Rilonacept
Medication
title: "Rilonacept" type: doc version: 1 created: 2026-02-28 author: "Wikipedia contributors" status: active scope: public tags: ["engineered-proteins", "immunosuppressants", "orphan-drugs"] description: "Medication" topic_path: "general/engineered-proteins" source: "https://en.wikipedia.org/wiki/Rilonacept" license: "CC BY-SA 4.0" wikipedia_page_id: 0 wikipedia_revision_id: 0
::summary Medication ::
::data[format=table title="Infobox drug"]
| Field | Value |
|---|---|
| type | |
| Verifiedfields | changed |
| verifiedrevid | 464382495 |
| tradename | Arcalyst |
| Drugs.com | |
| licence_EU | yes |
| DailyMedID | Rilonacept |
| licence_US | |
| routes_of_administration | Subcutaneous |
| ATC_prefix | L04 |
| ATC_suffix | AC04 |
| legal_AU | |
| legal_BR | |
| legal_CA | |
| legal_DE | |
| legal_NZ | |
| legal_UK | |
| legal_US | Rx-only |
| legal_US_comment | |
| legal_EU | Rx-only |
| legal_EU_comment | |
| legal_UN | |
| legal_status | |
| CAS_number_Ref | |
| CAS_number | 501081-76-1 |
| DrugBank_Ref | |
| DrugBank | DB06372 |
| ChemSpiderID_Ref | |
| ChemSpiderID | none |
| UNII_Ref | |
| UNII | 8K80YB5GMG |
| KEGG | D06635 |
| ChEMBL_Ref | |
| ChEMBL | 1201830 |
| synonyms | IL-1 Trap |
| C | 9030 |
| :: |
| drug_name = | INN = | type = | Verifiedfields = changed | verifiedrevid = 464382495 | image = | width = | alt = | caption =
| pronounce = | tradename = Arcalyst | Drugs.com = | MedlinePlus = | licence_EU = yes | DailyMedID = Rilonacept | licence_US = | routes_of_administration = Subcutaneous | class = | ATC_prefix = L04 | ATC_suffix = AC04 | ATC_supplemental =
| legal_AU = | legal_AU_comment = | legal_BR = | legal_BR_comment = | legal_CA = | legal_CA_comment = | legal_DE = | legal_DE_comment = | legal_NZ = | legal_NZ_comment = | legal_UK = | legal_UK_comment = | legal_US = Rx-only | legal_US_comment = | legal_EU = Rx-only | legal_EU_comment = | legal_UN = | legal_UN_comment = | legal_status =
| bioavailability = | protein_bound = | metabolism = | metabolites = | onset = | elimination_half-life = | duration_of_action = | excretion =
| CAS_number_Ref = | CAS_number = 501081-76-1 | PubChem = | IUPHAR_ligand = | DrugBank_Ref = | DrugBank = DB06372 | ChemSpiderID_Ref = | ChemSpiderID = none | UNII_Ref = | UNII = 8K80YB5GMG | KEGG_Ref = | KEGG = D06635 | ChEBI_Ref = | ChEBI = | ChEMBL_Ref = | ChEMBL = 1201830 | NIAID_ChemDB = | PDB_ligand = | synonyms = IL-1 Trap
| IUPAC_name = | C = 9030 | H = 13932 | N = 2400 | O = 2670 | S = 74 | SMILES = | StdInChI = | StdInChI_comment = | StdInChIKey = | density = | density_notes = | melting_point = | melting_high = | melting_notes = | boiling_point = | boiling_notes = | solubility = | sol_units = | specific_rotation =
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.
Rilonacept is a dimeric fusion protein consisting of the ligand-binding domains of the extracellular portions of the human interleukin-1 receptor component (IL-1R1) and IL-1 receptor accessory protein (IL-1RAcP) linked in-line to the fragment-crystallizable portion (Fc region) of human IgG1 that binds and neutralizes IL-1.
Rilonacept was given an orphan drug designation by the U.S. Food and Drug Administration (FDA) and is used for the treatment of cryopyrin-associated periodic syndromes (CAPS), including familial cold autoinflammatory syndrome, Muckle–Wells syndrome. Rilonacept is the first drug approved by the FDA to treat recurrent pericarditis. Rilonacept was approved for medical use in the United States in February 2008.
On May 8, 2012, an FDA Advisory Panel voted 11–0 against the approval of rilonacept for the treatment of gout, stating that the benefits did not outweigh the risks associated with the drug.
References
References
- "Arcalyst- rilonacept injection, powder, lyophilized, for solution".
- (17 September 2018). "Rilonacept Regeneron (previously Arcalyst) EPAR".
- (18 March 2021). "FDA Approves First Treatment for Disease That Causes Recurrent Inflammation in Sac Surrounding Heart".
- (October 2009). "The interleukin 1 inhibitor rilonacept in treatment of chronic gouty arthritis: results of a placebo-controlled, monosequence crossover, non-randomised, single-blind pilot study". Annals of the Rheumatic Diseases.
- (May 2008). "Molecule of the month. Rilonacept". Drug News & Perspectives.
- "Arcalyst FDA Approval History - Drugs.com".
- (2 May 2008). "Drug Approval Package: Arcalyst (Rilonacept) NDA #125249".
- (8 May 2012). "Medical News: FDA Panel Nixes Gout Drug - in Rheumatology, General Rheumatology from MedPage Today".
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