tocilizumab
Trade name: actemra
mAbapprovedCOVID-19
Approved
Jan 8, 2010
Tocilizumab, sold under the brand name Actemra among others, is an immunosuppressive drug, used for the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis, cytokine release syndrome, COVID‑19, and systemic sclerosis-associated interstitial lung disease (SSc-ILD). It is a recombinant humanized monoclonal antibody of the immunoglobulin IgG1 subclass against the interleukin-6 receptor (IL-6R). Interleukin 6 (IL-6) is a cytokine that plays an important role in immune response and is implicated in the pathogenesis of many diseases, such as autoimmune diseases, multiple myeloma and prostate cancer. Tocilizumab was jointly developed by Osaka University and Chugai, and was licensed in 2003 by Hoffmann-La Roche. — Wikipedia
Clinical trial activity
436 trials · 281 clinical orgs · 6 marketing orgs
Phase 1
98
Phase 2
267
Phase 3
142
Phase 4
61
Earliest trial started Aug 1, 2001 (NCT00144651)
Timeline
2000s
2010s
Indications
Studied for
- Acute Chest Syndrome · Phase 3
- Adalimumab · Phase 4
- Adamantinoma · Phase 2
- Adrenal Cortex Hormones · Phase 4
- Allografts · Phase 2
- Amyotrophic Lateral Sclerosis · Phase 2
- Anemia, Sickle Cell · Phase 3
- Aneurysm · Phase 2
- Antigens, CD19 · Phase 1
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis · Phase 2
- Ascites · Phase 1
- Astrocytoma · Phase 2
- Atherosclerosis · Phase 3
- Autoimmune Diseases · Phase 2
- Behcet Syndrome · Phase 2
- Biliary Tract Neoplasms · Phase 1
- Biological Therapy · Phase 2
- Biomarkers · Phase 3
- Bone Marrow Transplantation · Phase 2
- Brain Diseases · Phase 3
- Brain Ischemia · Phase 1
- Breast Neoplasms · Phase 2
- Carcinoma · Phase 2
- Carcinoma, Giant Cell · Phase 2
- Carcinoma, Hepatocellular · Phase 2
- Carcinoma, Neuroendocrine · Phase 1
- Carcinoma, Non-Small-Cell Lung · Phase 2
- Carcinoma, Renal Cell · Phase 1/Phase 2
- Carcinoma, Transitional Cell · Phase 2
- Castleman Disease · Phase 2
- Cerebral Infarction · Phase 3
- Chondrocalcinosis · Phase 2
- Cogan Syndrome · Phase 2
- Colorectal Neoplasms · Phase 1/Phase 2
- Coronary Artery Disease · Phase 3
- Coronary Disease · Phase 2
- Coronaviridae Infections · Phase 3
- Coronavirus · Phase 3
- Coronavirus Infections · Phase 3
- COVID-19 · Phase 4
- Craniopharyngioma · Phase 2
- Cryoglobulinemia · Phase 2
- Cytokine Release Syndrome · Phase 4
- Depressive Disorder, Treatment-Resistant · Phase 2
- Dermatomyositis · Phase 2
- Dexamethasone · Phase 4
- Diabetes Mellitus · Phase 3
- Diabetes Mellitus, Type 1 · Phase 2
- Drug Combinations · Phase 4
- Drug-Related Side Effects and Adverse Reactions · Phase 2
- Drugs, Investigational · Phase 4
- Endotoxemia · Phase 4
- Epilepsy · Phase 3
- Erdheim-Chester Disease · Phase 2
- Esophageal Neoplasms · Phase 2
- Familial Mediterranean Fever · Phase 2
- Fever · Phase 2
- Fibrous Dysplasia of Bone · Phase 2
- Giant Cell Arteritis · Phase 4
- Glioblastoma · Phase 2
- Graft Rejection · Phase 4
- Graft vs Host Disease · Phase 2
- Granuloma · Phase 1/Phase 2
- Granulomatosis with Polyangiitis · Phase 2
- Granulomatous Disease, Chronic · Phase 1/Phase 2
- Graves Ophthalmopathy · Phase 4
- Healthy Volunteers · Phase 4
- Heart Arrest · Phase 2
- Heart Transplantation · Phase 2
- Hematologic Neoplasms · Phase 2
- Hematoma, Subdural, Chronic · Phase 1/Phase 2
- Hematopoietic Stem Cell Transplantation · Phase 2
- HIV Infections · Phase 1/Phase 2
- Hodgkin Disease · Phase 2
- IgA Vasculitis · Phase 2
- Immunosuppression Therapy · Phase 4
- Inflammation · Phase 4
- Intensive Care Units · Phase 3
- Interleukin 1 Receptor Antagonist Protein · Phase 4
- Interleukin-6 · Phase 3
