X
API Suppliers
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
0
Other Suppliers
0
USA (Orange Book)
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
Annual Reports
0
0
Details:
Exkivity® (mobocertinib) is a kinase inhibitor of the EGFR that irreversibly binds to and inhibits EGFR exon 20 insertion mutations at lower concentrations than wild type (WT) EGFR. It is being investigated for EGFR Exon 20 Insertion mutations in advanced NSCLC.
Lead Product(s): Mobocertinib
Therapeutic Area: Oncology Product Name: Exkivity
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 02, 2023
Details:
Exkivity® (mobocertinib) is a kinase inhibitor of the EGFR that irreversibly binds to and inhibits EGFR exon 20 insertion mutations at lower concentrations than wild type (WT) EGFR. It is being investigated for EGFR Exon 20 Insertion mutations in advanced NSCLC.
Lead Product(s): Mobocertinib
Therapeutic Area: Oncology Product Name: Exkivity
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 04, 2023
Details:
Exkivity (mobocertinib) is an oral tyrosine kinase inhibitor specifically designed to selectively target epidermal growth factor receptor (EGFR) Exon20 insertion mutations. It is currently approved for the treatment of NSCLC with EGFR Exon20 insertion mutations.
Lead Product(s): Mobocertinib
Therapeutic Area: Oncology Product Name: Exkivity
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 11, 2023
Details:
EXKIVITY, which was granted priority review and received Breakthrough Therapy Designation, Fast Track Designation and Orphan Drug Designation from the FDA, is the first and only approved oral therapy specifically designed to target EGFR Exon20 insertion mutations.
Lead Product(s): Mobocertinib
Therapeutic Area: Oncology Product Name: Exkivity
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 15, 2021
Details:
The NDA for mobocertinib is primarily based on results from the Phase 1/2 trial, which is evaluating the safety and efficacy of oral mobocertinib in patients with mNSCLC.
Lead Product(s): Mobocertinib
Therapeutic Area: Oncology Product Name: TAK-788
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 28, 2021
Details:
Collaboration aims at developing blood-based companion diagnostics for use with marketed and investigational treatments in Takeda’s late-stage lung cancer portfolio. Companion diagnostics, if approved, would be used to identify patients who may be eligible for mobocertinib.
Lead Product(s): Mobocertinib
Therapeutic Area: Oncology Product Name: TAK-788
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Takeda Pharmaceutical
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration September 18, 2020
Details:
Takeda is featuring updated 10-month follow-up results from the Phase 1/2 trial of mobocertinib (TAK-788), demonstrating mobocertinib achieved a duration of response of more than one year in the trial’s study population of patients with EGFR Exon20 insertion+ metastatic NSCLC.
Lead Product(s): Mobocertinib
Therapeutic Area: Oncology Product Name: TAK-788
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 18, 2020
Details:
Breakthrough Therapy Designation is based on the overall response rate and the long-term benefit seen in patients who responded in a Ph 1/2 study evaluating the safety and efficacy of mobocertinib.
Lead Product(s): Mobocertinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] 
Market Place
