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Arcalyst

(Rilonacept)

Phase 3Protein / enzyme

KKiniksa Pharmaceuticals (UK), Ltd.

Rilonacept is used to treat rare inflammatory conditions, including cryopyrin-associated periodic syndromes (CAPS) and gout attacks. It works by blocking proteins in the body that cause inflammation and pain.[1] Arcalyst is currently being investigated across 23 indications[3], with its most advanced program in Phase 3.[1]

Arcalyst is one of 440 small molecule programs targeting Cardiovascular Disease. It is currently in Phase 3.

23

Indications

24

Total Trials

1

Active Trials

439

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Cardiovascular DiseaseActive, not recruiting

ArthritisUnknown

HepatitisActive, not recruiting

Familial Mediterranean FeverActive, not recruiting

PericarditisUnknown

Muckle-Wells SyndromeUnknown

Systemic Juvenile Idiopathic ArthritisActive, not recruiting

Immune System DiseaseUnknown

AtherosclerosisActive, not recruiting

Cardiac SarcoidosisActive, not recruiting

Cardiovascular DiseasePhase 2

Active, not recruiting

ArthritisPreclinical

Unknown

HepatitisPhase 2

Active, not recruiting

Familial Mediterranean FeverPhase 2

Active, not recruiting

PericarditisPreclinical

Unknown

Muckle-Wells SyndromePreclinical

Unknown

Systemic Juvenile Idiopathic ArthritisPhase 1

Active, not recruiting

Immune System DiseasePreclinical

Unknown

AtherosclerosisPhase 2

Active, not recruiting

Cardiac SarcoidosisPhase 2

Active, not recruiting

Showing 10 of 23 indications

Competition

Competitive Landscape

540 competitors in Chronic Kidney Disease

#DrugCompanyPhaseTrials

Arcalyst

KKiniksa Pharmaceuticals (UK), Ltd.

Aranesp

Epogen

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Uloric

Lorelco

Sovaldi

Glucotrol

Vemlidy

Activase

Sodium Valproate

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2Recruiting

Cardiac Sarcoidosis

NCT06660732

Clinical

Trials by Indication[1]

Gout4 trials

PREventative Study Against URate-Lowering Drug-Induced Gout Exacerbations (PRE-SURGE 2)

Completed· Regeneron logo

Regeneron·Phase 3·NCT00958438·248 enrolled

Study Utilizing Rilonacept in Gout Exacerbations

Completed· Regeneron logo

Regeneron·Phase 3·NCT00855920·225 enrolled

PREventative Study Against URate-lowering Drug-induced Gout Exacerbations 1

Completed· Regeneron logo

Regeneron·Phase 3·NCT00829829·241 enrolled

Show 1 more trial

Review of Safety Using Rilonacept in Preventing Gout Exacerbations (RE-SURGE)

Completed· Regeneron logo

Regeneron·Phase 3·NCT00856206·1,315 enrolled

Chronic Kidney Disease2 trials

Study of the Safety and Effectiveness of Rilonacept (IL-1 Trap) Administered Subcutaneously in Subjects With Non Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) and Anemia

Withdrawn· Regeneron logo

Regeneron·Phase 2·NCT00609544

Interleukin-1 Trap to Treat Vascular Dysfunction in Chronic Kidney Disease (CKD)

Completed·UUniversity of Colorado, Denver·Phase 4·NCT01663103·42 enrolled

Systemic Juvenile Idiopathic Arthritis2 trials

Study to Evaluate the Safety and Tolerability of Two Doses of Rilonacept in Pediatric Subjects With Active Systemic Juvenile Idiopathic Arthritis (SJIA)

Completed· Regeneron logo

Regeneron·Phase 1·NCT01803321·24 enrolled

Safety and Effectiveness of Rilonacept for Treating Systemic Juvenile Idiopathic Arthritis in Children and Young Adults