- Interleukin-6 Inhibitors · Phase 3
- Intracranial Arteriosclerosis · Phase 3
- Ischemia · Phase 3
- Ischemic Stroke · Phase 3
- Janus Kinase Inhibitors · Phase 3
- Kidney Failure, Chronic · Phase 3
- Kidney Transplantation · Phase 2
- Leukemia · Phase 2
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 2
- Leukemia, Myeloid, Acute · Phase 2
- Liver Neoplasms · Phase 1/Phase 2
- Lung Diseases, Interstitial · Phase 3
- Lung Neoplasms · Phase 2
- Lung Transplantation · Phase 2
- Lupus Erythematosus, Systemic · Phase 1
- Lymphohistiocytosis, Hemophagocytic · Phase 2
- Lymphoma · Phase 3
- Lymphoma, B-Cell · Phase 1
- Lymphoma, Follicular · Phase 3
- Lymphoma, Large B-Cell, Diffuse · Phase 3
- Lymphoma, Large-Cell, Immunoblastic · Phase 1
- Lymphoma, Mantle-Cell · Phase 2
- Lymphoma, Non-Hodgkin · Phase 3
- Lymphoma, Primary Cutaneous Anaplastic Large Cell · Phase 1
- Macrophage Activation Syndrome · Phase 2
- Macular Edema · Phase 2
- Major Depressive Disorder · Phase 2
- Melanoma · Phase 2
- Methotrexate · Phase 4
- Motor Neuron Disease · Phase 2
- Multiple Myeloma · Phase 4
- Myasthenia Gravis · Phase 2/Phase 3
- Myelin-Oligodendrocyte Glycoprotein · Phase 2/Phase 3
- Myelodysplastic-Myeloproliferative Diseases · Phase 2
- Myelodysplastic Syndromes · Phase 2
- Myeloproliferative Disorders · Phase 2
- Myocardial Infarction · Phase 2
- Neoplasm Metastasis · Phase 1
- Neoplasms · Phase 4
- Neuromyelitis Optica · Phase 2/Phase 3
- Nidovirales Infections · Phase 3
- Non-ST Elevated Myocardial Infarction · Phase 2
- Optic Neuropathy, Ischemic · Phase 2
- Osteoarthritis · Phase 3
- Out-of-Hospital Cardiac Arrest · Phase 2
- Ovarian Neoplasms · Phase 1/Phase 2
- Pancreatic Neoplasms · Phase 2
- Pancreatitis, Chronic · Phase 2
- Pharmacokinetics · Phase 1
- Pleural Effusion, Malignant · Phase 1
- Pneumonia · Phase 4
- Pneumonia, Viral · Phase 2
- Polyarteritis Nodosa · Phase 2
- Polychondritis, Relapsing · Phase 2
- Polymyalgia Rheumatica · Phase 3
- Polymyositis · Phase 2
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma · Phase 1/Phase 2
- Precursor Cell Lymphoblastic Leukemia-Lymphoma · Phase 2
- Psychotic Disorders · Phase 4
- Pulmonary Arterial Hypertension · Phase 2
- Pulmonary Disease, Chronic Obstructive · Phase 3
- Respiratory Distress Syndrome · Phase 2
- Respiratory Insufficiency · Phase 2
- Respiratory Tract Diseases · Phase 3
- Respiratory Tract Infections · Phase 3
- Retroperitoneal Fibrosis · Phase 4
- Rheumatic Diseases · Phase 2
- RNA Virus Infections · Phase 3
- SARS-CoV-2 · Phase 3
- Schizophrenia · Phase 4
- Schnitzler Syndrome · Phase 2
- Scleroderma, Systemic · Phase 3
- Sepsis · Phase 4
- Severe Acute Respiratory Syndrome · Phase 3
- Severe Fever with Thrombocytopenia Syndrome · Phase 4
- Shock, Cardiogenic · Phase 2
- Sjogren's Syndrome · Phase 2/Phase 3
- Small Cell Lung Carcinoma · Phase 1
- Spondylitis, Ankylosing · Phase 3
- Squamous Cell Carcinoma of Head and Neck · Phase 2
- Still's Disease, Adult-Onset · Phase 2
- Stroke · Phase 3
- Subarachnoid Hemorrhage · Phase 1
- Systemic Inflammatory Response Syndrome · Phase 2
- Takayasu Arteritis · Phase 4
- Therapeutics · Phase 4
- Triple Negative Breast Neoplasms · Phase 2
- Ultrasonography · Phase 3
- Ureteral Neoplasms · Phase 2
- Urethral Neoplasms · Phase 2
- Urinary Bladder Neoplasms · Phase 2
- Uveitis · Phase 2
- Uveitis, Intermediate · Phase 1/Phase 2
- Uveitis, Posterior · Phase 1/Phase 2
- Vascular Diseases · Phase 3
- Vasculitis · Phase 2
- Virus Diseases · Phase 3
Mechanism of action
- Interleukin-6 receptor alpha subunitINHIBITOR
IL6R inhibitor
Complex with beta subunit in membrane bound form, but binds to soluble (alpha only) form too
