Tocilizumab clinical trials
Tocilizumab is named as an intervention in 72 current clinical trials in our France, Spain, USA, China, Australia, Italy, South Korea, Canada, Israel, UK, Germany, Belgium, Denmark, Poland, Netherlands, Japan, Brazil, Taiwan, Sweden, Czechia, Mexico, Turkey, India, Switzerland, Portugal, Austria, Egypt, Norway, Ireland and Singapore registers. 37 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Hoffmann-La Roche (19). The most-studied condition is Multiple Myeloma. The EU clinical trials register (CTIS) separately lists 13 authorised or ongoing trials, 1 with a site in Ireland.
Where Tocilizumab is approved
All regulators →Of the three regulators tracked here, the first to approve Tocilizumab was the EU, on 16 Jan 2009. It is approved in 3 of the 3 regulators tracked here.
- 5 FDA-approved biosimilars, 2 interchangeable: Avtozma, Avtozma, Tofidence, Tyenne and others
- 3 EU safety letters (DHPC), latest: medication error;quality defect for Avtozma, 3 Apr 2026
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Tocilizumab
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Tocilizumab works
All drug targets →- Interleukin-6 receptor alpha subunit inhibitor InhibitorTarget: IL6R interleukin 6 receptor✓ In ChEMBL and the Guide to Pharmacology
- COVID-19Phase 3
- COVID-19–associated multisystem inflammatory syndrome in childrenPhase 3
- Graves ophthalmopathyPhase 3
- Orthomyxoviridae infectious diseasePhase 3
- SeizurePhase 3
- Takayasu arteritisPhase 3
- Acute chest syndromePhase 3
- Acute respiratory distress syndromePhase 3
- Ankylosing spondylitisPhase 3
- Breast cancerPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1237022, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 6881, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Tocilizumab
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 6 technology appraisals of Tocilizumab. 5 are current, and 5 of these recommend it for at least some patients. 1 older appraisal was replaced or withdrawn.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Nirmatrelvir plus ritonavir and tocilizumab for treating COVID-19 NICE TA878 | Optimised Recommended Not recommended | 29 Mar 2023 Updated 26 Feb 2026 | Current |
| Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed NICE TA375 | Optimised | 26 Jan 2016 | Current |
| Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis NICE TA373 | Recommended | 16 Dec 2015 | Current |
| Tocilizumab for the treatment of rheumatoid arthritis NICE TA247 | Recommended | 22 Feb 2012 | Current |
| Tocilizumab for the treatment of systemic juvenile idiopathic arthritis NICE TA238 | Recommended Not recommended | 14 Dec 2011 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Tocilizumab
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 13 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: RoActemra, Avtozma (biosimilar), Tosmova (previously Tocilizumab STADA and Tofidence) (biosimilar), Tuyory (biosimilar), Tyenne (biosimilar)EMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Tocilizumab
- ATC code
- L04AC07
- ChEMBL
- CHEMBL1237022
- DrugBank
- DB06273
- CAS number
- 375823-41-9
- FDA UNII
- I031V2H011
- Wikidata
- Q425154
- Wikipedia
- Tocilizumab
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Tocilizumab
72 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Tocilizumab in the EU trials register (CTIS)
13 trials · 1 in IrelandAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Tocilizumab. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
Tocilizumab across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
13 single-substance products containing Tocilizumab on the HPRA medicines list.
- Avtozma 162 mg solution for injection in pre-filled penCelltrion Healthcare Hungary Kft. · EU/1/24/1896/010-012
- Avtozma 162 mg solution for injection in pre-filled syringeCelltrion Healthcare Hungary Kft. · EU/1/24/1896/007-009
- Avtozma 20 mg/mL concentrate for solution for infusionCelltrion Healthcare Hungary Kft. · EU/1/24/1896/001-006
- RoActemra 162 mg Solution for injectionRoche Registration GmbH · EU/1/08/492/007-008
- RoActemra 162 mg Solution for injectionRoche Registration GmbH · EU/1/08/492/009-010
Supply shortages
- RoActemraEU (EMA) · Shortage resolved · first published 3 Sep 2021
Recent approvals
- TuyoryEMA · 27 Apr 2026 · biosimilar · Chemical Works of Gedeon Richter Plc. (Gedeon Richter Plc.)
