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Drug

Lorlatinib

Approved · EMA
ClassALK tyrosine kinase receptor inhibitorEmerging researchLate-stage development

Also known as Lorbrena.

RxNorm2103164ChEMBLCHEMBL3286830ATCL01ED05UNIIOSP71S83EU
1
Research papers
19
Active clinical trials
2
Protein targets
1
Regulatory events
Latest activity
beta

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

A Phase 1/2 Study of Combination Lorlatinib and Ramucirumab in Patients With Advanced ALK-rearranged Lung Cancers

Clinical trial2026-07-10Results expected Q3 2028 · ClinicalTrials.gov

A Pilot Study of Lorlatinib for Treatment of Children With Newly Diagnosed High-Grade Glioma With ROS-1 (ROS Proto-Oncogene 1, Receptor Tyrosine Kinase) or ALK (Anaplastic Lymphoma Kinase) Fusion

Clinical trial2026-06-29Results expected Q3 2029 · ClinicalTrials.gov

A Phase I, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of AQUA07 Monotherapy and Combination Therapy in Patients With Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer

Clinical trial2026-06-01Results expected Q3 2030 · ClinicalTrials.gov

LOREA : ANALYSIS OF THE EFFECTIVENESS AND SAFETY OF LORLATINIB IN UNTREATED ALK-POSITIVE NSCLC PATIENTS IN A FRENCH NON INTERVENTIONAL STUDY

Clinical trial2026-05-06Results expected Q4 2028 · ClinicalTrials.gov

Lorlatinib Plus Local Consolidation Therapy In ALK Positive Advanced Non-Small Cell Lung Cancer

Clinical trial2026-05-05Results expected Q3 2028 · ClinicalTrials.gov

An Open-label, Single-arm, Multicenter, Prospective Study of Lorlatinib in Patients With ALK-Positive NSCLC With Brain or Leptomeningeal Metastases

Clinical trial2026-04-30Primary completion · ClinicalTrials.gov

Phase II, Open-label, Single-arm, Prospective, Multi-center Study to Evaluate the Efficacy and Safety of Lorlatinib as Neoadjuvant Treatment in Surgically Resectable Stage IB-IIIB ALK-rearranged Non-Small Cell Lung Cancer (NEOLORA)

Clinical trial2026-04-30Primary completion · ClinicalTrials.gov

A Biomarker-Driven Protocol for Previously Treated ALK-Positive Non-Squamous NSCLC Patients: The NCI-NRG ALK Protocol

Clinical trial2026-03-17Terminated · ClinicalTrials.gov

A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or ALK Inhibitor Therapy Added to Intensive Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma (NBL)

Clinical trial2026-02-27Results expected Q3 2030 · ClinicalTrials.gov

A Phase 2 Open Label Study of Oral Lorlatinib in Patients With Relapsed ALK Positive Lymphoma Previously Treated With ALK Inhibitors (CRU3)

Clinical trial2025-12-31Completed · 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

Approval: Lorviqua (EMA)

Regulatory2019-05-06EMA

Profile

Identifiers & mechanism

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

Canonical name
Lorlatinib
Aliases & brands
Lorbrena
RxNorm CUI
2103164
ChEMBL ID
CHEMBL3286830
ATC codes
L01ED05
UNII
OSP71S83EU
Primary mechanism
ALK tyrosine kinase receptor inhibitor
Regulatory jurisdictions
ema

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

ALK tyrosine kinase receptor
ALK · Q9UM73
INHIBITORALK tyrosine kinase receptor inhibitor
Echinoderm microtubule-associated protein-like 4
EML4 · Q9HC35
INHIBITOREML4-ALK inhibitor

Regulatory timeline

1 event

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
2019-05-06
Latest approval
2019-05-06
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2019-05-06Approval
Approval: Lorviqua (EMA)
Indication: Lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)?positive advanced non?small cell lung cancer (NSCLC) previously not… Show full indication

Lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)?positive advanced non?small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. Lorviqua as monotherapy is indicated for the treatment of adult patients with ALK?positive advanced NSCLC whose disease has progressed after: alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy; or crizotinib and at least one other ALK TKI.

