Drug

Brigatinib

Approved · EMA

ClassEpidermal growth factor receptor erbB1 inhibitorEmerging researchLate-stage development

Also known as Alunbrig.

RxNorm1921217 ChEMBLCHEMBL3545311 ATCL01ED04UNIIHYW8DB273J

Research papers

Active clinical trials

Protein targets

Regulatory events

Latest activity

beta

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

Phase Ib Study of Brigatinib Plus Bevacizumab in Patients With ALK-Rearranged Non-Small Cell Lung Cancer (NSCLC) Who Have Previously Progressed on Prior ALK-Directed Therapy

Clinical trial2026-07-01Results expected Q1 2027 · ClinicalTrials.gov

ADOPT: Adaptive Organoid-Based Precision Therapy Study in Pancreatic Cancer - A Prospective Single-Arm Phase II Trial

Clinical trial2026-06-23Results expected Q1 2028 · ClinicalTrials.gov

Advancing Brigatinib Properties in Anaplastic Lymphoma Kinase Positive Non-small Cell Lung Cancer (ALK+ NSCLC) Patients

Clinical trial2026-05-30Completed · ClinicalTrials.gov

Innovative Trial for Understanding the Impact of Targeted Therapies in NF2-Related Schwannomatosis (INTUITT-NF2)

Clinical trial2026-05-06Results expected Q4 2029 · 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

Clinical Utility of Liquid Biopsy as a Tool to Assess the Evolution of Brigatinib Treated Patients With Non-small Cell Lung Cancer With EML4-ALK Translocation: an Exploratory Study

Clinical trial2026-02-04Results expected Q4 2026 · ClinicalTrials.gov

BRIGHTSTAR: A Pilot Trial of Local Consolidative Therapy (LCT) With Brigatinib in Tyrosine Kinase Inhibitor-Naive ALK-Rearranged Advanced NSCLC

Clinical trial2026-01-28Primary completion · ClinicalTrials.gov

A Phase I/II Study of Brigatinib in Pediatric and Young Adult Patients With ALK+ Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors or Other Solid Tumors

Clinical trial2025-12-05Results expected Q4 2033 · ClinicalTrials.gov

A Phase 3 Randomized Open-label Study of Brigatinib (ALUNBRIG®) Versus Alectinib (ALECENSA®) in Advanced Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer Patients Who Have Progressed on Crizotinib (XALKORI®)

Clinical trial2025-09-12Results posted · ClinicalTrials.gov

A Phase II Randomized, Open-Labelled, Multicenter Study of Safety & Efficacy of Combination Brigatinib and Carboplatin-Pemetrexed Therapy or Brigatinib Monotherapy as First-Line Treatment in Advanced ALK-Positive Non-Small Cell Lung Cancer

Clinical trial2025-09-01Primary completion · ClinicalTrials.gov

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

Approval: Alunbrig (EMA)

Regulatory2018-11-22EMA

Profile

Identifiers & mechanism

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

Canonical name

Brigatinib

Aliases & brands

Alunbrig

RxNorm CUI

1921217

ChEMBL ID

CHEMBL3545311

ATC codes

L01ED04

UNII

HYW8DB273J

Primary mechanism

Epidermal growth factor receptor erbB1 inhibitor

Regulatory jurisdictions

ema

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Epidermal growth factor receptor

EGFR · P00533

INHIBITOREpidermal growth factor receptor erbB1 inhibitor

ALK tyrosine kinase receptor

ALK · Q9UM73

INHIBITORALK tyrosine kinase receptor 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

2018-11-22

Latest approval

2018-11-22

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2018-11-22Approval

Approval: Alunbrig (EMA)

Indication: Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)?positive advanced non?small cell lung cancer (NSCLC) previously not… Show full indication

Alunbrig is indicated as monotherapy 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. Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase ALKpositive advanced NSCLC previously treated with crizotinib.

Evidence ↗

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

Clinical trials

28 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 = 28

Phase 15Phase 1 / 23Phase 218Phase 32

Late-stage studies

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

CompletedPH IIITakedan=2482024

A Phase 3 Multicenter Open-label Study of Brigatinib (AP26113) Versus Crizotinib in Patients With ALK-positive Advanced Lung Cancer

CompletedPH IIIAriad Pharmaceuticalsn=2752021

Recent completions

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

Advancing Brigatinib Properties in Anaplastic Lymphoma Kinase Positive Non-small Cell Lung Cancer (ALK+ NSCLC) Patients

CompletedPH IIInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwestn=1182026

CompletedPH IIITakedan=2482024

Brigatinib in Patients With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib

CompletedPH IIAriad Pharmaceuticalsn=1032024

A Phase 1, Open-Label, Randomized, Single-Dose, 2-Period, Crossover Study to Evaluate the Relative Bioavailability of Brigatinib Administered as an Oral Solution Versus an Immediate-Release Tablet in Adult Healthy Subjects

CompletedPH ITakedan=122024

A Single-Arm, Multicenter, Phase 2 Study of Brigatinib in Japanese Patients With ALK-Positive Non-Small Cell Lung Cancer (NSCLC)

CompletedPH IITakedan=1042021

A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate Midazolam in Patients With ALK-Positive or ROS1-Positive Solid Tumors

CompletedPH ITakedan=242021

Research activity

1 papers

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

Most influential

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

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 Brigatinib, with an overlapping disease area.

Shared target1 shared disease1 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.