorded |
| Comparator or background therapy101 trials | ||||||
| Phase 1 | NCT04652765 Comparator | Feb → Sep 2021 | COVID-19 | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02458716 Background | Mar 2015 → Jan 2020 | metastatic carcinoma in the bone, metastatic prostate carcinoma, prostate adenocarcinoma | Rutgers, The State University of New Jersey | Completed | No outcome recorded |
| Phase 1 | NCT02487823 Background | Oct 2014 → Nov 2017 | metastatic prostate carcinoma | Institut Paoli-Calmettes | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT01420250 Background | Sep 2011 → Jul 2015 | prostate cancer | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Completed | No outcome recorded |
| Phase 1 | NCT00943956 Background | Jan 2009 → Dec 2012 | prostate cancer | Institut du Cancer de Montpellier - Val d'Aurelle | Completed | No outcome recorded |
| Phase 1 | NCT00702923 Background | Jul 2008 → Sep 2011 | prostate cancer | University of Wisconsin, Madison | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00631527 Background | Feb 2008 → Jan 2015 | prostate cancer | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT00512668 Background | Sep 2007 → Jan 2008 | prostate adenocarcinoma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 1 | NCT00099086 Background | Jan 2007 → Jan 2011 | prostate cancer | Medical University of South Carolina | Completed | No outcome recorded |
| Phase 1 | NCT00959335 Comparator | Aug 2006 | hypertrichosis, prostate cancer | Sandoz | Completed | No outcome recorded |
| Phase 1 | NCT00482807 Background | Aug 2004 → Mar 2010 | prostate cancer | University of Nebraska | Completed | No outcome recorded |
| Phase 1 | NCT00328614 Background | Mar 2003 → Feb 2009 | prostate cancer | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Completed | No outcome recorded |
| Phase 1 | NCT00026377 Background | Nov 2001 → Mar 2002 | prostate cancer | University of Chicago | Completed | No outcome recorded |
| Phase 1/2 | NCT01020305 Background | Oct 2009 → Apr 2012 | castration-resistant prostate carcinoma, hormone-resistant prostate carcinoma, metastatic neoplasm | Sandy Srinivas | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT00924807 Background | Sep 2008 → Dec 2013 | prostate cancer | Beth Israel Medical Center | Terminated | No outcome recorded |
| Phase 1/2 | NCT00075192 Background | Mar 2004 → Mar 2006 | prostate neoplasm | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT07593079 Background | Oct 2026 → Nov 2027 expected | metastatic prostate carcinoma | Washington University School of Medicine | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07393867 Background | Apr → Dec 2026 expected | prostate cancer | Martin T. King, MD, PhD | Recruiting | No outcome recorded |
| Phase 2 | NCT07455903 Background | Apr 2026 → Oct 2029 expected | prostate carcinoma | Baptist Health South Florida | Recruiting | No outcome recorded |
| Phase 2 | NCT06528210 Background | Apr 2025 → Jun 2026 | prostate adenocarcinoma | OHSU Knight Cancer Institute | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT05555017 Background | Feb 2023 → Nov 2024 | prostate cancer | The Netherlands Cancer Institute | Unknown | No outcome recorded |
| Phase 2 | NCT05513365 Background | Sep 2022 → Sep 2025 overdue | salivary duct carcinoma | Radboud University Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT04734730 Background | May 2021 → Aug 2027 expected | prostate adenocarcinoma | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT04374279 Comparator | Apr 2021 → Jan 2022 | COVID-19 | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Withdrawn | No outcome recorded |
| Phase 2 | NCT03809000 Comparator | Apr 2019 → Apr 2023 overdue | prostate cancer | RTOG Foundation, Inc. | Active not recruiting | Missed primary |
| Phase 2 | NCT02582749 Background | Apr 2016 → Sep 2017 | metastatic carcinoma in the bone, prostate cancer | Ajjai Alva, MD | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT02678520 Background | Dec 2015 → Feb 2016 | prostate cancer | University of Kansas Medical Center | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02742675 Background | Sep 2015 → Mar 2021 | prostate cancer | Fudan University | Unknown | No outcome recorded |
