Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Tolebrutinib
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Tolebrutinib gets US Priority Review for Multiple Sclerosis
Details : SAR442168 (tolebrutinib) is an investigational brain-penetrant and bioactive BTK inhibitor. Tolebrutinib is being evaluated for relapsing forms of MS, nrSPMS and PPMS.
Product Name : SAR442168
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 25, 2025
Lead Product(s) : Tolebrutinib
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Tolebrutinib
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Tolebrutinib Receives Breakthrough Therapy Status From FDA for Secondary MS
Details : SAR442168 (tolebrutinib) is an investigational brain-penetrant and bioactive BTK inhibitor. Tolebrutinib is being evaluated for relapsing forms of MS, nrSPMS and PPMS.
Product Name : SAR442168
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 12, 2024
Lead Product(s) : Tolebrutinib
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Tolebrutinib
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : SAR442168
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 09, 2024
Lead Product(s) : Tolebrutinib
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Tolebrutinib
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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...
Product Name : SAR442168
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 23, 2023
Lead Product(s) : Tolebrutinib
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Tolebrutinib
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : SAR442168
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 08, 2022
Lead Product(s) : Tolebrutinib
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Tolebrutinib
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : SAR442168
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 30, 2022
Lead Product(s) : Tolebrutinib
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Tolebrutinib
Therapeutic Area : Neurology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : SAR442168
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 24, 2022
Lead Product(s) : Tolebrutinib
Therapeutic Area : Neurology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Tolebrutinib
Therapeutic Area : Neurology
Study Phase : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : SAR442168
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 13, 2021
Lead Product(s) : Tolebrutinib
Therapeutic Area : Neurology
Highest Development Status : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Tolebrutinib
Therapeutic Area : Neurology
Study Phase : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : SAR442168
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 02, 2020
Lead Product(s) : Tolebrutinib
Therapeutic Area : Neurology
Highest Development Status : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Tolebrutinib
Therapeutic Area : Neurology
Study Phase : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : SAR442168
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 17, 2020
Lead Product(s) : Tolebrutinib
Therapeutic Area : Neurology
Highest Development Status : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable