Alunbrig

(Brigatinib)

Phase 3Small molecule

Alunbrig is a small molecule that works as ALK Tyrosine Kinase Receptor Inhibitor; Epidermal Growth Factor Receptor Erbb1 Inhibitor.[2] It is being investigated across 7 indications, with its most advanced program in Phase 3.[1]

Alunbrig is one of 142 small molecule programs targeting Pancreatic Ductal Carcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

141

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Pancreatic Ductal CarcinomaRecruiting

Erectile DysfunctionActive, not recruiting

Locally Advanced Lung Non-Small Cell CarcinomaActive, not recruiting

Neurofibromatosis Type 2Recruiting

Lung CancerCompleted

Non-Small Cell Lung CancerCompleted

Liquid BiopsyActive, not recruiting

Pancreatic Ductal CarcinomaPhase 2

Recruiting

Erectile DysfunctionPreclinical

Active, not recruiting

Locally Advanced Lung Non-Small Cell CarcinomaPhase 1

Active, not recruiting

Neurofibromatosis Type 2Phase 2

Recruiting

Lung CancerPhase 3

Completed

Non-Small Cell Lung CancerPhase 3

Completed

Liquid BiopsyPhase 2

Active, not recruiting

Competition

Competitive Landscape

449 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Alunbrig

Takeda

Phase 3

13 2

BL-B01D1

SSichuan Baili Pharmaceutical Co., Ltd.

Phase 3

10 3

Monalizumab

AstraZeneca

Phase 3

5 4

QL1706

Qilu Pharmaceutical Co., Ltd.

Phase 3

3 5

Remeron

OOrganon and Co

Preclinical

1 6

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—7

Valemetostat Tosylate

Daiichi Sankyo

Preclinical

1 8

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—9

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Recruiting

Erectile Dysfunction

NCT06532149

Q4 2026

Phase 2Active, not recruiting

Liquid Biopsy

NCT04223596

Q1 2027

Phase 2Active, not recruiting

Non-Small Cell Lung Cancer

NCT03737994

Phase 1Active, not recruiting

Locally Advanced Lung Non-Small Cell Carcinoma

NCT04227028

Q1 2028

Phase 2Recruiting

Pancreatic Ductal Carcinoma

NCT06813079

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer13 trials

A Study to Evaluate the Efficacy of Brigatinib (AP26113) in Participants With Anaplastic Lymphoma Kinase (ALK)-Positive, Non-small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib

Completed·AAriad Pharmaceuticals·Phase 2·NCT02094573·222 enrolled

Brigatinib and Binimetinib in Treating Patients With Stage IIIB-IV ALK or ROS1-Rearranged Non-small Cell Lung Cancer

Terminated·UUniversity of California, San Francisco·Phase 1·NCT04005144·3 enrolled

Brigatinib Post Definitive Chemo-radiotherapy in Patients with ALK-fusion Non-small Cell Lung Cancer

Withdrawn·EETOP IBCSG Partners Foundation·Phase 2·NCT05718297

Show 10 more trials

Brigatinib Plus Chemotherapy or Local Consolidation Therapy in ALK Positive Advanced Non-small Cell Lung Cancer (BrightStar-2)

Withdrawn·MM.D. Anderson Cancer Center·Phase 2·NCT06522360

A Window of Opportunity Study for Investigating Drug Tolerant Persister (DTP) to Preoperative Brigatinib in Resectable Non-small Cell Lung Cancer (NSCLC) Harboring ALK Fusions.

Unknown status·YYonsei University·Phase 2·NCT05361564·12 enrolled

ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) Participants

Completed·AAriad Pharmaceuticals·Phase 3·NCT02737501·275 enrolled

An Expanded Access Study of Brigatinib for Patients With ALK-positive Advanced Non-Small Cell Lung Cancer

No longer available·AAriad Pharmaceuticals··NCT02784158

A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway.

Completed· Pfizer logo

Pfizer··NCT05834348·5,279 enrolled

Phase 2 Study of Brigatinib in Japanese Participants With Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer (NSCLC)

Completed· Takeda logo

Takeda·Phase 2·NCT03410108·104 enrolled

A Study to Determine Progression-free Survival (PFS) and Evaluate Participant Experience for Participants With Metastatic Anaplastic Lymphoma Kinase-positive (ALK+) Non-Small Cell Lung Cancer (NSCLC) Treated With Anaplastic Lymphoma Kinase (ALK) Inhibitors

Completed· Takeda logo

Takeda··NCT03546894·111 enrolled

Survey of Brigatinib Used To Treat People With Non-Small Cell Lung Cancer

Recruiting· Takeda logo

Takeda··NCT05100069·500 enrolled

Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03737994·10 enrolled

Local Consolidative Therapy and Brigatinib in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT03707938·35 enrolled

Lung Cancer4 trials

Study of Safety and Efficacy of Brigatinib Plus Chemotherapy or Brigatinib Only in Advanced ALK-Positive Lung Cancer (MASTERPROTOCOL ALK)

Active, not recruiting·IIntergroupe Francophone de Cancerologie Thoracique·Phase 2·NCT05200481·110 enrolled

A Study to Learn About Brigatinib Treatment Information Available in Chinese Participants With Non-Small-cell Lung Cancer (NSCLC)

