Drugs / Rilonacept
Rilonacept
also known as
IL-1 Trap · Arcalyst · interleukin-1 Trap · KPL-914 · Rilonacept regeneron (previously arcalyst)
Protein / enzyme biologic targets IL1B via inhibition
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed idiopathic recurrent pericarditis 1 milestone | |||||
| Filed | US (FDA) | — | idiopathic recurrent pericarditis | 2020-11-23 | “today announced that the U.S. Food and Drug Administration (FDA) accepted the supplemental Biologics License Application (sBLA) for rilonacept in recurrent pericarditis.” kiniksa.com ↗ “Rilonacept for the treatment of DIRA is currently pending FDA approval following the submission of a supplemental BLA in June 2020 .” kiniksa.com ↗ “Rilonacept for the treatment of DIRA is currently under FDA review following the submission of an sBLA in June 2020 .” kiniksa.com ↗ |
| Withdrawn Indication not stated 4 milestones | |||||
| Label expansions (2) | US (FDA) | ARCALYST | — | 2020-12-18 – 2021-03-18 | fda.gov ↗ |
| Withdrawn | EU (EMA) | Rilonacept Regeneron (previously Arcalyst) | — | 2012-10-24 | europa.eu ↗ |
| Approved | EU (EMA) | Rilonacept Regeneron (previously Arcalyst) | — | 2009-10-23 | europa.eu ↗ |
| Approved | US (FDA) | ARCALYST | — | 2008-02-27 | fda.gov ↗ |
Trials 20
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02828033 | Feb 2017 → Mar 2018 | autoimmune inner ear disease | Stanley Cohen | Unknown | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT00962026 | Feb 2011 → Mar 2013 | type 1 diabetes mellitus | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT01803321 | Nov 2005 → Jun 2008 | systemic-onset juvenile idiopathic arthritis | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 211 trials · 1 met primary | ||||||
| Phase 2 | NCT06660732 | Mar 2025 → Nov 2026 expected | cardiac sarcoidosis | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 2 | NCT03980522 | Jan 2018 → May 2019 | pericarditis | Kiniksa Pharmaceuticals (UK), Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT01903798 | Dec 2014 → Apr 2016 | alcoholic hepatitis | Southern California Institute for Research and Education | Completed | No outcome recorded |
| Phase 2 | NCT01801449 | Feb 2013 → Apr 2016 | — | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Completed | No outcome recorded |
| Phase 2 | NCT01045772 | Jan 2009 → Sep 2010 | Muckle-Wells syndrome, Schnitzler syndrome | Charite University, Berlin, Germany | Completed | No outcome recorded |
| Phase 2 | NCT00534495 | Nov 2008 → Jun 2013 | juvenile idiopathic arthritis | Montefiore Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT00582907 | Aug 2008 → Sep 2011 | autosomal recessive familial Mediterranean fever | The Cleveland Clinic | Completed | No outcome recorded |
| Phase 2 | NCT00610363 | Nov 2007 → Oct 2008 | gout | Regeneron Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT00417417 | Dec 2006 → Apr 2008 | atherosclerosis, coronary artery disorder | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 2 | NCT00094900 | Oct 2004 → Sep 2010 | adult-onset Still disease, familial Mediterranean fever | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Completed | No outcome recorded |
| Phase 2 | NCT00609544 | — | anemia, chronic kidney disease | Regeneron Pharmaceuticals | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 35 trials · 3 met primary | ||||||
| Phase 3 | NCT03737110 | Jan 2019 → May 2020 | pericarditis | Kiniksa Pharmaceuticals (UK), Ltd. | Completed | Met primary |
| Phase 3 | NCT01459796 | Nov 2011 → Jun 2013 | gout | Regeneron Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT00958438 | Jul 2009 → Dec 2010 | gout | Regeneron Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT00856206 | Mar 2009 → Jan 2011 | gout | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00288704 | Dec 2005 → Jun 2008 | Muckle-Wells syndrome, cold urticaria, familial cold autoinflammatory syndrome | Regeneron Pharmaceuticals | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT01663103 | Aug 2012 → Dec 2014 | chronic kidney disease | University of Colorado, Denver | Completed | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 1/2 | NCT01538719 Comparator | Dec 2011 → Jan 2017 | diffuse cutaneous systemic sclerosis, diffuse scleroderma | Boston University | Completed | No outcome recorded |
| Phase 2 | NCT02171416 Comparator | Jan 2015 → Feb 2018 | cold urticaria | Charite University, Berlin, Germany | Completed | No outcome recorded |
| Phase 2 | NCT00897715 Comparator | Jan 2013 → Feb 2015 | cardiovascular disorder, chronic kidney disease | VA Office of Research and Development | Completed | No outcome recorded |
| Phase 3 | NCT00855920 Comparator | Mar 2009 → Feb 2010 | gout | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00829829 Comparator | Feb 2009 → May 2010 | gout | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| — | NCT01830699 Comparator | Mar 2013 → Mar 2014 | bursitis | Keesler Air Force Base Medical Center | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2021-03-18 | Kiniksa Pharmaceuticals International, plc | Regulatory Kiniksa Announces FDA Approval of ARCALYST ® (rilonacept) for Recurrent Pericarditis kiniksa.com ↗ |
