ARCALYST
Arcalyst (rilonacept) is an interleukin-1 blocker indicated for the treatment of rare autoinflammatory conditions and recurrent inflammatory heart disease. It is used in adults and pediatric patients aged 12 and older for Cryopyrin-Associated Periodic Syndromes (CAPS) and recurrent pericarditis. Additionally, the medication is indicated for the maintenance of remission in adults and pediatric patients weighing at least 10 kg with Deficiency of Interleukin-1 Receptor Antagonist (DIRA). The therapy plays a critical role in managing systemic inflammation and reducing the risk of disease recurrence.
How ARCALYST Works
Rilonacept functions as a cytokine trap by acting as a soluble decoy receptor that binds to both interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β). By capturing these cytokines, the drug prevents them from interacting with cell surface receptors and triggering the inflammatory cascade. This mechanism addresses the excessive IL-1 signaling caused by genetic mutations in CAPS and DIRA or the inflammatory processes involved in recurrent pericarditis. The drug also binds to the interleukin-1 receptor antagonist (IL-1ra) to further modulate the immune response.
Details
- Status
- Prescription
- First Approved
- 2008-02-27
- Routes
- SINGLE-USE
- Dosage Forms
- VIAL
ARCALYST Approval History
What ARCALYST Treats
5 indicationsARCALYST is approved for 5 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cryopyrin-Associated Periodic Syndromes
- Familial Cold Autoinflammatory Syndrome
- Muckle-Wells Syndrome
- Deficiency of Interleukin-1 Receptor Antagonist
- Recurrent Pericarditis
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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.
ARCALYST FDA Label Details
ProIndications & Usage
FDA Label (PDF)ARCALYST (rilonacept) is an interleukin-1 blocker indicated for: Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS), and Muckle-Wells Syndrome (MWS) in adults and children 12 years and older Maintenance of remission of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) in adults and pediatric patients weighing 10 kg or more Treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and children 12 years and older 1.1 Cryopyrin-Associated Periodic Syndromes, Familial Cold Autoinflammatory Syndrome...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.