Completed·MMontefiore Medical Center·Phase 2·NCT00534495·71 enrolled

Atherosclerosis1 trial

Rilonacept to Improve Artery Function in Patients With Atherosclerosis

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT00417417·10 enrolled

Hearing Loss1 trial

Rilonacept for Treatment of Autoimmune Neurosensory Hearing Loss

Unknown status·SStanley Cohen·Phase 1·NCT02828033·10 enrolled

14 more indications

Systemic Sclerosis1 trial

IL1-TRAP, Rilonacept, in Systemic Sclerosis

Completed·—·Phase 1/2·NCT01538719·24 enrolled

Bursitis1 trial

Rilonacept (Arcalyst ®) in the Treatment of Subacromial Bursitis

Completed·KKeesler Air Force Base Medical Center·N/A·NCT01830699·33 enrolled

Cardiovascular Disease1 trial

Inflammation in Chronic Kidney Disease and Cardiovascular Disease - The Role of Genetics and Interleukin-1 Receptor Antagonist (IL-1ra)

Completed·VVA Office of Research and Development·Phase 2·NCT00897715·15 enrolled

Familial Mediterranean Fever1 trial

Rilonacept for Treatment of Familial Mediterranean Fever (FMF)

Completed·TThe Cleveland Clinic·Phase 2·NCT00582907·14 enrolled

Diabetes Mellitus1 trial

Rilonacept in Diabetes Mellitus Type 1: Safety Study

Completed·UUniversity of Texas Southwestern Medical Center·Phase 1·NCT00962026·13 enrolled

Effectiveness1 trial

Study of the Safety and Effectiveness of Rilonacept for the Prevention of Gout Flares

Completed· Regeneron logo

Regeneron·Phase 2·NCT00610363·83 enrolled

Cardiac Sarcoidosis1 trial

Rilonacept in Subjects With Cardiac Sarcoidosis

Recruiting·MMayo Clinic·Phase 2·NCT06660732·60 enrolled

Urticaria1 trial

Cold Contact Urticaria Treatment With Rilonacept

Completed·—·Phase 2·NCT02171416·20 enrolled

Muckle-Wells syndrome1 trial

Safety and Tolerability of Rilonacept in Muckle-Wells Syndrome (MWS) or Schnitzler Syndrome (SchS)

Completed·—·Phase 2·NCT01045772·10 enrolled

Safety and Efficacy1 trial

Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares

Terminated· Regeneron logo

Regeneron·Phase 3·NCT01459796·220 enrolled

Cryopyrin-Associated Periodic Syndrome1 trial

Rilonacept for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)

Completed· Regeneron logo

Regeneron·Phase 3·NCT00288704·104 enrolled

Hepatitis1 trial

A Safety and Efficacy Study of Mycophenolate Mofetil and Rilonacept in Patients With Alcoholic Hepatitis

Completed·SSouthern California Institute for Research and Education·Phase 2·NCT01903798·4 enrolled

Pericarditis1 trial

Study to Assess the Efficacy and Safety of Rilonacept Treatment in Participants With Recurrent Pericarditis

Completed·KKiniksa Pharmaceuticals (UK), Ltd.·Phase 3·NCT03737110·86 enrolled

Interleukin1 trial

Rilonacept for Deficiency of the Interleukin-1 Receptor Antagonist (DIRA)

Completed·NNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)·Phase 2·NCT01801449·6 enrolled

Regulatory

FDA Approval Timeline[4]

Feb 27, 2008

ARCALYST

BLA BLA125249

Sources

References

[1]
ClinicalTrials.gov — 24 trial records for Rilonacept. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Rilonacept compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Rilonacept. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA125249). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Kiniksa Pharmaceuticals (UK), Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Interleukin-1 Beta Inhibitor[2]
Modality: Protein / enzyme[2]
Highest Phase: Phase 3[1]
Company: KKiniksa Pharmaceuticals (UK), Ltd.

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