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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: 25 Dec 2025

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At a glance

  • Originator Medarex; NovImmune SA
  • Developer Brigham and Women's Hospital; 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; Multiple system atrophy
  • Preclinical Amyotrophic lateral sclerosis; Haemorrhage; Obesity; Post acute COVID 19 syndrome; Spinal cord injuries; 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

  • 12 Dec 2025 Phase-II clinical trials in Alzheimer's disease (Combination therapy, Early-stage disease) in USA (Intranasal) (NCT06489548)
  • 12 Dec 2025 Phase-II clinical trials in Alzheimer's disease (Early-stage disease, Monotherapy) in USA (Intranasal) (NCT06489548)
  • 14 Aug 2025 Phase-II clinical trials in Multiple system atrophy (In adults, In the elderly) in USA (Intranasal) (NCT06868628)

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