| 2020-11-23 | Kiniksa Pharmaceuticals International, plc | Regulatory Kiniksa Announces U.S. FDA Acceptance of sBLA and Priority Review for Rilonacept in Recurrent Pericarditis kiniksa.com ↗
Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a biopharmaceutical company with a pipeline of assets designed to modulate immunological pathways across a spectrum of diseases, today announced that the U.S. Food and Drug Administration (FDA) accepted the supplemental Biologics License Application (sBLA) for rilonacept in recurrent pericarditis. |
| 2020-11-17 | Kiniksa Pharmaceuticals International, plc | Results Kiniksa Announces New England Journal of Medicine Publication of Rilonacept Phase 3 Data in Recurrent Pericarditis and Late-Breaking Science Presentation at American Heart Association Scientific Sessions 2020 kiniksa.com ↗
Data were reported which showed that patients treated with rilonacept experienced a 96% reduction in risk of recurrent pericarditis events. |
| 2020-07-16 | Kiniksa Pharmaceuticals International, plc | Regulatory Kiniksa Announces U.S. Orphan Drug Designation for Rilonacept for the Treatment of Pericarditis kiniksa.com ↗ |
| 2020-06-29 | Kiniksa Pharmaceuticals International, plc | Results Kiniksa Announces Positive Data from Phase 3 Trial of Rilonacept in Recurrent Pericarditis (RHAPSODY) kiniksa.com ↗
RHAPSODY met its prespecified primary and all major secondary efficacy endpoints, showing that rilonacept improved clinically meaningful outcomes associated with the unmet medical need in recurrent pericarditis, a painful and debilitating autoinflammatory disease. |
| 2020-03-30 | Kiniksa Pharmaceuticals International, plc | Results Kiniksa Highlights Phase 2 Study Data Showing the Corticosteroid-Sparing Effect of Rilonacept in Patients with Recurrent Pericarditis at the American College of Cardiology's 69th Annual Scientific Session kiniksa.com ↗
The analysis, which showed the corticosteroid-sparing effect of rilonacept treatment in the Phase 2 trial, was included in a virtual poster at the American College of Cardiology’s (ACC) 69 th Annual Scientific Session. |
| 2019-11-20 | Kiniksa Pharmaceuticals International, plc | Regulatory Kiniksa Announces Breakthrough Therapy Designation for Rilonacept for the Treatment of Recurrent Pericarditis kiniksa.com ↗
Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutic medicines for patients with significant unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for rilonacept for the treatment of recurrent pericarditis. |
| 2019-11-16 | Kiniksa Pharmaceuticals International, plc | Results Kiniksa Presents Rilonacept Final Phase 2 Clinical Data at the American Heart Association Scientific Sessions 2019 kiniksa.com ↗ |
| 2019-03-18 | Kiniksa Pharmaceuticals International, plc | Results Kiniksa Presents Rilonacept Interim Phase 2 Clinical Data Poster at the American College of Cardiology’s 68th Annual Scientific Session kiniksa.com ↗ |
| 2018-12-11 | Kiniksa Pharmaceuticals International, plc | Results Kiniksa Announces Rilonacept Interim Phase 2 Clinical Data and Initiates Pivotal Phase 3 Clinical Trial kiniksa.com ↗
The data show reductions in both inflammation and reported pain after the first dose which persisted throughout the treatment period. |
All press releases naming this drug 16 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 31 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Rilonacept | “rilonacept (IL-1 Trap)” PMID 18668591 ↗ Aug 2008 |
| Known as | Arcalyst | “This group will continue Prednisolone (40mg/day). Additionally, they will receive rilonacept (Arcalyst®) once a week for 21 days.” NCT01903798 ↗1“A Pilot Open-Label Study of Rilonacept (Arcalyst) in the Deficiency of the Interleukin-1 Receptor Antagonist (DIRA)” NCT01801449 ↗ |
| Known as | IL-1 Trap | “OBJECTIVE: To evaluate the efficacy and safety of IL-1 inhibitor rilonacept (IL-1 Trap) for gout flare (GF) prevention during initiation of uric acid-lowering therapy (ULT)...” PMID 23485476 ↗ Mar 20133“the interleukin (IL-1) blocker, rilonacept (IL-1 Trap), demonstrated efficacy for gout flare prevention during initiation of urate-lowering therapy.” PMID 23375025 ↗ Feb 2013 “rilonacept (IL-1 Trap)” NCT01803321 ↗ “rilonacept (IL-1 Trap)” PMID 18668591 ↗ Aug 2008 |
| Known as | interleukin-1 Trap | “Efficacy and safety of rilonacept (interleukin-1 Trap) in patients with cryopyrin-associated periodic syndromes: results from two sequential placebo-controlled studies.” PMID 18668535 ↗ Aug 20081“interleukin-1 inhibitor rilonacept (interleukin-1 Trap)” PMID 18668591 ↗ Aug 2008 |
| Known as | KPL-914 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03980522 ↗ |
| Known as | Rilonacept regeneron (previously arcalyst) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201830 ↗ |
| Action | Inhibit | “The interleukin-1 inhibitor rilonacept” PMID 23031624 ↗ Sep 20121“Interleukin-1 beta inhibitor” CHEMBL1201830 ↗ |
| Modality | Protein / enzyme biologic | “investigational biological agent, rilonacept” NCT00417417 ↗ |
| Route | Subcutaneous | “weekly subcutaneous rilonacept 160 mg” PMID 23031624 ↗ Sep 2012 |
| Target | IL1B | “Interleukin-1 beta inhibitor” CHEMBL1201830 ↗ |