Friday, July 10, 2026

Drug profile · INN

nilutamide

nilutamide (NILUTAMIDE) is a androgen receptor antagonist. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 1
News articles 0
Drug details — nilutamide
US status
approved
Class
Route
ORAL
Patents
0
Programs
1
Data quality
0.84

Quick answer

nilutamide (NILUTAMIDE) is a androgen receptor antagonist. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN nilutamide
Brand NILUTAMIDE
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

Pipeline programs

  1. CAAA617C12301 Phase 3 · Novartis India · PSMA-positive metastatic hormone-sensitive prostate cancer (

Related & competitor drugs

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

Frequently asked questions

What is nilutamide?

nilutamide (NILUTAMIDE) is a androgen receptor antagonist. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for nilutamide?

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

What is the US approval status of nilutamide?

nilutamide 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.