| Phase 2 | NCT02059213 Background | Jun 2014 → Sep 2017 | prostate cancer | University of Michigan Rogel Cancer Center | Completed | Missed primary |
| Phase 2 | NCT02058706 Comparator | May 2014 → Mar 2021 | prostate adenocarcinoma | Barbara Ann Karmanos Cancer Institute | Completed | Met primary |
| Phase 2 | NCT01658527 Comparator | Jan 2014 → Jan 2016 | prostate cancer | European Organisation for Research and Treatment of Cancer - EORTC | Withdrawn | No outcome recorded |
| Phase 2 | NCT01786265 Background | Feb 2013 → Feb 2027 expected | prostate adenocarcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01664923 Comparator | Aug 2012 → Feb 2015 | prostate cancer | Pfizer | Completed | Met primary |
| Phase 2 | NCT01531205 Background | May 2012 → Sep 2013 | prostate cancer | H. Lee Moffitt Cancer Center and Research Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01288911 Comparator | Mar 2011 → Oct 2014 | prostate neoplasm | Astellas Pharma Inc | Completed | Met primary |
| Phase 2 | NCT01120236 Background | Dec 2010 → Jun 2015 | prostate adenocarcinoma | National Cancer Institute (NCI) | Completed | Missed primary |
| Phase 2 | NCT01200810 Background | Aug 2010 → Aug 2012 | prostate adenocarcinoma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 2 | NCT00666666 Background | Jul 2009 → May 2011 | prostate adenocarcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT00866554 Comparator | Mar 2009 → Mar 2019 | erectile dysfunction, prostate cancer | CHU de Quebec-Universite Laval | Completed | No outcome recorded |
| Phase 2 | NCT00757692 Comparator | Jan 2009 → Feb 2012 | prostate cancer | British Columbia Cancer Agency | Completed | No outcome recorded |
| Phase 2 | NCT00685633 Comparator | Dec 2008 → Jun 2010 | prostate cancer | Eastern Cooperative Oncology Group | Withdrawn | No outcome recorded |
| Phase 2 | NCT00769795 Background | Oct 2008 → Aug 2011 | prostate cancer | University of Washington | Completed | No outcome recorded |
| Phase 2 | NCT00777959 Background | Oct 2008 → May 2011 | prostate cancer | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT00776594 Background | Oct 2008 → Dec 2014 | prostate cancer | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT00659438 Background | Feb 2008 → Nov 2010 | prostate cancer | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 2 | NCT00521781 Background | Aug 2007 → Sep 2008 | prostate neoplasm | The Methodist Hospital Research Institute | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT00430235 Background | Mar 2007 → Aug 2010 | prostate adenocarcinoma | British Columbia Cancer Agency | Completed | No outcome recorded |
| Phase 2 | NCT00298155 Comparator | Jul 2006 → Jun 2010 | cancer, prostate neoplasm | University of Washington | Completed | No outcome recorded |
| Phase 2 | NCT00108732 Background | Feb 2006 → Oct 2010 | grade III prostatic intraepithelial neoplasia | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT00170157 Background | Jun 2004 → Apr 2011 | prostate adenocarcinoma | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT00283803 Background | Mar 2002 → Oct 2011 | prostate cancer | University of Washington | Completed | No outcome recorded |
| Phase 2 | NCT00244920 Background | Jan 2002 → Jun 2007 | prostate cancer | OHSU Knight Cancer Institute | Withdrawn | No outcome recorded |
| Phase 2 | NCT00031889 Comparator | Aug 2001 → Jun 2002 | prostate cancer | Swiss Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT00003517 Background | — | prostate adenocarcinoma | Burzynski Research Institute | Withdrawn | No outcome recorded |
| Phase 2/3 | NCT03348670 Background | Aug 2023 → Nov 2026 expected | prostate cancer | Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT04787744 Background | Jul 2021 → Sep 2026 overdue | metastatic prostate carcinoma | VA Office of Research and Development | Recruiting | No outcome recorded |
| Phase 2/3 | NCT03070886 Background | Apr 2017 → Oct 2025 overdue | prostate adenocarcinoma | NRG Oncology | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06650579 Background | Jan 2025 → Jul 2029 expected | prostate carcinoma | Emory University | Recruiting | No outcome recorded |
