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Itolizumab - Biocon/Equillium

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Drug Profile

Itolizumab - Biocon/Equillium

Alternative Names: Alzumab-L; Anti-CD6 monoclonal antibody - Biocon/CIMAB; Anti-CD6 monoclonal antibody h-T1; Anti-CD6-monoclonal-antibody-Biocon; Bmab600; EQ-001; h T1; Humanised anti-CD6 monoclonal antibody ior t1; T12 antibody; T12 monoclonal antibody; T1h; T1hT

Latest Information Update: 02 Jul 2025

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At a glance

  • Originator Center of Molecular Immunology
  • Developer Biocon; Biotech Pharmaceutical; Equillium
  • Class Anti-inflammatories; Antiasthmatics; Antipsoriatics; Antirheumatics; Monoclonal antibodies; Urologics
  • Mechanism of Action CD6 antigen inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Graft-versus-host disease
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Plaque psoriasis
  • Registered Cytokine release syndrome; SARS-CoV-2 acute respiratory disease
  • Phase III Graft-versus-host disease
  • Phase II Ulcerative colitis
  • Phase I Lupus nephritis; Systemic lupus erythematosus
  • No development reported Asthma; Autoimmune disorders; Multiple sclerosis; Psoriasis
  • Discontinued Rheumatoid arthritis

Most Recent Events

  • 17 Jun 2025 Equillium terminates a phase III EQUATOR trial in Graft-versus-host disease (Combination therapy, In adolescents, In children, In the elderly, In adults) in the US, Australia, Canada, Italy, Spain, France, Germany, Portugal, Israel, South Korea, New Zealand, Portugal and Belgium due to The FDA declined to grant Breakthrough Therapy designation or support an Accelerated Approval pathway based on the EQUATOR study data (NCT05263999)
  • 24 Apr 2025 Equillium receives feedback after Type D meeting with the US FDA for itolizumab in Graft versus host disease
  • 27 Mar 2025 Equillium anticipates feedback from FDA for Breakthrough therapy designation and outcome from the FDA meeting to review EQUATOR data for accelerated approval in May 2025

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