menu
    • menu
    [{"orgOrder":0,"company":"Pfizer Inc","sponsor":"Celcuity","pharmaFlowCategory":"D","therapeuticArea":"Oncology","country":"","productType":"Small molecule","year":"2021","type":"Licensing Agreement","leadProduct":"Gedatolisib","moa":"PI3K\/mTOR","graph1":"Oncology","graph2":"Phase I","graph3":"Pfizer Inc","amount2":0.34000000000000002,"highestDevelopmentShortName":"Ph I","therapeuticAreaShortName":"Oncology","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","therapeuticArea":"Oncology","country":"","productType":"Small molecule","year":"2021","type":"Collaboration","leadProduct":"Gedatolisib","moa":"Pan-PI3K class I","graph1":"Oncology","graph2":"IND Enabling","graph3":"Celcuity","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"Intravenous","sponsorNew":"Celcuity \/ Pfizer","highestDevelopmentStatusID":"5","companyTruncated":"Celcuity \/ Pfizer"},{"orgOrder":0,"company":"Celcuity","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Oncology","country":"","productType":"Small molecule","year":"2022","type":"Not Applicable","leadProduct":"Gedatolisib","moa":"","graph1":"Oncology","graph2":"Phase III","graph3":"Celcuity","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"Infusion","sponsorNew":"Celcuity \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Celcuity \/ Not Applicable"},{"orgOrder":0,"company":"Celcuity","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Oncology","country":"","productType":"Small molecule","year":"2022","type":"Not Applicable","leadProduct":"Gedatolisib","moa":"","graph1":"Oncology","graph2":"Phase III","graph3":"Celcuity","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"Infusion","sponsorNew":"Celcuity \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Celcuity \/ Not Applicable"},{"orgOrder":0,"company":"Celcuity","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Oncology","country":"","productType":"Small molecule","year":"2022","type":"Not Applicable","leadProduct":"Gedatolisib","moa":"","graph1":"Oncology","graph2":"Phase III","graph3":"Celcuity","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"Infusion","sponsorNew":"Celcuity \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Celcuity \/ Not Applicable"},{"orgOrder":0,"company":"Celcuity","sponsor":"Bayer AG","pharmaFlowCategory":"D","therapeuticArea":"Oncology","country":"","productType":"Small molecule","year":"2023","type":"Collaboration","leadProduct":"Gedatolisib","moa":"","graph1":"Oncology","graph2":"Phase I\/ Phase II","graph3":"Celcuity","amount2":0,"highestDevelopmentShortName":"Ph I\/II","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"Infusion","sponsorNew":"Celcuity \/ Bayer AG","highestDevelopmentStatusID":"7","companyTruncated":"Celcuity \/ Bayer AG"},{"orgOrder":0,"company":"Celcuity","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Oncology","country":"","productType":"Small molecule","year":"2023","type":"Not Applicable","leadProduct":"Gedatolisib","moa":"","graph1":"Oncology","graph2":"Phase I\/ Phase II","graph3":"Celcuity","amount2":0,"highestDevelopmentShortName":"Ph I\/II","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"Infusion","sponsorNew":"Celcuity \/ Not Applicable","highestDevelopmentStatusID":"7","companyTruncated":"Celcuity \/ Not Applicable"},{"orgOrder":0,"company":"Celcuity","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Oncology","country":"","productType":"Small molecule","year":"2024","type":"Not Applicable","leadProduct":"Gedatolisib","moa":"","graph1":"Oncology","graph2":"Phase I\/ Phase II","graph3":"Celcuity","amount2":0,"highestDevelopmentShortName":"Ph I\/II","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"Infusion","sponsorNew":"Celcuity \/ Not Applicable","highestDevelopmentStatusID":"7","companyTruncated":"Celcuity \/ Not Applicable"},{"orgOrder":0,"company":"Celcuity","sponsor":"Undisclosed","pharmaFlowCategory":"D","therapeuticArea":"Oncology","country":"","productType":"Small molecule","year":"2024","type":"Financing","leadProduct":"Gedatolisib","moa":"","graph1":"Oncology","graph2":"Phase III","graph3":"Celcuity","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"","sponsorNew":"Celcuity \/ Undisclosed","highestDevelopmentStatusID":"10","companyTruncated":"Celcuity \/ Undisclosed"}]

    Find Clinical Drug Pipeline Developments & Deals for Gedatolisib

    Menu

    Gedatolisib

    DEVELOPMENTS

    DIGITAL CONTENT

    PharmaCompass
    Xls
    Filters Filter
    ×
    FILTER:
    filter
    Company Name
      filter

      Year

        filter

        DEALS // DEV.

          filter

          Country

            filter
            Sponsor
              filter

              Therapeutic Area

                filter

                Study Phase

                  filter

                  Deal Type

                    filter

                    Product Type

                      filter

                      Dosage Form

                        filter

                        Lead Product

                          filter

                          Target

                            Loading...
                            refresh Filters
                            refresh Reset Filter
                            refresh Reset Filter
                            price-trend All Developments

                            Therapeutic Area by Lead Product

                            Study Phase by Lead Product

                            Company by Lead Product

                            Top Deals by Deal Size (USD bn)

                            01

                            Celcuity

                            U.S.A arrow
                            Medlab Asia & Asia Health
                            Not Confirmed

                            Celcuity

                            U.S.A arrow
                            Medlab Asia & Asia Health
                            Not Confirmed
                            • fda
                            • EDQM
                            • WHO-GMP
                            Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

                            Lead Product(s) : Gedatolisib,Palbociclib,Fulvestrant

                            Therapeutic Area : Oncology

                            Study Phase : Phase III

                            Sponsor : Undisclosed

                            Deal Size : Undisclosed

                            Deal Type : Financing

                            DEALS_DEV arrow-down

                            Celcuity Plans Phase 3 Trial for Gedatolisib in Advanced Breast Cancer with Financing

                            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

                            blank

                            Stock Recap
                            #PipelineProspector

                            Data Compilation
                            #PharmaFlow

                            Virtual Booth

                            02

                            Celcuity

                            U.S.A arrow
                            Medlab Asia & Asia Health
                            Not Confirmed

                            Celcuity

                            U.S.A arrow
                            Medlab Asia & Asia Health
                            Not Confirmed
                            • fda
                            • EDQM
                            • WHO-GMP
                            Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

                            Lead Product(s) : Gedatolisib,Darolutamide

                            Therapeutic Area : Oncology

                            Study Phase : Phase I/ Phase II

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Celcuity Doses First Patient in Phase 1b/2 Trial of Gedatolisib for Prostate Cancer

                            Details : PKI-587 (gedatolisib) is an intravenously administered pan-class I isoform PI3K and mTOR inhibitor, evaluated with Nubeqa (darolutamide) for 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

                            blank

                            Stock Recap
                            #PipelineProspector

                            Data Compilation
                            #PharmaFlow

                            Virtual Booth

                            03

                            Celcuity

                            U.S.A arrow
                            Medlab Asia & Asia Health
                            Not Confirmed

                            Celcuity

                            U.S.A arrow
                            Medlab Asia & Asia Health
                            Not Confirmed
                            • fda
                            • EDQM
                            • WHO-GMP
                            Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

                            Lead Product(s) : Gedatolisib,Darolutamide

                            Therapeutic Area : Oncology

                            Study Phase : IND Enabling

                            Sponsor : Bayer AG

                            Deal Size : Undisclosed

                            Deal Type : Collaboration

                            DEALS_DEV arrow-down

                            Celcuity Enters into a Clinical Trial Collaboration and Supply Agreement with Bayer to Provide Nubeqa® (darol...

                            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

                            blank

                            Stock Recap
                            #PipelineProspector

                            Data Compilation
                            #PharmaFlow

                            Virtual Booth

                            04

                            Celcuity

                            U.S.A arrow
                            Medlab Asia & Asia Health
                            Not Confirmed

                            Celcuity

                            U.S.A arrow
                            Medlab Asia & Asia Health
                            Not Confirmed
                            • fda
                            • EDQM
                            • WHO-GMP
                            Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

                            Lead Product(s) : Gedatolisib,Darolutamide

                            Therapeutic Area : Oncology

                            Study Phase : IND Enabling

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Celcuity Announces Plan to Conduct Phase 1b/2 Clinical Trial in Metastatic Castration Resistant Prostate Cance...

                            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

                            blank

                            Stock Recap
                            #PipelineProspector

                            Data Compilation
                            #PharmaFlow

                            Virtual Booth

                            05

                            Celcuity

                            U.S.A arrow
                            Medlab Asia & Asia Health
                            Not Confirmed

                            Celcuity

                            U.S.A arrow
                            Medlab Asia & Asia Health
                            Not Confirmed
                            • fda
                            • EDQM
                            • WHO-GMP
                            Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

                            Lead Product(s) : Gedatolisib,Palbociclib,Fulvestrant

                            Therapeutic Area : Oncology

                            Study Phase : Phase I

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Celcuity Presents Updated Results of Phase 1b Study of Gedatolisib in Patients with Advanced Breast Cancer at ...

                            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

                            blank

                            Stock Recap
                            #PipelineProspector

                            Data Compilation
                            #PharmaFlow

                            Virtual Booth

                            06

                            Celcuity

                            U.S.A arrow
                            Medlab Asia & Asia Health
                            Not Confirmed

                            Celcuity

                            U.S.A arrow
                            Medlab Asia & Asia Health
                            Not Confirmed
                            • fda
                            • EDQM
                            • WHO-GMP
                            Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

                            Lead Product(s) : Gedatolisib,Palbociclib,Fulvestrant

                            Therapeutic Area : Oncology

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Celcuity Announces First Patient Dosed in Phase 3 VIKTORIA-1 Clinical Trial of Gedatolisib for the Treatment o...

                            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

                            blank

                            Stock Recap
                            #PipelineProspector

                            Data Compilation
                            #PharmaFlow

                            Virtual Booth

                            07

                            Celcuity

                            U.S.A arrow
                            Medlab Asia & Asia Health
                            Not Confirmed

                            Celcuity

                            U.S.A arrow
                            Medlab Asia & Asia Health
                            Not Confirmed
                            • fda
                            • EDQM
                            • WHO-GMP
                            Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

                            Lead Product(s) : Gedatolisib,Palbociclib,Undisclosed

                            Therapeutic Area : Oncology

                            Study Phase : Phase I

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Celcuity to Present Additional Data for Gedatolisib at the 2022 San Antonio Breast Cancer Symposium

                            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

                            blank

                            Stock Recap
                            #PipelineProspector

                            Data Compilation
                            #PharmaFlow

                            Virtual Booth

                            08

                            Celcuity

                            U.S.A arrow
                            Medlab Asia & Asia Health
                            Not Confirmed

                            Celcuity

                            U.S.A arrow
                            Medlab Asia & Asia Health
                            Not Confirmed
                            • fda
                            • EDQM
                            • WHO-GMP
                            Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

                            Lead Product(s) : Gedatolisib,Palbociclib

                            Therapeutic Area : Oncology

                            Study Phase : IND Enabling

                            Sponsor : Pfizer Inc

                            Deal Size : Undisclosed

                            Deal Type : Collaboration

                            DEALS_DEV arrow-down

                            Celcuity Announces Clinical Trial Collaboration and Supply Agreement with Pfizer to Provide Ibrance(R) (Palboc...

                            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

                            blank

                            Stock Recap
                            #PipelineProspector

                            Data Compilation
                            #PharmaFlow

                            Virtual Booth

                            09

                            Pfizer Inc

                            U.S.A arrow
                            Medlab Asia & Asia Health
                            Not Confirmed

                            Pfizer Inc

                            U.S.A arrow
                            Medlab Asia & Asia Health
                            Not Confirmed
                            • fda
                            • EDQM
                            • WHO-GMP
                            Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

                            Lead Product(s) : Gedatolisib

                            Therapeutic Area : Oncology

                            Study Phase : Phase I

                            Sponsor : Celcuity

                            Deal Size : $340.0 million

                            Deal Type : Licensing Agreement

                            DEALS_DEV arrow-down

                            Celcuity Announces Licensing Agreement with Pfizer to Develop and Commercialize Gedatolisib

                            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

                            blank

                            Stock Recap
                            #PipelineProspector

                            Data Compilation
                            #PharmaFlow

                            Virtual Booth