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Tolebrutinib - Sanofi

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Drug Profile

Tolebrutinib - Sanofi

Alternative Names: BTKi'168; BTKi('168); PRN2246; SAR-442168

Latest Information Update: 09 Apr 2024

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At a glance

  • Originator Principia Biopharma
  • Developer Principia Biopharma; Sanofi
  • Class Amines; Anti-inflammatories; Imidazoles; Phenyl ethers; Piperidines; Pyridines; Small molecules
  • Mechanism of Action Agammaglobulinaemia tyrosine kinase inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Multiple sclerosis
  • Phase I Kidney disorders
  • No development reported CNS disorders; Inflammation
  • Discontinued Myasthenia gravis

Most Recent Events

  • 29 Feb 2024 Pharmacodynamics, efficacy and adverse events data from a phase II trial in Multiple sclerosis presented at the Americas Committee for Treatment and Research in Multiple Sclerosis Forum 2024 (ACTRIMS-2024)
  • 11 Oct 2023 Preliminary efficacy data from phase II trial in Multiple sclerosis presented by Sanofi at the Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS-ECTRIMS-2023)
  • 11 Oct 2023 Updated efficacy and adverse event data from a phase IIb long term extension trial in Multiple sclerosis presented at the 9th Triennial joint meeting of Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS-ECTRIMS-2023)
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