Arcalyst, Rilonacept regeneron (previously arcalyst)(rilonacept)
Arcalyst (rilonacept) is a protein pharmaceutical. Rilonacept was first approved as Arcalyst on 2008-02-27. It is used to treat inborn genetic diseases and inflammation in the USA. It has been approved in Europe to treat cryopyrin-associated periodic syndromes. The pharmaceutical is active against interleukin-1 beta.
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Commercial
Trade Name
FDA
EMA
Arcalyst
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Rilonacept
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Arcalyst | rilonacept | Kiniksa Pharmaceuticals | N-125249 RX | 2008-02-27 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| arcalyst | Biologic Licensing Application | 2025-03-07 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| inborn genetic diseases | EFO_0000508 | D030342 | — |
| inflammation | MP_0001845 | D007249 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
rilonacept, Arcalyst, Kiniksa Pharmaceuticals (UK), Ltd. | |||
| 2028-03-18 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J2793 | Injection, rilonacept, 1 mg |
Clinical
Clinical Trials
28 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gout | D006073 | EFO_0004274 | M10 | — | 1 | 5 | — | — | 6 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | 1 | — | 4 | — | — | 5 |
| Inborn genetic diseases | D030342 | EFO_0000508 | — | — | — | 5 | — | — | 5 |
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | — | — | 4 | — | — | 4 |
| Rheumatic diseases | D012216 | — | M79.0 | — | — | 4 | — | — | 4 |
| Joint diseases | D007592 | — | M12.9 | — | — | 4 | — | — | 4 |
| Musculoskeletal diseases | D009140 | — | — | — | — | 4 | — | — | 4 |
| Inborn errors metabolism | D008661 | — | — | — | — | 4 | — | — | 4 |
| Inborn errors purine-pyrimidine metabolism | D011686 | Orphanet_79224 | E79 | — | — | 4 | — | — | 4 |
| Urticaria | D014581 | EFO_0005531 | L50 | — | 1 | 1 | — | — | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | 1 | 1 | — | — | — | 1 |
| Localized scleroderma | D012594 | EFO_1001361 | L94.0 | 1 | 1 | — | — | — | 1 |
| Diffuse scleroderma | D045743 | EFO_0000404 | — | 1 | 1 | — | — | — | 1 |
| Sclerosis | D012598 | — | — | 1 | 1 | — | — | — | 1 |
| Chronic renal insufficiency | D051436 | — | N18 | — | 1 | — | — | — | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 1 | — | — | — | 1 |
| Anemia | D000740 | EFO_0004272 | D64.9 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hearing loss | D034381 | EFO_0004238 | H91.9 | 1 | — | — | — | — | 1 |
| Deafness | D003638 | EFO_0001063 | H91.9 | 1 | — | — | — | — | 1 |
| Juvenile arthritis | D001171 | EFO_1002007 | M08 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Rilonacept |
| INN | rilonacept |
| Description | [653-glycine][human interleukin-1 receptor accessory protein-(1-339)-peptide (extracellular domain fragment) fusion protein with human type 1 interleukin-1 receptor-(5-316)-peptide (extracellular domain fragment) fusion protein with human immunoglobulin G1-(229 C-terminal residues)-peptide (Fc fragment)], (659-659':662-662')-bisdisulfide dimer |
| Classification | Protein |
| Drug class | receptor molecules or membrane ligands, natural, modified or modified: interleukin receptors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201830 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB06372 |
| UNII ID | 8K80YB5GMG (ChemIDplus, GSRS) |
Target
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Variants
No data
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Arcalyst – Regeneron Pharmaceuticals
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Trends
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Safety
Black-box Warning
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Adverse Events
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897 adverse events reported
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