Drug

Crizotinib

Approved · EMA

ClassHepatocyte growth factor receptor inhibitorEmerging researchLate-stage developmentSteady momentum

Also known as Xalkori, (R)-crizotinib, Crizotinibum.

RxNorm1148495 ChEMBLCHEMBL601719 ATCL01ED01UNII53AH36668S

Research papers

Active clinical trials

Protein targets

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Molecular Analysis for Therapy Choice (MATCH)

Clinical trial2026-07-31Results expected Q4 2026 · ClinicalTrials.gov

Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

Clinical trial2026-07-02Results expected Q3 2026 · ClinicalTrials.gov

Platform Study of Genotyping Guided Precision Medicine for Rare Tumors in China

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

Randomized, Multicenter, Phase III, Open-Label Study of Alectinib Versus Crizotinib in Asian Patients With Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer

Clinical trial2026-06-24Results posted · ClinicalTrials.gov

A Phase 1/2 Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions

Clinical trial2026-06-08Results expected Q1 2027 · ClinicalTrials.gov

Molecular Characterization and Clinical Outcomes of ALK Tyrosine Kinase Inhibitors in ALK-rearranged Advanced Squamous Cell Carcinoma

Clinical trial2026-06-01Primary completion · ClinicalTrials.gov

Lorlatinib Versus Crizotinib in Patients With Advanced <i>ALK</i>-Positive Non-Small Cell Lung Cancer: 5-Year Outcomes From the Phase III CROWN Study.

Research2024-05-31Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Brigatinib Versus Crizotinib in ALK Inhibitor-Naive Advanced ALK-Positive NSCLC: Final Results of Phase 3 ALTA-1L Trial.

Research2021-09-16Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer

Drug Safety Update: Crizotinib (Xalkori▼): risk of cardiac failure

Regulatory2015-11-12MHRA

First-line crizotinib versus chemotherapy in ALK-positive lung cancer.

Research2014-12-01The New England journal of medicine

Approval: Xalkori (EMA)

Regulatory2012-10-23EMA

ROS1 rearrangements define a unique molecular class of lung cancers.

Research2012-01-03Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Crizotinib

Aliases & brands

Xalkori(R)-crizotinibCrizotinibum

RxNorm CUI

1148495

ChEMBL ID

CHEMBL601719

ATC codes

L01ED01

UNII

53AH36668S

Primary mechanism

Hepatocyte growth factor receptor inhibitor

Regulatory jurisdictions

emamhra

Pharmacology & targets

6 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Hepatocyte growth factor receptor

MET · P08581

INHIBITORHepatocyte growth factor receptor inhibitor

ALK tyrosine kinase receptor

ALK · Q9UM73

INHIBITORALK tyrosine kinase receptor inhibitor

Echinoderm microtubule-associated protein-like 4

EML4 · Q9HC35

INHIBITOREML4-ALK inhibitor

Nucleophosmin

NPM1 · P06748

INHIBITORNPM/ALK (Nucleophosmin/ALK tyrosine kinase receptor) inhibitor

Proto-oncogene tyrosine-protein kinase ROS

ROS1 · P08922

INHIBITORProto-oncogene tyrosine-protein kinase ROS inhibitor

Macrophage-stimulating protein receptor

MST1R · Q04912

INHIBITORMacrophage-stimulating protein receptor inhibitor

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2012-10-23

Latest approval

2012-10-23

Authorities

EMA · MHRA

Total events

emaEuropean Medicines Agency· 1 event

2012-10-23Approval

Approval: Xalkori (EMA)

Indication: Xalkori as monotherapy is indicated for: The first line treatment of adults with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) The… Show full indication

Xalkori as monotherapy is indicated for: The first line treatment of adults with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) The treatment of adults with previously treated anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) The treatment of adults with ROS1 positive advanced non small cell lung cancer (NSCLC) The treatment of paediatric patients (age 1 to <18 years) with relapsed or refractory systemic anaplastic lymphoma kinase (ALK) positive anaplastic large cell lymphoma (ALCL) The treatment of paediatric patients (age 1 to <18 years) with recurrent or refractory anaplastic lymphoma kinase (ALK) positive unresectable inflammatory myofibroblastic tumour (IMT)

Evidence ↗

mhraMedicines and Healthcare products Regulatory Agency· 1 event

2015-11-12Safety communicationSafety

Drug Safety Update: Crizotinib (Xalkori▼): risk of cardiac failure

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

93 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

registered trials across all phases

LATEST COMPLETION 2026

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 93

Early Phase 11Phase 124Phase 1 / 27Phase 237Phase 2 / 32Phase 316Phase 44Phase N / A2

