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    [{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Neurology","country":"FRANCE","productType":"Small molecule","year":"2020","type":"Not Applicable","leadProduct":"SAR442168","moa":"BTK","graph1":"Neurology","graph2":"Phase II","graph3":"Sanofi","amount2":0,"highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Neurology","amount2New":0,"dosageForm":"Film Coated Tablet","sponsorNew":"Sanofi \/ Not Applicable","highestDevelopmentStatusID":"8","companyTruncated":"Sanofi \/ Not Applicable"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Neurology","country":"FRANCE","productType":"Small molecule","year":"2020","type":"Not Applicable","leadProduct":"SAR442168","moa":"BTK","graph1":"Neurology","graph2":"Phase II","graph3":"Sanofi","amount2":0,"highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Neurology","amount2New":0,"dosageForm":"Film Coated 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Applicable"},{"orgOrder":0,"company":"Koneksa","sponsor":"Sanofi","pharmaFlowCategory":"D","therapeuticArea":"Immunology","country":"","productType":"Small molecule","year":"2021","type":"Collaboration","leadProduct":"Tolebrutinib","moa":"BTK","graph1":"Immunology","graph2":"Phase III","graph3":"Koneksa","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Immunology","amount2New":0,"dosageForm":"Tablet, Film Coated","sponsorNew":"Koneksa \/ Sanofi","highestDevelopmentStatusID":"10","companyTruncated":"Koneksa \/ Sanofi"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Neurology","country":"","productType":"Small molecule","year":"2022","type":"Not Applicable","leadProduct":"Tolebrutinib","moa":"BTK","graph1":"Neurology","graph2":"Phase III","graph3":"Sanofi","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Neurology","amount2New":0,"dosageForm":"Tablet, Film Coated","sponsorNew":"Sanofi \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Sanofi \/ Not Applicable"},{"orgOrder":0,"company":"Terran Biosciences","sponsor":"Sanofi","pharmaFlowCategory":"D","therapeuticArea":"Neurology","country":"","productType":"Small molecule","year":"2022","type":"Licensing Agreement","leadProduct":"Tolebrutinib","moa":"BTK","graph1":"Neurology","graph2":"Phase III","graph3":"Terran Biosciences","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Neurology","amount2New":0,"dosageForm":"Tablet, Film Coated","sponsorNew":"Terran Biosciences \/ Sanofi","highestDevelopmentStatusID":"10","companyTruncated":"Terran Biosciences \/ Sanofi"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Neurology","country":"","productType":"Small molecule","year":"2022","type":"Not Applicable","leadProduct":"Tolebrutinib","moa":"BTK","graph1":"Neurology","graph2":"Phase 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    Find Clinical Drug Pipeline Developments & Deals for Tolebrutinib

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                            01

                            Sanofi

                            France
                            Fi Europe 2024
                            Not Confirmed
                            • fda
                            • EDQM
                            • WHO-GMP
                            Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

                            Lead Product(s) : Tolebrutinib

                            Therapeutic Area : Neurology

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Sanofi MS Drug Tolebrutinib Misses Goal in Relapsing Disease Trials

                            Details : SAR442168 (tolebrutinib) is an investigational brain-penetrant and bioactive BTK inhibitor. Tolebrutinib is being evaluated for relapsing forms of MS, nrSPMS and PPMS.

                            Brand Name : SAR442168

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            September 02, 2024

                            Lead Product(s) : Tolebrutinib

                            Therapeutic Area : Neurology

                            Highest Development Status : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            02

                            Sanofi

                            France
                            Fi Europe 2024
                            Not Confirmed
                            • fda
                            • EDQM
                            • WHO-GMP
                            Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

                            Lead Product(s) : Tolebrutinib

                            Therapeutic Area : Neurology

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            New Data for Tolebrutinib, Sanofi’s Investigational Brain-Penetrant BTK Inhibitor, Showed Significant Effect...

                            Details : SAR442168 (tolebrutinib) is an investigational brain-penetrant and bioactive BTK inhibitor that achieves CSF concentrations predicted to modulate B lymphocytes and microglial cells. Tolebrutinib is being evaluated for relapsing forms of MS, nrSPMS and PP...

                            Brand Name : SAR442168

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            February 23, 2023

                            Lead Product(s) : Tolebrutinib

                            Therapeutic Area : Neurology

                            Highest Development Status : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            03

                            Sanofi

                            France
                            Fi Europe 2024
                            Not Confirmed
                            • fda
                            • EDQM
                            • WHO-GMP
                            Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

                            Lead Product(s) : Tolebrutinib

                            Therapeutic Area : Neurology

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Tolebrutinib Clinical Trial Program Update

                            Details : SAR442168 (tolebrutinib) is an investigational brain-penetrant and bioactive Bruton’s tyrosine kinase (BTK) inhibitor that achieves CSF concentrations sufficient to modulate B lymphocytes and microglial cells.

                            Brand Name : SAR442168

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            August 08, 2022

                            Lead Product(s) : Tolebrutinib

                            Therapeutic Area : Neurology

                            Highest Development Status : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            04

                            Sanofi

                            France
                            Fi Europe 2024
                            Not Confirmed
                            • fda
                            • EDQM
                            • WHO-GMP
                            Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

                            Lead Product(s) : Tolebrutinib

                            Therapeutic Area : Neurology

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Patient Enrollment of Phase III Tolebrutinib Trials Paused in the U.S.

                            Details : SAR442168 (tolebrutinib) is an investigational brain-penetrant and bioactive Bruton’s tyrosine kinase (BTK) inhibitor that achieves CSF concentrations needed for targeting B lymphocytes and microglial cells.

                            Brand Name : SAR442168

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            June 30, 2022

                            Lead Product(s) : Tolebrutinib

                            Therapeutic Area : Neurology

                            Highest Development Status : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            05

                            Sanofi

                            France
                            Fi Europe 2024
                            Not Confirmed
                            • fda
                            • EDQM
                            • WHO-GMP
                            Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

                            Lead Product(s) : Tolebrutinib

                            Therapeutic Area : Neurology

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            New Preclinical Tolebrutinib Data Demonstrated Superior Brain Penetration and Potency

                            Details : Preclinical findings showed that tolebrutinib, among the investigational BTK inhibitors tested, had the best combination of brain penetration and potency that reinforces its potential to impact neuroinflammation.

                            Brand Name : SAR442168

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            February 24, 2022

                            Lead Product(s) : Tolebrutinib

                            Therapeutic Area : Neurology

                            Highest Development Status : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            06

                            Sanofi

                            France
                            Fi Europe 2024
                            Not Confirmed
                            • fda
                            • EDQM
                            • WHO-GMP
                            Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

                            Lead Product(s) : Tolebrutinib

                            Therapeutic Area : Immunology

                            Study Phase : Phase II

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            New Long-Term Data Reinforcing Promising Safety and Efficacy Profile of Brain-Penetrant Tolebrutinib Presented...

                            Details : Tolebrutinib is an investigational brain-penetrant Bruton’s tyrosine kinase inhibitor that achieves CSF concentrations needed for targeting B lymphocytes and microglial cells, modulating neuroinflammation.

                            Brand Name : Undisclosed

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            October 13, 2021

                            Lead Product(s) : Tolebrutinib

                            Therapeutic Area : Immunology

                            Highest Development Status : Phase II

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            07

                            Sanofi

                            France
                            Fi Europe 2024
                            Not Confirmed
                            • fda
                            • EDQM
                            • WHO-GMP
                            Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

                            Lead Product(s) : Tolebrutinib

                            Therapeutic Area : Immunology

                            Study Phase : Phase III

                            Sponsor : Sanofi

                            Deal Size : $3,680.0 million

                            Deal Type : Acquisition

                            DEALS_DEV arrow-down

                            Sanofi to acquire Principia Biopharma

                            Details : The acquisition expands and accelerates development of Sanofi's BTK inhibitors consisting ‘168, rilzabrutinib and PRN473 Topical, across multiple indications.

                            Brand Name : SAR442168

                            Molecule Type : Small molecule

                            Upfront Cash : $3,680

                            August 17, 2020

                            Lead Product(s) : Tolebrutinib

                            Therapeutic Area : Immunology

                            Highest Development Status : Phase III

                            Sponsor : Sanofi

                            Deal Size : $3,680.0 million

                            Deal Type : Acquisition

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                            08

                            Sanofi

                            France
                            Fi Europe 2024
                            Not Confirmed
                            • fda
                            • EDQM
                            • WHO-GMP
                            Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

                            Lead Product(s) : Tolebrutinib

                            Therapeutic Area : Neurology

                            Study Phase : Phase III

                            Sponsor : Sanofi

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Principia Announces First Patient Enrolled in Sanofi’s Phase 3 Trial of SAR442168 in Relapsing Multiple Scle...

                            Details : First patient has been enrolled in Sanofi’s Phase 3 clinical trial of SAR442168 in patients with relapsing M.S. SAR442168, discovered by Principia, is a BTK inhibitor that crosses the blood-brain barrier and modulates immune cell function in both the p...

                            Brand Name : SAR442168

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            June 23, 2020

                            Lead Product(s) : Tolebrutinib

                            Therapeutic Area : Neurology

                            Highest Development Status : Phase III

                            Sponsor : Sanofi

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            09

                            Sanofi

                            France
                            Fi Europe 2024
                            Not Confirmed
                            • fda
                            • EDQM
                            • WHO-GMP
                            Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

                            Lead Product(s) : Tolebrutinib

                            Therapeutic Area : Neurology

                            Study Phase : Phase II

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Sanofi to Present Phase 2 Detailed Results of its Brain-Penetrant BTK Inhibitor in Relapsing Multiple Sclerosi...

                            Details : Study’s primary endpoint was met, demonstrating that the BTK inhibitor significantly reduced disease activity associated with multiple sclerosis (MS) as measured by magnetic resonance imaging.

                            Brand Name : Undisclosed

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            April 17, 2020

                            Lead Product(s) : Tolebrutinib

                            Therapeutic Area : Neurology

                            Highest Development Status : Phase II

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            10

                            Sanofi

                            France
                            Fi Europe 2024
                            Not Confirmed
                            • fda
                            • EDQM
                            • WHO-GMP
                            Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

                            Lead Product(s) : Tolebrutinib

                            Therapeutic Area : Neurology

                            Study Phase : Phase II

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Sanofi brain-penetrant BTK inhibitor meets primary endpoint

                            Details : Sanofi’s BTK inhibitor will be first disease-modifying therapy to address sources of multiple sclerosis damage in the brain.

                            Brand Name : Undisclosed

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            February 06, 2020

                            Lead Product(s) : Tolebrutinib

                            Therapeutic Area : Neurology

                            Highest Development Status : Phase II

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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