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Foralumab - Tiziana Life Sciences

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Drug Profile

Foralumab - Tiziana Life Sciences

Alternative Names: NI-0401; NI-0401/α-CD3; TZLS-401

Latest Information Update: 26 Jul 2024

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At a glance

  • Originator Medarex; NovImmune SA
  • Developer Light Chain Bioscience; NovImmune SA; Tiziana Life Sciences
  • Class Anti-inflammatories; Antidementias; Antihaemorrhagics; Antihyperglycaemics; Hepatoprotectants; Monoclonal antibodies
  • Mechanism of Action CD3 antigen 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 II Crohn's disease; Multiple sclerosis
  • Preclinical Alzheimer's disease; Amyotrophic lateral sclerosis; Haemorrhage; Type 1 diabetes mellitus
  • No development reported Cytokine release syndrome; Non-alcoholic steatohepatitis; Primary biliary cirrhosis; Type 2 diabetes mellitus
  • Discontinued Transplant rejection

Most Recent Events

  • 24 Jul 2024 Foralumab - Tiziana Life Sciences receives Fast Track designation for Multiple sclerosis [Intranasal] in USA
  • 26 Jun 2024 The US FDA allows intranasal foralumab to be used under an Expanded Access (EA) IND in moderate Alzheimer’s disease
  • 06 Jun 2024 Updated efficacy data from a phase IIa trial in multiple sclerosis released by Tiziana

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