Data updated: May 26, 2026
XALKORI (crizotinib)
Cytochrome P450 3A Inhibitors Genetically Validated
Trial Activity: Stable 25 active trials
Oncology
Approved 2011-08-26
XALKORI is indicated for the treatment of Non-Small Cell Lung Cancer; Anaplastic Large Cell Lymphoma; Inflammatory Myofibroblastic Tumor.
How XALKORI Works
Crizotinib is an inhibitor of receptor tyrosine kinases, including ALK, ROS1, Hepatocyte Growth Factor Receptor (HGFR, c-Met), and Recepteur d'Origine Nantais (RON). In cancers where the ALK or ROS1 genes are rearranged, oncogenic fusion proteins are expressed that drive constitutive kinase activity. Crizotinib demonstrates concentration-dependent inhibition of the phosphorylation of these kinases, thereby disrupting downstream signaling pathways. This inhibition results in decreased cell proliferation, reduced tumor cell survival, and the induction of apoptosis in tumors expressing these fusion proteins.
Development Insights
Pfizer conducting 34 trials (40%)
151 indications explored (Broad Platform)
→ healthy (11 trials)
→ non-small cell lung cancer (10 trials)
→ advanced malignant solid neoplasm (6 trials)
9
Indications
--
Phase 3 Trials
4
Priority Reviews
14
Years on Market
Details
- Status
- Prescription
- First Approved
- 2011-08-26
- Patent Cliff
- 2029
- Routes
- ORAL
- Dosage Forms
- CAPSULE, PELLETS, CAPSULE
XALKORI Approval History
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
63 FDA actions from 2011 to 2023 · 7 indication expansions
Dec 2015 SUPPL Priority
Mfg
Aug 2014 SUPPL Priority
Mfg
Feb 2014 SUPPL Priority
Mfg
Sep 2013 SUPPL Priority
Mfg
Mar 2013 SUPPL Priority
Mfg
What XALKORI Treats
3 indicationsXALKORI is approved for 3 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Non-Small Cell Lung Cancer
- Anaplastic Large Cell Lymphoma
- Inflammatory Myofibroblastic Tumor
Source: FDA Label
XALKORI Target & Pathway
ProTarget
A receptor tyrosine kinase that, when mutated or rearranged, drives cancer cell growth. ALK rearrangements occur in about 5% of non-small cell lung cancers. Inhibiting ALK blocks aberrant signaling that promotes tumor survival and proliferation.
XALKORI Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
9
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
3
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
Unlock 16 more competitors across all three rings.
Upgrade to Pro Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in XALKORI's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications XALKORI treats. First-in-class if their pivotal trials read out positive.
Tiragolumab MTIG7192A / RG6058 ~ Mixed — Ph3 readout
Hoffmann-La Roche TIGIT · monoclonal antibody (anti-TIGIT) · 10 Phase 3 trials
Ceralasertib AZD6738 ~ Mixed — Ph3 readout
AstraZeneca ATR · small-molecule ATR kinase inhibitor · 2 Phase 3 trials
Uliledlimab TJ004309
TJ Biopharma Co., Ltd. NT5E · monoclonal antibody (anti-CD73) · 1 Phase 3 trial
Drugs Similar to XALKORI
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Clinical Trial Registry
72 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02465060 | NCI-2015-00054 NCI-2015-00054, EAY131 | Ph 2 | active not recruiting | Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) |
| NCT04439266 results posted | NCI-2020-03270 NCI-2020-03270, EAY131-F | Ph 2 | active not recruiting | Testing Crizotinib as a Potential Targeted Treatment in Cancers With ALK Genetic Changes (MATCH-Subprotocol F) |
| NCT06360575 results posted | NCI-2024-01127 NCI-2024-01127, EAY131-C2 | Ph 2 | active not recruiting | Testing Crizotinib as Potentially Targeted Treatment in Cancers With MET Exon 14 Deletion Genetic Changes (MATCH - Subprotocol C2) |
| NCT04439253 results posted | NCI-2020-03269 NCI-2020-03269, EAY131-G | Ph 2 | active not recruiting | Testing Crizotinib as a Potential Targeted Treatment in Cancers With ROS1 Genetic Changes (MATCH-Subprotocol G) |
| NCT02664935 | RG_14-072 2014-000814-73, ISRCTN38344105 | Ph 2 | completed | National Lung Matrix Trial: Multi-drug Phase II Trial in Non-Small Cell Lung Cancer |
