Anakinra
Highest phase reached
Approved
Drug type
Protein
First approval year
2001
- First approval year
- 2001
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Protein
- Drug name
- Anakinra
- antril
- Antril
- kineret
- Kineret
- alta 2530
- Alta-2530
- alta2530
- Alta2530
- amg 719
- AMG 719
- AMG-719
- anakinra
- Anakinra
- ANAKINRA
- anakinra (150mg)
- Anakinra (AN)
- Anakinra (high dose)
- Anakinra (IL-1Ra)
- Anakinra (interleukin-1 receptor antagonist)
- anakinra (Kineret)
- Anakinra (Kineret)
- Anakinra (Kineret®)
- Anakinra (r-metHuIL-1ra)
- Anakinra (standard dose)
- Anakinra (weeks 1-2)
- Anakinra (weeks 3-12)
- ANAKINRA [EMA EPAR]
- anakinra [INN]
- ANAKINRA [MART.]
And 33 more, listed on the interactive page.
- ATC classification codes
- L04AC03
Sources for recorded values
- CAS registry numbers
- 143090-92-0
- ChEMBL ID
- CHEMBL1201570
- PubChem compound IDs
- 90470007
- RxNorm IDs (RxCUI)
- 72435
- FDA ingredient codes (UNII)
- 9013DUQ28K
- Applicant
- BIOVITRUM AB
- Approval date
- 14 Nov 2001
- Application number
- BLA103950
- Status
- Authorised
- Status date
- 8 Mar 2002
- Authorisation date
- 8 Mar 2002
- Approved indications
- Rheumatoid Arthritis (RA) Kineret is indicated in adults for the treatment of the signs and symptoms of RA in combination with methotrexate, with an inadequate response to methotrexate alone. COVID-19 Kineret is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adult patients with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure determined by plasma concentration of soluble urokinase plasminogen activator receptor (suPAR) ? 6 ng/ml. Periodic fever syndromes Kineret is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above: Cryopyrin-Associated Periodic Syndromes (CAPS) Kineret is indicated for the treatment of CAPS, including: Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA) Muckle-Wells Syndrome (MWS) Familial Cold Autoinflammatory Syndrome (FCAS) Familial Mediterranean Fever (FMF) Kineret is indicated for the treatment of Familial Mediterranean Fever (FMF). Kineret should be given in combination with colchicine, if appropriate. Still’s Disease Kineret is indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of Still’s disease, including Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still’s Disease (AOSD), with active systemic features of moderate to high disease activity, or in patients with continued disease activity after treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids. Kineret can be given as monotherapy or in combination with other anti-inflammatory drugs and disease-modifying antirheumatic drugs (DMARDs).
- Product number
- EMEA/H/C/000363
- Authorisation holder
- Swedish Orphan Biovitrum AB (publ)
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Arthritis, Rheumatoid
- COVID-19 virus infection
European medicines record
- Patents
- 0
- Designations
- 2
- Earliest recorded loss of exclusivity
- 18 Dec 2027
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- anakinra
- Type
- Peptide
- Drug name stem
- -kinra
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Mechanism
- Interleukin-1 receptor antagonist
- Action type
- Antagonist
- Target
- Interleukin-1 receptor type 1
- Protein identifier
- P14778
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- Interleukin-1 receptor, type I
- Gene symbol
- IL1RAP
- Protein identifier
- P14778
- Median affinity
- 7.82
- Affinity units
- pKd
- Primary target
- Yes
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- Interleukin-1 receptor, type I
- Gene symbol
- IL1R1
- Protein identifier
- Q9NPH3
- Median affinity
- 7.82
- Affinity units
- pKd
- Primary target
- Yes
Open Targets mechanisms
- Mechanism
- Interleukin-1 receptor antagonist
- Action type
- Antagonist
- Target
- Interleukin-1 receptor type 1
- Condition
- Leukemia, Lymphocytic, Chronic, B-Cell
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000095
- Subject identifier
- D015451
- Condition
- Lymphoma, Follicular
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000096
- Subject identifier
- D008224
- Condition
- Metabolic Syndrome
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000195
- Subject identifier
- D024821
- Condition
- Dermatomyositis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000398
- Subject identifier
- D003882
- Condition
- Diabetes Mellitus
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000400
- Subject identifier
- D003920
- Condition
- Immune System Diseases
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000540
- Subject identifier
- D007154
- Condition
- Infections
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000544
- Subject identifier
- D007239
- Condition
- Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Polycystic Ovary Syndrome
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000660
- Subject identifier
- D011085
- Condition
- Arthritis, Rheumatoid
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000685
- Subject identifier
- D001172
- Condition
- Severe Acute Respiratory Syndrome
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000694
- Subject identifier
- D045169
- Condition
- Virus Diseases
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000763
- Subject identifier
- D014777
- Condition
- HIV Infections
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000764
- Subject identifier
- D015658
- Condition
- Endometriosis
- Highest recorded phase
- 0.5
- Condition identifier
- EFO:0001065
- Subject identifier
- D004715
- Condition
- Hypertension, Pulmonary
- Highest recorded phase
- 1
- Condition identifier
- EFO:0001361
- Subject identifier
- D006976
- Condition
- Multiple Myeloma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001378
- Subject identifier
- D009101
- Condition
- Arthritis, Juvenile
- Highest recorded phase
- 2
- Condition identifier
- EFO:0002609
- Subject identifier
- D001171
- Condition
- Pancreatic Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0002618
- Subject identifier
- D010190
- Condition
- Smoldering Multiple Myeloma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0003073
- Subject identifier
- D000075122
- Condition
- Pneumonia
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003106
- Subject identifier
- D011014
- Condition
- Heart Failure
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003144
- Subject identifier
- D006333
- Condition
- Pain
- Highest recorded phase
- 1
- Condition identifier
- EFO:0003843
- Subject identifier
- D010146
- Condition
- Renal Insufficiency, Chronic
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003884
- Subject identifier
- D051436
- Condition
- Severe Dengue
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004227
- Subject identifier
- D019595
- Condition
- Hearing Loss
- Highest recorded phase
- 1
- Condition identifier
- EFO:0004238
- Subject identifier
- D034381
And 39 more, listed on the interactive page.
- Condition identifier
- EFO_0000095
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000096
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000195
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000400
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000540
- Condition identifier
- EFO_0000616
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000660
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000685
- Condition identifier
- EFO_0001065
- Condition identifier
- EFO_0001361
- Highest recorded phase
- 1
- Condition identifier
- EFO_0001378
- Highest recorded phase
- 2
- Condition identifier
- EFO_0002609
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003106
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003144
- Condition identifier
- EFO_0003884
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004227
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004238
- Condition identifier
- EFO_0004246
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004274
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004540
- Condition identifier
- EFO_0005669
- Highest recorded phase
- 2
- Condition identifier
- EFO_0007135
- Highest recorded phase
- 3
- Condition identifier
- EFO_0007427
- Highest recorded phase
- 2
- Condition identifier
- EFO_0007948
- Highest recorded phase
- 1
- Condition identifier
- EFO_0008526
- Highest recorded phase
- 3
And 116 more, listed on the interactive page.
- Event
- acne cystic
- Reports
- 46
- Reporting signal score
- 194.762
- Event
- adenovirus infection
- Reports
- 29
- Reporting signal score
- 79.8295
- Event
- adrenal insufficiency
- Reports
- 133
- Reporting signal score
- 357.706
- Event
- ankle arthroplasty
- Reports
- 37
- Reporting signal score
- 186.064
- Event
- ankle operation
- Reports
- 47
- Reporting signal score
- 191.976
- Event
- anti-cyclic citrullinated peptide antibody positive
- Reports
- 48
- Reporting signal score
- 128.786
- Event
- antibody test positive
- Reports
- 66
- Reporting signal score
- 253.141
- Event
- apparent death
- Reports
- 192
- Reporting signal score
- 899.579
- Event
- arthralgia
- Reports
- 375
- Reporting signal score
- 287.936
- Event
- arthritis
- Reports
- 134
- Reporting signal score
- 181.34
- Event
- arthrodesis
- Reports
- 37
- Reporting signal score
- 139.086
- Event
- arthropathy
- Reports
- 309
- Reporting signal score
- 690.528
- Event
- back disorder
- Reports
- 39
- Reporting signal score
- 67.4785
- Event
- body height below normal
- Reports
- 106
- Reporting signal score
- 536.018
- Event
- bone density decreased
- Reports
- 137
- Reporting signal score
- 453.771
- Event
- c-reactive protein abnormal
- Reports
- 74
- Reporting signal score
- 213.619
- Event
- c-reactive protein increased
- Reports
- 202
- Reporting signal score
- 394.858
- Event
- clubbing
- Reports
- 16
- Reporting signal score
- 61.403
- Event
- condition aggravated
- Reports
- 518
- Reporting signal score
- 641.321
- Event
- cutaneous vasculitis
- Reports
- 94
- Reporting signal score
- 351.697
- Event
- deep vein thrombosis
- Reports
- 198
- Reporting signal score
- 259.661
- Event
- deformity
- Reports
- 86
- Reporting signal score
- 312.866
- Event
- diverticulitis
- Reports
- 205
- Reporting signal score
- 490.992
- Event
- drug hypersensitivity
- Reports
- 217
- Reporting signal score
- 103.175
- Event
- drug intolerance
- Reports
- 464
- Reporting signal score
- 881.224
And 82 more, listed on the interactive page.
- NCT00037648
- NCT00037700
- NCT00111410
- NCT00537667
- NCT00072111
- NCT00110916
- NCT00214851
- NCT00332254
- NCT00635154
- NCT03233776
- NCT03430011
- NCT04099901
- NCT00645840
- NCT00711503
- NCT01346085
- NCT01477476
- NCT03182426
- NCT00681109
- NCT00789724
- NCT01950299
- NCT01033656
- NCT05814159
- NCT01165008
- NCT01277315
- NCT01285245
And 72 more, listed on the interactive page.
- Dose
- 100 mg
- Route
- Subcutaneous
- How often
- Daily
- Discard unused portions
- Rotate injection sites
- Use a new syringe for each dose
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
Sequences
- Component
- Sequence
- Type
- Protein
- Sequence
- MRPSGRKSSKMQAFRIWDVNQKTFYLRNNQLVAGYLQGPNVNLEEKIDVVPIEPHALFLGIHGGKMCLSCVKSGDETRLQLEAVNITDLSENRKQDKRFAFIRSDSGPTTSFESAACPGWFLCTAMEADQPVSLTNMPDEGVMVTKFYFQEDE
- 66658-234
- Recorded assays
- 1
- Active assays
- 0
Related records
Trials (282)
- "IL-1β Blockade to Prevent Immunothrombosis in Recipients of a Pancreatic Organ"
- 3 Anthracyclines, 2 Types of Consolidation With Different ARA-C Doses and Maintenance in Adult Acute Myeloid Leukemia
- A Clinical Trial of Anakinra for Steroid-Resistant Autoimmune Inner Ear Disease
- A Dose-Block Randomized, Placebo Controlled (Double-blind), Active Controlled(Open-label), Dose-escalation Study
- A Dose-Escalation to Rash Study of Tarceva (Erlotinib) Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer
- A Phase 2 Trial of Anakinra for the Prevention of CAR-T Cell Mediated Neurotoxicity
- A Pilot Study to Assess the Immunogenicity and Reactogenicity of High Versus Standard Dose TIV
- A Pilot Study Using Anakinra/Kineret for the Treatment of Patients With Severe Atopic Dermatitis
- A Pilot, Prospective, Non-randomized Evaluation of the Safety of Anakinra Plus Standard Chemotherapy
- A Rheumatoid Arthritis (RA) Study Treating Signs and Symptoms of RA in People With RA & Receiving Methotrexate
- A Safety and Efficacy Study of Concomitant Administration of ChAd63/MVA ME-TRAP + RTS,S
- A Safety Study of SGN-CD33A in Combination With Standard-of-care in Patients With AML
- A Study in Patients With COVID-19 and Respiratory Distress Not Requiring Mechanical Ventilation, to Compare Standard-of-care With Anakinra and Tocilizumab Treatment The Immunomodulation-CoV Assessment (ImmCoVA) Study
- A Study of Anakinra in Japanese Patients With Still's Disease (SJIA and AOSD)
- A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
- A Study of CART-PSMA-TGFβRDN in Patients With Metastatic Castration Resistant Prostate Cancer
- A Study of CellCept (Mycophenolate Mofetil) Combined With Tacrolimus and Corticosteroids in Kidney Transplant Patients.
- A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Liver Transplant Patients.
- A Study of Firsekibart Versus Anakinra in Adult-Onset Still's Disease
- A Study of JNJ-77474462 in Healthy Participants
Approved for (5)
- CINCA syndrome
- COVID-19
- Familial cold autoinflammatory syndrome
- Immune system disorder
- Rheumatoid arthritis
In development for (56)
- Acute myocardial infarction Phase 3
- Acute respiratory distress syndrome Phase 2
- Adult-onset Still disease Phase 3
- Alcoholic hepatitis Phase 2
- Allergic contact dermatitis Phase 3
- Amyotrophic lateral sclerosis Phase 2
- Asthma Phase 1
- B-cell chronic lymphocytic leukemia Phase 1
- Blepharitis Phase 1
- Brain injury Phase 2
- Breast cancer Phase 1
- Cardiac sarcoidosis Phase 2
- Chronic granulomatous disease Early phase 1
- Chronic kidney disease Phase 2
- Cystic fibrosis Phase 2
- Dengue hemorrhagic fever Phase 2
- Dermatomyositis Phase 2
- Diabetes mellitus Phase 2
- Endometriosis Early phase 1
- Exocrine pancreatic carcinoma Phase 1
Other linked conditions (3)
- Acute myocarditis
- Cryopyrin-associated periodic syndrome
- Type 2 diabetes mellitus
Targets (1)
- IL1R1 Interleukin-1 receptor antagonist