Tocilizumab is a recombinant humanized monoclonal antibody IL-6 receptor inhibitor used to treat inflammatory and autoimmune conditions. It was first described in the literature in 2003 when Chugai, a subsidiary of Roche began developing IL-6 inhibiting monoclonal antibodies. Tocilizumab was granted FDA approval on 8 January 2010 to treat a number of inflammatory and autoimmune disorders, such as different types of arthritis and cytokine release syndrome. It was later approved by Health Canada on 30 April 2010. After being investigated to treat severely ill patients with COVID-19, tocilizumab was approved by the European Commission in December 2021 to treat COVID-19 in adults receiving systemic corticosteroids and supplemental oxygen or mechanical ventilation. Subsequently, it was granted approval by Health Canada and the FDA in October and December 2022, respectively. Tocilizumab-bavi, a biosimilar drug, was approved by the FDA in September 2023.
Tocilizumab is a recombinant humanized monoclonal antibody IL-6 receptor inhibitor used to treat inflammatory and autoimmune conditions. It was first described in the literature in 2003 when Chugai, a subsidiary of Roche began developing IL-6 inhibiting monoclonal antibodies. Tocilizumab was granted FDA approval on 8 January 2010 to treat a number of inflammatory and autoimmune disorders, such as different types of arthritis and cytokine release syndrome. It was later approved by Health Canada on 30 April 2010. After being investigated to treat severely ill patients with COVID-19, tocilizumab was approved by the European Commission in December 2021 to treat COVID-19 in adults receiving systemic corticosteroids and supplemental oxygen or mechanical ventilation. Subsequently, it was granted approval by Health Canada and the FDA in October and December 2022, respectively. Tocilizumab-bavi, a biosimilar drug, was approved by the FDA in September 2023.
Tocilizumab is indicated to treat moderate to severe rheumatoid arthritis, giant cell arteritis, systemic sclerosis-associated interstitial lung disease, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome. Tocilizumab is also used to treat coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
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Title | Posted | Study ID | Phase | Status | Sponsor |
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2022/02/02 | Phase 1 | Terminated | |||
2022/01/26 | Phase 2 | Active, not recruiting | |||
2022/01/06 | Phase 2 | UNKNOWN | |||
2021/12/29 | Phase 3 | Active, not recruiting | |||
2021/12/27 | Phase 1 | Recruiting | |||
2021/12/20 | Phase 1 | Completed | |||
2021/12/13 | Phase 1 | Completed | |||
2021/11/24 | Phase 4 | Withdrawn | |||
2021/11/24 | N/A | Completed | |||
2021/11/22 | Phase 1 | Terminated |
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Product Name | Registration Code | Company | Category | Sale Type | Reg. Date |
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HK-59202 | Part 1, Schedule 1 & Schedule 3 Poison | POM | 2010/02/08 | ||
HK-63771 | Part 1, Schedule 1 & Schedule 3 Poison | POM | 2015/06/25 | ||
HK-59201 | Part 1, Schedule 1 & Schedule 3 Poison | POM | 2010/02/08 | ||
HK-59200 | Part 1, Schedule 1 & Schedule 3 Poison | POM | 2010/02/08 |
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