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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: 18 Apr 2025

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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

  • Preregistration Multiple sclerosis
  • No development reported CNS disorders; Inflammation
  • Discontinued Myasthenia gravis

Most Recent Events

  • 08 Apr 2025 Sanofi announces intention to receive a decision of MAA for Multiple sclerosis in European Union in the first quarter of 2026
  • 25 Mar 2025 Preregistration for Multiple sclerosis in European Union (PO)
  • 25 Mar 2025 US FDA assigns PDUFA action date of 28/09/2025 for Tolebrutinib for Multiple sclerosis

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