| NCT03737994 results posted | NCI-2018-02486 NCI-2018-02486, NRG-LU003 | Ph 2 | terminated | Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer |
| NCT06563999 NUMER | GASTO-10117 | Ph 2 | recruiting | Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations. |
| NCT06564324 | AB-106-G318 | Ph 3 | recruiting | A Phase III Study Comparing Taletrectinib With Standard Therapy in ROS1 Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients |
| NCT05160922 | A8081075 2024-511128-15-00 | Ph 4 | active not recruiting | Crizotinib Continuation Clinical Study |
| NCT03297606 CAPTUR | PM1 ESR-17-12831, CA209-9DL | Ph 2 | recruiting | Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) |
| NCT06357975 results posted | NCI-2024-01126 NCI-2024-01126, EAY131-C1 | Ph 2 | active not recruiting | Testing Crizotinib as Potentially Targeted Treatment in Cancers With MET Genetic Changes (MATCH - Subprotocol C1) |
| NCT02838420 results posted | YO29449 | Ph 3 | active not recruiting | A Study to Evaluate and Compare the Efficacy and Safety of Alectinib Versus Crizotinib and to Evaluate the Pharmacokinetics of Alectinib in Asian Participants With Treatment-Naive Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) |
| NCT04283669 NF110 results posted | IRB-300003645 W81XWH-17-2-0037 | Ph 2 | completed | Phase 2 Clinical Trial of Crizotinib for Children and Adults With Neurofibromatosis Type 2 and Progressive Vestibular Schwannomas |
| NCT04693468 | 2020-0436 NCI-2020-06041, 2020-0436 | Ph 1 | recruiting | Talazoparib and Palbociclib, Axitinib, or Crizotinib for the Treatment of Advanced or Metastatic Solid Tumors, TalaCom Trial |
| NCT04603807 | MO41552 2019-003859-11, 2023-507494-18-00 | Ph 3 | active not recruiting | A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases |
| NCT03194893 | BO39694 2017-000207-24 | Ph 3 | active not recruiting | A Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer |
| NCT05987332 | IDE196-002 | Ph 2, Ph 3 | active not recruiting | IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma |
| NCT03947385 | IDE196-001 | Ph 1, Ph 2 | recruiting | Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions |
| NCT02201992 | E4512 NCI-2014-01507, s16-02072 | Ph 3 | active not recruiting | Crizotinib in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Removed by Surgery and ALK Fusion Mutations (An ALCHEMIST Treatment Trial) |
| NCT03052608 results posted | B7461006 2023-509169-19-00 | Ph 3 | active not recruiting | A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC |
| NCT06140836 | CA127-1030 U1111-1292-0487 | Ph 3 | active not recruiting | A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3) |
| NCT02767804 | X396-CLI-301 | Ph 3 | active not recruiting | eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients |
| NCT02075840 ALEX results posted | BO28984 2013-004133-33 | Ph 3 | completed | A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants |
| NCT06082635 | TGRX-326-3001-NSCLC-CN | Ph 3 | active not recruiting | TGRX-326 Chinese Phase III for Advanced Non-small Cell Lung Cancer (NSCLC) |
| NCT01121588 results posted | A8081013 2010-022978-14 | Ph 1 | terminated | Studying An Investigational Drug Crizotinib (PF-02341066) In Non Non-Small Cell Lung Cancer Tumors That Are Positive For Anaplastic Lymphoma Kinase (ALK) |
| NCT02761057 results posted | NCI-2015-01707 NCI-2015-01707, S1500 | Ph 2 | completed | Testing Cabozantinib, Crizotinib, Savolitinib and Sunitinib in Kidney Cancer Which Has Progressed |
| NCT03672643 results posted | A8081067 | Ph 4 | terminated | Long Term Safety Observation of Crizotinib in Chinese NSCLC Population |
| NCT05014464 ATPase | 20210119 | Ph 2 | recruiting | ALK Tyrosine Kinase Inhibitors in ALK-rearranged Advanced Squamous Cell Carcinoma |
| NCT01970865 results posted | B7461001 2013-002620-17 | Ph 1, Ph 2 | completed | A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations |
| NCT01712217 | AT13387-05 2012-001575-37 | Ph 1, Ph 2 | completed | A Study of AT13387 in Patients With Non-Small Cell Lung Cancer (NSCLC) Alone and in Combination With Crizotinib |
