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 |
|---|---|---|---|---|---|---|---|---|---|
| Arthritis | D001168 | EFO_0005856 | M05-M14 | — | 5 | 1 | 3 | 5 | 14 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | 3 | 1 | 3 | 7 | 14 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 3 | — | 1 | 3 | 7 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 1 | 6 | — | 1 | — | 7 |
| Mucocutaneous lymph node syndrome | D009080 | EFO_0004246 | M30.3 | 2 | 2 | 1 | 1 | 1 | 6 |
| Sepsis | D018805 | EFO_0001420 | A41.9 | — | 3 | 2 | 1 | 1 | 6 |
| Recurrence | D012008 | — | — | 1 | 2 | — | 1 | 1 | 5 |
| Pericarditis | D010493 | EFO_0007427 | I30 | — | 1 | 1 | 1 | 2 | 5 |
| Hereditary autoinflammatory diseases | D056660 | — | — | — | — | 2 | 1 | — | 3 |
| Familial mediterranean fever | D010505 | — | M04.1 | — | — | 2 | 1 | — | 3 |
Show 6 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | — | U07.1 | — | 9 | 11 | — | 7 | 24 |
| Inflammation | D007249 | MP_0001845 | — | 4 | 8 | 2 | — | 5 | 15 |
| Heart failure | D006333 | EFO_0003144 | I50 | 3 | 9 | 2 | — | 2 | 12 |
| Syndrome | D013577 | — | — | 1 | 6 | 3 | — | 3 | 10 |
| Cytokine release syndrome | D000080424 | — | D89.83 | 1 | 6 | 4 | — | — | 8 |
| Infections | D007239 | EFO_0000544 | — | 1 | 3 | 1 | — | 3 | 7 |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | 5 | 1 | — | 1 | 6 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 3 | 6 | 1 | — | — | 6 |
| Juvenile arthritis | D001171 | EFO_1002007 | M08 | — | 3 | 3 | — | 1 | 6 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | 3 | 3 | 1 | — | — | 6 |
Show 37 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | — | C90.0 | 2 | 4 | — | — | — | 5 |
| Plasma cell neoplasms | D054219 | — | — | 2 | 4 | — | — | — | 5 |
| Acute lung injury | D055371 | EFO_0004610 | — | — | 1 | — | — | 3 | 4 |
| Newborn respiratory distress syndrome | D012127 | — | P22 | — | 1 | — | — | 3 | 4 |
| Lymphoma | D008223 | — | C85.9 | — | 4 | — | — | — | 4 |
| B-cell lymphoma | D016393 | — | — | — | 4 | — | — | — | 4 |
| Asthma | D001249 | EFO_0000270 | J45 | 3 | 3 | — | — | 1 | 4 |
| Communicable diseases | D003141 | — | — | 1 | 1 | — | — | 2 | 4 |
| Macrophage activation syndrome | D055501 | EFO_1001806 | — | 1 | 3 | — | — | — | 4 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | 3 | — | — | 1 | 4 |
Show 90 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pain | D010146 | EFO_0003843 | R52 | 1 | — | — | — | 2 | 3 |
| Healthy volunteers/patients | — | — | — | 3 | — | — | — | — | 3 |
| Pulmonary arterial hypertension | D000081029 | — | — | 1 | — | — | — | 1 | 2 |
| Neoplasms | D009369 | — | C80 | 2 | — | — | — | — | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | — | — | — | — | 1 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 1 | — | — | — | — | 1 |
| Smoldering multiple myeloma | D000075122 | — | — | 1 | — | — | — | — | 1 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 1 | — | — | — | — | 1 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | — | — | — | — | 1 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | 1 | — | — | — | — | 1 |
Show 15 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Menorrhagia | D008595 | EFO_0003945 | N92.0 | — | — | — | — | 1 | 1 |
| Hemophilia a | D006467 | EFO_0007267 | D66 | — | — | — | — | 1 | 1 |
| Down syndrome | D004314 | EFO_0001064 | Q90 | — | — | — | — | 1 | 1 |
| Blood coagulation disorders | D001778 | EFO_0009314 | D68.9 | — | — | — | — | 1 | 1 |
| Hyperaldosteronism | D006929 | — | E26 | — | — | — | — | 1 | 1 |
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | — | — | — | 1 | 1 |
| Hyperphosphatemia | D054559 | — | — | — | — | — | — | 1 | 1 |
| Edema | D004487 | — | R60.9 | — | — | — | — | 1 | 1 |
| Hypokalemia | D007008 | — | E87.6 | — | — | — | — | 1 | 1 |
| Sleep initiation and maintenance disorders | D007319 | — | F51.01 | — | — | — | — | 1 | 1 |
Show 41 more
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) |
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Anakinra
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Safety
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13,896 adverse events reported
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