Enzalutamide

Generic Name: Enzalutamide

Brand Names: Xtandi, Enzalutamide Viatris

Drug Type: Small Molecule

Chemical Formula: C_₂₁H_₁₆F_₄N_₄O_₂S

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)

Clinical Trials

Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC

Phase 3

Active, not recruiting

Conditions: Metastatic Prostate Cancer
Prostate Adenocarcinoma

Interventions: Drug: Abiraterone Acetate
Drug: Cabozantinib
Drug: Enzalutamide
Drug: Atezolizumab
Drug: Prednisone

First Posted Date: 2020-06-24

Last Posted Date: 2024-11-25

Lead Sponsor: Exelixis

Target Recruit Count: 575

Registration Number: NCT04446117

Locations: 🇺🇸
Exelixis Clinical Site #6, Baltimore, Maryland, United States
🇺🇸
Exelixis Clinical Site #18, Philadelphia, Pennsylvania, United States
🇵🇱
Exelixis Clinical Site #243, Otwock, Mazowieckie, Poland

and more 275 locations

Enzalutamide With Lu PSMA-617 Versus Enzalutamide Alone in Men With Metastatic Castration-resistant Prostate Cancer

Phase 2

Active, not recruiting

Conditions: Metastatic Castration-Resistant Prostate Cancer

Interventions: Drug: Lu-PSMA
Drug: Enzalutamide

First Posted Date: 2020-06-05

Last Posted Date: 2024-02-07

Lead Sponsor: Australian and New Zealand Urogenital and Prostate Cancer Trials Group

Target Recruit Count: 162

Registration Number: NCT04419402

Locations: 🇦🇺
St George Hospital, Kogarah, New South Wales, Australia
🇦🇺
Calvary Mater Newcastle, Newcastle, New South Wales, Australia
🇦🇺
The Alfred Hospital, Melbourne, Victoria, Australia

and more 12 locations

Patient Preference of Apalutamide Versus Enzalutamide in Patients With Recurrent or Metastatic Hormone-Sensitive Prostate Cancer

Phase 3

Terminated

Conditions: Prostate Cancer

Interventions: Drug: Apalutamide
Drug: Enzalutamide

First Posted Date: 2020-06-01

Last Posted Date: 2024-01-05

Lead Sponsor: Chinese University of Hong Kong

Target Recruit Count: 74

Registration Number: NCT04409288

Locations: 🇭🇰
Prince of Wales Hospital, Shatin, Hong Kong

Adenosine Receptor Antagonist Combination Therapy for Metastatic Castrate Resistant Prostate Cancer

Phase 1

Active, not recruiting

Conditions: Androgen-Resistant Prostatic Neoplasms
Castration Resistant Prostatic Neoplasms
Prostatic Neoplasms, Castration-Resistant
Prostatic Cancer, Castration-Resistant

Interventions: Drug: Etrumadenant
Drug: Zimberelimab
Drug: Quemliclustat
Drug: SG
Drug: Docetaxel
Drug: Enzalutamide

First Posted Date: 2020-05-11

Last Posted Date: 2024-06-03

Lead Sponsor: Arcus Biosciences, Inc.

Target Recruit Count: 173

Registration Number: NCT04381832

Locations: 🇺🇸
Florida Cancer Specialists East, West Palm Beach, Florida, United States
🇺🇸
The Oncology Institute of Hope & Innovation, Cerritos, California, United States
🇺🇸
The University of California, Los Angeles, Encino, California, United States

and more 16 locations

Sequential Testosterone and Enzalutamide Prevents Unfavorable Progression

Phase 2

Recruiting

Conditions: Castration Resistant Metastatic Prostate Cancer

Interventions: Drug: Enzalutamide
Drug: Testosterone cypionate
Drug: Testosterone enanthate

First Posted Date: 2020-04-27

Last Posted Date: 2025-01-06

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 150

Registration Number: NCT04363164

Locations: 🇺🇸
Dana-Faber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
University of Washington/Fred Hutchinson Cancer Center, Seattle, Washington, United States
🇺🇸
University of Nebraska Medical Center, Omaha, Nebraska, United States

and more 3 locations

Androgen Receptor Directed Therapy on Cognitive Function in Patients Treated With Darolutamide or Enzalutamide

