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)
Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC
- Conditions
- Prostate Cancer
- Interventions
- First Posted Date
- 2021-03-29
- Last Posted Date
- 2025-05-13
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 599
- Registration Number
- NCT04821622
- Locations
- 🇭🇺
Jahn Ferenc Del-pesti Korhaz es Rendelointezet, Budapest, Hungary
🇮🇳Indraprastha Apollo Hospital, New Delhi, Delhi, India
🇮🇳Bhaktivedanta Hospital and Research Institute, Mumbai, Thane, Maharashtra, India
Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer
- Conditions
- Recurrent Prostate CancerProstate CancerOligometastasisOligorecurrenceDe Novo Prostate CancerMetastatic Prostate Cancer
- Interventions
- Procedure: PET-directed Local Therapy using SurgeryRadiation: PET-directed Local Therapy using RadiationOther: Salvage Local Therapy for locally recurrent diseaseRadiation: Prostate-directed Radiation for De novo oligometastatic prostate cancer
- First Posted Date
- 2021-03-09
- Last Posted Date
- 2025-01-07
- Lead Sponsor
- VA Office of Research and Development
- Target Recruit Count
- 464
- Registration Number
- NCT04787744
- Locations
- 🇺🇸
VA Long Beach Healthcare System, Long Beach, CA, Long Beach, California, United States
🇺🇸VA Greater Los Angeles Healthcare System, West Los Angeles, CA, West Los Angeles, California, United States
🇺🇸Bay Pines VA Healthcare System, Pay Pines, FL, Bay Pines, Florida, United States
Open-label, Multicenter Study of Intramuscular PRL-02 Depot in Patients With Advanced Prostate Cancer
- Conditions
- Prostate CancerMetastatic Castration Resistant Prostate CancerMetastatic Castration-sensitive Prostate Cancer
- Interventions
- First Posted Date
- 2021-01-28
- Last Posted Date
- 2025-03-20
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 100
- Registration Number
- NCT04729114
- Locations
- 🇺🇸
Florida Urology Partners, Tampa, Florida, United States
🇺🇸Fort Wayne Medical Oncology and Hematology, Inc., Fort Wayne, Indiana, United States
🇺🇸First Urology, Jeffersonville, Indiana, United States
Detecting Metastases by PyL PET/CT in Subjects Starting Enzalutamide for Untreated Castration Resistant Prostate Cancer.
- First Posted Date
- 2020-12-07
- Last Posted Date
- 2025-05-15
- Lead Sponsor
- CHU de Quebec-Universite Laval
- Target Recruit Count
- 50
- Registration Number
- NCT04655365
- Locations
- 🇨🇦
CHUM, Montréal, Quebec, Canada
🇨🇦CUSM, Montréal, Quebec, Canada
🇨🇦CIUSSS de l'Estrie - CHUS, Sherbrooke, Quebec, Canada
Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment
- Conditions
- Metastatic Castration-Resistant Prostate Cancer
- Interventions
- First Posted Date
- 2020-12-01
- Last Posted Date
- 2024-11-01
- Lead Sponsor
- POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company
- Target Recruit Count
- 415
- Registration Number
- NCT04647526
- Locations
- 🇺🇸
VA Greater Los Angeles Healthcare System, Los Angeles, California, United States
🇺🇸Greater Dayton Cancer Center, Kettering, Ohio, United States
🇺🇸Perelman Center for Advanced Medicine, Philadelphia, Pennsylvania, United States
Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC)
- Conditions
- Metastatic Castration-resistant Prostate Cancer
- Interventions
- First Posted Date
- 2020-11-17
- Last Posted Date
- 2024-08-29
- Lead Sponsor
- Amgen
- Target Recruit Count
- 65
- Registration Number
- NCT04631601
- Locations
- 🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸University of California at Irvine Medical Center, Orange, California, United States
🇺🇸University of California San Francisco Mission Bay Campus, San Francisco, California, United States
Enzalutamide Treatment in COVID-19
- First Posted Date
- 2020-07-17
- Last Posted Date
- 2022-06-02
- Lead Sponsor
- Andreas Josefsson
- Target Recruit Count
- 42
- Registration Number
- NCT04475601
- Locations
- 🇸🇪
Linköping University Hospital, Linköping, Sweden
🇸🇪Sundsvall Region Hosptial, Sundsvall, Sweden
🇸🇪Anders Bjartell, Malmö, Skåne, Sweden
ZEN-3694, Enzalutamide, and Pembrolizumab for the Treatment of Metastatic Castration-Resistant Prostate Cancer
- Conditions
- Castration-Resistant Prostate CarcinomaMetastatic Prostate AdenocarcinomaMetastatic Prostate Small Cell CarcinomaStage IV Prostate Cancer AJCC v8Stage IVA Prostate Cancer AJCC v8Stage IVB Prostate Cancer AJCC v8
- Interventions
- First Posted Date
- 2020-07-15
- Last Posted Date
- 2025-05-13
- Lead Sponsor
- Rahul Aggarwal
- Target Recruit Count
- 54
- Registration Number
- NCT04471974
- Locations
- 🇺🇸
University of California, San Francisco, San Francisco, California, United States
🇺🇸University of Chicago, Evergreen Park, Illinois, United States
🇺🇸University of Michigan, Ann Arbor, Michigan, United States
Randomized Open Label Phase II Study to Evaluate the Efficacy of Enzalutamide in High Risk Male Outpatients With COVID-1
- First Posted Date
- 2020-07-02
- Last Posted Date
- 2022-08-10
- Lead Sponsor
- Ricardo Pereira Mestre
- Target Recruit Count
- 7
- Registration Number
- NCT04456049
- Locations
- 🇨🇭
Oncology Institute of Southern Switzerland (IOSI), Bellinzona, Switzerland
A Clinical Study Evaluating the Benefit of Adding Rucaparib to Enzalutamide for Men with Metastatic Prostate Cancer That Has Become Resistant to Testosterone-Deprivation Therapy
- Conditions
- Castration-Resistant Prostate CarcinomaMetastatic Prostate AdenocarcinomaStage IV Prostate Cancer AJCC V8Stage IVA Prostate Cancer AJCC V8Stage IVB Prostate Cancer AJCC V8
- Interventions
- Drug: PlaceboOther: Quality-of-Life AssessmentOther: Questionnaire Administration
- First Posted Date
- 2020-07-02
- Last Posted Date
- 2025-01-15
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Target Recruit Count
- 61
- Registration Number
- NCT04455750
- Locations
- 🇺🇸
Anchorage Associates in Radiation Medicine, Anchorage, Alaska, United States
🇺🇸Anchorage Oncology Centre, Anchorage, Alaska, United States
🇺🇸Providence Alaska Medical Center, Anchorage, Alaska, United States
Drug Development Updates
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