| Phase 3 | NCT05050084 Background | Dec 2021 → Nov 2026 expected | prostate adenocarcinoma | NRG Oncology | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04513717 Background | Jan 2021 → Dec 2033 expected | prostate adenocarcinoma | NRG Oncology | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03488810 Comparator | Mar 2020 → Jun 2026 | prostate cancer | European Organisation for Research and Treatment of Cancer - EORTC | Withdrawn | No outcome recorded |
| Phase 3 | NCT03678025 Background | Sep 2018 → Apr 2033 expected | prostate adenocarcinoma | SWOG Cancer Research Network | Recruiting | No outcome recorded |
| Phase 3 | NCT03520478 Comparator | May 2018 → Apr 2023 | prostate cancer | Jiangsu HengRui Medicine Co., Ltd. | Unknown | Met primary |
| Phase 3 | NCT02531516 Comparator | Nov 2015 → Mar 2027 expected | prostate neoplasm | Aragon Pharmaceuticals, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02446405 Comparator | Mar 2014 → Dec 2026 expected | prostate cancer | University of Sydney | Active not recruiting | Met primary |
| Phase 3 | NCT02085252 Background | Jun 2013 → Nov 2016 | prostate cancer | Takeda | Completed | Met primary |
| Phase 3 | NCT01809691 Comparator | Mar 2013 → Mar 2022 | prostate cancer | SWOG Cancer Research Network | Completed | Missed primary |
| Phase 3 | NCT01546987 Background | May 2012 → Nov 2021 | prostate cancer | Radiation Therapy Oncology Group | Completed | Missed primary |
| Phase 3 | NCT01313273 Background | Jun 2011 → Jun 2013 | prostate cancer | Ipsen | Terminated | No outcome recorded |
| Phase 3 | NCT00884273 Comparator | Aug 2009 → Mar 2011 | prostate cancer | Ferring Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT00831233 Comparator | Apr 2009 → Jun 2010 | prostate cancer | Ferring Pharmaceuticals | Terminated | Met primary Stop: Enrollment |
| Phase 3 | NCT00833248 Comparator | Apr 2009 → Sep 2011 | prostate cancer | Ferring Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT03119857 Comparator | Feb 2009 → Apr 2023 | prostate cancer | Göteborg University | Unknown | No outcome recorded |
| Phase 3 | NCT00651326 Comparator | Jun 2008 → May 2010 | prostate cancer | NCIC Clinical Trials Group | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00514917 Background | Jul 2007 → Sep 2012 | prostate neoplasm | Sanofi | Terminated | Missed primary |
| Phase 3 | NCT00309985 Background | Sep 2006 → Dec 2013 | metastatic prostate carcinoma | ECOG-ACRIN Cancer Research Group | Completed | Met primary |
| Phase 3 | NCT00288080 Background | Dec 2005 → Apr 2014 | prostate cancer | Radiation Therapy Oncology Group | Completed | Met primary |
| Phase 3 | NCT02175212 Comparator | Nov 2005 → Jun 2014 | prostate adenocarcinoma | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | Completed | No outcome recorded |
| Phase 3 | NCT00388804 Comparator | Feb 2005 → Apr 2011 | prostate cancer | M.D. Anderson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00243646 Comparator | Aug 2004 → Jul 2009 | prostate cancer | Schiffler Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00233610 Background | Dec 2003 → Oct 2007 | prostate cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00764166 Background | Jun 2003 → Nov 2009 | prostate adenocarcinoma | Assistance Publique - Hôpitaux de Paris | Unknown | Missed primary |
| Phase 3 | NCT00055731 Background | Nov 2002 → Dec 2010 | prostate cancer | UNICANCER | Completed | Met primary |
| Phase 3 | NCT00030654 Background | Oct 2002 → Feb 2005 | prostate cancer | Radiation Therapy Oncology Group | Completed | No outcome recorded |
| Phase 3 | NCT00004054 Background | Jan 2000 → Apr 2010 | prostate cancer | Radiation Therapy Oncology Group | Completed | Missed primary |
| Phase 3 | NCT00004124 Background | Oct 1999 → Aug 2017 | prostate cancer | SWOG Cancer Research Network | Completed | Missed primary |
| Phase 3 | NCT00003653 Comparator | Jan 1999 → Oct 2010 | prostate cancer | NCIC Clinical Trials Group | Completed | No outcome recorded |
| Phase 3 | NCT00841113 Comparator | Jan 1999 → Feb 2001 | prostate cancer | Speciality European Pharma Limited | Completed | No outcome recorded |