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

CRIZOTINIB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM PFIZER-SPONSORED CRIZOTINIB CLINICAL STUDIES

Active, not recruitingPH IVPfizern=272028

AN OPEN-LABEL, SINGLE-ARM STUDY OF THE LONG-TERM SAFETY OF XALKORI (REGISTERED) IN PATIENTS FROM CHINA WITH ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC) HARBORING A TRANSLOCATION OR INVERSION EVENT INVOLVING THE ANAPLASTIC LYMPHOMA KINASE (ALK) OR ROS1 LOCUS WHO HAVE PREVIOUSLY BEEN TREATED ON A STUDY OF XALKORI (REGISTERED)

TerminatedPH IVPfizern=412023

Single-arm, Multi-center Clinical Study of Crizotinib Combined With Etoposide Capsule Followed by Auto-HSCT for Relapsed and Refractory Anaplastic Lymphoma Kinase (ALK)-Positive Anaplastic Large Cell Lymphoma (ALCL)

Unknown statusPH IVMingzhi Zhangn=202021

A Multicenter Prospective Study of Treatment ALK(+) Systemic Anaplastic Large Cell Lymphoma With Crizotinib

WithdrawnPH IVJun Zhu2017

A Randomized Phase III Trial for Surgically Resected Early Stage Non-small Cell Lung Cancer: Crizotinib Versus Observation for Patients With Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

Active, not recruitingPH IIIECOG-ACRIN Cancer Research Groupn=1662036

Recent completions

Trials that read out recently, adding to the completed evidence base.

Randomized, Multicenter, Phase III, Open-Label Study of Alectinib Versus Crizotinib in Asian Patients With Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer

CompletedPH IIIHoffmann-La Rochen=1872026

A Multicenter, International, Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer

CompletedPH IIIHoffmann-La Rochen=502025

Randomized, Multicenter, Phase III, Open-Label Study of Alectinib Versus Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer

CompletedPH IIIHoffmann-La Rochen=3032025

Open-label, Phase 2 Clinical Trial of Crizotinib for Children and Adults With Neurofibromatosis Type 2 and Progressive Vestibular Schwannomas

CompletedPH IIUniversity of Alabama at Birminghamn=122025

Phase II Study of Crizotinib for ROS1 and MET Activated Lung Cancer (CROME)

CompletedPH IIUniversity Health Network, Toronton=332024

Phase II Study of ROS1 Targeting With Crizotinib in Advanced E-cadherin Negative, ER Positive Lobular Breast Cancer, Diffuse Gastric Cancer, Triple Negative Lobular Breast Cancer or CDH1-mutated Solid Tumours

CompletedPH IIRoyal Marsden NHS Foundation Trustn=332024

Research activity

4 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20122024

Most influential

First-line crizotinib versus chemotherapy in ALK-positive lung cancer.

The New England journal of medicine · 2014 · 2,470 cites

ROS1 rearrangements define a unique molecular class of lung cancers.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2012 · 1,121 cites

Brigatinib Versus Crizotinib in ALK Inhibitor-Naive Advanced ALK-Positive NSCLC: Final Results of Phase 3 ALTA-1L Trial.

Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2021 · 300 cites

Lorlatinib Versus Crizotinib in Patients With Advanced <i>ALK</i>-Positive Non-Small Cell Lung Cancer: 5-Year Outcomes From the Phase III CROWN Study.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024 · 254 cites

Related diseases

3 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Active research areas

Lung Neoplasms4 Carcinoma, Non-Small-Cell Lung3 Adenocarcinoma2

Related drugs

6 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Lorlatinib

Acts on the same molecular target as Crizotinib, with 2 overlapping disease areas.

2 shared targets2 shared diseases1 shared paper

Brigatinib

Acts on the same molecular target as Crizotinib, with an overlapping disease area.

Shared target1 shared disease1 shared paper

Carboplatin

Studied across 3 of the same disease areas as Crizotinib in the shared literature.

3 shared diseases1 shared paper

Cisplatin

Studied across 3 of the same disease areas as Crizotinib in the shared literature.

3 shared diseases1 shared paper

Guanine

Studied across 3 of the same disease areas as Crizotinib in the shared literature.

3 shared diseases1 shared paper

Pemetrexed

Studied across 3 of the same disease areas as Crizotinib in the shared literature.

3 shared diseases1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.