| NCT04084717 | 18-5607 CROME / WI235747 | Ph 2 | recruiting | Study of Crizotinib for ROS1 and MET Activated Lung Cancer |
| NCT04322578 CONFIRM | 20203017 | Ph 2 | recruiting | Crizotinb or Standard Chemotherapy in Met Exon 14 Skipping Advanced NSCLC |
| NCT01979536 results posted | NCI-2013-02167 NCI-2013-02167, s14-01970 | Ph 2 | completed | Brentuximab Vedotin or Crizotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II-IV Anaplastic Large Cell Lymphoma |
| NCT02034981 AcSé | UC-0105/1303 2013-000885-13 | Ph 2 | completed | Phase 2 Study Assessing Efficacy and Safety of Crizotinib in Patients Harboring an Alteration on ALK, MET or ROS1 |
| NCT02925234 DRUP | M15DRU | Ph 2 | recruiting | The Drug Rediscovery Protocol (DRUP Trial) |
| NCT01606878 results posted | ADVL1212 NCI-2012-01968, CDR0000734059 | Ph 1 | completed | Crizotinib and Combination Chemotherapy in Treating Younger Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma |
| NCT02223819 results posted | AAAO8010 | Ph 2 | completed | Crizotinib in High-Risk Uveal Melanoma Following Definitive Therapy |
| NCT02584634 results posted | B9991005 2015-001879-43, JAVELIN LUNG 101 | Ph 1, Ph 2 | terminated | Study to Evaluate Safety, Efficacy, Pharmacokinetics And Pharmacodynamics Of Avelumab In Combination With Either Crizotinib Or PF-06463922 In Patients With NSCLC. (Javelin Lung 101) |
| NCT01744652 | 2012-0721 NCI-2013-00071 | Ph 1 | completed | Dasatinib and Crizotinib in Advanced Cancer |
| NCT02419287 | CRU1 | Ph 2 | completed | Pilot Study of Crizotinib in Relapsed ALK+ Lymphomas |
| NCT05725200 EVIDENT | EVIDENT | Ph 2 | recruiting | Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer |
| NCT02612194 results posted | LCI-GU-URO-CRI-001 | Ph 2 | terminated | LCI-GU-URO-CRI-001: Crizotinib in Patients With c-MET or RON-Positive Metastatic Urothelial Cancer |
| NCT02183870 EUCROSS | EUCROSS 2013-002737-38, DRKS00005409 | Ph 2 | completed | EUCROSS: European Trial on Crizotinib in ROS1 Translocated Lung Cancer |
| NCT02270034 | GEINO 1402 | Ph 1 | completed | Study to Evaluate Safety and Activity of Crizotinib With Temozolomide and Radiotherapy in Newly Diagnosed Glioblastoma |
| NCT03088930 results posted | 16-2025.cc | Ph 2 | completed | Evaluating Crizotinib in the Neoadjuvant Setting in Patients With Non-small Cell Lung Cancer |
| NCT04856293 | A8081074 | Ph 1 | completed | Bioequivalence Study for Crizotinib Encapsulated Microsphere Formulation (eMS) |
| NCT02207504 | 14-230 | Ph 1 | completed | Crizotinib in Combination With Enzalutamide in Metastatic Castration-resistant Prostate Cancer |
| NCT02737501 ALTA-1L results posted | AP26113-13-301 U1111-1210-4363, 2015-003447-19 | Ph 3 | completed | ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) Participants |
| NCT02574078 CheckMate370 results posted | CA209-370 | Ph 1, Ph 2 | completed | A Study of Nivolumab in Advanced Non-Small Cell Lung Cancer (NSCLC) |
| NCT01945021 results posted | OO 12-01 | Ph 2 | completed | Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC |
Showing 50 of 72 trials
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Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
XALKORI FDA Label Details
Indications & Usage
FDA Label (PDF)XALKORI is indicated for the treatment of Non-Small Cell Lung Cancer; Anaplastic Large Cell Lymphoma; Inflammatory Myofibroblastic Tumor.
View full patent landscape →
3 OB patents · 3 families ·
143 international docs across 50 countries
XALKORI Patents & Exclusivity
Latest Patent: Nov 2029
Exclusivity: Jul 2029
Patents (3 active)
Exclusivity
ODE-328
Until Jan 2028
ODE-407
Until Jul 2029
ODE-328
Until Jan 2028
ODE-407
Until Jul 2029
ODE-328
Until Jan 2028
ODE-407
Until Jul 2029
ODE-328
Until Jan 2028
ODE-407
Until Jul 2029
Source: FDA Orange Book
Pro Intelligence Preview
Deep insights for XALKORI
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2029
- • 65 active patents
Trial Analysis
- • 84 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Unlock Full Intelligence
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment