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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
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
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
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
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
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
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
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
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
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