| Phase 3 | NCT00672282 Comparator | Oct 1995 → Aug 2008 | prostate cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00673205 Comparator | Sep 1995 → Aug 2008 | prostate cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00002633 Comparator | Feb 1995 → Sep 2011 | prostate cancer | NCIC Clinical Trials Group | Completed | No outcome recorded |
| Phase 4 | NCT07848828 Comparator | Aug 2026 → Jul 2028 expected | dysautonomia, hypertensive disorder, kidney disorder, prostate cancer | Virginia Commonwealth University | Recruiting | No outcome recorded |
| Phase 4 | NCT05700903 Comparator | Sep 2023 → Jul 2025 | dysautonomia, hypertensive disorder, kidney disorder, prostate cancer | University of Colorado, Denver | Terminated | No outcome recorded |
| Phase 4 | NCT00470834 Background | May 2007 → Feb 2013 | prostate cancer | GlaxoSmithKline | Completed | Missed primary |
| — | NCT05628363 Background | Jan 2023 → Oct 2025 overdue | prostate cancer | Washington University School of Medicine | Active not recruiting | No outcome recorded |
| — | NCT02615223 Background | Nov 2015 → Dec 2017 | prostate cancer | Tianjin Medical University Cancer Institute and Hospital | Unknown | No outcome recorded |
| — | NCT02605226 Background | Nov 2015 → Dec 2017 | prostate cancer | Tianjin Medical University Cancer Institute and Hospital | Unknown | No outcome recorded |
| — | NCT02454543 Background | May 2015 → Dec 2019 overdue | prostate cancer | Martini-Klinik am UKE GmbH | Active not recruiting | No outcome recorded |
| — | NCT02346253 Background | Jan 2015 → Dec 2021 | prostate adenocarcinoma | Stanford University | Completed | No outcome recorded |
| — | NCT00551044 Comparator | Aug 2003 → Aug 2005 | prostate cancer | Wirral University Teaching Hospital NHS Trust | Completed | No outcome recorded |
| — | NCT00536653 Comparator | Oct 1999 → Jan 2007 | osteoporosis | Wirral University Teaching Hospital NHS Trust | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2015-04-03 | Astellas Pharma Inc | Results ENZALUTAMIDE DEMONSTRATES STATISTICALLY SIGNIFICANT IMPROVEMENT IN PROGRESSION FREE SURVIVAL COMPARED WITH BICALUTAMIDE IN STRIVE TRIAL astellas.com ↗
The study achieved its primary endpoint demonstrating a statistically significant increase in progression-free survival (PFS) for enzalutamide compared with bicalutamide (Hazard Ratio = 0.24; 95% Confidence Interval, 0.18-0.32; p<0.0001). |
| 2015-01-23 | Astellas Pharma Inc | Results ENZALUTAMIDE PHASE 2 TERRAIN TRIAL DEMONSTRATED STATISTICALLY SIGNIFICANT INCREASE IN PFS AS COMPARED TO BICALUTAMIDE IN METASTATIC PROSTATE CANCER astellas.com ↗
Median PFS was 15.7 months in the enzalutamide group compared to 5.8 months in the bicalutamide group. |
| 2009-07-07 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharma announces USFDA approval for generic Casodex® tablets sunpharma.com ↗
Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE:SUNPHARMA, BSE: 524715) announced that USFDA has granted its subsidiary an approval for an Abbreviated New Drug Application (ANDA) for generic Casodex ®, bicalutamide tablets. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2019-12-20 | AstraZeneca | AstraZeneca divests rights to Arimidex and Casodex in Europe and certain additional countries astrazeneca.com ↗ |
| 2015-04-03 | Astellas Pharma Inc | ENZALUTAMIDE DEMONSTRATES STATISTICALLY SIGNIFICANT IMPROVEMENT IN PROGRESSION FREE SURVIVAL COMPARED WITH BICALUTAMIDE IN STRIVE TRIAL astellas.com ↗ |
| 2015-01-23 | Astellas Pharma Inc | ENZALUTAMIDE PHASE 2 TERRAIN TRIAL DEMONSTRATED STATISTICALLY SIGNIFICANT INCREASE IN PFS AS COMPARED TO BICALUTAMIDE IN METASTATIC PROSTATE CANCER astellas.com ↗ |
