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
-
Clinical Trials
Related News

A Study Evaluating Enzalutamide Pharmacokinetics and Pharmacodynamics, and Related Changes After Drug Switch

First Posted Date
2018-12-19
Last Posted Date
2020-11-03
Lead Sponsor
Hinova Pharmaceuticals Inc.
Target Recruit Count
10
Registration Number
NCT03778047
Locations
🇨🇳

Medical Ethics Committee of Hunan Cancer Hospital, Changsha, China

A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study

First Posted Date
2018-12-07
Last Posted Date
2024-12-20
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
1000
Registration Number
NCT03768063
Locations
🇺🇸

Univ of Alabama at Birmingham; UAB Comprehensive Cancer Ctr, Birmingham, Alabama, United States

🇺🇸

HonorHealth Research Institute - Pima - Virginia G. Piper Cancer Care Network, Scottsdale, Arizona, United States

🇺🇸

University of Arkansas for Medical Sciences; Winthrop Rockefeller Cancer Institute, Little Rock, Arkansas, United States

and more 199 locations

Neoadjuvant Pembrolizumab Plus Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer

First Posted Date
2018-11-26
Last Posted Date
2022-04-20
Lead Sponsor
Mark Garzotto, MD
Target Recruit Count
32
Registration Number
NCT03753243
Locations
🇺🇸

VA Portland Healthcare System, Portland, Oregon, United States

Enzalutamide With Venetoclax in Treating Patients With Metastatic Castration Resistant Prostate Cancer

First Posted Date
2018-11-23
Last Posted Date
2023-10-16
Lead Sponsor
Roswell Park Cancer Institute
Target Recruit Count
10
Registration Number
NCT03751436
Locations
🇺🇸

Roswell Park Cancer Institute, Buffalo, New York, United States

Enzalutamide and Decitabine in Treating Patients With Metastatic Castration Resistant Prostate Cancer

First Posted Date
2018-10-17
Last Posted Date
2022-10-05
Lead Sponsor
Roswell Park Cancer Institute
Registration Number
NCT03709550
Locations
🇺🇸

Roswell Park Cancer Institute, Buffalo, New York, United States

Imaging Study to Compare Effects of Darolutamide and Enzalutamide With Respect to Placebo on the Blood Flow in the Brain in Healthy Male Volunteers.

First Posted Date
2018-10-12
Last Posted Date
2020-10-30
Lead Sponsor
Bayer
Target Recruit Count
26
Registration Number
NCT03704519
Locations
🇬🇧

Centre for Neuroimaging Sciences, King's College, London, United Kingdom

Biomarker Analysis of Castration-resistant Prostate Cancer Undergoing Treatment With Docetaxel Followed by Enzalutamide

First Posted Date
2018-10-09
Last Posted Date
2024-04-15
Lead Sponsor
Instituto do Cancer do Estado de São Paulo
Target Recruit Count
30
Registration Number
NCT03700099
Locations
🇧🇷

Instituto do Câncer do Estado de São Paulo, São Paulo, SP, Brazil

PF-06952229 Treatment in Adult Patients With Advanced Solid Tumors

First Posted Date
2018-09-26
Last Posted Date
2024-06-26
Lead Sponsor
Pfizer
Target Recruit Count
49
Registration Number
NCT03685591
Locations
🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

The Sarah Cannon Research Institute / Tennessee Oncology, PLLC, Nashville, Tennessee, United States

🇺🇸

Tennessee Oncology, PLLC, Nashville, Tennessee, United States

and more 12 locations

Study of Drug 1 (Enzalutamide) Plus Drug 2 (Relacorilant) for Patients With Prostate Cancer

Phase 1
Active, not recruiting
Conditions
Prostate Cancer
Interventions
Drug: Enzalutamide
Drug: Relacorilant
First Posted Date
2018-09-18
Last Posted Date
2024-07-31
Lead Sponsor
University of Chicago
Target Recruit Count
35
Registration Number
NCT03674814
Locations
🇺🇸

University Of Chicago Medicine Comprehensive Cancer Center, Chicago, Illinois, United States

A Safety and Efficacy Study of Enzalutamide in Indian Patients With Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated With Docetaxel-Based Chemotherapy

First Posted Date
2018-08-22
Last Posted Date
2024-11-15
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
52
Registration Number
NCT03641560
Locations
🇮🇳

Site IN00003, Nashik, India

🇮🇳

Site IN00002, Ahmedabad, India

🇮🇳

Site IN00008, Kolkata, India

and more 5 locations
© Copyright 2024. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy