Wednesday, July 8, 2026

Drug profile · INN

crizotinib

crizotinib (XALKORI) is a hepatocyte growth factor receptor inhibitor. Associated with Pfizer Australia 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 (L01) L01ED01
US status approved
Patents linked 0
Pipeline programs 9
News articles 3
Drug details — crizotinib

Quick answer

crizotinib (XALKORI) is a hepatocyte growth factor receptor inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN crizotinib
Brand XALKORI
Mechanism Hepatocyte growth factor receptor inhibitor
Target ALK tyrosine kinase receptor
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route ORAL
Formulation CAPSULE
ATC code L01ED01

Mechanism of action

Hepatocyte growth factor receptor inhibitor

Primary target: ALK tyrosine kinase receptor

Approval history

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

Recent coverage

Pipeline programs

  1. BO28984 Phase 3 · HOFFMANN-LA ROCHE · Anaplastic lymphoma kinase (ALK)-positive non-small cell lun
  2. CA127-1030 Phase 3 · Bristol-Myers Squibb Australia · Non small cell lung cancer (NSCLC)
  3. IDE196-002 Phase 3 · IDEAYA Biosciences · HLA-A2 negative metastatic uveal melanoma
  4. IDE196-002 Phase 3 · IDEAYA Biosciences · HLA-A2 negative metastatic uveal melanoma
  5. MO41552 Phase 3 · HOFFMANN-LA ROCHE · Non-small cell lung cancer with ROS proto-oncogene 1, recept
  6. ABP-2019 Phase 2 · George Institute for · locally advanced (stage III) and not suitable for curative t
  7. CRISP ITCC-053 Phase 2 · Disc Medicine · Neuroblastoma (NBL), Rhabdomyosarcoma (RMS), Inflammatory My
  8. A8081075 Approved · First Biotech (Australia) · This Master Protocol for Crizotinib Continuation Sub-Studies

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)

Frequently asked questions

What is crizotinib?

crizotinib (XALKORI) is a hepatocyte growth factor receptor inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for crizotinib?

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

What is the US approval status of crizotinib?

crizotinib 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.