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 | 2021-03-31 |
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
164 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatic encephalopathy | D006501 | K72.91 | 1 | 5 | 8 | 7 | 9 | 29 | |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 6 | 8 | 8 | 7 | 27 |
| Irritable bowel syndrome | D043183 | EFO_0000555 | K58 | 2 | 6 | 2 | 5 | 3 | 15 |
| Diarrhea | D003967 | HP_0002014 | R19.7 | — | 2 | 7 | 3 | 1 | 12 |
| Portal hypertension | D006975 | EFO_0000666 | K76.6 | — | 1 | 2 | 2 | — | 4 |
| Ascites | D001201 | HP_0001541 | R18 | — | — | 2 | 1 | — | 3 |
| Hepatitis c | D006526 | B19.2 | — | 2 | — | 1 | — | 3 | |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | — | — | 1 | 1 | 2 |
| Hiv | D006678 | O98.7 | 1 | 1 | — | 1 | — | 2 | |
| Clostridium infections | D003015 | EFO_1000874 | A05.2 | — | — | 1 | 1 | — | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Crohn disease | D003424 | EFO_0000384 | K50 | 1 | 7 | 4 | — | — | 11 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | 3 | 3 | 2 | — | — | 5 |
| Alcoholic hepatitis | D006519 | EFO_1001345 | K70.1 | — | 1 | 1 | — | — | 2 |
| Healthy volunteers/patients | — | 1 | 1 | 1 | — | — | 2 | ||
| Collagenous colitis | D046729 | EFO_1001293 | K52.831 | — | — | 1 | — | — | 1 |
| Bacterial infections | D001424 | A49 | — | — | 1 | — | — | 1 | |
| Fibrosis | D005355 | — | 1 | 1 | — | — | 1 | ||
| Diverticulitis | D004238 | EFO_1001460 | K57 | — | 1 | 1 | — | — | 1 |
| Peritonitis | D010538 | EFO_0008588 | K65 | — | — | 1 | — | — | 1 |
| Campylobacter infections | D002169 | EFO_0007190 | — | 1 | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Rosacea | D012393 | L71 | — | 3 | — | — | — | 3 | |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | — | 2 | — | — | — | 2 |
| Microscopic colitis | D046728 | EFO_1001295 | K52.83 | — | 1 | — | — | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | — | 1 |
| Insulin resistance | D007333 | EFO_0002614 | — | 1 | — | — | — | 1 | |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | — | 1 | — | — | — | 1 |
| Dyspepsia | D004415 | EFO_0008533 | K30 | — | 1 | — | — | — | 1 |
| Gastroparesis | D018589 | EFO_1000948 | K31.84 | — | 1 | — | — | — | 1 |
| Inflammation | D007249 | 1 | 1 | — | — | — | 1 | ||
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | — | — | — | — | 1 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | 1 | — | — | — | — | 1 | ||
| Persian gulf syndrome | D018923 | EFO_0007430 | 1 | — | — | — | — | 1 | |
| Neoplasms | D009369 | C80 | 1 | — | — | — | — | 1 | |
| Bone marrow transplantation | D016026 | 1 | — | — | — | — | 1 | ||
| Waldenstrom macroglobulinemia | D008258 | C88.0 | 1 | — | — | — | — | 1 | |
| Paraproteinemias | D010265 | D47.2 | 1 | — | — | — | — | 1 | |
| Sclerosing cholangitis | D015209 | EFO_0004268 | K83.01 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gastrointestinal hemorrhage | D006471 | K92.2 | — | — | — | — | 2 | 2 | |
| Esophageal and gastric varices | D004932 | EFO_0009545 | I85 | — | — | — | — | 2 | 2 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | — | — | — | — | 1 | 1 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | — | 1 | 1 |
| End stage liver disease | D058625 | EFO_1001311 | K72.1 | — | — | — | — | 1 | 1 |
| Acute-on-chronic liver failure | D065290 | — | — | — | — | 1 | 1 | ||
| Parkinsonian disorders | D020734 | HP_0001300 | — | — | — | — | 1 | 1 | |
| Gastrointestinal diseases | D005767 | — | — | — | — | 1 | 1 | ||
| Digestive system diseases | D004066 | EFO_0000405 | K92.9 | — | — | — | — | 1 | 1 |
| Stomach diseases | D013272 | — | — | — | — | 1 | 1 |
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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 | 501081-76-1 |
| RxCUI | 763450 |
| ChEMBL ID | CHEMBL1201830 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB06372 |
| UNII ID | 8K80YB5GMG (ChemIDplus, GSRS) |
Target
Alternate
No data
Variants
Clinical Variant
No data
Financial
Arcalyst - Regeneron Pharmaceuticals
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Trends
PubMed Central
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Additional graphs summarizing 1,274 documents
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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9,135 adverse events reported
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