Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Mobocertinib Succinate
Therapeutic Area : Oncology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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...
Product Name : Exkivity
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 01, 2023
Lead Product(s) : Mobocertinib Succinate
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Mobocertinib Succinate
Therapeutic Area : Oncology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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...
Product Name : Exkivity
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 05, 2023
Lead Product(s) : Mobocertinib Succinate
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Mobocertinib Succinate
Therapeutic Area : Oncology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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...
Product Name : Exkivity
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 10, 2023
Lead Product(s) : Mobocertinib Succinate
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Mobocertinib Succinate
Therapeutic Area : Oncology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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 ...
Product Name : Exkivity
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 15, 2021
Lead Product(s) : Mobocertinib Succinate
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Mobocertinib Succinate
Therapeutic Area : Oncology
Study Phase : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Exkivity
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 28, 2021
Lead Product(s) : Mobocertinib Succinate
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Mobocertinib Succinate
Therapeutic Area : Oncology
Study Phase : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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...
Product Name : Exkivity
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 18, 2020
Lead Product(s) : Mobocertinib Succinate
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Mobocertinib Succinate
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...
Product Name : TAK-788
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
September 18, 2020
Lead Product(s) : Mobocertinib Succinate
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Sponsor : Takeda Pharmaceutical
Deal Size : Undisclosed
Deal Type : Collaboration
Lead Product(s) : Mobocertinib Succinate
Therapeutic Area : Oncology
Study Phase : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Exkivity
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 27, 2020
Lead Product(s) : Mobocertinib Succinate
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable