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[{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sanofi brain-penetrant BTK inhibitor meets primary endpoint","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase II","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Phase II"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sanofi to Present Phase 2 Detailed Results of its Brain-Penetrant BTK Inhibitor in Relapsing Multiple Sclerosis","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase II","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Phase II"},{"orgOrder":0,"company":"Sanofi","sponsor":"Sanofi","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Principia Announces First Patient Enrolled in Sanofi\u2019s Phase 3 Trial of SAR442168 in Relapsing Multiple Sclerosis","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Sanofi","sponsor":"Sanofi","pharmaFlowCategory":"D","amount":"$3,680.0 million","upfrontCash":"$3,680","newsHeadline":"Sanofi to acquire Principia Biopharma","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"},{"orgOrder":0,"company":"Koneksa","sponsor":"Sanofi","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Koneksa Broadens Multi-Year CNS Research Collaboration with Sanofi","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2021","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"},{"orgOrder":0,"company":"Terran Biosciences","sponsor":"Sanofi","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Terran Biosciences Announces Licensing Deal with Sanofi for Two Late-Stage CNS Pipeline Assets ","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Long-Term Data Reinforcing Promising Safety and Efficacy Profile of Brain-Penetrant Tolebrutinib Presented at ECTRIMS 2021","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase II","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2021","url1":"","url2":"","graph1":"Immunology","graph2":"Phase II"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Preclinical Tolebrutinib Data Demonstrated Superior Brain Penetration and Potency","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Patient Enrollment of Phase III Tolebrutinib Trials Paused in the U.S.","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Tolebrutinib Clinical Trial Program Update","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Data for Tolebrutinib, Sanofi\u2019s Investigational Brain-Penetrant BTK Inhibitor, Showed Significant Effect On CNS Immune Mediators that Drive MS Disease Progression","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"}]

Find Clinical Drug Pipeline Developments & Deals for Tolebrutinib

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            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 PPMS.

            Lead Product(s): Tolebrutinib

            Therapeutic Area: Neurology Product Name: SAR442168

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 23, 2023

            Sanofi Company Banner

            Iran Expo

            Not Confirmed

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            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.

            Lead Product(s): Tolebrutinib

            Therapeutic Area: Neurology Product Name: SAR442168

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 08, 2022

            Sanofi Company Banner

            Iran Expo

            Not Confirmed

            envelop Contact Supplier

            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.

            Lead Product(s): Tolebrutinib

            Therapeutic Area: Neurology Product Name: SAR442168

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 30, 2022

            Sanofi Company Banner

            Iran Expo

            Not Confirmed

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            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.

            Lead Product(s): Tolebrutinib

            Therapeutic Area: Neurology Product Name: SAR442168

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 24, 2022

            Sanofi Company Banner

            Iran Expo

            Not Confirmed

            envelop Contact Supplier

            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.

            Lead Product(s): Tolebrutinib

            Therapeutic Area: Immunology Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 13, 2021

            Sanofi Company Banner

            Iran Expo

            Not Confirmed

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            Details:

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

            Lead Product(s): Tolebrutinib

            Therapeutic Area: Immunology Product Name: SAR442168

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Sanofi

            Deal Size: $3,680.0 million Upfront Cash: $3,680

            Deal Type: Acquisition August 17, 2020

            Sanofi Company Banner

            Iran Expo

            Not Confirmed

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            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 periphery and in the CNS.

            Lead Product(s): Tolebrutinib

            Therapeutic Area: Neurology Product Name: SAR442168

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Sanofi

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 23, 2020

            Sanofi Company Banner

            Iran Expo

            Not Confirmed

            envelop Contact Supplier

            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.

            Lead Product(s): Tolebrutinib

            Therapeutic Area: Neurology Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 17, 2020

            Sanofi Company Banner

            Iran Expo

            Not Confirmed

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            Details:

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

            Lead Product(s): Tolebrutinib

            Therapeutic Area: Neurology Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 06, 2020

            Sanofi Company Banner

            Iran Expo

            Not Confirmed

            envelop Contact Supplier

            Details:

            Terran plans to quickly advance the development of the lead SAR442168 and other assets for neurological and psychiatric indications, which include several novel applications where there is a large unmet medical need.

            Lead Product(s): Tolebrutinib

            Therapeutic Area: Neurology Product Name: SAR442168

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Sanofi

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement April 21, 2022

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