Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Mobocertinib
Therapeutic Area : Oncology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Takeda Provides Update on EXKIVITY® (mobocertinib)
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 advanc...
Brand Name : Exkivity
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 02, 2023
Lead Product(s) : Mobocertinib
Therapeutic Area : Oncology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Mobocertinib
Therapeutic Area : Oncology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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 advanc...
Brand Name : Exkivity
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 04, 2023
Lead Product(s) : Mobocertinib
Therapeutic Area : Oncology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Mobocertinib
Therapeutic Area : Oncology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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 mu...
Brand Name : Exkivity
Molecule Type : Small molecule
Upfront Cash : Not Applicable
January 11, 2023
Lead Product(s) : Mobocertinib
Therapeutic Area : Oncology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Mobocertinib
Therapeutic Area : Oncology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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 ...
Brand Name : Exkivity
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 15, 2021
Lead Product(s) : Mobocertinib
Therapeutic Area : Oncology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Mobocertinib
Therapeutic Area : Oncology
Study Phase : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : TAK-788
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 28, 2021
Lead Product(s) : Mobocertinib
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Mobocertinib
Therapeutic Area : Oncology
Study Phase : Phase I/ Phase II
Sponsor : Takeda Pharmaceutical
Deal Size : Undisclosed
Deal Type : Collaboration
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 eli...
Brand Name : TAK-788
Molecule Type : Small molecule
Upfront Cash : Undisclosed
September 18, 2020
Lead Product(s) : Mobocertinib
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Sponsor : Takeda Pharmaceutical
Deal Size : Undisclosed
Deal Type : Collaboration
Lead Product(s) : Mobocertinib
Therapeutic Area : Oncology
Study Phase : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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 ins...
Brand Name : TAK-788
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 18, 2020
Lead Product(s) : Mobocertinib
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Mobocertinib
Therapeutic Area : Oncology
Study Phase : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 27, 2020
Lead Product(s) : Mobocertinib
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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