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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: 07 Apr 2025

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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 Alzheimer's disease; Crohn's disease; Multiple sclerosis
  • Preclinical Amyotrophic lateral sclerosis; Haemorrhage; Obesity; Post acute COVID 19 syndrome; Traumatic brain injuries; 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

  • 25 Mar 2025 Tiziana Life Sciences plans a 6-month open-label extension (OLE) study for Multiple sclerosis
  • 11 Mar 2025 Brigham and Women's Hospital plans II trial for Multiple system atrophy in the US in April 2025 (Intranasal) (NCT06868628)
  • 05 Mar 2025 Tiziana Life Sciences files an IND application with the US FDA in USA for Amyotrophic lateral sclerosis

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