Wednesday, July 8, 2026

Drug profile · INN

bicalutamide

bicalutamide (APO-BICALUTAMIDE) is a androgen receptor antagonist. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved TGA: approved
US status approved
Patents linked 0
Pipeline programs 8
News articles 0
Drug details — bicalutamide
US status
approved
Class
Route
ORAL
Patents
0
Programs
8
Data quality
0.89

Quick answer

bicalutamide (APO-BICALUTAMIDE) is a androgen receptor antagonist. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN bicalutamide
Brand APO-BICALUTAMIDE
Mechanism Androgen Receptor antagonist
Target Androgen receptor
Route ORAL
Formulation TABLET

Mechanism of action

Androgen Receptor antagonist

Primary target: Androgen receptor

Approval history

Authority Status Date
FDA approved
TGA approved

Pipeline programs

  1. CAAA617C12301 Phase 3 · Novartis India · PSMA-positive metastatic hormone-sensitive prostate cancer (
  2. CTRIAL-IE 14-06 Phase 3 · Ningbo Cancer Hospital · Metastatic Prostate Cancer
  3. Casodex® Film-coated Tablets for Localised prostate cancer at hi… Phase 3 · Ningbo Cancer Hospital · Localised prostate cancer at high risk of recurrence
  4. SHR-3680-III-HSPC Phase 3 · Anaxis Pharma · Metastatic hormone-sensitive prostate cancer with high tumor
  5. Bicalutamide Phase 2 · Chinese Academy of · Breast Neoplasms
  6. SELUMETINIB for Metastatic breast cancer Phase 2 · Istituto Gentili Italia · Metastatic breast cancer
  7. 2693-CL-2101 Phase 1 · Astellas Pharma · Hot Flush
  8. Bicalutamide Phase 1 · Teva Pharma · Healthy

Related & competitor drugs

  1. danazol Progesterone receptor agonist
  2. nandrolone decanoate Androgen Receptor agonist
  3. testosterone Genito-urinary system and sex hormones (G03)
  4. testosterone cypionate Androgen Receptor agonist
  5. apalutamide Antineoplastic and immunomodulating agents (L02)
  6. clascoterone Dermatologicals (D10)

Frequently asked questions

What is bicalutamide?

bicalutamide (APO-BICALUTAMIDE) is a androgen receptor antagonist. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for bicalutamide?

APO-BICALUTAMIDE is a marketed brand name for bicalutamide. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of bicalutamide?

bicalutamide 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.