Abiraterone

Generic Name
Abiraterone
Brand Names
Yonsa, Zytiga, Abiraterone Krka, Abiraterone Accord, Abiraterone Mylan
Drug Type
Small Molecule
Chemical Formula
C24H31NO
CAS Number
154229-19-3
Unique Ingredient Identifier
G819A456D0
Background

Abiraterone is a potent, irreversible, and selective inhibitor of 17 αhydroxylase/C17,20-lyase (CYP17), an enzyme expressed in testicular, adrenal, and prostatic tumour tissues, to regulate androgen biosynthesis. Abiraterone was first approved by the FDA and EMA on April, July, and September 2011, respectively. It is used to treat metastatic castration-resistant prostate cancer and hormone-sensitive high-risk metastatic prostate cancer.

As abiraterone has poor oral bioavailability and is susceptible to hydrolysis by esterases, abiraterone acetate was developed as an orally bioavailable prodrug with enhanced stability and absorption.

Indication

Abiraterone is indicated for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in combination with methylprednisolone or prednisone.

In Europe and Canada, it is also used in patients with mCRPC who are asymptomatic or mildly symptomatic after the failure of androgen deprivation therapy for whom chemotherapy is not yet clinically indicated. In Europe, it is used in patients whose disease has progressed on or after a docetaxel-based chemotherapy regimen. In Canada, it is used in patients who have received prior chemotherapy containing docetaxel after the failure of androgen deprivation therapy.

Abiraterone is indicated in combination with prednisone for the treatment of metastatic high-risk castration-sensitive prostate cancer (CSPC). In Europe and Canada, it may also be used in combination with prednisolone and androgen deprivation therapy in newly diagnosed patients.

In Canada and the US, abiraterone is also available in a combination product with niraparib, which is indicated with prednisone for the treatment of adults with deleterious or suspected deleterious BRCA-mutated (BRCAm) mCRPC. In Canada, this combination product is also used with prednisolone and is reserved for patients who are asymptomatic or mildly symptomatic, and in whom chemotherapy is not clinically indicated.

Associated Conditions
Metastatic Castration Sensitive Prostate Cancer (mCSPC), Metastatic Castration-Resistant Prostate Cancer (mCRPC), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Associated Therapies
-

AASUR in High Risk Prostate Cancer

First Posted Date
2016-05-13
Last Posted Date
2024-05-21
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
64
Registration Number
NCT02772588
Locations
🇺🇸

John Hopkins Medical Center, Baltimore, Maryland, United States

🇺🇸

Memorial Sloan Kettering Commack, Commack, New York, United States

🇺🇸

Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States

and more 8 locations

Denosumab Plus Enzalutamide, Abiraterone and Prednisone Compared to Denosumab Plus Enzalutamide Alone for Men With Castrate Resistant Prostate Cancer (CRPC) With Bone Metastases

First Posted Date
2016-05-02
Last Posted Date
2019-11-08
Lead Sponsor
University of Hawaii
Target Recruit Count
1
Registration Number
NCT02758132
Locations
🇺🇸

University of Hawaii Cancer Center, Honolulu, Hawaii, United States

Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies

First Posted Date
2016-03-17
Last Posted Date
2022-04-28
Lead Sponsor
Incyte Corporation
Target Recruit Count
137
Registration Number
NCT02711137
Locations
🇺🇸

Yale University, New Haven, Connecticut, United States

🇺🇸

Hematology - Oncology Associates of Treasure Coast, Port Saint Lucie, Florida, United States

🇺🇸

The Methodist Hospital, Houston, Texas, United States

and more 15 locations

Abiraterone Acetate, Prednisone, and Apalutamide With or Without Ipilimumab or Cabazitaxel and Carboplatin in Treating Patients With Metastatic Castration-Resistant Prostate Cancer

First Posted Date
2016-03-09
Last Posted Date
2024-11-28
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
196
Registration Number
NCT02703623
Locations
🇺🇸

MD Anderson in Katy, Houston, Texas, United States

🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

🇺🇸

MD Anderson in Sugar Land, Sugar Land, Texas, United States

Abiraterone-Rechallenge Study for CRPC Patients

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2016-01-15
Last Posted Date
2017-03-24
Lead Sponsor
Aurelius Omlin
Target Recruit Count
4
Registration Number
NCT02656615
Locations
🇨🇭

Cantonal Hospital St.Gallen, St.Gallen, Switzerland

🇨🇭

Cantonal Hospital Chur, Chur, Graubuenden, Switzerland

🇨🇭

University Hospital Basel, Basel, Switzerland

Androgen Reduction in Congenital Adrenal Hyperplasia, Phase 1

Phase 1
Suspended
Conditions
Interventions
First Posted Date
2015-10-14
Last Posted Date
2024-03-13
Lead Sponsor
University of Texas Southwestern Medical Center
Target Recruit Count
36
Registration Number
NCT02574910
Locations
🇺🇸

Children's Hospital of Los Angeles, Los Angeles, California, United States

🇺🇸

Children's Medical Center, Dallas, Texas, United States

🇺🇸

National Institutes of Health, Bethesda, Maryland, United States

and more 1 locations

Cabazitaxel Versus the Switch to Alternative AR-targeted Agent (Enzalutamide or Abiraterone) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Patients Previously Treated With Docetaxel and Who Rapidly Failed a Prior AR-targeted Agent

First Posted Date
2015-06-30
Last Posted Date
2022-05-27
Lead Sponsor
Sanofi
Target Recruit Count
255
Registration Number
NCT02485691
Locations
🇧🇪

Investigational Site Number 056007, Brussels, Belgium

🇧🇪

Investigational Site Number 056005, Leuven, Belgium

🇫🇷

Investigational Site Number 250010, Clermont Ferrand, France

and more 62 locations

Adaptive Abiraterone Therapy for Metastatic Castration Resistant Prostate Cancer

Early Phase 1
Active, not recruiting
Conditions
Interventions
First Posted Date
2015-04-14
Last Posted Date
2024-11-27
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Target Recruit Count
19
Registration Number
NCT02415621
Locations
🇺🇸

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

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