Friday, July 10, 2026

Drug profile · INN

abiraterone

abiraterone (ABIRATERONE DR.REDDY''S) is a steroid 5-alpha-reductase inhibitor. Associated with Alphapharm Pty Ltd.

EMA: approved TGA: approved NMPA: clinical trials Antineoplastic and immunomodulating agents (L02) L02BX03
Patents linked 0
Pipeline programs 42
News articles 4
Drug details — abiraterone

Quick answer

abiraterone (ABIRATERONE DR.REDDY''S) is a steroid 5-alpha-reductase inhibitor. Associated with Alphapharm Pty Ltd.

Key facts

INN abiraterone
Brand ABIRATERONE DR.REDDY''S
Mechanism Steroid 5-alpha-reductase inhibitor
Target Androgen receptor
Therapeutic class Antineoplastic and immunomodulating agents (L02)
ATC code L02BX03

Mechanism of action

Steroid 5-alpha-reductase inhibitor

Primary target: Androgen receptor

Approval history

Authority Status Date
EMA approved
TGA approved
NMPA clinical trials

Recent coverage

FDA Approves Capivasertib for PTEN-Deficient Prostate Cancer
High impact Newsprostate cancerJun 15, 2026

FDA Approves Capivasertib for PTEN-Deficient Prostate Cancer

FDA · prostate cancer · 6 min

FDA Approves Capivasertib for PTEN-Deficient prostate cancer, expanding TRUQAP into a new oncology setting. The approval pairs capivasertib with abiraterone and prednisone for adults with PTEN-deficient metastatic androgen pathway modulation-naive or sensitive disease.

Dr. Sarah Mitchell
FDA approves capivasertib plus abiraterone and prednisone in PTEN-deficient mHSPC
High impact Newsprostate cancerJun 14, 2026

FDA approves capivasertib plus abiraterone and prednisone in PTEN-deficient mHSPC

FDA · prostate cancer · 6 min

The FDA approved capivasertib plus abiraterone and prednisone for adult patients with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive prostate cancer. The move creates a new catalyst for AstraZeneca’s Truqap and adds a biomarker-defined prostate cancer use to track.

Dr. Elena Rossi
Truqap gains US approval in PTEN-deficient metastatic prostate cancer
High impact Newsprostate cancerJun 13, 2026

Truqap gains US approval in PTEN-deficient metastatic prostate cancer

FDA · prostate cancer · 6 min

AstraZeneca’s Truqap (capivasertib) has been approved in the US with abiraterone and prednisone for PTEN-deficient metastatic prostate cancer. The move creates a first-in-class targeted option and a new catalyst to watch for BD teams, investors, and analysts.

Dr. Elena Rossi
FDA Advisory Committee Recommends AstraZeneca's TRUQAP for PTEN-Deficient Prostate Cancer
Critical impact NewsOncology - Prostate CancerMay 1, 2026

FDA Advisory Committee Recommends AstraZeneca's TRUQAP for PTEN-Deficient Prostate Cancer

FDA · Oncology - Prostate Cancer · 3 min

FDA Advisory Committee votes 7-1 to recommend AstraZeneca's TRUQAP (capivasertib) for PTEN-deficient metastatic hormone-sensitive prostate cancer patients.

James Chen, PharmD

Pipeline programs

  1. 20230005 Phase 3 · Amgen · Metastatic castration-resistant prostate cancer (mCRPC)
  2. 20230239 Phase 3 · Amgen · Metastatic castration-resistant prostate cancer (mCRPC)
  3. 56021927PCR3001 Phase 3 · Janssen-Cilag International N.V · Metastatic castration-resistant prostate cancer (mCRPC)
  4. 64091742PCR3001 Phase 3 · Janssen-Cilag International N.V · Metastatic Prostate Cancer
  5. 67652000PCR3002 Phase 3 · Janssen-Cilag International N.V · Deleterious Germline or Somatic Homologous Recombination Rep
  6. ARN-509-003 Phase 3 · Anaxis Pharma · Castration-Resistant Prostate Cancer
  7. Abiraterone - Usual Phase 3 · Lxo Ireland Designated · Prostate Cancer
  8. BX44273 Phase 3 · HOFFMANN-LA ROCHE · This is an extension study designed to provide continued tre

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)

Frequently asked questions

What is abiraterone?

abiraterone (ABIRATERONE DR.REDDY''S) is a steroid 5-alpha-reductase inhibitor. Associated with Alphapharm Pty Ltd.

What is the brand name for abiraterone?

ABIRATERONE DR.REDDY''S is a marketed brand name for abiraterone. Check FDA Drugs@FDA for the current US label holder and prescribing information.