Itolizumab is under clinical development by Biocon and currently in the Phase I and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Itolizumab’s likelihood of approval (LoA) and phase transition for Asthma took place on 05 Jan 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Itolizumab Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Itolizumab overview

Itolizumab (T1h, Alzumab / Anti-CD6 ) is a humanized recombinant anti-CD6 monoclonal antibody. It is formulated as injection solution for intravenous infusion. It is indicated for the treatment of patients with active moderate to severe chronic plaque psoriasis who are candidates for systemic therapy. Alzumab is indicated for emergency use in the treatment of cytokine release syndrome (CRS) in moderate to severe ARDS (acute respiratory distress syndrome) patients due to COVID-19.

The drug candidate is under development for the treatment of Coronavirus disease 2019 (COVID-19), systemic lupus erythematosus, acute graft-versus-host disease (aGVHD), lupus nephritis, asthma, ulcerative colitis and chronic graft-versus-host disease (cGVHD). It is administered intravenously and subcutaneously. It was also under development for vitiligo, psoriatic arthritis, psoriasis, rheumatoid arthritis, multiple sclerosis, dermatological disorders, refractory lupus nephritis and severe asthma.

Biocon overview

Biocon is a biopharmaceutical company that focuses on the research and development of therapies for the treatment of chronic conditions such as cancer, diabetes and autoimmune diseases. It offers a range of active pharmaceutical ingredients (APIs), branded formulations, complex biologics and biosimilars including monoclonal antibodies (MAbs), rh-Insulin and insulin analogs. The company also provides services including contract manufacturing, drug licensing, research, development and manufacturing of small and large molecules for biotechnology and pharmaceutical companies across the world. It has a manufacturing facility and R&D center at BioXcell, Malaysia. It operates overseas offices in the UK, Ireland, the US, Switzerland, Dubai, and Malaysia. Biocon is headquartered in Bangalore, Karnataka, India.

Quick View Itolizumab LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Itolizumab
Administration Pathway
  • Intravenous
  • Subcutaneous
Therapeutic Areas
  • Central Nervous System
  • Dermatology
  • Gastrointestinal
  • Immunology
  • Infectious Disease
  • Musculoskeletal Disorders
  • Respiratory
Key Developers
  • Sponsor Company: Biocon
  • Originator: Center of Molecular Immunology
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.