rilonacept

Trade name: arcalyst

Recombinant proteinapprovedOrphan Drug ^FDA

Approved

Feb 27, 2008

Rilonacept, sold under the brand name Arcalyst, is a medication used to treat cryopyrin-associated periodic syndromes, including familial cold autoinflammatory syndrome, and Muckle–Wells syndrome; deficiency of interleukin-1 receptor antagonist; and recurrent pericarditis. Rilonacept is an interleukin 1 inhibitor. — Wikipedia

Clinical trial activity

26 trials · 25 clinical orgs · 2 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Oct 1, 2004 (NCT00094900)

Timeline

2000s

Jan 1, 2004
Earliest Phase 2 Sponsor(trial)
Dec 20, 2004
Orphan Drug Designation
Jan 1, 2005
Regeneron — Earliest Phase 1 Sponsor(trial)
Jan 1, 2005
Regeneron — Earliest Phase 3 Sponsor(trial)
Feb 27, 2008
Regeneron — Earliest FDA Approval
Feb 27, 2008
Regeneron — Marketing Organization
Feb 27, 2008
Regeneron — NDA Organization
Feb 27, 2008
Kiniksa Pharmaceuticals, Ltd. — Marketing Organization
Feb 27, 2008
Kiniksa Pharmaceuticals, Ltd. — NDA Secondary Org

Mechanism of action

Interleukin-1 betaINHIBITOR
IL1B inhibitor
- Interleukin-1 beta (IL1B) ↗
Interleukin-1 alphaINHIBITOR
IL1A inhibitor
- Interleukin-1 alpha (IL1A) ↗

Approval history

approvedFeb 27, 2008

Chemistry & pharmacology

Chirality: Single Stereoisomer
Inorganic: No
Polymer: No
Delivery: Parenteral
Availability: Prescription Only
Multi-specific: No

Oral

Parenteral

Yes

Topical

Sources

Also known as

arcalyst
arcalyst
arcalyst
il-1 trap
il-1 trap
interleukin-1 (il-1) trap
interleukin-1 trap
interleukin-1 trap
rilonacept
rilonacept
rilonacept
rilonacept
rilonacept
rilonacept
rilonacept
rilonacept
rilonacept
rilonacept

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT06660732	Phase 2	Nov 30, 2024	Johns Hopkins University, Mayo Clinic
NCT03737110	Phase 3	Dec 6, 2018	Kiniksa Pharmaceuticals, Ltd.
NCT03980522	Phase 2	Jan 24, 2018	Kiniksa Pharmaceuticals, Ltd.
NCT02828033	Early Phase 1 (Phase 1)	Jul 1, 2016	Metroplex Clinical Research, Regeneron
NCT02171416	Phase 2	Jan 1, 2015	Humboldt University, Regeneron
NCT01903798	Phase 2	Dec 1, 2014	Department of Veteran Affairs, Los Angeles Biomedical Research Institute, National Institute on Alcohol Abuse and Alcoholism (NIAAA), Southern California Institute for Research and Education, University of Southern California
NCT01830699	N/A	Mar 1, 2013	Keesler Medical Center, United States Air Force
NCT01801449	Phase 2	Feb 12, 2013	National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NCT00897715	N/A	Jan 1, 2013	Department of Veteran Affairs
NCT01663103	Phase 4	Aug 1, 2012	University of Colorado, University of Colorado, Denver
NCT01538719	Phase 1/Phase 2 (Phase 2)	Dec 1, 2011	Boston University, Regeneron
NCT01459796	Phase 3	Nov 1, 2011	Regeneron
NCT00962026	Phase 1	Feb 1, 2011	The University of Texas, Dallas
NCT00958438	Phase 3	Jul 1, 2009	Regeneron
NCT00855920	Phase 3	Mar 1, 2009	Regeneron
NCT00856206	Phase 3	Mar 1, 2009	Regeneron
NCT00829829	Phase 3	Feb 1, 2009	Regeneron
NCT01045772	Phase 2	Jan 1, 2009	Humboldt University
NCT00534495	Phase 2	Nov 1, 2008	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Yeshiva University
NCT00582907	Phase 2	Aug 1, 2008	Hebrew University, University of Rochester

Showing 20 of 26 trials

Page 1 / 2

Organizations

Research & Development (25)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Regeneron	For profit	12	9	3	2005
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Government	3	2	1	2004
Department of Veteran Affairs	Government	2	1	2	2013
Humboldt University	Academic/Hospital	2	2	1	2009
Kiniksa Pharmaceuticals, Ltd.	For profit	2	2	2	2018
Boston University	Academic/Hospital	1	1	1	2011
Hebrew University	Academic/Hospital	1	0	1	2008
INC Research	For profit	1	0	1	2007
Johns Hopkins University	Academic/Hospital	1	0	1	2024
Keesler Medical Center	Academic/Hospital	1	0	1	2013
Los Angeles Biomedical Research Institute	Academic/Hospital	1	0	1	2014
Mayo Clinic	Academic/Hospital	1	1	1	2024
Metroplex Clinical Research	For profit	1	1	1	2016
National Heart, Lung, and Blood Institute (NHLBI)	Government	1	1	1	2006
National Institute of Allergy and Infectious Diseases (NIAID)	Government	1	0	1	2013
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Government	1	0	1	2014
National Institutes of Health (NIH)	Government	1	0	1	2006
Southern California Institute for Research and Education	Academic/Hospital	1	1	1	2014
The University of Texas, Dallas	Academic/Hospital	1	1	1	2011
United States Air Force	Government	1	1	1	2013

25 organizations