Active, not recruiting· Takeda logo

Takeda··NCT05721950·154 enrolled

A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer

Completed· Takeda logo

Takeda·Phase 3·NCT03596866·248 enrolled

Show 1 more trial

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

Completed·AAriad Pharmaceuticals·Phase 2·NCT03535740·103 enrolled

NSCLC2 trials

Brigatinib in ALK-positive NSCLC Identified Via Blood-based Assays

Unknown status·JJI-YOUN HAN·Phase 2·NCT04074993·35 enrolled

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

Completed·IInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest·Phase 2·NCT04318938·118 enrolled

Adult1 trial

A Study to Compare the Relative Bioavailability of Brigatinib When Swallowed as a Solution Versus When Swallowed as a Tablet in Healthy Adults

Completed· Takeda logo

Takeda·Phase 1·NCT06132867·12 enrolled

Immunotherapy1 trial

The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy

Unknown status·FFondazione per la Medicina Personalizzata·Phase 2·NCT04591431·400 enrolled

14 more indications

Liquid Biopsy1 trial

Clinical Utility of Liquid Biopsy in Brigatinib ALK+ Patients

Active, not recruiting·FFundación GECP·Phase 2·NCT04223596·33 enrolled

Treatment1 trial

Trial of Brigatinib After Treatment With Next-Generation ALK Inhibitors

Terminated·CCriterium, Inc.·Phase 2·NCT02706626·32 enrolled

Other Solid Tumors1 trial

Brigatinib in Pediatric and Young Adult Patients With ALK+ ALCL, IMT or Other Solid Tumors

Recruiting·PPrincess Maxima Center for Pediatric Oncology·Phase 1/2·NCT04925609·65 enrolled

Tyrosine Kinase Inhibitor1 trial

Real-world Therapy of ALK-positive NSCLC in Sweden: the Sequencing of ALK Tyrosine Kinase Inhibitor Drugs and Their Therapeutic Outcomes Based on Data From National Registers.

Completed· Pfizer logo

Pfizer··NCT04647110·549 enrolled

Metastatic Solid Cancers1 trial

Brigatinib in Treating Patients With ALK and ROS1 Gene Alterations and Locally Advanced or Metastatic Solid Cancers

Withdrawn·SSameek Roychowdhury·Phase 2·NCT03868423

Lymphoma1 trial

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of the Oral Anaplastic Lymphoma Kinase (ALK)/Epidermal Growth Factor Receptor (EGFR) Inhibitor Brigatinib (AP26113)

Completed·AAriad Pharmaceuticals·Phase 1/2·NCT01449461·137 enrolled

Inflammatory Myofibroblastic Tumor1 trial

Pharmacokinetics, Safety, and Efficacy of Brigatinib Monotherapy in Pediatric and Young Adult Participants With ALK+ Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors or Other Solid Tumors

Withdrawn· Takeda logo

Takeda·Phase 1/2·NCT04260009

Solid Tumors1 trial

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

Completed· Takeda logo

Takeda·Phase 1·NCT03420742·24 enrolled

Anaplastic Large Cell Lymphoma1 trial

Brigatinib in Relapsed or Refractory ALK-Positive Anaplastic Large Cell Lymphoma

Withdrawn·FFox Chase Cancer Center·Phase 2·NCT03719898

Trial1 trial

Brigatinib Before Brain Irradiation Trial (B3i Trial)

Terminated·UUniversity of Colorado, Denver·Phase 2·NCT04634110·1 enrolled

Erectile Dysfunction1 trial

ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer

Recruiting·FFondazione Policlinico Universitario Agostino Gemelli IRCCS··NCT06532149·80 enrolled

Neurofibromatosis Type 21 trial

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

Recruiting·SScott R. Plotkin, MD, PhD·Phase 2·NCT04374305·109 enrolled

Locally Advanced Lung Non-Small Cell Carcinoma1 trial

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

Active, not recruiting·CCity of Hope Medical Center·Phase 1·NCT04227028·5 enrolled

Pancreatic Ductal Carcinoma1 trial

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

Recruiting·UUniversity Health Network, Toronto·Phase 2·NCT06813079·25 enrolled

Regulatory

FDA Approval Timeline[4]

Apr 28, 2017

ALUNBRIG

NDA NDA208772

Sources

References

[1]
ClinicalTrials.gov — 35 trial records for Brigatinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Brigatinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Brigatinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA208772). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Alunbrig. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Takeda company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: ALK Tyrosine Kinase Receptor Inhibitor; Epidermal Growth Factor Receptor Erbb1 Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Takeda

Patent Landscape[5]

Patent Cliff

May 21, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9273077May 21, 2029

9012462Apr 28, 2031

9611283Apr 10, 2034

10385078Nov 10, 2035

Alunbrig

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q1 2027

Q1 2028

Trials by Indication[1]

Non-Small Cell Lung Cancer13 trials

Lung Cancer4 trials

NSCLC2 trials

Adult1 trial

Immunotherapy1 trial

Liquid Biopsy1 trial

Treatment1 trial

Other Solid Tumors1 trial

Tyrosine Kinase Inhibitor1 trial

Metastatic Solid Cancers1 trial

Lymphoma1 trial

Inflammatory Myofibroblastic Tumor1 trial

Solid Tumors1 trial

Anaplastic Large Cell Lymphoma1 trial

Trial1 trial

Erectile Dysfunction1 trial

Neurofibromatosis Type 21 trial

Locally Advanced Lung Non-Small Cell Carcinoma1 trial

Pancreatic Ductal Carcinoma1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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