Wednesday, July 8, 2026
🇺🇸 FDA

Drug profile · INN

apalutamide

ERLYAND

apalutamide (ERLYAND) is a androgen receptor antagonist. Associated with Janssen-Cilag Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved PMDA: approved NMPA: clinical trials Antineoplastic and immunomodulating agents (L02) L02BB05
US status approved
Patents linked 8
Pipeline programs 15
News articles 0
Drug details — apalutamide
US status
approved
Class
Antineoplastic and immunomodulating agents (L02)
Route
ORAL
Patents
8
Programs
15
Data quality
0.84
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Quick answer

apalutamide (ERLYAND) is a androgen receptor antagonist. Associated with Janssen-Cilag Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN apalutamide
Brand ERLYAND
Mechanism Androgen Receptor antagonist
Target Androgen receptor
Therapeutic class Antineoplastic and immunomodulating agents (L02)
Route ORAL
Formulation TABLET
ATC code L02BB05
Originator Janssen-Cilag Pty Ltd

Mechanism of action

Androgen Receptor antagonist

Primary target: Androgen receptor

Approval history

Authority Status Date
FDA approved —
EMA approved —
TGA approved —
PMDA approved —
NMPA clinical trials —

Pipeline programs

Search pipeline Sponsor programs
  1. 56021927PCR3001 Phase 3 · Janssen-Cilag International N.V · Metastatic castration-resistant prostate cancer (mCRPC)
  2. 56021927PCR3002 Phase 3 · Janssen-Cilag International N.V · Metastatic Hormone-sensitive Prostate Cancer
  3. ARN-509-003 Phase 3 · Anaxis Pharma · Castration-Resistant Prostate Cancer
  4. Apalutamide Phase 3 · Janssen Cilag International · Metastatic Castrate-sensitive Prostate Cancer
  5. CAAA617C12301 Phase 3 · Novartis India · PSMA-positive metastatic hormone-sensitive prostate cancer (
  6. EORTC-2238-GUCG Phase 3 · Ningbo Cancer Hospital · Metastatic hormone naïve prostate cancer (mHNPC)
  7. Niraparib tosylate monohydrate + abiraterone... for Prostate Cancer Phase 3 · George Institute for · Prostate Cancer
  8. REINFORCE Phase 3 · Disc Medicine · Metastatic hormone-sensitive prostate cancer

Related & competitor drugs

Browse all 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)

Related patents

Browse patents Janssen-Cilag Pty Ltd patent hub

  1. EP 3708579

    CLAUDIN-6-SPEZIFISCHE IMMUNREZPTOREN UND T-ZELL-EPITOPE

    Expires Tue Sep 11 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  2. WO 2020095183

    COMBINAISON POUR LE TRAITEMENT DU CANCER

    Expires Wed May 09 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  3. US 9987261

    Substituted diazaspiroalkanes as androgen receptor modulators

    Expires Mon May 31 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  4. US 9388159

    Substituted diazaspiroalkanes as androgen receptor modulators

    Expires Mon Jul 07 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  5. EP 3027208

    DIAGNOSE UND THERAPIE VON KREBS MIT KREBSSTAMMZELLEN

    Expires Tue Jun 03 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  6. US 8802689

    Androgen receptor modulator for the treatment of prostate cancer and androgen receptor-associated diseases

    Expires Mon Aug 07 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  7. CA 3169263

    AGENTS DE TRAITEMENT DE MALADIES CANCEREUSES EXPRIMANT CLAUDINE

    Expires Wed May 17 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  8. US 8445507

    Androgen receptor modulator for the treatment of prostate cancer and androgen receptor-associated diseases

    Expires Mon May 16 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is apalutamide?

apalutamide (ERLYAND) is a androgen receptor antagonist. Associated with Janssen-Cilag Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for apalutamide?

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

What is the US approval status of apalutamide?

apalutamide 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.

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