Kineret(anakinra)
Kineret (anakinra) is a protein pharmaceutical. Anakinra was first approved as Kineret on 2001-11-14. It is used to treat cryopyrin-associated periodic syndromes and rheumatoid arthritis in the USA. It has been approved in Europe to treat rheumatoid arthritis.
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Commercial
Trade Name
FDA
EMA
Kineret
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)
Anakinra
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Kineret | anakinra | Orphan Medical | N-103950 RX | 2001-11-14 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| kineret | Biologic Licensing Application | 2025-07-30 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| rheumatoid arthritis | EFO_0000685 | D001172 | M06.9 |
| cryopyrin-associated periodic syndromes | — | D056587 | M04.2 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
anakinra, Kineret, Swedish Orphan Biovitrum AB (publ) | |||
| 2027-12-18 | Orphan excl. | ||
Patent Expiration
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HCPCS
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Clinical
Clinical Trials
207 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fever | D005334 | — | R50.9 | — | — | — | 1 | — | 1 |
| Hereditary autoinflammatory diseases | D056660 | — | — | — | — | — | 1 | — | 1 |
| Familial mediterranean fever | D010505 | — | M04.1 | — | — | — | 1 | — | 1 |
| Brucellosis | D002006 | EFO_0007185 | A23 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Juvenile arthritis | D001171 | EFO_1002007 | M08 | — | — | 2 | — | 1 | 3 |
| Mucocutaneous lymph node syndrome | D009080 | EFO_0004246 | M30.3 | — | 1 | 1 | — | — | 2 |
| Adult-onset still's disease | D016706 | EFO_0007135 | M06.1 | — | — | 2 | — | — | 2 |
| Covid-19 | D000086382 | — | U07.1 | — | 1 | 1 | — | — | 2 |
| Infections | D007239 | EFO_0000544 | — | — | 1 | 1 | — | — | 1 |
| Sars-cov-2 | D000086402 | — | — | — | 1 | 1 | — | — | 1 |
| Respiratory signs and symptoms | D012818 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Arthritis | D001168 | EFO_0005856 | M05-M14 | — | 1 | — | — | 1 | 2 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | — | 1 | — | — | — | 1 |
| B-cell lymphoma | D016393 | — | — | — | 1 | — | — | — | 1 |
| Gouty arthritis | D015210 | — | — | — | 1 | — | — | — | 1 |
| Ear diseases | D004427 | EFO_1001455 | H93.9 | — | 1 | — | — | — | 1 |
| Meniere disease | D008575 | EFO_0006862 | H81.0 | — | 1 | — | — | — | 1 |
| Labyrinth diseases | D007759 | — | — | — | 1 | — | — | — | 1 |
| Labyrinthitis | D007762 | — | H83.0 | — | 1 | — | — | — | 1 |
| Cytokine release syndrome | D000080424 | — | D89.83 | — | 1 | — | — | — | 1 |
| Mucopolysaccharidoses | D009083 | — | E76.3 | 1 | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 1 | — | — | — | — | 1 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 1 | — | — | — | — | 1 |
| Lymphoid leukemia | D007945 | — | C91 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | — | — | — | 1 | 1 |
| Cryopyrin-associated periodic syndromes | D056587 | — | M04.2 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Anakinra |
| INN | anakinra |
| Description | Interleukin-1 receptor antagonist protein precursor (IL-1ra) (IRAP) |
| Classification | Protein |
| Drug class | interleukin receptor antagonists: interleukin-1 (IL-1) receptor antagonists |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201570 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00026 |
| UNII ID | 9013DUQ28K (ChemIDplus, GSRS) |
Target
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Estimated US medical usage
Anakinra
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Trends
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Additional graphs summarizing 17,938 documents
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Safety
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13,896 adverse events reported
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