KINERET
Kineret (anakinra) is an interleukin-1 receptor antagonist indicated for the treatment of several inflammatory and autoinflammatory conditions. It is used to reduce signs and symptoms and slow structural damage in adults with moderately to severely active rheumatoid arthritis who have failed at least one disease-modifying antirheumatic drug. The medication is also approved for the treatment of Neonatal-Onset Multisystem Inflammatory Disease and Deficiency of Interleukin-1 Receptor Antagonist. Kineret may be used as a monotherapy or in combination with other disease-modifying drugs, excluding tumor necrosis factor blocking agents.
How KINERET Works
Kineret blocks the biological activity of interleukin-1 (IL-1) alpha and beta by competitively inhibiting their binding to the interleukin-1 type I receptor. This receptor is expressed in various tissues and organs where IL-1 normally mediates inflammatory responses, cartilage degradation, and bone resorption. In patients with Neonatal-Onset Multisystem Inflammatory Disease or Deficiency of Interleukin-1 Receptor Antagonist, the drug addresses systemic inflammation caused by excessive or unopposed IL-1 signaling. By neutralizing these pathways, the medication helps manage the inflammatory and immunological manifestations of these diseases.
Details
- Status
- Prescription
- First Approved
- 2001-11-14
- Routes
- SUBCUTANEOUS
- Dosage Forms
- VIAL
KINERET Approval History
What KINERET Treats
4 indicationsKINERET is approved for 4 conditions since its original approval in 2001. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Rheumatoid Arthritis
- Cryopyrin-Associated Periodic Syndromes
- Neonatal-Onset Multisystem Inflammatory Disease
- Deficiency of Interleukin-1 Receptor Antagonist
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
KINERET FDA Label Details
ProIndications & Usage
FDA Label (PDF)KINERET is an interleukin-1 receptor antagonist indicated for: Rheumatoid Arthritis (RA) Reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis, in patients 18 years of age or older who have failed 1 or more disease modifying antirheumatic drugs (DMARDs) Cryopyrin-Associated Periodic Syndromes (CAPS) Treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID) Deficiency of Interleukin-1 Receptor Antagonist (DIRA) Treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) 1.1 Active Rheumatoid Arth...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.