| 2009-07-07 | Sun Pharmaceutical Industries, Inc. | Sun Pharma announces USFDA approval for generic Casodex® tablets sunpharma.com ↗ |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 209 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Bicalutamide | “Participants were randomly assigned (1:1), using a centralised web-based system and stratified by volume of disease, planned use of concurrent docetaxel and bone antiresorptive...” PMID 36990608 ↗ Apr 2023191“All patients receive neoadjuvant androgen-deprivation therapy comprising bicalutamide orally (PO) once daily or flutamide PO thrice daily for 4-6 months, and luteinizing...” NCT01368588 ↗ “Patients treated with leuprolide, goserelin, or degarelix should also receive an androgen receptor antagonist (flutamide or bicalutamide) for 30 days from the start of GnRH...” NCT05628363 ↗ “A course of bicalutamide 50 mg daily orally for 14-21 days is recommended for patients starting LHRH agonist therapy and suspected to be at risk for tumor flare, e.g.,...” NCT01531205 ↗ “A Multi-centre, Single-arm, Prospective Study to Assess Efficacy and Safety of Neoadjuvant Hormone Therapy Using Zoladex (Goserelin) and Casodex (Bicalutamide) in Patients With...” NCT03971110 ↗ “Androgen blockade : 36 months of androgen blockade : bicalutamide 50 mg die for one month, goserelin 10.8 mg x 12 Q 3 months + radiation therapy : pelvis 44 grays , prostate 70...” NCT00223171 ↗ “Phase 2 Trial of Maximum Androgen Blockade (MAB) Dose Escalation From 50 mg to 150 mg Bicalutamide (Casodex) for Biochemical Failure in Prostate Cancer Patients” NCT00554086 ↗ “Non steroidal anti androgens (e.g. bicalutamide 50 mg/day to be administered till progression) plus LHRH-a (e.g. triptorelin 3.75 mg/month till progression.” NCT01313273 ↗ “Non-steroidal anti-androgen (e. g. flutamide, bicalutamide) PO daily for 4 weeks, started 2 weeks before the first LHRH agonist injection” NCT03488810 ↗ “Patients were treated with the combination of ridaforolimus 30 mg/day for 5 consecutive days each week and bicalutamide 50 mg/day.” PMID 23921574 ↗ Aug 2013 “BAY 43-9006, 400 mg, PO, BID in a 28-day cycle(morning and evening) Bicalutamide 50 mg po Once daily in a 28-day cycle (morning)” NCT00430235 ↗ |
| Known as | Bic | “The randomized phase 3 CHART trial (NCT03520478) revealed that rezvilutamide (REZ) plus androgen deprivation therapy (ADT) in high-volume, metastatic, hormone-sensitive...” PMID 39690158 ↗ Dec 20241“bicalutamide (Bic), 50 mg daily, was added to each arm.” PMID 41609418 ↗ Jan 2026 |
| Known as | Bicalutamida | ChEMBL registry synonym — accepted as the source's own label CHEMBL409 ↗ |
| Known as | Bicalutamide(Casodex) | “bicalutamide (Casodex®)” NCT01531205 ↗1“Bicalutamide(Casodex)” NCT00866554 ↗ |
| Known as | Calutide | ChEMBL registry synonym — accepted as the source's own label CHEMBL409 ↗ |
| Known as | CASODEX | “A Randomized, Placebo-Controlled Phase IIb Clinical Trial of 2-Difluoromethylornithine (DFMO) Versus Bicalutamide (CASODEX) Alone and in Combination in Patients With Prostate...” NCT00086736 ↗23“Anti-Androgen drugs, like Casodex® (bicalutamide) also stop cell growth by blocking male hormones like testosterone.” NCT00631527 ↗ “Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA)” NCT00960310 ↗ “Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA)” NCT00959335 ↗ “Flutamide (Eulexin) or bicalutamide (Casodex) may be used as the antiandrogens.” NCT00003026 ↗ “flutamide 250 mg PO tid for 4 wks OR casodex 50 mg PO daily for 4 wks” NCT00006359 ↗ “BKM120, LH-RH agonists (suprefact) and bicalutamide (casodex)” NCT02487823 ↗ “bicalutamide (Casodex), goserelin (Zoladex)” NCT00293696 ↗ “an antiandrogen such as Eulexin or Casodex” NCT00283803 ↗ “Bicalutamide (Casodex)” NCT00636259 ↗ “3. Lupron/ Casodex” NCT02911350 ↗ |
| Known as | CDX | “an antiandrogen (nilutamide [ANAN], flutamide [FLUT], bicalutamide [CDX], or cyproterone acetate [CPTR])” NCT00003653 ↗ |
| Known as | Cosudex | ChEMBL registry synonym — accepted as the source's own label CHEMBL409 ↗ |
| Known as | ICI 176,334 | ChEMBL registry synonym — accepted as the source's own label CHEMBL409 ↗ |
| Known as | ICI176,334-1 | “Oral Mucosal Absorption Study of ICI176,334-1 (Bicalutamide New Formulation) in Japanese Healthy Male Subjects” NCT01416883 ↗ |
| Known as | Kalumid | ChEMBL registry synonym — accepted as the source's own label CHEMBL409 ↗ |
| Known as | NSC-759816 | ChEMBL registry synonym — accepted as the source's own label CHEMBL409 ↗ |
| Action | Inhibit | “reducing the production of androgens” NCT00002874 ↗ |
| Modality | Other / unclassified | “high-dose nonsteroidal antiandrogen (bicalutamide, 150 mg/d)” PMID 32215583 ↗ May 2020 |
| Route | Oral | “Bicalutamide 50 mg po QD” NCT00002633 ↗ |
| Target | AR | “Bicalutamide, an androgen receptor (AR) antagonist” NCT00630344 ↗ |