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Drug

Tocilizumab

Approved · EMA
ClassInterleukin-6 receptor alpha subunit inhibitorEmerging researchLate-stage developmentRising momentum
Also known as Actemra, Avtozma, Tofidence, Tyenne+1 more

Actemra, Avtozma, Tofidence, Tyenne, Atlizumab.

13
Research papers
52
Active clinical trials
IL6R
Primary target
6
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Approval: Tuyory (EMA)

Regulatory2026-04-27EMA

Approval: Avtozma (EMA)

Regulatory2025-02-14EMA

Approval: Tyenne (EMA)

Regulatory2023-09-15EMA

Interleukin-6 blockade with tocilizumab increases Tregs and reduces T effector cytokines in renal graft inflammation: A randomized controlled trial.

Research2021-01-21American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Tocilizumab
Aliases & brands
ActemraAvtozmaTofidenceTyenneAtlizumab
RxNorm CUI
612865
ChEMBL ID
CHEMBL1237022
ATC codes
L04AC07
UNII
I031V2H011
Primary mechanism
Interleukin-6 receptor alpha subunit inhibitor
Regulatory jurisdictions
emamhra

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

INHIBITORInterleukin-6 receptor alpha subunit inhibitor

Regulatory timeline

6 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2009-01-16
Latest approval
2026-04-27
Authorities
EMA · MHRA
Total events
6
emaEuropean Medicines Agency· 5 events
2026-04-27Approval
Approval: Tuyory (EMA)
Indication: Rheumatoid arthritis (RA) Tuyory, in combination with methotrexate (MTX), is indicated for:- the treatment of severe, active and progressive RA in adults not previously treatedShow full indication

Rheumatoid arthritis (RA) Tuyory, in combination with methotrexate (MTX), is indicated for:- the treatment of severe, active and progressive RA in adults not previously treated with MTX.- the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease- modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists.In these patients, Tuyory can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.Tocilizumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate. Coronavirus disease 2019 (COVID-19) Tuyory is indicated for the treatment of COVID-19 in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. Systemic juvenile idiopathic arthritis (sJIA) Tuyory is indicated for the treatment of active sJIA in patients 1 year of age and older, who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids. Tuyory can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX.Polyarticular juvenile idiopathic arthritis (pJIA) Tuyory in combination with MTX is indicated for the treatment of pJIA (rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. Tuyory can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.Cytokine release syndrome (CRS) Tuyory is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening CRS in adults and paediatric patients 2 years of age and older. Giant cell arteritis (GCA) Tuyory is indicated for the treatment of GCA in adult patients.

Evidence ↗
2025-02-14Approval
Approval: Avtozma (EMA)
Indication: Avtozma, in combination with methotrexate (MTX), is indicated for: the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated withShow full indication

Avtozma, 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. the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. In these patients, Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate. Avtozma is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. Avtozma is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. Avtozma can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX. Avtozma in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older. Avtozma, 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. the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. In these patients, Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate. Avtozma is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 1 year of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. Avtozma can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX. Avtozma in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma is indicated for the treatment of Giant Cell Arteritis (GCA) in adult patients. Avtozma, 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. the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. In these patients, Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate. Avtozma is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 12 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids (see Section 4.2). Avtozma can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX. Avtozma in combination with methotrexate (MTX) is indicated for thetreatment of juvenile idiopathic polyarthritis (pJIA; rheumatoidfactor positive or negative and extended oligoarthritis) in patients 12 years of age and older, who have responded inadequately to previous therapy with MTX (see Section4.2). Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma is indicated for the treatment of Giant Cell Arteritis (GCA) in adult patients.

Evidence ↗
2024-06-20Approval
Approval: Tocilizumab STADA (previously Tofidence) (EMA)
Indication: Rheumatoid arthritis (RA): - the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with methotrexate (MTX) (monotherapy or inShow full indication

Rheumatoid arthritis (RA): - the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with methotrexate (MTX) (monotherapy or in combination with MTX). - the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumor necrosis factor (TNF) antagonists (monotherapy or in combination with MTX). Coronavirus disease 2019 (COVID-19): the treatment of coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. Polyarticular juvenile idiopathic arthritis (pJIA): the treatment of juvenile idiopathic polyarthritis (PJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX (monotherapy or in combination with MTX). Systemic juvenile idiopathic arthritis (sJIA): the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids (monotherapy or in combination with MTX).

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2019-07-17Safety communicationSafety
Drug Safety Update: Tocilizumab (RoActemra): rare risk of serious liver injury including cases requiring transplantation
Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

198 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
198
registered trials across all phases
LATEST COMPLETION 2025
52
Active studies
36
Recruiting
89
Late-stage (III+)
93
Completed
53
Discontinued
PHASE DISTRIBUTIONn = 198
Early Phase 12Phase 131Phase 1 / 219Phase 257Phase 2 / 35Phase 350Phase 425Phase N / A9

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

13 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20142021
Most influential

Tisagenlecleucel in Children and Young Adults with B-Cell Lymphoblastic Leukemia.

The New England journal of medicine · 2018 · 4,269 cites

Chimeric antigen receptor T cells for sustained remissions in leukemia.

The New England journal of medicine · 2014 · 4,230 cites

IL-6 in inflammation, immunity, and disease.

Cold Spring Harbor perspectives in biology · 2014 · 3,349 cites

The COVID-19 Cytokine Storm; What We Know So Far.

Frontiers in immunology · 2020 · 1,100 cites
Recent papers
Major research themes8
COVID-19 Drug Treatment3Antibodies, Monoclonal, Humanized1Antigens, CD191Betacoronavirus1COVID-191Cytokines1Fever1Genetic Therapy1
Journals, researchers & institutions
Top journals
  • Frontiers in immunology2
  • The New England journal of medicine2
  • American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons1
  • Clinical pharmacology and therapeutics1
  • Cold Spring Harbor perspectives in biology1
  • JAMA1
Leading researchers
  • Grupp SA2
  • Hermine O2
  • June CH2
  • Levine BL2
  • Mariette X2
  • Maude SL2
  • Porcher R2
  • Ravaud P2
Leading institutions
free-text, unnormalised
  • Ain Shams University1
  • Albert Schweitzer Hospital1
  • Bristol Medical School1
  • Center for Biologics Evaluation and Research1
  • Center for Clinical Management and Research1
  • Center for Drug Evaluation and Research1

Related diseases

6 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Related drugs

5 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Acts on the same molecular target as Tocilizumab, with 2 overlapping disease areas.

Shared target2 shared diseases1 shared paper

Studied across 4 of the same disease areas as Tocilizumab in the shared literature.

4 shared diseases1 shared paper

Studied across 3 of the same disease areas as Tocilizumab in the shared literature.

3 shared diseases1 shared paper

Studied across 3 of the same disease areas as Tocilizumab in the shared literature.

3 shared diseases1 shared paper

Studied across 2 of the same disease areas as Tocilizumab in the shared literature.

2 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.