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
-

Study to Evaluate CCS1477 in Advanced Tumours

First Posted Date
2018-06-26
Last Posted Date
2024-07-17
Lead Sponsor
CellCentric Ltd.
Target Recruit Count
350
Registration Number
NCT03568656
Locations
🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Thomas Jefferson University, Sidney Kimmel Cancer Center, Philadelphia, Pennsylvania, United States

🇺🇸

New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, New York, United States

and more 19 locations

Abiraterone With Discontinuation of Gonadotropin-Releasing Hormone Analogues in Metastatic Prostate Cancer

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2018-06-21
Last Posted Date
2022-09-26
Lead Sponsor
Montefiore Medical Center
Target Recruit Count
32
Registration Number
NCT03565835
Locations
🇺🇸

Montefiore Medical Center, Bronx, New York, United States

Androgen Reduction in Congenital Adrenal Hyperplasia

First Posted Date
2018-06-07
Last Posted Date
2023-02-01
Lead Sponsor
University of Texas Southwestern Medical Center
Registration Number
NCT03548246
Locations
🇺🇸

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

🇺🇸

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

🇺🇸

National Institutes of Health, Bethesda, Maryland, United States

and more 1 locations

Intermittent Androgen Deprivation Therapy for Stage IV Castration Sensitive Prostate Cancer

First Posted Date
2018-04-27
Last Posted Date
2024-11-28
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Target Recruit Count
17
Registration Number
NCT03511196
Locations
🇺🇸

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

Multi-arm Multi-modality Therapy for Very High Risk Localized and Low Volume Metastatic Prostatic Adenocarcinoma

First Posted Date
2018-02-19
Last Posted Date
2024-11-28
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
102
Registration Number
NCT03436654
Locations
🇺🇸

University of Chicago, Chicago, Illinois, United States

🇺🇸

Northwestern University, Evanston, Illinois, United States

🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

and more 8 locations

Study of TRC105 With Abiraterone and With Enzalutamide in Prostate Cancer Patients Progressing on Therapy

First Posted Date
2018-02-01
Last Posted Date
2020-12-30
Lead Sponsor
Cedars-Sinai Medical Center
Target Recruit Count
11
Registration Number
NCT03418324
Locations
🇺🇸

Cedars Sinai Medical Center, Los Angeles, California, United States

Abiraterone Acetate and Antiandrogen Therapy With or Without Cabazitaxel and Prednisone in Treating Patients With Metastatic, Castration-Resistant Prostate Cancer Previously Treated With Docetaxel

First Posted Date
2018-02-01
Last Posted Date
2024-11-01
Lead Sponsor
ECOG-ACRIN Cancer Research Group
Target Recruit Count
223
Registration Number
NCT03419234
Locations
🇺🇸

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States

🇺🇸

Richard L. Roudebush Veterans Affairs Medical Center, Indianapolis, Indiana, United States

🇺🇸

Sidney and Lois Eskenazi Hospital, Indianapolis, Indiana, United States

and more 668 locations
© Copyright 2024. All Rights Reserved by MedPath