Conditions studied with Tocilizumab
83 conditionsAll 83 conditions
| Condition (as registered) | Trials |
|---|---|
| Multiple Myeloma | 8 |
| Non-Hodgkin Lymphoma | 3 |
| Lymphoma | 3 |
| Systemic Sclerosis | 3 |
| Rheumatoid Arthritis | 3 |
| Takayasu Arteritis | 3 |
| Systemic Lupus Erythematosus | 2 |
| Systemic Juvenile Idiopathic Arthritis | 2 |
| Acute Ischemic Stroke | 2 |
| Respiratory Tract Diseases | 1 |
| Influenza (Pandemic) | 1 |
| Influenza | 1 |
| Community Acquired Pneumonia | 1 |
| Juvenile Idiopathic Arthritis | 1 |
| Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma | 1 |
| Recurrent Ovarian Cancer | 1 |
| Recurrent Fallopian Tube Cancer | 1 |
| Recurrent Primary Peritoneal Cancer | 1 |
| Recurrent Endometrial Cancer | 1 |
| Solid Tumors | 1 |
| Lymphoma, Non-Hodgkin | 1 |
| Metastatic Breast Cancer | 1 |
| B-cell Non-Hodgkin Lymphoma | 1 |
| Diffuse Large B-cell Lymphoma | 1 |
| Follicular Lymphoma | 1 |
| Advanced Liver Cancers | 1 |
| Relapsed/Refractory Multiple Myeloma (RRMM) | 1 |
| Non-Hodgkin's Lymphoma | 1 |
| Mature B-Cell Non-Hodgkin Lymphoma | 1 |
| Idiopathic Inflammatory Myopathy | 1 |
| Refractory Autoimmune Diseases | 1 |
| Pneumonia | 1 |
| Lupus Erythematosus, Systemic | 1 |
| Dermatomyositis | 1 |
| Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease | 1 |
| Rheumatoid Arthritis Associated Interstitial Lung Disease | 1 |
| Thyroid-Associated Ophthalmopathy | 1 |
| Cerebral Venous Thrombosis | 1 |
| Ischemic Stroke | 1 |
| Tocilizumab | 1 |
| Adalimumab | 1 |
| Treatment | 1 |
| Aneurysm | 1 |
| Behcet Syndrome, Vascular Type | 1 |
| Polyarticular Course Juvenile Idiopathic Arthritis (JIA) | 1 |
| Sepsis | 1 |
| New Onset Refractory Status Epilepticus | 1 |
| New-Onset Refractory Status Epilepticus | 1 |
| Febrile Infection-Related Epilepsy Syndrome (FIRES) | 1 |
| Giant Cell Arteritis | 1 |
| Neurovascular Disorder | 1 |
| Calcium Pyrophosphate Deposition Disease | 1 |
| B-cell Acute Lymphoblastic Leukemia | 1 |
| Granulomatosis With Polyangiitis | 1 |
| Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis | 1 |
| Antibody-mediated Rejection | 1 |
| Esophageal Adenocarcinoma | 1 |
| Oesophageal Adenocarcinoma | 1 |
| Resectable Carcinoma | 1 |
| Acute Myocardial Infarction | 1 |
| Cardiogenic Shock | 1 |
| Pancreatitis, Chronic | 1 |
| Interstitial Lung Disease | 1 |
| Kidney Transplantation | 1 |
| Acute Hypoxemic Respiratory Failure | 1 |
| Relapsed Cancer | 1 |
| Refractory Cancer | 1 |
| Adamantinomatous Craniopharyngioma | 1 |
| Recurrent Adamantinomatous Craniopharyngioma | 1 |
| Lactating Women on Select DOI | 1 |
| Breastfed Infants of Mothers on Select DOI | 1 |
| Treatment-Resistant Major Depressive Disorder | 1 |
| Sars-CoV2 | 1 |
| Hepatocellular Carcinoma (HCC) | 1 |
| Ankylosing Spondylitis | 1 |
| Psoriatic Arthritis | 1 |
| Relapsed or Refractory Multiple Myeloma | 1 |
| Mantle Cell Lymphoma | 1 |
| Mantle Cell Lymphoma Refractory | 1 |
| Chronic Lymphocytic Leukaemia | 1 |
| Small Lymphocytic Lymphoma | 1 |
| Hematologic Malignancies | 1 |
| Systemic Juvenile Idiopathic Arthritis (sJIA) | 1 |
Sponsors
lead sponsor per trial+ 22 more sponsors in the trial list above.
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Tocilizumab trials
How many clinical trials are testing Tocilizumab?
72 current trials in our France, Spain, USA, China, Australia, Italy, South Korea, Canada, Israel, UK, Germany, Belgium, Denmark, Poland, Netherlands, Japan, Brazil, Taiwan, Sweden, Czechia, Mexico, Turkey, India, Switzerland, Portugal, Austria, Egypt, Norway, Ireland and Singapore registers name Tocilizumab (also registered as RO4877533) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Tocilizumab trials recruiting patients?
Yes. 37 of the 72 trials are recruiting: 15 with sites in France, 14 with sites in Spain, 10 with sites in USA, 12 with sites in China, 15 with sites in Australia, 11 with sites in Italy, 9 with sites in South Korea, 9 with sites in Canada, 8 with sites in Israel, 6 with sites in UK, 9 with sites in Germany, 3 with sites in Belgium, 3 with sites in Denmark, 6 with sites in Poland, 6 with sites in Netherlands, 4 with sites in Japan, 5 with sites in Brazil, 3 with sites in Taiwan, 5 with sites in Sweden, 4 with sites in Czechia, 2 with sites in Mexico, 2 with sites in Turkey, 2 with sites in India, 1 with sites in Switzerland, 3 with sites in Portugal, 1 with sites in Austria, 1 with sites in Egypt and 1 with sites in Ireland. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Tocilizumab clinical trials?
Hoffmann-La Roche (19), Genentech, Inc (6), Assistance Publique - Hôpitaux de Paris (4) and Juno Therapeutics, Inc., a Bristol-Myers Squibb Company (3), among 37 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Tocilizumab clinical trials in Ireland?
Yes. 1 trial in our Ireland register (ClinicalTrials.gov), and 1 trial in the EU register (CTIS) list a site in Ireland. Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.
Is Tocilizumab licensed in Ireland?
Yes. The HPRA medicines list includes 13 single-substance products containing Tocilizumab, for example Avtozma 162 mg solution for injection in pre-filled pen (Celltrion Healthcare Hungary Kft.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Tocilizumab shortage?
The registers we track list 1 entry for Tocilizumab: RoActemra (EU: shortage resolved). Shortages are product- and country-specific; check with a pharmacist.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Tocilizumab works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Tocilizumab works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Tocilizumab (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.