[{"orgOrder":0,"company":"Pfizer Inc","sponsor":"Celcuity","pharmaFlowCategory":"D","amount":"$340.0 million","upfrontCash":"$5.0 million","newsHeadline":"Celcuity Announces Licensing Agreement with Pfizer to Develop and Commercialize Gedatolisib","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2021","year":"2021","type":"Licensing Agreement","leadProduct":"Gedatolisib","moa":"PI3K\/mTOR","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I","graph3":"Pfizer Inc","amount2":0.34000000000000002,"therapeuticAreaNew":"Oncology","highestDevelopmentStatusNew":"Phase I","highestDevelopmentShortName":"Ph I","therapeuticAreaShortName":"Oncology","productSubType":"","amount2New":0.34000000000000002,"dosageForm":"Intravenous Injection","sponsorNew":"Pfizer Inc \/ Celcuity","highestDevelopmentStatusID":"6","companyTruncated":"Pfizer Inc \/ Celcuity"},{"orgOrder":0,"company":"Celcuity","sponsor":"Pfizer Inc","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Celcuity Announces Clinical Trial Collaboration and Supply Agreement with Pfizer to Provide Ibrance(R) (Palbociclib) for Planned Phase 3 Clinical Trial","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2021","year":"2021","type":"Collaboration","leadProduct":"Gedatolisib","moa":"Pan-PI3K class I","url1":"","url2":"","graph1":"Oncology","graph2":"IND Enabling","graph3":"Celcuity","amount2":0,"therapeuticAreaNew":"Oncology","highestDevelopmentStatusNew":"IND Enabling","highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Oncology","productSubType":"","amount2New":0,"dosageForm":"Intravenous","sponsorNew":"Celcuity \/ Pfizer","highestDevelopmentStatusID":"5","companyTruncated":"Celcuity \/ Pfizer"},{"orgOrder":0,"company":"Celcuity","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Celcuity to Present Additional Data for Gedatolisib at the 2022 San Antonio Breast Cancer Symposium","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2022","year":"2022","type":"Not Applicable","leadProduct":"Gedatolisib","moa":"","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III","graph3":"Celcuity","amount2":0,"therapeuticAreaNew":"Oncology","highestDevelopmentStatusNew":"Phase III","highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Oncology","productSubType":"","amount2New":0,"dosageForm":"Infusion","sponsorNew":"Celcuity \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Celcuity \/ Not Applicable"},{"orgOrder":0,"company":"Celcuity","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Celcuity Announces First Patient Dosed in Phase 3 VIKTORIA-1 Clinical Trial of Gedatolisib for the Treatment of HR+\/HER2- Advanced Breast Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2022","year":"2022","type":"Not Applicable","leadProduct":"Gedatolisib","moa":"","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III","graph3":"Celcuity","amount2":0,"therapeuticAreaNew":"Oncology","highestDevelopmentStatusNew":"Phase III","highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Oncology","productSubType":"Small molecule","amount2New":0,"dosageForm":"Infusion","sponsorNew":"Celcuity \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Celcuity \/ Not Applicable"},{"orgOrder":0,"company":"Celcuity","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Celcuity Presents Updated Results of Phase 1b Study of Gedatolisib in Patients with Advanced Breast Cancer at the 2022 San Antonio Breast Cancer Symposium","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2022","year":"2022","type":"Not Applicable","leadProduct":"Gedatolisib","moa":"","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III","graph3":"Celcuity","amount2":0,"therapeuticAreaNew":"Oncology","highestDevelopmentStatusNew":"Phase III","highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Oncology","productSubType":"","amount2New":0,"dosageForm":"Infusion","sponsorNew":"Celcuity \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Celcuity \/ Not Applicable"},{"orgOrder":0,"company":"Celcuity","sponsor":"Bayer AG","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Celcuity Enters into a Clinical Trial Collaboration and Supply Agreement with Bayer to Provide Nubeqa\u00ae (darolutamide) for Planned Phase 1b\/2 Clinical Trial","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2023","year":"2023","type":"Collaboration","leadProduct":"Gedatolisib","moa":"","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II","graph3":"Celcuity","amount2":0,"therapeuticAreaNew":"Oncology","highestDevelopmentStatusNew":"Phase I\/ Phase II","highestDevelopmentShortName":"Ph I\/II","therapeuticAreaShortName":"Oncology","productSubType":"","amount2New":0,"dosageForm":"Infusion","sponsorNew":"Celcuity \/ Bayer AG","highestDevelopmentStatusID":"7","companyTruncated":"Celcuity \/ Bayer AG"},{"orgOrder":0,"company":"Celcuity","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Celcuity Announces Plan to Conduct Phase 1b\/2 Clinical Trial in Metastatic Castration Resistant Prostate Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2023","year":"2023","type":"Not Applicable","leadProduct":"Gedatolisib","moa":"","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II","graph3":"Celcuity","amount2":0,"therapeuticAreaNew":"Oncology","highestDevelopmentStatusNew":"Phase I\/ Phase II","highestDevelopmentShortName":"Ph I\/II","therapeuticAreaShortName":"Oncology","productSubType":"","amount2New":0,"dosageForm":"Infusion","sponsorNew":"Celcuity \/ Not Applicable","highestDevelopmentStatusID":"7","companyTruncated":"Celcuity \/ Not Applicable"},{"orgOrder":0,"company":"Celcuity","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Celcuity Announces First Patient Dosed in Phase 1b\/2 CELC-G-201 Clinical Trial of Gedatolisib for the Treatment of Metastatic Castration Resistant Prostate Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2024","year":"2024","type":"Not Applicable","leadProduct":"Gedatolisib","moa":"","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II","graph3":"Celcuity","amount2":0,"therapeuticAreaNew":"Oncology","highestDevelopmentStatusNew":"Phase I\/ Phase II","highestDevelopmentShortName":"Ph I\/II","therapeuticAreaShortName":"Oncology","productSubType":"","amount2New":0,"dosageForm":"Infusion","sponsorNew":"Celcuity \/ Not Applicable","highestDevelopmentStatusID":"7","companyTruncated":"Celcuity \/ Not Applicable"},{"orgOrder":0,"company":"Celcuity","sponsor":"Undisclosed","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Celcuity Plans Phase 3 Trial for Gedatolisib in Advanced Breast Cancer with Financing","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2024","year":"2024","type":"Financing","leadProduct":"Gedatolisib","moa":"","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III","graph3":"Celcuity","amount2":0,"therapeuticAreaNew":"Oncology","highestDevelopmentStatusNew":"Phase III","highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Oncology","productSubType":"Small molecule","amount2New":0,"dosageForm":"","sponsorNew":"Celcuity \/ Undisclosed","highestDevelopmentStatusID":"10","companyTruncated":"Celcuity \/ Undisclosed"}]

Find Clinical Drug Pipeline Developments & Deals for Gedatolisib

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                          Top Deals by Deal Size (USD bn)

                          01

                          Discovery on Target
                          Not Confirmed
                          Discovery on Target
                          Not Confirmed

                          Details : The financing aims to support the clinical development of PKI-587 (gedatolisib), which is being evaluated in the late-stage trial studies for the treatment of HR+/HER2- advanced Breast Cancer.

                          Brand Name : PKI-587

                          Molecule Type : Small molecule

                          Upfront Cash : Undisclosed

                          May 30, 2024

                          Lead Product(s) : Gedatolisib,Palbociclib,Fulvestrant

                          Therapeutic Area : Oncology

                          Highest Development Status : Phase III

                          Sponsor : Undisclosed

                          Deal Size : Undisclosed

                          Deal Type : Financing

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                          02

                          Discovery on Target
                          Not Confirmed
                          Discovery on Target
                          Not Confirmed

                          Details : PKI-587 (gedatolisib) is an investigational, intravenously administered pan-class I isoform PI3K and mTOR inhibitor. It is being evaluated in combination with Nubeqa (darolutamide) for the treatment of metastatic castration resistant prostate cancer.

                          Brand Name : PKI-587

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          February 22, 2024

                          Lead Product(s) : Gedatolisib,Darolutamide

                          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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                          03

                          Discovery on Target
                          Not Confirmed
                          Discovery on Target
                          Not Confirmed

                          Details : Under the agreement, Bayer will provide Nubeqa to Celcuity for its Phase 1b/2 trial of PKI-587 (gedatolisib), a potent inhibitor that selectively targets all Class I isoforms of PI3K and mTOR, in combination with darolutamide in metastatic castration res...

                          Brand Name : PF-05212384

                          Molecule Type : Small molecule

                          Upfront Cash : Undisclosed

                          August 22, 2023

                          Lead Product(s) : Gedatolisib,Darolutamide

                          Therapeutic Area : Oncology

                          Highest Development Status : IND Enabling

                          Sponsor : Bayer AG

                          Deal Size : Undisclosed

                          Deal Type : Collaboration

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                          04

                          Discovery on Target
                          Not Confirmed
                          Discovery on Target
                          Not Confirmed

                          Details : PKI-587 (gedatolisib) is a potent inhibitor that selectively targets all Class I isoforms of PI3K and mTOR, and investigating in ombination with darolutamide for the treatment of patients with metastatic castration resistant prostate cancer.

                          Brand Name : PF-05212384

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          August 22, 2023

                          Lead Product(s) : Gedatolisib,Darolutamide

                          Therapeutic Area : Oncology

                          Highest Development Status : IND Enabling

                          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 : PKI-587 (Gedatolisib) is a potent, reversible dual inhibitor that selectively targets all Class I PI3K isoforms and mTOR. Its in Phase 1b clinical trial in combination with palbociclib and endocrine therapy for patients with HR+/HER2- advanced breast can...

                          Brand Name : PKI-587

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          December 09, 2022

                          Lead Product(s) : Gedatolisib,Palbociclib,Fulvestrant

                          Therapeutic Area : Oncology

                          Highest Development Status : Phase I

                          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 : Gedatolisib for the treatment of HR+/HER2- advanced breast cancer that has progressed after treatment with a CDK4/6 inhibitor in combination with an aromatase inhibitor.

                          Brand Name : PKI-587

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          December 07, 2022

                          Lead Product(s) : Gedatolisib,Palbociclib,Fulvestrant

                          Therapeutic Area : Oncology

                          Highest Development Status : Phase III

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          07

                          Discovery on Target
                          Not Confirmed
                          Discovery on Target
                          Not Confirmed

                          Details : PKI-587 (gedatolisib) is a potent, reversible dual inhibitor that selectively targets all Class 1 PI3K isoforms and mTOR. Its MOA and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that ta...

                          Brand Name : PKI-587

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          November 22, 2022

                          Lead Product(s) : Gedatolisib,Palbociclib,Undisclosed

                          Therapeutic Area : Oncology

                          Highest Development Status : Phase I

                          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 : Under the terms of collaboration with Pfizer will provide Ibrance® (palbociclib) for use in Celcuity's Phase 3 clinical trial to evaluate gedatolisib, in combination with palbociclib, and Faslodex® (fulvestrant), in patients with ER+/HER2- advanced bre...

                          Brand Name : Undisclosed

                          Molecule Type : Small molecule

                          Upfront Cash : Undisclosed

                          November 15, 2021

                          Lead Product(s) : Gedatolisib,Palbociclib

                          Therapeutic Area : Oncology

                          Highest Development Status : IND Enabling

                          Sponsor : Pfizer Inc

                          Deal Size : Undisclosed

                          Deal Type : Collaboration

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                          09

                          Discovery on Target
                          Not Confirmed
                          Discovery on Target
                          Not Confirmed

                          Details : Gedatolisib is a Phase 1b pan-PI3K/mTOR inhibitor. Under the terms of the licensing agreement, Pfizer provided Celcuity with a worldwide license to develop and commercialize gedatolisib.

                          Brand Name : PF-05212384

                          Molecule Type : Small molecule

                          Upfront Cash : $5.0 million

                          April 08, 2021

                          Lead Product(s) : Gedatolisib

                          Therapeutic Area : Oncology

                          Highest Development Status : Phase I

                          Sponsor : Celcuity

                          Deal Size : $340.0 million

                          Deal Type : Licensing Agreement

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