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
- -
A Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide in Participants With Metastatic Castration-Resistant Prostrate Cancer (mCRPC) After Failure of an Androgen Synthesis Inhibitor And Failure of, Ineligibility For, or Refusal of a Taxane Regimen
- Conditions
- Interventions
- First Posted Date
- 2017-01-10
- Last Posted Date
- 2024-08-09
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 759
- Registration Number
- NCT03016312
- Locations
- 🇺🇸
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
🇺🇸City of Hope Medical Grp Inc., Duarte, California, United States
🇺🇸University of California San Diego, La Jolla, California, United States
Study of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study)
- Conditions
- Interventions
- First Posted Date
- 2016-12-09
- Last Posted Date
- 2023-10-06
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 387
- Registration Number
- NCT02987543
- Locations
- 🇬🇧
Research Site, Sutton, United Kingdom
A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
- Conditions
- Interventions
- First Posted Date
- 2016-11-09
- Last Posted Date
- 2024-12-09
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 900
- Registration Number
- NCT02960022
- Locations
- 🇫🇷
Site FR33021, Bordeaux Cedex, France
🇺🇸Site US10052, Anchorage, Alaska, United States
🇺🇸Site US10011, Tucson, Arizona, United States
Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- Breast Cancer
- Conditions
- Interventions
- First Posted Date
- 2016-11-04
- Last Posted Date
- 2024-06-10
- Lead Sponsor
- University of Colorado, Denver
- Target Recruit Count
- 61
- Registration Number
- NCT02955394
- Locations
- 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸West Cancer Center, Germantown, Tennessee, United States
🇺🇸University of Colorado, Aurora, Colorado, United States
Enzalutamide and Indomethacin in Treating Patients With Recurrent or Metastatic Hormone-Resistant Prostate Cancer
- Conditions
- Interventions
- First Posted Date
- 2016-10-17
- Last Posted Date
- 2023-11-29
- Lead Sponsor
- Mamta Parikh
- Target Recruit Count
- 38
- Registration Number
- NCT02935205
- Locations
- 🇺🇸
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
Efficacy and Safety Study of Enzalutamide in Combination With Paclitaxel Chemotherapy or as Monotherapy Versus Placebo With Paclitaxel in Patients With Advanced, Diagnostic-Positive, Triple-Negative Breast Cancer
- First Posted Date
- 2016-10-11
- Last Posted Date
- 2018-10-22
- Lead Sponsor
- Pfizer
- Registration Number
- NCT02929576
Study on Enzalutamide and Flutamide in Patients With Castration Resistant Prostate Cancer
- Conditions
- Interventions
- First Posted Date
- 2016-09-29
- Last Posted Date
- 2024-12-09
- Lead Sponsor
- Astellas Pharma Inc
- Target Recruit Count
- 206
- Registration Number
- NCT02918968
- Locations
- 🇯🇵
Site JP00051, Iizuka, Fukuoka, Japan
🇯🇵Site JP00019, Sagamihara, Kanagawa, Japan
🇯🇵Site JP00024, Nagoya, Aichi, Japan
Prostate Cancer Intensive, Non-Cross Reactive Therapy (PRINT) for Castration Resistant Prostate Cancer (CRPC)
- Conditions
- Interventions
- First Posted Date
- 2016-09-16
- Last Posted Date
- 2024-02-07
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- Target Recruit Count
- 40
- Registration Number
- NCT02903160
- Locations
- 🇺🇸
Mount Sinai Beth Israel, New York, New York, United States
🇺🇸Icahn School of Medicine at Mount Sinai, New York, New York, United States
Enzalutamide Before Surgery in Treating Patients With Kidney Cancer
- Conditions
- Interventions
- First Posted Date
- 2016-08-31
- Last Posted Date
- 2021-09-16
- Lead Sponsor
- Rutgers, The State University of New Jersey
- Target Recruit Count
- 3
- Registration Number
- NCT02885649
- Locations
- 🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Use of an Experimental Drug, CC-115, With Enzalutamide in Men With Castration-Resistant Prostate Cancer
- Conditions
- Interventions
- First Posted Date
- 2016-07-14
- Last Posted Date
- 2023-01-19
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 40
- Registration Number
- NCT02833883
- Locations
- 🇺🇸
University of California San Francisco, San Francisco, California, United States
🇺🇸John Hopkins Medical Center, Baltimore, Maryland, United States
🇺🇸Duke University Medical Center, Durham, North Carolina, United States
Drug Development Updates
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