Drug Profile


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

Latest Information Update: 02 Aug 2017

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At a glance

  • Originator Medarex; NovImmune SA
  • Developer 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.

  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Crohn's disease
  • Phase I Non-alcoholic steatohepatitis; Primary biliary cirrhosis
  • Preclinical Inflammatory bowel diseases; Type 2 diabetes mellitus
  • Discontinued Transplant rejection; Type 1 diabetes mellitus

Most Recent Events

  • 03 Oct 2017 Tiziana Life Sciences plans a phase II trial for Non-alcoholic steatohepatitis and Type-2 diabetes mellitus (NCT03291249)
  • 28 Jul 2017 Tiziana Life Sciences plans clinical trials for Type-2 diabetes mellitus
  • 19 Jun 2017 Tiziana Life Sciences plans phase II trials for Non-alcoholic steatohepatitis and Primary biliary cirrhosis (PO) (Tiziana Life Sciences Pipeline, June 2017)
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