Product Description
Brigatinib is used to treat a certain type of non-small cell lung cancer (NSCLC) that has spread to other parts of the bodys. Brigatinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. (Sourced from: https://medlineplus.gov/druginfo/meds/a617016.html)
Mechanisms of Action: ALK Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Indonesia | Ireland | Israel | Italy | Japan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | Norway | Peru | Philippines | Poland | Portugal | Romania | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States
Approved Indications: None
Known Adverse Events: None
Company: Takeda
Company Location: Asia Pacific
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Canada, Chile, China, Croatia, France, Germany, Greece, Hong Kong, Italy, Japan, Korea, Mexico, Netherlands, Romania, Russia, South Korea, Spain, Sweden, Taiwan, Thailand, United States
Active Clinical Trial Count: 14
Recent & Upcoming Milestones
- Alunbrig's pdufa set for June 23, 2020, to expand use for first-line treatment of alk+ metastatic non-small cell lung cancer.
Highest Development Phases
Phase 3: Non-Small-Cell Lung Cancer|Small Cell Lung Cancer
Phase 2: Breast Cancer|Ependymoma|Granuloma|Intestinal Cancer|Large-Cell Anaplastic Lymphoma|Lymphoma|Meningioma|Neurilemmoma|Neurofibromatoses|Neurofibromatosis 1|Neurofibromatosis 2|Neuroma, Acoustic|Squamous Cell Carcinoma
Phase 1: Healthy Volunteers
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT04374305 |
INTUITT-NF2 | P2 |
Active, not recruiting |
Neurofibromatosis 1|Neurofibromatoses|Neurofibromatosis 2|Meningioma|Ependymoma|Neuroma, Acoustic|Neurilemmoma |
2029-12-01 |
12% |
2024-11-19 |
Primary Endpoints|Treatments|Trial Status |
NCT04318938 |
NCT04318938 | P2 |
Active, not recruiting |
Non-Small-Cell Lung Cancer|Small Cell Lung Cancer |
2026-01-16 |
12% |
2024-10-16 |
|
2019-001828-36 |
ABP | P2 |
Active, not recruiting |
Lymphoma|Non-Small-Cell Lung Cancer |
2025-10-21 |
2025-05-06 |
Treatments |
|
2018-002190-21 |
ROME | P2 |
Completed |
Non-Small-Cell Lung Cancer|Intestinal Cancer|Breast Cancer |
2024-09-06 |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
NCT03737994 |
The NCI-NRG ALK Protocol | P2 |
Active, not recruiting |
Squamous Cell Carcinoma|Non-Small-Cell Lung Cancer |
2021-07-21 |
2024-01-04 |
Primary Endpoints|Treatments |
|
NCT04925609 |
Briga-PED | P2 |
Recruiting |
Granuloma|Large-Cell Anaplastic Lymphoma |
2033-12-01 |
12% |
2025-12-06 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
2018-001957-29 |
2018-001957-29 | P3 |
Completed |
Non-Small-Cell Lung Cancer |
2024-09-12 |
48% |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
NCT06132867 |
Brigatinib-1004 | P1 |
Completed |
Healthy Volunteers |
2024-02-17 |
50% |
2025-01-24 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments |
NCT03596866 |
ALTA-3 | P3 |
Completed |
Small Cell Lung Cancer|Non-Small-Cell Lung Cancer |
2024-02-27 |
48% |
2024-09-25 |
Primary Endpoints |
2024-513947-94-00 |
ABP-2019 | P2 |
Active, not recruiting |
Non-Small-Cell Lung Cancer|Small Cell Lung Cancer |
2026-01-16 |
2025-05-02 |
Treatments |
|
JapicCTI-194851 |
JapicCTI-194851 | P2 |
Active |
Non-Small-Cell Lung Cancer |
2025-06-30 |
|||
2018-000635-27 |
2018-000635-27 | P2 |
Completed |
Non-Small-Cell Lung Cancer|Lymphoma |
2024-08-21 |
70% |
2025-06-27 |
Treatments |
CTR20182341 |
CTR20182341 | P2 |
Completed |
Non-Small-Cell Lung Cancer |
2024-08-21 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
2019-004070-26 |
BRICE | P2 |
Active, not recruiting |
Non-Small-Cell Lung Cancer |
2023-09-23 |
2022-03-13 |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
05/14/2025 |
News Article |
Kesmalea Therapeutics Appoints Industry Veteran Tim Clackson to Board of Directors |
|
09/09/2024 |
News Article |
Updated Data for Nuvalent's ALK-Selective Inhibitor, NVL-655, and ROS1-Selective Inhibitor, Zidesamtinib, Continue to Support Potential Best-in-Class Profiles |
|
03/27/2024 |
News Article |
IDRx Appoints David P. Kerstein, M.D., as Chief Medical Officer |
|
03/12/2024 |
News Article |
IDRx Strengthens Executive Team with Appointments of Tim Clackson, Ph.D., as CEO and Brad Dahms as CFO and CBO |