brigatinib (alunbrig) Report issue

Small molecule Orphan Drug FDA Approved FDA Accelerated Approval FDA Priority Review FDA
AACT ChEMBL DrugBank Drugs@FDA PubChem

Active Ingredient History

NOW
  • Now
Brigatinib (AP26113) is an investigational, targeted cancer medicine discovered internally at ARIAD Pharmaceuticals, Inc. Brigatinib has exhibited activity as a potent dual inhibitor of anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR). It is in development for the treatment of patients with anaplastic lymphoma kinase positive (ALK+) non-small cell cancer (NSCLC) whose disease is resistant to crizotinib. Brigatinib is currently being evaluated in the global Phase 2 ALTA (ALK in Lung Cancer Trial of AP26113) trial that is anticipated to form the basis for its initial regulatory review. ARIAD has also initiated the Phase 3 ALTA 1L trial to assess the efficacy of brigatinib in comparison to crizotinib. Brigatinib was granted orphan drug designation by the U.S. Food and Drug Administration (FDA) in May 2016 for the treatment of certain subtypes of non-small cell lung cancer (NSCLC). The designation is for anaplastic lymphoma kinase-positive (ALK+), c-ros 1 oncogene positive (ROS1+), or epidermal growth factor receptor positive (EGFR+) non-small cell lung cancer (NSCLC). Brigatinib received breakthrough therapy designation from the FDA in October 2014 for the treatment of patients with ALK+ NSCLC whose disease is resistant to crizotinib. Both designations were based on results from an ongoing Phase 1/2 trial that showed anti-tumor activity of brigatinib in patients with ALK+ NSCLC, including patients with active brain metastases.   NCATS

Chemistry

  • SMILES: COC1=C(NC2=NC=C(Cl)C(NC3=CC=CC=C3P(C)(C)=O)=N2)C=CC(=C1)N4CCC(CC4)N5CCN(C)CC5
  • InChIKey: AILRADAXUVEEIR-UHFFFAOYSA-N
  • Mol. Mass: 584.092
  • ALogP: 5.09
  • ChEMBL Molecule:
    brigatinib  
More Chemistry

Pharmacology

Drug Pricing (per unit)

Australia

$46.4297 - $185.7181

United States

$131.0573 - $498.7729
More Pricing Detail

Note: This drug pricing data is preliminary, incomplete, and may contain errors.

Alternative names

alunbrig | ap26113 | ap-26113 | brigatinib

Organizations (29)

Research & Development (29)

Organization Org Type FDA approvals Clinical Trials involvement Org ID Force Sort

Marketing (2)

Organization Org Type FDA approvals Clinical Trials involvement Org ID Force Sort

Indications (19)

Approved Indications (1)


 

Carcinoma, Non-Small-Cell Lung

Experimental Indications - Clinical Trial Phases 1-4 (19)


 

Brain Neoplasms (Phase 2)

Breast Neoplasms (Phase 2)

Carcinoma (Phase 3)

Carcinoma, Non-Small-Cell Lung ()

Ependymoma (Phase 2)

Gastrointestinal Neoplasms (Phase 2)

Healthy Volunteers (Phase 1)

Lung Neoplasms (Phase 3)

Lymphoma (Phase 3)

Lymphoma, Large-Cell, Anaplastic (Phase 2)

Meningioma (Phase 2)

Mutation (Phase 2)

Neoplasm Metastasis (Phase 2)

Neoplasms (Phase 2)

Neurofibromatosis 2 (Phase 2)

Neuroma, Acoustic (Phase 2)

Oncogene Proteins (Phase 2)

Oncogenes (Phase 2)

Vestibular Diseases (Phase 2)

Overview

  • Highest Phase: Phase 3
  • # of Trials: 27
  • # of Trial Organizations: 29

Trials by Phase

Trial Phase Start Date Organizations Indications

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