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Drug

Etanercept

Approved · EMA
Emerging researchLate-stage development

Also known as Enbrel, Eticovo, TNFR-Immunoadhesin, Recombinant human TNF.

RxNorm214555UNIIOP401G7OJC
2
Research papers
12
Active clinical trials
1
Regulatory events
Latest activity
beta

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

Clinical Trial of Etanercept (TNF-α Blocker) for Treatment of Blast-Induced Tinnitus

Clinical trial2026-02-23Results expected Q3 2026 · ClinicalTrials.gov

Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review.

Research2017-08-01BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy

Approval: Erelzi (EMA)

Regulatory2017-06-23EMA

Evidence confidence

1 claim

How strongly the incorporated evidence supports specific clinical claims about this treatment. A confidence figure is a current summary of evidence strength, not a permanent verdict.

Is at least as effective as active comparators for an ACR response in rheumatoid arthritis
59%Moderate confidence
Uncertainty ±18%Evidence coverage: MinimalUpdated 27 July 2026

High point estimate, but substantial uncertainty remains.

Confidence has a moderate point estimate but a wide uncertainty band — the evidence base is still thin.

Profile

Identifiers & mechanism

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

Canonical name
Etanercept
Aliases & brands
EnbrelEticovoTNFR-ImmunoadhesinRecombinant human TNF
RxNorm CUI
214555
UNII
OP401G7OJC
Regulatory jurisdictions
ema

Regulatory timeline

1 event

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
2017-06-23
Latest approval
2017-06-23
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2017-06-23Approval
Approval: Erelzi (EMA)
Indication: Rheumatoid arthritis Erelzi in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response toShow full indication

Rheumatoid arthritis Erelzi in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease?modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate. Erelzi can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Erelzi is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Etanercept, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X?ray and to improve physical function. Juvenile idiopathic arthritis Treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of enthesitis?related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy. Etanercept has not been studied in children aged less than 2 years. Psoriatic arthritis Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease?modifying antirheumatic drug therapy has been inadequate. Etanercept has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X?ray in patients with polyarticular symmetrical subtypes of the disease. Axial spondyloarthritis Ankylosing spondylitis (AS) Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Non-radiographic axial spondyloarthritis Treatment of adults with severe non?radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C?reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to non?steroidal anti?inflammatory drugs (NSAIDs). Plaque psoriasis Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet?A light (PUVA). Paediatric plaque psoriasis Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.

Evidence ↗

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

Clinical trials

187 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
187
registered trials across all phases
LATEST COMPLETION 2025
12
Active studies
10
Recruiting
130
Late-stage (III+)
131
Completed
44
Discontinued
PHASE DISTRIBUTIONn = 187
Early Phase 12Phase 113Phase 1 / 29Phase 233Phase 2 / 39Phase 347Phase 464Phase N / A10

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

2 papers

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

Publications over time
20172025
Most influential

Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review.

BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2017 · 231 cites
Recent papers

Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review.

BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2017 · 231 cites
Major research themes4
Neuronal Plasticity1Recombinant Proteins1Synapses1tau Proteins1
Journals, researchers & institutions
Top journals
  • BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy1
  • Molecular brain1
Leading researchers
  • Al-Saleh J1
  • Balsa A1
  • Barile-Fabris L1
  • Hawes C1
  • Horiuchi T1
  • Hu NW1
  • Klyubin I1
  • Kola B1
Leading institutions
free-text, unnormalised
  • Collegeville1
  • Dubai Hospital1
  • Hospital de Especialidades Centro Médico Nacional Siglo XXI1
  • Instituto de Investigación Sanitaria del Hospital Universitario La Paz (IdiPAZ)1
  • Keio University School of Medicine1
  • Kyushu University Beppu Hospital1

Related drugs

2 matches

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

Studied across 6 of the same disease areas as Etanercept in the shared literature.

6 shared diseases1 shared paper

Studied across 6 of the same disease areas as Etanercept in the shared literature.

6 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.