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Drug

Anakinra

Approved · EMA
Emerging researchLate-stage developmentSteady momentum

Also known as Anakinra (E. coli), IL-1RA, Interleukin-1 receptor antagonist anakinra, Kineret.

RxNorm72435UNII9013DUQ28K
4
Research papers
25
Active clinical trials
1
Regulatory events
Latest activity
beta

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

The Effects of IL-1 Blockade on Inotrope Sensitivity in Patients With Heart Failure (AID-HEART)

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Clinical trial2026-07-09Results expected Q1 2028 · ClinicalTrials.gov

BRIDGE - Blocking Receptor of IL-1β for Donor Graft Edema Reduction

Clinical trial2026-06-25Results expected Q3 2027 · ClinicalTrials.gov

Approval: Kineret (EMA)

Regulatory2002-03-08EMA

Profile

Identifiers & mechanism

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

Canonical name
Anakinra
Aliases & brands
Anakinra (E. coli)IL-1RAInterleukin-1 receptor antagonist anakinraKineret
RxNorm CUI
72435
UNII
9013DUQ28K
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
2002-03-08
Latest approval
2002-03-08
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2002-03-08Approval
Approval: Kineret (EMA)
Indication: Rheumatoid Arthritis (RA) Kineret is indicated in adults for the treatment of the signs and symptoms of RA in combination with methotrexate, with an inadequate response toShow full indication

Rheumatoid Arthritis (RA) Kineret is indicated in adults for the treatment of the signs and symptoms of RA in combination with methotrexate, with an inadequate response to methotrexate alone. COVID-19 Kineret is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adult patients with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure determined by plasma concentration of soluble urokinase plasminogen activator receptor (suPAR) ? 6 ng/ml. Periodic fever syndromes Kineret is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above: Cryopyrin-Associated Periodic Syndromes (CAPS) Kineret is indicated for the treatment of CAPS, including: Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA) Muckle-Wells Syndrome (MWS) Familial Cold Autoinflammatory Syndrome (FCAS) Familial Mediterranean Fever (FMF) Kineret is indicated for the treatment of Familial Mediterranean Fever (FMF). Kineret should be given in combination with colchicine, if appropriate. Still’s Disease Kineret is indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of Still’s disease, including Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still’s Disease (AOSD), with active systemic features of moderate to high disease activity, or in patients with continued disease activity after treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids. Kineret can be given as monotherapy or in combination with other anti-inflammatory drugs and disease-modifying antirheumatic drugs (DMARDs).

Evidence ↗

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

Clinical trials

142 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
142
registered trials across all phases
LATEST COMPLETION 2025
25
Active studies
19
Recruiting
47
Late-stage (III+)
80
Completed
37
Discontinued
PHASE DISTRIBUTIONn = 142
Early Phase 14Phase 118Phase 1 / 219Phase 254Phase 2 / 312Phase 319Phase 46Phase 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

4 papers

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

Publications over time
20132024
Most influential
Recent papers
Major research themes4
COVID-19 Drug Treatment1Hospitals, University1Interleukin 1 Receptor Antagonist Protein1Renal Dialysis1
Journals, researchers & institutions
Top journals
  • Journal of cachexia, sarcopenia and muscle1
  • The American journal of cardiology1
  • The Journal of clinical investigation1
  • The Lancet. Respiratory medicine1
Leading researchers
  • Abbate A1
  • Abouzaki NA1
  • Abumrad NN1
  • Alsouqi A1
  • Biondi-Zoccai G1
  • Deger SM1
  • Dinarello CA1
  • Ertuglu LA1
Leading institutions
free-text, unnormalised
  • Division of Clinical Pharmacology1
  • Dokuz Eylul University1
  • Hofstra North Shore–LIJ School of Medicine at the Long Island Jewish Medical Center Campus1
  • University of Pittsburgh Medical Center1
  • Vanderbilt Center Kidney Disease1
  • Vanderbilt University Medical Center1
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.