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Drug ReportsRilonacept
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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Events Timeline
5D
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3M
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YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
hereditary congenital and neonatal diseases and abnormalitiesD009358
skin and connective tissue diseasesD017437
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
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
ArcalystrilonaceptKiniksa PharmaceuticalsN-125249 RX2008-02-27
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
arcalystBiologic Licensing Application2023-05-08
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
inborn genetic diseasesEFO_0000508D030342—
inflammationMP_0001845D007249—
cryopyrin-associated periodic syndromes—D056587M04.2
Agency Specific
FDA
EMA
Expiration
Code
rilonacept, Arcalyst, Kiniksa Pharmaceuticals (UK), Ltd.
2028-03-18Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L04: Immunosuppressants
— L04A: Immunosuppressants
— L04AC: Interleukin inhibitors
— L04AC04: Rilonacept
HCPCS
Code
Description
J2793
Injection, rilonacept, 1 mg
Clinical
Clinical Trials
27 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic renal insufficiencyD051436—N18—2—1—3
Kidney diseasesD007674EFO_0003086N08—2—1—3
Renal insufficiencyD051437HP_0000083N19———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
GoutD006073EFO_0004274M10—15——6
Familial mediterranean feverD010505—M04.1—22——4
FeverD005334HP_0001945R50.9—12——3
SyndromeD013577———12——3
Hereditary autoinflammatory diseasesD056660———21——3
AmyloidosisD000686EFO_1001875E85——2——2
HyperthermiaD000084462———11——2
UrticariaD014581EFO_0005531L50—11——2
Cold urticariaD000096703———11——2
RecurrenceD012008———11——2
Show 3 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InflammationD007249MP_0001845——3———3
BrucellosisD002006EFO_0007185A23—2———2
Juvenile arthritisD001171EFO_1002007M0811———2
ArthritisD001168HP_0001369M05-M1411———2
Adult-onset still's diseaseD016706EFO_0007135M06.1—1———1
HepatitisD006505HP_0012115K75.9—1———1
Hepatitis aD006506EFO_0007305B15—1———1
Alcoholic hepatitisD006519EFO_1001345K70.1—1———1
Cardiovascular diseasesD002318HP_0001626——1———1
Systemic sclerodermaD012595EFO_0000717M34.011———1
Show 11 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Diabetes mellitusD003920HP_0000819E08-E131————1
Type 1 diabetes mellitusD003922EFO_0001359E101————1
Hearing lossD034381EFO_0004238H91.91————1
DeafnessD003638EFO_0001063H91.91————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
BursitisD002062EFO_1000941M71.9————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameRilonacept
INNrilonacept
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 classreceptor molecules or membrane ligands, natural, modified or modified: interleukin receptors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL1201830
ChEBI ID—
PubChem CID—
DrugBank—
UNII ID8K80YB5GMG (ChemIDplus, GSRS)
Target
Agency Approved
IL1B
IL1B
Organism
Homo sapiens
Gene name
IL1B
Gene synonyms
IL1F2
NCBI Gene ID
3553
Protein name
interleukin-1 beta
Protein synonyms
Catabolin, IL-1 beta, interleukin 1beta, preinterleukin 1 beta, pro-interleukin-1-beta
Uniprot ID
Q9UCT6
Mouse ortholog
Il1b (16176)
interleukin-1 beta (Q2M4J6)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Arcalyst – Regeneron Pharmaceuticals
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,510 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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357 adverse events reported
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