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
- -
Docetaxel/Prednisone Versus Docetaxel/Prednisone and Enzalutamide in Castration-Resistant Prostate Cancer
- Conditions
- Interventions
- First Posted Date
- 2016-02-18
- Last Posted Date
- 2021-04-09
- Lead Sponsor
- Prostate Cancer Clinical Trials Consortium
- Target Recruit Count
- 9
- Registration Number
- NCT02685267
- Locations
- 🇺🇸
Univesity of Wisconsin, Madison, Wisconsin, United States
🇺🇸Roswell Park Cancer Institute, Buffalo, New York, United States
🇺🇸The University of Chicago, Chicago, Illinois, United States
Enzalutamide, Carboplatin, and Paclitaxel in Treating Patients With Stage III-IV or Recurrent Endometrioid Endometrial Cancer
- Conditions
- Stage IIIC Uterine Corpus Cancer AJCC v7Stage III Uterine Corpus Cancer AJCC v7Recurrent Endometrial Endometrioid AdenocarcinomaStage IIIA Uterine Corpus Cancer AJCC v7Stage IVA Uterine Corpus Cancer AJCC v7Stage IVB Uterine Corpus Cancer AJCC v7Recurrent Uterine Corpus CarcinomaStage IIIB Uterine Corpus Cancer AJCC v7Stage IV Uterine Corpus Cancer AJCC v7
- Interventions
- First Posted Date
- 2016-02-17
- Last Posted Date
- 2023-10-16
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 53
- Registration Number
- NCT02684227
- Locations
- 🇺🇸
MD Anderson League City, Nassau Bay, Texas, United States
🇺🇸MD Anderson in Katy, Houston, Texas, United States
🇺🇸MD Anderson in Sugar Land, Sugar Land, Texas, United States
Short-term Preoperative Treatment With Enzalutamide, Alone or in Combination With Exemestane in Primary Breast Cancer
- Conditions
- Interventions
- First Posted Date
- 2016-02-09
- Last Posted Date
- 2024-07-05
- Lead Sponsor
- Queen Mary University of London
- Target Recruit Count
- 221
- Registration Number
- NCT02676986
- Locations
- 🇺🇸
MD Anderson Cancer Centre, Houston, Texas, United States
🇩🇪Evangelische Kliniken Gelsenkirchen, Gelsenkirchen, Germany
🇩🇪Evangelisches Waldkrankenhaus Spandau, Berlin, Germany
A Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
- Conditions
- Interventions
- First Posted Date
- 2016-02-09
- Last Posted Date
- 2024-12-20
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 1150
- Registration Number
- NCT02677896
- Locations
- 🇨🇱
Site CL56003, Santiago, Chile
🇺🇸Site US10060, Greenville, North Carolina, United States
🇨🇦Site CA15010, Brampton, Ontario, Canada
Long-Term Specified Drug Use-Results Survey for Xtandi Capsule
- First Posted Date
- 2016-02-01
- Last Posted Date
- 2024-11-21
- Lead Sponsor
- Astellas Pharma Inc
- Target Recruit Count
- 1018
- Registration Number
- NCT02669771
Study of Enzalutamide With and Without Sorafenib in Advanced Hepatocellular Carcinoma Patients
- Conditions
- Interventions
- First Posted Date
- 2015-12-30
- Last Posted Date
- 2021-03-05
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 28
- Registration Number
- NCT02642913
- Locations
- 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸Roswell Park Cancer Institute, Buffalo, New York, United States
🇺🇸Washington University School of Medicine, Saint Louis, Missouri, United States
Investigation of Metformin in Patients With Castration Resistant Prostate Cancer in Combination With Enzalutamide vs. Enzalutamide Alone
- Conditions
- Interventions
- First Posted Date
- 2015-12-29
- Last Posted Date
- 2023-06-27
- Lead Sponsor
- Swiss Group for Clinical Cancer Research
- Target Recruit Count
- 169
- Registration Number
- NCT02640534
- Locations
- 🇨🇭
Hôpital du Valais, Sion, Switzerland
🇨🇭UniversitätsSpital Zürich, Zürich, Switzerland
🇨🇭Spital Thurgau AG, Frauenfeld, Switzerland
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5829 (Alobresib) as a Single Agent and In Combination With Enzalutamide in Participants With Metastatic Castrate-Resistant Prostate Cancer
- Conditions
- Interventions
- First Posted Date
- 2015-11-17
- Last Posted Date
- 2020-12-08
- Lead Sponsor
- Gilead Sciences
- Target Recruit Count
- 31
- Registration Number
- NCT02607228
Enzalutamide for Bladder Cancer Chemoprevention
- First Posted Date
- 2015-11-16
- Last Posted Date
- 2018-10-03
- Lead Sponsor
- University of Rochester
- Target Recruit Count
- 1
- Registration Number
- NCT02605863
- Locations
- 🇺🇸
University of Rochester, Rochester, New York, United States
Biomarker-Driven Therapy With Nivolumab and Ipilimumab in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Expressing AR-V7
- Conditions
- Interventions
- First Posted Date
- 2015-11-10
- Last Posted Date
- 2022-02-03
- Target Recruit Count
- 32
- Registration Number
- NCT02601014
- Locations
- 🇺🇸
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Drug Development Updates
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