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Foralumab - Tiziana Life Sciences

Drug Profile

Foralumab - Tiziana Life Sciences

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

Latest Information Update: 03 Dec 2018

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At a glance

  • Originator Medarex; NovImmune SA
  • Developer Harvard Medical School; NovImmune SA; Tiziana Life Sciences
  • Class Anti-inflammatories; Hepatoprotectants; Monoclonal antibodies
  • Mechanism of Action CD3 antigen inhibitors; Immunomodulators
  • 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
  • Phase I Neurodegenerative disorders; Primary biliary cirrhosis
  • Preclinical Inflammatory bowel diseases; Non-alcoholic steatohepatitis; Type 2 diabetes mellitus
  • Discontinued Transplant rejection; Type 1 diabetes mellitus

Most Recent Events

  • 28 Nov 2018 Phase-I clinical trials in Neurodegenerative disorders (In volunteers) in USA (Intranasal)
  • 28 Nov 2018 Tiziana Life Sciences intends to file an IND application for a phase I trial in healthy volunteers for Crohn's disease (PO) in the first quarter of 2019
  • 28 Nov 2018 Tiziana Life Sciences intends to file an IND application for a phase I trial in healthy volunteers for Non-alcoholic steatohepatitis (PO) in the first quarter of 2019
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