Wednesday, July 8, 2026

Drug profile · INN

gefitinib

gefitinib (CIPLA GEFITINIB) is a epidermal growth factor receptor erbb1 inhibitor. Associated with Cipla Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved NMPA: clinical trials Antineoplastic and immunomodulating agents (L01) L01XE02
US status approved
Patents linked 1
Pipeline programs 7
News articles 0
Drug details — gefitinib
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
ORAL
Patents
1
Programs
7
Data quality
0.84

Quick answer

gefitinib (CIPLA GEFITINIB) is a epidermal growth factor receptor erbb1 inhibitor. Associated with Cipla Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN gefitinib
Brand CIPLA GEFITINIB
Mechanism Epidermal growth factor receptor erbB1 inhibitor
Target Epidermal growth factor receptor
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route ORAL
Formulation TABLET
ATC code L01XE02

Mechanism of action

Epidermal growth factor receptor erbB1 inhibitor

Primary target: Epidermal growth factor receptor

Approval history

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

Pipeline programs

  1. Gefitinib Phase 3 · AstraZeneca · NSCLC
  2. Gefitinib Phase 3 · AstraZeneca · Non-Small-Cell Lung Carcinoma
  3. Gefitinib Phase 3 · Chinese Academy of · Non-small Cell Lung Cancer
  4. CINC280A2X02B Phase 2 · Novartis India · cMET-dependent malignancies
  5. Gefitinib Phase 2 · AstraZeneca · Head and Neck Cancer
  6. PB-2018-V12 Phase 1 · Chongqing Precision Biotech · Non-small Cell Lung Cancer
  7. Gefitinib Unknown · Chinese Academy of · Lung Cancer

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. US 8017321

    Gefitinib sensitivity-related gene expression and products and methods related thereto

    Expires Mon Sep 08 2031 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is gefitinib?

gefitinib (CIPLA GEFITINIB) is a epidermal growth factor receptor erbb1 inhibitor. Associated with Cipla Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for gefitinib?

CIPLA GEFITINIB is a marketed brand name for gefitinib. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of gefitinib?

gefitinib 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.