Phase 2

Active, not recruiting

Conditions: Hormone Sensitive Prostate Cancer
Prostate Cancer Metastatic
Non-metastatic Prostate Cancer
Metastatic Prostate Cancer
Prostate Cancer
Castrate Resistant Prostate Cancer

Interventions: Drug: Darolutamide
Drug: Enzalutamide

First Posted Date: 2020-04-06

Last Posted Date: 2025-05-01

Lead Sponsor: Alliance Foundation Trials, LLC.

Target Recruit Count: 111

Registration Number: NCT04335682

Locations: 🇺🇸
University of California - San Francisco at Mount Zion, San Francisco, California, United States
🇺🇸
Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States
🇺🇸
University of Chicago, Chicago, Illinois, United States

and more 5 locations

Enzalutamide Plus Talazoparib for the Treatment of Hormone Sensitive Prostate Cancer (ZZ-First)

Phase 2

Completed

Conditions: Metastatic Prostate Cancer

Interventions: Drug: Enzalutamide
Drug: Talazoparib

First Posted Date: 2020-04-03

Last Posted Date: 2025-05-11

Lead Sponsor: MedSIR

Target Recruit Count: 54

Registration Number: NCT04332744

Locations: 🇪🇸
Hospital Universitario Virgen de la Victoria, Málaga, Spain
🇪🇸
Instituto Valenciano de Oncología (IVO), Valencia, Spain
🇪🇸
Institut Català d'Oncologia Badalona, Badalona, Spain

and more 5 locations

a Vigibase Pharmacovigilance Study of ENzalutamide Drug-induced neurotoxicitY

Completed

Conditions: Neuropathy
Prostate Cancer
Epilepsy
Encephalopathy

Interventions: Drug: Enzalutamide

First Posted Date: 2020-03-02

Last Posted Date: 2023-04-13

Lead Sponsor: Groupe Hospitalier Pitie-Salpetriere

Target Recruit Count: 500000

Registration Number: NCT04290611

Locations: 🇫🇷
Centre d'Investigation Clinique Hôpital Pitié-Salpêtrière, Paris, France

Study of Abiraterone Acetate or Enzalutamide, Atezolizumab, GnRH Analog and Radiation Therapy in Men With Newly Diagnosed Hormone-sensitive Prostate Cancer

Phase 2

Active, not recruiting

Conditions: Metastatic Prostate Cancer

Interventions: Drug: Atezolizumab
Drug: Abiraterone
Drug: Prednisone
Drug: GnRH analog
Radiation: Stereotactic Body Radiotherapy (SBRT)
Drug: Enzalutamide
Other: Follow up

First Posted Date: 2020-02-10

Last Posted Date: 2025-04-27

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 28

Registration Number: NCT04262154

Locations: 🇺🇸
Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale, New York, United States
🇺🇸
Memorial Sloan Kettering Cancer Commack (Limited Protocol Activities), Commack, New York, United States
🇺🇸
Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison, New York, United States

and more 5 locations

A Study Comparing ARB With Radium-223 vs ARB Therapy With Placebo and the Effect Upon Survival for mCRPC Patients

Phase 3

Terminated

Conditions: Metastatic Castration-resistant Prostate Cancer

Interventions: Drug: Enzalutamide during Lead-in Period
Drug: Lead-in Enzalutamide followed by Placebo/Enzalutamide
Drug: Darolutamide during Lead-in Period
Drug: Lead-in Darolutamide followed by Placebo/Darolutamide
Drug: Lead-in Enzalutamide followed by Radium-223/Enzalutamide
Drug: Lead-in Darolutamide followed by Radium-223/Darolutamide

First Posted Date: 2020-01-23

Last Posted Date: 2022-10-07

Lead Sponsor: MANA RBM

Target Recruit Count: 23

Registration Number: NCT04237584

Locations: 🇺🇸
Research Site, Myrtle Beach, South Carolina, United States

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