[{"orgOrder":0,"company":"Takeda Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Takeda Announces U.S. FDA Breakthrough Therapy Designation for Mobocertinib for Treatment of NSCLC Patients ","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2020","year":"2020","type":"Not Applicable","leadProduct":"Mobocertinib","moa":"EGFR","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II","graph3":"Takeda Pharmaceutical","amount2":0,"therapeuticAreaNew":"Oncology","highestDevelopmentStatusNew":"Phase I\/ Phase II","highestDevelopmentShortName":"Ph I\/II","therapeuticAreaShortName":"Oncology","productSubType":"","amount2New":0,"dosageForm":"Capsule","sponsorNew":"Takeda Pharmaceutical \/ Not Applicable","highestDevelopmentStatusID":"7","companyTruncated":"Takeda Pharmaceutical \/ Not Applicable"},{"orgOrder":0,"company":"Foundation Medicine","sponsor":"Takeda Pharmaceutical","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Foundation Medicine and Takeda Announce Collaboration To Develop FoundationOne\u00aeCDx and FoundationOne\u00aeLiquid CDx","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2020","year":"2020","type":"Collaboration","leadProduct":"Mobocertinib","moa":"EGFR","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II","graph3":"Foundation Medicine","amount2":0,"therapeuticAreaNew":"Oncology","highestDevelopmentStatusNew":"Phase I\/ Phase II","highestDevelopmentShortName":"Ph I\/II","therapeuticAreaShortName":"Oncology","productSubType":"","amount2New":0,"dosageForm":"Capsule","sponsorNew":"Foundation Medicine \/ Takeda Pharmaceutical","highestDevelopmentStatusID":"7","companyTruncated":"Foundation Medicine \/ Takeda Pharmaceutical"},{"orgOrder":0,"company":"Takeda Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Takeda Presents New Data Highlighting Scientific Advancements in Lung Cancer at ESMO Virtual Congress","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2020","year":"2020","type":"Not Applicable","leadProduct":"Mobocertinib","moa":"EGFR","url1":"","url2":"","graph1":"Oncology","graph2":"Approved","graph3":"Takeda Pharmaceutical","amount2":0,"therapeuticAreaNew":"Oncology","highestDevelopmentStatusNew":"Approved","highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Oncology","productSubType":"","amount2New":0,"dosageForm":"Capsule","sponsorNew":"Takeda 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Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"","productType":"Small molecule","productStatus":"Approved","date":"May 2023","year":"2023","type":"Not Applicable","leadProduct":"Mobocertinib","moa":"","url1":"","url2":"","graph1":"Oncology","graph2":"Approved","graph3":"FoundationOne","amount2":0,"therapeuticAreaNew":"Oncology","highestDevelopmentStatusNew":"Approved","highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Oncology","productSubType":"Cytotoxic Drug","amount2New":0,"dosageForm":"Capsule","sponsorNew":"FoundationOne \/ Not Applicable","highestDevelopmentStatusID":"12","companyTruncated":"FoundationOne \/ Not Applicable"},{"orgOrder":0,"company":"Takeda Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Takeda Provides Update on EXKIVITY\u00ae (mobocertinib)","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"","productType":"Small molecule","productStatus":"Approved","date":"October 2023","year":"2023","type":"Not Applicable","leadProduct":"Mobocertinib","moa":"","url1":"","url2":"","graph1":"Oncology","graph2":"Approved","graph3":"Takeda Pharmaceutical","amount2":0,"therapeuticAreaNew":"Oncology","highestDevelopmentStatusNew":"Approved","highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Oncology","productSubType":"Cytotoxic Drug","amount2New":0,"dosageForm":"Capsule","sponsorNew":"Takeda Pharmaceutical \/ Not Applicable","highestDevelopmentStatusID":"12","companyTruncated":"Takeda Pharmaceutical \/ Not Applicable"}]

Find Clinical Drug Pipeline Developments & Deals for Mobocertinib

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                          01

                          Discovery on Target
                          Not Confirmed
                          Discovery on Target
                          Not Confirmed

                          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

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                          02

                          Discovery on Target
                          Not Confirmed
                          Discovery on Target
                          Not Confirmed

                          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

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                          03

                          Discovery on Target
                          Not Confirmed
                          Discovery on Target
                          Not Confirmed

                          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

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                          04

                          Discovery on Target
                          Not Confirmed
                          Discovery on Target
                          Not Confirmed

                          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

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                          05

                          Discovery on Target
                          Not Confirmed
                          Discovery on Target
                          Not Confirmed

                          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

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                          06

                          Discovery on Target
                          Not Confirmed
                          Discovery on Target
                          Not Confirmed

                          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

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                          07

                          Discovery on Target
                          Not Confirmed
                          Discovery on Target
                          Not Confirmed

                          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

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                          08

                          Discovery on Target
                          Not Confirmed
                          Discovery on Target
                          Not Confirmed

                          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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