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 · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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| Withdrawn | EU (EMA) | Rilonacept Regeneron (previously Arcalyst) | — | 2012-10-24 | europa.eu ↗ |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 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 6 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01538719 Comparator | Dec 2011 → Jan 2017 | diffuse cutaneous systemic sclerosis, diffuse scleroderma | Boston University | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| 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 32 trials | ||||||
| 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 |
| Phase not applicable1 trial | ||||||
| — | NCT01830699 Comparator | Mar 2013 → Mar 2014 | bursitis | Keesler Air Force Base Medical Center | Completed | No outcome recorded |
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 200825“Rilonacept” NCT00288704 ↗ |
| 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 ↗ |