Tocilizumab

Generic Name
Tocilizumab
Brand Names
Actemra, RoActemra, Tyenne, Tofidence
Drug Type
Biotech
Chemical Formula
-
CAS Number
375823-41-9
Unique Ingredient Identifier
I031V2H011
Background

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.

Indication

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).

Associated Conditions
Coronavirus Disease 2019 (COVID‑19), Cytokine Release Syndrome caused by CAR-T Cell Therapy, Giant Cell Arteritis (GCA), Juvenile Chronic Polyarthritis, Moderate to Severe Rheumatoid Arthritis, Moderately to Severely Active Rheumatoid Arthritis, Polyarticular Juvenile Idiopathic Arthritis, Systemic Juvenile Idiopathic Arthritis (SJIA), Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD), Active systemic Juvenile idiopathic arthritis, Severe, active Rheumatoid arthritis
Associated Therapies
Monotherapy

Tocilizumab for Cytokine Release Syndrome Prophylaxis in Haploidentical Transplantation

First Posted Date
2018-05-22
Last Posted Date
2021-03-08
Lead Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
Target Recruit Count
30
Registration Number
NCT03533101
Locations
🇲🇽

Hospital Universitario Dr. Jose E Gonzalez UANL, Monterrey, Nuevo Leon, Mexico

Phase I, Pharmacokinetic, Safety and Tolerability Study in Healthy Volunteers

Phase 1
Completed
Conditions
Interventions
First Posted Date
2018-05-11
Last Posted Date
2019-02-26
Lead Sponsor
Mycenax Biotech Inc.
Target Recruit Count
190
Registration Number
NCT03522012
Locations
🇦🇺

Nucleus Network, Melbourne, Victoria, Australia

A Study of Glofitamab in Combination With Rituximab or Obinutuzumab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP), or Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (CHP) in Participants With Non-Hodgkin Lymphomas or With DLBCL

First Posted Date
2018-03-16
Last Posted Date
2024-10-22
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
172
Registration Number
NCT03467373
Locations
🇩🇰

Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT, København Ø, Denmark

🇺🇸

University of Alabama Medical Center, Birmingham, Alabama, United States

🇺🇸

Fox Chase-Temple Cancer Center, Philadelphia, Pennsylvania, United States

and more 21 locations

CD19 T-CAR for Treatment of Children and Young Adults With r/r B-ALL

First Posted Date
2018-03-15
Last Posted Date
2023-02-24
Lead Sponsor
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Target Recruit Count
18
Registration Number
NCT03467256
Locations
🇷🇺

Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology, Moscow, Russian Federation

A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers

Phase 1
Active, not recruiting
Conditions
Interventions
First Posted Date
2018-02-27
Last Posted Date
2024-12-04
Lead Sponsor
Genentech, Inc.
Target Recruit Count
123
Registration Number
NCT03448042
Locations
🇳🇱

Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis, Amsterdam, Netherlands

🇺🇸

MD Anderson Cancer Center, Houston, Texas, United States

🇩🇰

Rigshospitalet, København Ø, Denmark

and more 25 locations

Effects of Antirheumatic Treatment on Levels of Survivin in Rheumatoid Arthritis Patients

First Posted Date
2018-02-22
Last Posted Date
2022-05-04
Lead Sponsor
Vastra Gotaland Region
Target Recruit Count
2500
Registration Number
NCT03440892
Locations
🇸🇪

Dept of Rheumatology and Inflammation research, Gothenburg, Sweden

A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer)

First Posted Date
2017-11-09
Last Posted Date
2024-06-03
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
675
Registration Number
NCT03337698
Locations
🇨🇳

Taipei Veterans General Hospital, Taipei City, Taiwan

🇪🇸

Hospital Clinico Universitario de Valencia, Valencia, Spain

🇨🇳

National Cheng Kung University Hospital; Gasterointestinal, Tainan City, Taiwan

and more 33 locations
© Copyright 2024. All Rights Reserved by MedPath