Thursday, July 9, 2026

Drug profile · INN

abiraterone acetate

abiraterone acetate (ABIRATERONE KRKA) is a cytochrome p450 17a1 inhibitor. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved Antineoplastic and immunomodulating agents (L02) L02BX03
US status approved
Patents linked 20
Pipeline programs 23
News articles 1
Drug details — abiraterone acetate
US status
approved
Class
Antineoplastic and immunomodulating agents (L02)
Route
ORAL
Patents
20
Programs
23
Data quality
0.89

Quick answer

abiraterone acetate (ABIRATERONE KRKA) is a cytochrome p450 17a1 inhibitor. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN abiraterone acetate
Brand ABIRATERONE KRKA
Mechanism Cytochrome P450 17A1 inhibitor
Target Steroid 17-alpha-hydroxylase/17,20 lyase
Therapeutic class Antineoplastic and immunomodulating agents (L02)
Route ORAL
Formulation TABLET
ATC code L02BX03

Mechanism of action

Cytochrome P450 17A1 inhibitor

Primary target: Steroid 17-alpha-hydroxylase/17,20 lyase

Approval history

Authority Status Date
FDA approved
EMA approved

Recent coverage

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. CAAA617B12302 Phase 3 · Novartis India · PSMA-positive metastatic castration-resistant prostate cance
  8. D361BC00001 Phase 3 · AstraZeneca · Metastatic Hormone-sensitive Prostate Cancer Characterised b

Related & competitor drugs

  1. anagrelide Antineoplastic and immunomodulating agents (L01)
  2. apremilast Antineoplastic and immunomodulating agents (L04)
  3. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  4. axitinib Antineoplastic and immunomodulating agents (L01)
  5. azacitidine Antineoplastic and immunomodulating agents (L01)
  6. azathioprine Antineoplastic and immunomodulating agents (L04)
  1. WO 2026112486

    MÉTHODES DE TRAITEMENT DE L'OBÉSITÉ ET DES AFFECTIONS LIÉES À L'OBÉSITÉ

    Expires Wed May 23 2046 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. WO 2026102199

    THÉRAPIE COMBINÉE D'UN INHIBITEUR DE PRMT5 ET DU DARAXONRASIB POUR UTILISATION DANS LE TRAITEMENT DU CANCER MTAP-NUL

    Expires Thu May 10 2046 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. WO 2026072909

    PROTÉINES DE LIAISON À FLT1 ET MÉTHODES D'UTILISATION

    Expires Wed Mar 28 2046 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. WO 2026055477

    COMPOSÉS MACROCYCLIQUES CONSTITUANT DES MODULATEURS DE KRAS ET LEURS UTILISATIONS

    Expires Wed Mar 07 2046 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. WO 2026039321

    MÉTHODES DE TRAITEMENT DU CANCER DE LA PROSTATE

    Expires Wed Feb 14 2046 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. WO 2026020076

    MÉTHODE DE TRAITEMENT DU PRURIGO NODULAIRE

    Expires Wed Jan 17 2046 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. WO 2026006398

    RÉDUCTASES D'IMINE MODIFIÉES ET LEURS PROCÉDÉS D'UTILISATION

    Expires Thu Dec 28 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. WO 2026006805

    COMPOSÉS À NOYAU À 6 CHAÎNONS UTILISÉS COMME MODULATEURS DE L'HÉLICASE À ADN RECQ DU SYNDROME DE WERNER ET LEURS UTILISATIONS

    Expires Thu Dec 28 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. WO 2026006803

    COMPOSÉS À NOYAU À 5 CHAÎNONS UTILISÉS EN TANT QUE MODULATEURS DE L'HÉLICASE D'ADN RECQ DU SYNDROME DE WERNER ET LEURS UTILISATIONS

    Expires Thu Dec 28 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  10. WO 2025265110

    COMPOSITIONS PHARMACEUTIQUES ORALES RENFERMANT UN COMPOSÉ DE NAPHTYRIDINE

    Expires Thu Dec 21 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  11. WO 2025260042

    CONSTRUCTIONS D'ARNI ET PROCÉDÉS D'INHIBITION DE L'EXPRESSION DE CNR1

    Expires Wed Dec 13 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  12. WO 2025259749

    FRAGMENTS VARIABLES À CHAÎNE UNIQUE STABLES

    Expires Wed Dec 13 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  13. WO 2025259515

    POLYTHÉRAPIE

    Expires Wed Dec 13 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  14. WO 2025250569

    TRAITEMENTS DU CANCER UTILISANT DES INHIBITEURS DE PRMT5 MTA-COOPÉRATIFS ET DES INHIBITEURS DE MAT2A

    Expires Wed Nov 29 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  15. WO 2025230878

    COMPOSÉS MACROCYCLIQUES UTILISÉS EN TANT QUE MODULATEURS DE KRAS ET LEURS UTILISATIONS

    Expires Wed Nov 01 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  16. WO 2025230862

    COMPOSÉS AMINÉS MACROCYCLIQUES UTILISÉS EN TANT QUE MODULATEURS DE KRAS ET LEURS UTILISATIONS

    Expires Wed Nov 01 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  17. WO 2025230860

    FORMES SOLIDES DE COMPOSÉS MACROCYCLIQUES ET LEURS UTILISATIONS

    Expires Wed Nov 01 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  18. US 2025333381

    SOLID STATE FORMS

    Expires Wed Oct 25 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  19. US 12427137

    Method for reducing methane production in animal stomach

    Expires Mon Sep 25 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  20. US 12389931

    Oyster peptide with effect of improving sexual function and preparation method thereof

    Expires Mon Aug 14 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is abiraterone acetate?

abiraterone acetate (ABIRATERONE KRKA) is a cytochrome p450 17a1 inhibitor. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for abiraterone acetate?

ABIRATERONE KRKA is a marketed brand name for abiraterone acetate. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of abiraterone acetate?

abiraterone acetate has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.