ALUNBRIG (brigatinib)
Alunbrig treats adults with a specific form of lung cancer known as ALK-positive metastatic non-small cell lung cancer. It helps patients whose cancer has spread to other parts of the body and is identified through specialized diagnostic testing. This medication is used to target the genetic drivers of the tumor, including certain mutations that may have developed resistance to other therapies.
How ALUNBRIG Works
Alunbrig works by blocking the activity of several tyrosine kinases, primarily targeting the ALK protein along with ROS1 and FLT-3. By inhibiting these proteins and their downstream signaling pathways, the drug stops the growth and survival of cancer cells. It is designed to remain effective against various mutant forms of the disease, including those that typically resist other inhibitors, and can reach tumors located in the brain.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2017-04-28
- Patent Cliff
- 2035
- Routes
- ORAL
- Dosage Forms
- TABLET
ALUNBRIG Approval History
What ALUNBRIG Treats
1 indicationsALUNBRIG is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Non-Small Cell Lung Cancer
ALUNBRIG Target & Pathway
ProTarget
A receptor that triggers cell growth, proliferation, and survival when activated. Mutations or overexpression of EGFR drive many cancers, particularly lung cancer. Blocking EGFR stops the growth signals that fuel tumor progression.
ALUNBRIG Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
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 ALUNBRIG's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ALUNBRIG treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ALUNBRIG
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
24 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04374305 INTUITT-NF2 | 19-828 | Ph 2 | recruiting | Innovative Trial for Understanding the Impact of Targeted Therapies in NF2-Related Schwannomatosis (INTUITT-NF2) |
| 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 |
| NCT04318938 | ABP | Ph 2 | active not recruiting | Advancing Brigatinib Properties in ALK+ NSCLC Patients by Deep Phenotyping |
| NCT04223596 CUBIK | GECP 19/01_CUBIK 2019-002369-36 | Ph 2 | active not recruiting | Clinical Utility of Liquid Biopsy in Brigatinib ALK+ Patients |
| NCT04925609 Briga-PED | ITCC-098 | Ph 1, Ph 2 | recruiting | Brigatinib in Pediatric and Young Adult Patients With ALK+ ALCL, IMT or Other Solid Tumors |
| NCT03707938 | 2018-0598 NCI-2018-02099, 2018-0598 | Ph 1 | active not recruiting | Local Consolidative Therapy and Brigatinib in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer |
| NCT04227028 | 20495 STU00211030, NU 19L01 | Ph 1 | active not recruiting | Brigatinib and Bevacizumab for the Treatment of ALK-Rearranged Locally Advanced, Metastatic, or Recurrent NSCLC |
| NCT03596866 ALTA-3 results posted | Brigatinib-3001 2018-001957-29 | Ph 3 | completed | A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer |
| NCT03535740 ALTA-2 results posted | Brigatinib-2002 2018-000635-27, NL66462.078.18 | Ph 2 | completed | A Study of Brigatinib in Participants With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib |
| NCT06522360 | 2024-0130 NCI-2024-06173 | Ph 2 | withdrawn | Brigatinib Plus Chemotherapy or Local Consolidation Therapy in ALK Positive Advanced Non-small Cell Lung Cancer (BrightStar-2) |
| NCT06813079 | ADOPT 24-5059 | Ph 2 | not yet recruiting | Using Tumor Models to Determine Treatments |
| NCT06132867 results posted | Brigatinib-1004 | Ph 1 | completed | A Study to Compare the Relative Bioavailability of Brigatinib When Swallowed as a Solution Versus When Swallowed as a Tablet in Healthy Adults |
| NCT05718297 BOUNCE | ETOP 21-21 | Ph 2 | withdrawn | Brigatinib Post Definitive Chemo-radiotherapy in Patients with ALK-fusion Non-small Cell Lung Cancer |
| NCT03410108 results posted | Brigatinib-2001 U1111-1204-8752, JapicCTI-183823 | Ph 2 | completed | Phase 2 Study of Brigatinib in Japanese Participants With Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer (NSCLC) |
| NCT03420742 results posted | Brigatinib-1001 U1111-1203-0166, 2018-001624-19 | Ph 1 | completed | A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate, Midazolam, in Participants With ALK-Positive or ROS1-Positive Solid Tumors |
| NCT02706626 results posted | ARI-AT-002 | Ph 2 | terminated | Trial of Brigatinib After Treatment With Next-Generation ALK Inhibitors |
| NCT04634110 results posted | 19-2862.cc P30CA046934 | Ph 2 | terminated | Brigatinib Before Brain Irradiation Trial (B3i Trial) |
| NCT04005144 | 186517 NCI-2019-02315 | Ph 1 | terminated | Brigatinib and Binimetinib in Treating Patients With Stage IIIB-IV ALK or ROS1-Rearranged Non-small Cell Lung Cancer |
| NCT03868423 | OSU-17060 NCI-2017-01394, P30CA016058 | Ph 2 | withdrawn | Brigatinib in Treating Patients With ALK and ROS1 Gene Alterations and Locally Advanced or Metastatic Solid Cancers |
| 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 |
| NCT01449461 results posted | AP26113-11-101 2011-005718-12, U1111-1196-8197 | Ph 1, Ph 2 | completed | 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) |
| NCT02094573 results posted | AP26113-13-201 2013-002134-21, U1111-1196-8246 | Ph 2 | completed | 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 |
| NCT03719898 | HM-117 18-1032 | Ph 2 | withdrawn | Brigatinib in Relapsed or Refractory ALK-Positive Anaplastic Large Cell Lymphoma |
| NCT04260009 | Brigatinib-1002 | Ph 1, Ph 2 | withdrawn | 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 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
ALUNBRIG FDA Label Details
Indications & Usage
FDA Label (PDF)ALUNBRIG is indicated for the treatment of Non-Small Cell Lung Cancer.
ALUNBRIG Patents & Exclusivity
Patents (4 active)
Exclusivity
Pro Intelligence Preview
Deep insights for ALUNBRIG
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2035
- • 36 active patents
Trial Analysis
- • 25 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
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