Alpha subunit is binding site
Approval history
- approvedJan 8, 2010
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Black box warning
Sources
- WikipediaTocilizumab ↗
- NCATSI031V2H011 ↗
- ChEMBLCHEMBL1237022 ↗
Also known as
- actemra
- actemra
- actemra
- actemra
- actemra roactemra
- atlizumab
- atlizumab
- atlizumab
- monoclonal antibody, mra
- mra
- mra
- mra
- r-1569
- r-1569
- rg-1569
- rhpm-1
- roactemra
- roactemra
- roactemra
- tocilizumab
- tocilizumab
- tocilizumab
- tocilizumab
- tocilizumab
- tocilizumab
- tocilizumab
- tocilizumab
- tocilizumab
- tocilizumab
- toclizumab
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07281027 | Phase 3 | Mar 1, 2026 | Patient-Centered Outcomes Research Institute, Yale University |
| NCT07108387 | Phase 2 | Dec 15, 2025 | National Institute of Allergy and Infectious Diseases (NIAID) |
| NCT07263776 | Phase 3 | Dec 1, 2025 | Capital Medical University |
| NCT07254637 | Phase 2 | Nov 30, 2025 | Assistance Publique - Hôpitaux de Paris, Fresenius |
| NCT06863480 | Phase 1 | Oct 30, 2025 | University of Florida |
| NCT07138898 | Phase 2 | Sep 30, 2025 | New York University |
| NCT07113743 | Phase 1/Phase 2 (Phase 2) | Sep 10, 2025 | National Institute of Allergy and Infectious Diseases (NIAID) |
| NCT07115745 | Phase 1 | Sep 4, 2025 | Bristol-Myers Squibb |
| NCT07052058 | Phase 2 | Aug 25, 2025 | Federal University of Health Science of Porto Alegre, Federal University of Rio Grande do Sul |
| NCT06941376 | Phase 2 | Aug 1, 2025 | University of Pennsylvania |
| NCT06934044 | Phase 1 | May 13, 2025 | Roche |
| NCT06818266 | Phase 3 | Apr 30, 2025 | Assistance Publique - Hôpitaux de Paris |
| NCT06654882 | Phase 3 | Feb 28, 2025 | Duke University, Patient-Centered Outcomes Research Institute |
| NCT06721910 | N/A | Jan 2, 2025 | University of Basel |
| NCT07006532 | N/A | Jan 1, 2025 | Shahid Beheshti University of Medical Sciences |
| NCT06726096 | Phase 3 | Dec 31, 2024 | Government of China |
| NCT06927375 | Phase 4 | Dec 12, 2024 | Jiao Tong University |
| NCT06624085 | Phase 1 | Nov 15, 2024 | Roche |
| NCT06624436 | Phase 4 | Oct 31, 2024 | Radboud University |
| NCT06251076 | Phase 4 | Oct 15, 2024 | Janssen Pharmaceutica NV, University of Toronto |
Showing 20 of 436 trials
Page 1 / 22
Organizations
Research & Development (281)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Roche | For profit | 164 | 143 | 5 | 2005 |
| Genentech | For profit | 21 | 8 | 5 | 2010 |
| Chugai | For profit | 19 | 17 | 4 | 2001 |
| University of Copenhagen | Academic/Hospital | 12 | 12 | 2 | 2016 |
| Assistance Publique - Hôpitaux de Paris | Academic/Hospital | 10 | 10 | 2 | 2018 |
| Harvard University | Academic/Hospital | 9 | 6 | 3 | 2015 |
| National Cancer Institute (NCI) | Government | 7 | 3 | 3 | 2011 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Government | 7 | 7 | 1 | 2015 |
| Chinese Academy of Medical Sciences | Academic/Hospital | 6 | 5 | 3 | 2018 |
| Peking University | Academic/Hospital | 5 | 2 | 5 | 2020 |
| University of Paris | Academic/Hospital | 5 | 5 | 3 | 2012 |
| Bristol-Myers Squibb | For profit | 4 | 1 | 4 | 2015 |
| Celltrion | For profit | 4 | 4 | 2 | 2021 |
| Government of China | Government | 4 | 3 | 3 | 2019 |
| Jiao Tong University | Academic/Hospital | 4 | 2 | 3 | 2020 |
| Medical College of Wisconsin | Academic/Hospital | 4 | 4 | 2 | 2011 |
| University of Bern | Academic/Hospital | 4 | 4 | 1 | 2011 |
| University of Pennsylvania | Academic/Hospital | 4 | 4 | 2 | 2013 |
| AO GENERIUM | For profit | 3 | 3 | 2 | 2022 |
| Biothera | For profit | 3 | 3 | 2 | 2018 |
281 organizations
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