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
- -
Pembrolizumab in Treating Patients With Metastatic Castration Resistant Prostate Cancer Previously Treated With Enzalutamide
- First Posted Date
- 2014-12-09
- Last Posted Date
- 2024-02-14
- Lead Sponsor
- OHSU Knight Cancer Institute
- Target Recruit Count
- 58
- Registration Number
- NCT02312557
- Locations
- 🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States
Enzalutamide in Combination With Gemcitabine and Cisplatin in Bladder Cancer
- Conditions
- Interventions
- First Posted Date
- 2014-11-25
- Last Posted Date
- 2019-08-01
- Target Recruit Count
- 10
- Registration Number
- NCT02300610
- Locations
- 🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
🇺🇸University of Minnesota, Masonic Cancer Center, Minneapolis, Minnesota, United States
An Asian Study to Evaluate Efficacy and Safety of Oral Enzalutamide in Progressive Metastatic Prostate Cancer Participants
- Conditions
- Interventions
- First Posted Date
- 2014-11-19
- Last Posted Date
- 2024-12-06
- Lead Sponsor
- Astellas Pharma Inc
- Target Recruit Count
- 395
- Registration Number
- NCT02294461
- Locations
- 🇨🇳
CN00115, Beijing, China
🇨🇳CN00112, Beijing, China
🇨🇳CN00114, Beijing, China
Analyze the Predictive Value of Gene TMPRSS2-ETS in Response to Enzalutamide in Patients With Prostate Cancer
- First Posted Date
- 2014-11-13
- Last Posted Date
- 2019-09-24
- Lead Sponsor
- Spanish Oncology Genito-Urinary Group
- Target Recruit Count
- 98
- Registration Number
- NCT02288936
- Locations
- 🇪🇸
Hospital Universitari Germans Trias I Pujol de Badalona, Badalona, Barcelona, Spain
🇪🇸Hospital Universitari Son Espases, Palma de Mallorca, Islas Baleares, Spain
🇪🇸Complejo Hospitalario Regional Reina Sofía, Córdoba, Spain
A Study to Assess the Benefit of Treatment Beyond Progression With Enzalutamide in Men Who Are Starting Treatment With Docetaxel After Worsening of Their Prostate Cancer When Taking Enzalutamide Alone
- Conditions
- Interventions
- First Posted Date
- 2014-11-11
- Last Posted Date
- 2024-04-05
- Lead Sponsor
- Astellas Pharma Europe Ltd.
- Target Recruit Count
- 688
- Registration Number
- NCT02288247
- Locations
- 🇩🇪
Site DE49017, Ulm, Germany
🇪🇸Site ES34003, Madrid, Spain
🇪🇸Site ES34005, Lugo, Spain
Testosterone Revival Abolishes Negative Symptoms, Fosters Objective Response and Modulates Enzalutamide Resistance
- Conditions
- Interventions
- First Posted Date
- 2014-11-10
- Last Posted Date
- 2020-11-06
- Target Recruit Count
- 222
- Registration Number
- NCT02286921
- Locations
- 🇺🇸
Piedmont Cancer Institute, Atlanta, Georgia, United States
🇺🇸University of Kansas Cancer Center, Kansas City, Kansas, United States
🇺🇸SKCCC at Johns Hopkins, Baltimore, Maryland, United States
Enzalutamide Versus Standard Androgen Deprivation Therapy for the Treatment Hormone Sensitive Prostate Cancer
- First Posted Date
- 2014-10-29
- Last Posted Date
- 2024-05-06
- Lead Sponsor
- University of Colorado, Denver
- Target Recruit Count
- 19
- Registration Number
- NCT02278185
- Locations
- 🇺🇸
University of Colorado Health - Poudre Valley Hospital, Fort Collins, Colorado, United States
🇺🇸University of Colorado Cancer Center - Anschutz Cancer Pavilion, Aurora, Colorado, United States
Enzalutamide/Leuprolide +/- Abiraterone/Pred in Prostate
- Conditions
- Interventions
- First Posted Date
- 2014-10-20
- Last Posted Date
- 2022-04-19
- Lead Sponsor
- Dana-Farber Cancer Institute
- Target Recruit Count
- 75
- Registration Number
- NCT02268175
- Locations
- 🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States
🇺🇸Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸Dana-Farber Cancer Institute, Boston, Massachusetts, United States
EXTEND Exercise Trial
- Conditions
- Interventions
- First Posted Date
- 2014-10-03
- Last Posted Date
- 2019-04-18
- Lead Sponsor
- Duke University
- Target Recruit Count
- 26
- Registration Number
- NCT02256111
- Locations
- 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸Duke University Medical Center, Durham, North Carolina, United States
Molecular Features and Pathways in Predicting Drug Resistance in Patients With Metastatic Castration-Resistant Prostate Cancer Receiving Enzalutamide
- First Posted Date
- 2014-08-29
- Last Posted Date
- 2020-09-28
- Lead Sponsor
- OHSU Knight Cancer Institute
- Target Recruit Count
- 41
- Registration Number
- NCT02228265
- Locations
- 🇺🇸
UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸UCSF Medical Center-Mount Zion, San Francisco, California, United States
🇺🇸OHSU Knight Cancer Institute, Portland, Oregon, United States
Drug Development Updates
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