Tocilizumab is under clinical development by Chugai Pharmaceutical and currently in the Phase I, Phase II 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 Tocilizumab’s likelihood of approval (LoA) and phase transition for Metastatic Hepatocellular Carcinoma (HCC) took place on 22 Jun 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

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

Tocilizumab overview

Tocilizumab (Actemra / Roactemra) is a humanized monoclonal antibody, acts as immunosupressant preparation. It is formulated as injectable solution and solution concentrate for intravenous or subcutaneous route of administration. Actemra is indicated for the treatment of rheumatoid arthritis in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease modifying anti-rheumatic drugs via intravenous and subcutaneous route. Tocilizumab intravenous route is indicated for the treatment of polyarticular juvenile idiopathic arthritis (PJIA) and systemic juvenile idiopathic arthritis in patients of 2 years age and older. Roactemra, in combination with methotrexate (MTX), is indicated for the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX. It is also indicated to treat adults with temporal arteritis, takayasu arteritis, and vasculitis, for the treatment of cytokine release syndrome induced by tumor-specific T cell infusion therapy. Actemra (tocilizumab) is used as emergency treatment for coronavirus disease 2019 (COVID-19) in hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Actemra is indicated for the treatment of pneumonia caused by SARS-CoV-2

The drug candidate is under development for the treatment of follicular lymphoma, metastatic hepatocellular carcinoma, non-small cell lung cancer, systemic sclerosis large-vessel vasculitis, giant cell arteritis, polymyalgia rheumatica, Behcet’s Uveitis, granulomatosis with polyangiitis, Schnitzler syndrome, pain, familial mediterranean fever and diffuse large b-cell lymphoma. It is also under development for COVID-19 pneumonia and in hospitalized adult patients with severe COVID-19. It was also under development for the treatment of idiopathic retroperitoneal fibrosis, pulmonary arterial hypertension, Grave's orbitopathy or thyroid eye disease, ankylosing spondylitis, giant lymph node hyperplasia and metastatic pancreatic cancer, polymyositis, dermatomyositis, amyotrophic lateral sclerosis and B-Cell Chronic Lymphocytic Leukemia.

Chugai Pharmaceutical overview

Chugai Pharmaceutical (Chugai), a subsidiary of Hoffmann-La Roche Ltd, is focused on the research, development, manufacturing, commercialization, import and export of biopharmaceuticals and therapeutic antibodies. The company offers products for the treatment of various therapeutic areas including, cancer; bone and joint diseases; renal diseases; immune disorders and infectious diseases and others. It also offers drugs to aid the kidney, liver and other organ transplants. It also has a range of product candidates in its pipeline. Operating through its network of subsidiaries, the company offers its pharmaceutical products in overseas markets including North America, Europe and Asia. Chugai is headquartered in Tokyo, Japan.

Quick View Tocilizumab LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Tocilizumab
Administration Pathway
  • Intravenous
  • Subcutaneous
Therapeutic Areas
  • Cardiovascular
  • Central Nervous System
  • Immunology
  • Infectious Disease
  • Metabolic Disorders
  • Musculoskeletal Disorders
  • Oncology
  • Ophthalmology
Key Developers
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.