Wednesday, July 8, 2026

Drug profile · INN

enzalutamide

enzalutamide (XTANDI) is a androgen receptor antagonist. Associated with Astellas Pharma Inc. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Antineoplastic and immunomodulating agents (L02) L02BB04
US status approved
Patents linked 20
Pipeline programs 46
News articles 1
Drug details — enzalutamide
US status
approved
Class
Antineoplastic and immunomodulating agents (L02)
Route
ORAL
Patents
20
Programs
46
Data quality
0.84

Quick answer

enzalutamide (XTANDI) is a androgen receptor antagonist. Associated with Astellas Pharma Inc. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN enzalutamide
Brand XTANDI
Mechanism Androgen Receptor antagonist
Target Androgen receptor
Therapeutic class Antineoplastic and immunomodulating agents (L02)
Route ORAL
Formulation CAPSULE
ATC code L02BB04

Mechanism of action

Androgen Receptor antagonist

Primary target: Androgen receptor

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Recent coverage

Pipeline programs

  1. 20230005 Phase 3 · Amgen · Metastatic castration-resistant prostate cancer (mCRPC)
  2. C2321003 Phase 3 · First Biotech (Australia) · METASTATIC CASTRATION RESISTANT PROSTATE CANCER
  3. C2321008 Phase 3 · First Biotech (Australia) · METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER
  4. C2321014 Phase 3 · First Biotech (Australia) · METASTATIC CASTRATION RESISTANT PROSTATE CANCER
  5. C3441021 Phase 3 · First Biotech (Australia) · Metastatic Castration-resistant Prostate Cancer
  6. C3441052 Phase 3 · First Biotech (Australia) · Metastatic Castration-sensitive Prostate Cancer
  7. CA071-1000 Phase 3 · Celgene · Metastatic Castration-resistant Prostate Cancer (mCRPC)
  8. CAAA617B12302 Phase 3 · Novartis India · PSMA-positive metastatic castration-resistant prostate cance

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)
  1. WO 2026100645

    MÉTHODES DE TRAITEMENT DES SYMPTÔMES VASOMOTEURS CHEZ DES PATIENTES ATTEINTES DE CANCER DU SEIN AVEC LE FÉZOLINÉTANT

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

    granted
  2. WO 2026078619

    ASSOCIATION DE TALAZOPARIB ET D'ENZALUTAMIDE DANS LE TRAITEMENT DU CANCER DE LA PROSTATE MÉTASTATIQUE RÉSISTANT À LA CASTRATION

    Expires Wed Apr 11 2046 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. WO 2026078615

    ASSOCIATION DE TALAZOPARIB ET D'ENZALUTAMIDE DANS LE TRAITEMENT DU CANCER DE LA PROSTATE MÉTASTATIQUE RÉSISTANT À LA CASTRATION

    Expires Wed Apr 11 2046 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. WO 2026033885

    POLYTHÉRAPIE FAISANT INTERVENIR DES AGENTS DE LIAISON BISPÉCIFIQUES SE LIANT À CLDN18.2 ET CD3 ET AGENTS STABILISANT OU AUGMENTANT L'EXPRESSION DE CLDN18.2

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

    granted
  5. WO 2025207099

    INHIBITEURS DE PPAR-DELTA POUR PRÉVENIR UNE FIBRILLATION AURICULAIRE POST-OPÉRATOIRE

    Expires Wed Sep 27 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. AR 133027

    COMPOSICIÓN FARMACÉUTICA QUE COMPRENDE UN COMPUESTO DE QUINAZOLINA

    Expires Tue Aug 15 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. WO 2025159142

    COMPOSÉ HÉTÉROCYCLIQUE POUR INDUIRE LA DÉGRADATION DE LA PROTÉINE KRAS

    Expires Wed Jul 26 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. WO 2025143118

    COMPOSITION PHARMACEUTIQUE POUR LE TRAITEMENT D'UNE LÉSION DE LA MOELLE ÉPINIÈRE ET PROCÉDÉ DE PRODUCTION D'UN MODÈLE ANIMAL DE PRIMATE NON HUMAIN POUR UNE LÉSION DE LA MOELLE ÉPINIÈRE

    Expires Wed Jun 28 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. WO 2025120866

    POLYTHÉRAPIE IMPLIQUANT DES AGENTS DE LIAISON BISPÉCIFIQUES SE LIANT À CLDN18.2 ET CD3 ET AGENTS STABILISANT OU AUGMENTANT L'EXPRESSION DE CLDN18.2

    Expires Wed Jun 07 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  10. WO 2025121445

    POLYTHÉRAPIE IMPLIQUANT DES AGENTS DE LIAISON BISPÉCIFIQUES SE LIANT À CLDN18.2 ET CD3 ET AGENTS STABILISANT OU AUGMENTANT L'EXPRESSION DE CLDN18.2

    Expires Wed Jun 07 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  11. WO 2025047847

    VARIANT DE RÉGION Fc

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

    granted
  12. WO 2025018295

    BACTÉRIOPHAGE MODIFIÉ

    Expires Wed Jan 18 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  13. WO 2024261256

    COMPOSITION PHARMACEUTIQUE COMPRENANT UN AGENT DE DÉGRADATION PAN-KRAS

    Expires Wed Dec 21 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  14. WO 2024219427

    PROCÉDÉ DE PRODUCTION DE LYMPHOCYTES INNÉS DE TYPE 2

    Expires Wed Oct 19 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  15. WO 2024162304

    LIPIDE CARBAMOYLE OU LIPIDE D'URÉE AYANT CHACUN UNE AMINE CYCLIQUE, NANOPARTICULES LIPIDIQUES LE CONTENANT ET COMPOSITION PHARMACEUTIQUE

    Expires Wed Aug 03 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  16. WO 2024141977

    CELLULES TUEUSES NATURELLES MODIFIÉES ET PROCÉDÉS ASSOCIÉS

    Expires Wed Jun 29 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  17. US 11666528

    Drug implants containing enzalutamide and methods of use thereof

    Expires Mon Jun 01 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  18. US 9126941

    Treatment of hyperproliferative disorders with diarylhydantoin compounds

    Expires Mon Sep 03 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  19. US 8183274

    Treatment of hyperproliferative disorders with diarylhydantoin compounds

    Expires Mon May 17 2032 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  20. US 7709517

    Diarylhydantoin compounds

    Expires Mon Apr 29 2030 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is enzalutamide?

enzalutamide (XTANDI) is a androgen receptor antagonist. Associated with Astellas Pharma Inc. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for enzalutamide?

XTANDI is a marketed brand name for enzalutamide. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of enzalutamide?

enzalutamide 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.