Evidence ↗

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

Clinical trials

39 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
39
registered trials across all phases
LATEST COMPLETION 2025
19
Active studies
12
Recruiting
9
Late-stage (III+)
10
Completed
10
Discontinued
PHASE DISTRIBUTIONn = 39
Early Phase 11Phase 19Phase 1 / 22Phase 218Phase 33Phase 45Phase N / A1

Late-stage studies

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

Explore the Mechanisms Underlying Disease Resistance and Potential Primary Resistance Mechanism of Induction Therapy Lorlatinib in Resectable Non-small Cell Lung Cancer (NSCLC) Harboring ALK Positive Mutation Revealed by Single-cell RNA Sequencing and Spatial Transcriptomics

Not yet recruitingPH IVThe First Affiliated Hospital of Guangzhou Medical Universityn=202027

An Open-label, Single-arm, Multicenter, Prospective Study of Lorlatinib in Patients With ALK-Positive NSCLC With Brain or Leptomeningeal Metastases

Active, not recruitingPH IVGuangdong Association of Clinical Trialsn=412027

LORLATINIB (PF-06463922) CONTINUATION PROTOCOL: AN OPEN-LABEL, SINGLE-ARM CONTINUATION STUDY FOR PARTICIPANTS WITH ALK-POSITIVE OR ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) CONTINUING FROM PFIZER SPONSORED LORLATINIB CLINICAL STUDIES

Active, not recruitingPH IVPfizern=762026

Single-Arm Study of Lorlatinib in Participants With Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer (NSCLC) Whose Disease Progressed After One Prior Second-Generation ALK Tyrosine Kinase Inhibitor (TKI)

CompletedPH IVPfizern=712024

SINGLE-ARM STUDY TO EVALUATE THE SAFETY OF LORLATINIB IN ALK INHIBITOR-TREATED UNRESECTABLE ADVANCED AND/OR RECURRENT ALK-POSITIVE NON-SMALL CELL LUNG CANCER PARTICIPANTS IN INDIA

CompletedPH IVPfizern=1002022

Recent completions

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

A Phase 2 Open Label Study of Oral Lorlatinib in Patients With Relapsed ALK Positive Lymphoma Previously Treated With ALK Inhibitors (CRU3)

CompletedPH IIUniversity of Milano Bicoccan=92025

Phase 1 Study of Lorlatinib (PF-06463922), an Oral Small Molecule Inhibitor of ALK/ROS1, for Patients With ALK-Driven Relapsed or Refractory Neuroblastoma

CompletedPH INew Approaches to Neuroblastoma Therapy Consortiumn=652025

A Phase II Non-randomized, Single Group Assignment, Open-label, Multicenter Study of Efficacy and Safety of Lorlatinib Monotherapy After Failure of First-line Second-generation ALK Kinase Inhibitor in Patients With Advanced ALK-positive Non-small Cell Lung Cancer

CompletedPH IIIntergroupe Francophone de Cancerologie Thoraciquen=232024

Single-Arm Study of Lorlatinib in Participants With Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer (NSCLC) Whose Disease Progressed After One Prior Second-Generation ALK Tyrosine Kinase Inhibitor (TKI)

CompletedPH IVPfizern=712024

A PHASE 2, MULTI-CENTER, OPEN-LABEL, DUAL-COHORT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF LORLATINIB (PF-06463922) MONOTHERAPY IN ALK INHIBITOR-TREATED LOCALLY ADVANCED OR METASTATIC ALK-POSITIVE NON-SMALL CELL LUNG CANCER PATIENTS IN CHINA

CompletedPH IIPfizern=1092024

A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL-GROUP STUDY TO EVALUATE THE PLASMA PHARMACOKINETICS AND SAFETY OF LORLATINIB IN PARTICIPANTS WITH MODERATE AND SEVERE HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITH NORMAL HEPATIC FUNCTION

CompletedPH IPfizern=212024

Research activity

1 papers

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

Most influential

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
Recent papers

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
Major research themes8
Aminopyridines1Anaplastic Lymphoma Kinase1Carcinoma, Non-Small-Cell Lung1Crizotinib1Lactams1Lactams, Macrocyclic1Lung Neoplasms1Pyrazoles1
Journals, researchers & institutions
Top journals
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology1
Leading researchers
  • Bauer TM1
  • de Marinis F1
  • Felip E1
  • Goto Y1
  • Kim DW1
  • Liu G1
  • Martini JF1
  • Mazieres J1
Leading institutions
free-text, unnormalised
  • European Institute of Oncology1
  • Greco-Hainsworth Centers for Research/Tennessee Oncology1
  • Guangdong Lung Cancer Institute1
  • Massachusetts General Hospital Cancer Center1
  • National Cancer Center Hospital1
  • National University Cancer Institute1

Related drugs

1 matches

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

Crizotinib

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

2 shared targets2 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.