ARCALYST (rilonacept)
ARCALYST is indicated for the treatment of Cryopyrin-Associated Periodic Syndromes; Familial Cold Autoinflammatory Syndrome; Muckle-Wells Syndrome; Deficiency of Interleukin-1 Receptor Antagonist; Recurrent Pericarditis.
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.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2008-02-27
- PDUFA Date
- 2026-06-19 (24d)
- Patent Cliff
- 2028
- 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
ARCALYST Target & Pathway
ProTarget
ARCALYST Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
16 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06660732 | 23-013175 | Ph 2 | recruiting | Rilonacept in Subjects With Cardiac Sarcoidosis |
| NCT01903798 results posted | SCAHC Clinical Trial 1U01AA021886 | Ph 2 | completed | A Safety and Efficacy Study of Mycophenolate Mofetil and Rilonacept in Patients With Alcoholic Hepatitis |
| NCT03737110 RHAPSODY results posted | KPL-914-C002 2018-002719-87 | Ph 3 | completed | Study to Assess the Efficacy and Safety of Rilonacept Treatment in Participants With Recurrent Pericarditis |
| NCT00897715 results posted | CDA-2-031-09S | Ph 2 | completed | Inflammation in Chronic Kidney Disease and Cardiovascular Disease - The Role of Genetics and Interleukin-1 Receptor Antagonist (IL-1ra) |
| NCT02171416 Cures | Cures 2012-005726-30 | Ph 2 | completed | Cold Contact Urticaria Treatment With Rilonacept |
| NCT01538719 results posted | H31332 | Ph 1, Ph 2 | completed | IL1-TRAP, Rilonacept, in Systemic Sclerosis |
| NCT01801449 results posted | 130086 13-AR-0086 | Ph 2 | completed | Rilonacept for Deficiency of the Interleukin-1 Receptor Antagonist (DIRA) |
| NCT01459796 UPSURGE results posted | IL1T-GA-1101 | Ph 3 | terminated | Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares |
| NCT00856206 results posted | IL1T-GA-0815 | Ph 3 | completed | Review of Safety Using Rilonacept in Preventing Gout Exacerbations (RE-SURGE) |
| NCT00958438 results posted | IL1T-GA-0816 2008-007762-39 | Ph 3 | completed | PREventative Study Against URate-Lowering Drug-Induced Gout Exacerbations (PRE-SURGE 2) |
| NCT00855920 SURGE results posted | IL1T-GA-0814 | Ph 3 | completed | Study Utilizing Rilonacept in Gout Exacerbations |
| NCT01663103 results posted | 12-0586 | Ph 4 | completed | Interleukin-1 Trap to Treat Vascular Dysfunction in Chronic Kidney Disease (CKD) |
| NCT00534495 results posted | N01 AR070015 268200700015C-2-0-0, HHSN2682007000015C | Ph 2 | completed | Safety and Effectiveness of Rilonacept for Treating Systemic Juvenile Idiopathic Arthritis in Children and Young Adults |
| NCT00962026 RID-A | IL1T-AI-1022 | Ph 1 | completed | Rilonacept in Diabetes Mellitus Type 1: Safety Study |
| NCT00582907 results posted | 1R01FD003435-01 FDA 1RO1FD003435-01 | Ph 2 | completed | Rilonacept for Treatment of Familial Mediterranean Fever (FMF) |
| NCT01045772 ACCILTRA1 | ACCILTRA1 EudraCT Number: 2006-004290-97 | Ph 2 | completed | Safety and Tolerability of Rilonacept in Muckle-Wells Syndrome (MWS) or Schnitzler Syndrome (SchS) |
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
Indications & Usage
FDA Label (PDF)ARCALYST is indicated for the treatment of Cryopyrin-Associated Periodic Syndromes; Familial Cold Autoinflammatory Syndrome; Muckle-Wells Syndrome; Deficiency of Interleukin-1 Receptor Antagonist; Recurrent Pericarditis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment