Enzalutamide
- Generic Name
- Enzalutamide
- Brand Names
- Xtandi, Enzalutamide Viatris
- Drug Type
- Small Molecule
- Chemical Formula
- C21H16F4N4O2S
- CAS Number
- 915087-33-1
- Unique Ingredient Identifier
- 93T0T9GKNU
- Background
Enzalutamide is an androgen receptor (AR) inhibitor for the treatment of castration-resistant prostate cancer (CRPC), both metastatic and non-metastatic. It is a second-generation antiandrogen agent that the FDA approved on August 31, 2012. Although androgen deprivation therapy (ADT) is the first-line treatment of prostate cancer and remission can be achieved, arising resistance is inevitable, becoming castration-resistant prostate cancer. Until recently, docetaxel is the only treatment available for metastatic CRPC; however, AR inhibitors have been developed for more targeted therapy, although first-generation AR inhibitors like bicalutamide did not substantially increase the survival rate. Second-generation such as enzalutamide is more efficacious due to a higher affinity to AR and no partial agonist activity compared to bicalutamide.
Due to a favorable pharmacological profile, a phase 1 study of enzalutamide was initiated in July 2007. Compared to the average time of 10 to 15 years for a drug to go from pre-clinical to clinical studies, enzalutamide was developed relatively rapidly.
- Indication
Enzalutamide is indicated for the treatment of castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer (mCRPC). It is also used in combination with talazoparib for the treatment of adult patients with HRR gene-mutated mCRPC.
- Associated Conditions
- Castration Resistant Prostate Cancer, Metastatic Castration Sensitive Prostate Cancer (mCSPC), Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- Associated Therapies
- -
Dexamethasone Prior to Re-treatment With Enzalutamide in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Previously Treated With Enzalutamide and Docetaxel
- First Posted Date
- 2015-07-08
- Last Posted Date
- 2018-07-12
- Target Recruit Count
- 5
- Registration Number
- NCT02491411
- Locations
- 🇺🇸
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Enzalutamide in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma
- Conditions
- Interventions
- First Posted Date
- 2015-07-02
- Last Posted Date
- 2021-08-10
- Lead Sponsor
- University of Washington
- Target Recruit Count
- 8
- Registration Number
- NCT02489123
- Locations
- 🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States
Cabazitaxel Versus the Switch to Alternative AR-targeted Agent (Enzalutamide or Abiraterone) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Patients Previously Treated With Docetaxel and Who Rapidly Failed a Prior AR-targeted Agent
- Conditions
- Interventions
- First Posted Date
- 2015-06-30
- Last Posted Date
- 2022-05-27
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 255
- Registration Number
- NCT02485691
- Locations
- 🇧🇪
Investigational Site Number 056007, Brussels, Belgium
🇧🇪Investigational Site Number 056005, Leuven, Belgium
🇫🇷Investigational Site Number 250010, Clermont Ferrand, France
Taselisib and Enzalutamide in Treating Patients With Androgen Receptor Positive Triple-Negative Metastatic Breast Cancer
- Conditions
- Interventions
- First Posted Date
- 2015-05-29
- Last Posted Date
- 2022-08-22
- Lead Sponsor
- Vanderbilt-Ingram Cancer Center
- Target Recruit Count
- 30
- Registration Number
- NCT02457910
- Locations
- 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸University of Alabama, Birmingham, Birmingham, Alabama, United States
🇺🇸Mayo Clinic, Rochester, Minnesota, United States
Addition of Enzalutamide to First Line Docetaxel for Castration Resistant Prostate Cancer
- Conditions
- Interventions
- First Posted Date
- 2015-05-25
- Last Posted Date
- 2024-05-30
- Lead Sponsor
- Santa Chiara Hospital
- Target Recruit Count
- 246
- Registration Number
- NCT02453009
- Locations
- 🇮🇹
Santa Chiara Hospital, Trento, Italy
Study of TGF-β Receptor Inhibitor Galunisertib (LY2157299) and Enzalutamide in Metastatic Castration-resistant Prostate Cancer
- Conditions
- Interventions
- First Posted Date
- 2015-05-22
- Last Posted Date
- 2024-10-21
- Target Recruit Count
- 60
- Registration Number
- NCT02452008
- Locations
- 🇺🇸
Sibley Memorial Hospital, Washington, District of Columbia, United States
🇺🇸Northwestern University, Chicago, Illinois, United States
🇺🇸University of Chicago, Chicago, Illinois, United States
Enzalutamide in Androgen Deprivation Therapy With Radiation Therapy for High Risk, Clinically Localised, Prostate Cancer
- Conditions
- Interventions
- First Posted Date
- 2015-05-18
- Last Posted Date
- 2024-02-13
- Lead Sponsor
- University of Sydney
- Target Recruit Count
- 802
- Registration Number
- NCT02446444
- Locations
- 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇦🇺Campbelltown Hospital, Campbelltown, New South Wales, Australia
Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer
- Conditions
- Interventions
- First Posted Date
- 2015-05-18
- Last Posted Date
- 2022-11-30
- Lead Sponsor
- University of Sydney
- Target Recruit Count
- 1125
- Registration Number
- NCT02446405
- Locations
- 🇨🇦
BCCA Vancouver Centre, Vancouver, British Columbia, Canada
🇦🇺Australian Urology Associates, Malvern, Victoria, Australia
🇦🇺Austin Hospital, Heidelberg, Victoria, Australia
A Study of Enzalutamide Re-treatment in Metastatic Castration-resistant Prostate Cancer After Docetaxel and/or Cabazitaxel Treatment
- Conditions
- Interventions
- First Posted Date
- 2015-05-12
- Last Posted Date
- 2018-04-19
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 4
- Registration Number
- NCT02441517
- Locations
- 🇺🇸
Site US10004, New York, New York, United States
🇺🇸Site US10003, Evanston, Illinois, United States
🇺🇸Site US10002, Myrtle Beach, South Carolina, United States
A Study of Galeterone Compared to Enzalutamide In Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic CRPC
- First Posted Date
- 2015-05-08
- Last Posted Date
- 2023-03-15
- Lead Sponsor
- LTN PHARMACEUTICALS, INC.
- Target Recruit Count
- 953
- Registration Number
- NCT02438007
- Locations
- 🇪🇸
Hospital Clínic i Provincial de Barcelona-Oncology, Barcelona, Spain
🇪🇸Unidad Cnio Ibima de Investigacion en Prostata, Malaga, Spain
🇪🇸Hospital General Universitario Gregorio Marañón, Madrid, Spain
Drug Development Updates
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