KINERET (anakinra)
KINERET is indicated for the treatment of Rheumatoid Arthritis; Cryopyrin-Associated Periodic Syndromes; Neonatal-Onset Multisystem Inflammatory Disease; Deficiency of Interleukin-1 Receptor Antagonist.
How KINERET Works
Kineret blocks the biological activity of interleukin-1 (IL-1) alpha and beta by competitively inhibiting their binding to the interleukin-1 type I receptor. This receptor is expressed in various tissues and organs where IL-1 normally mediates inflammatory responses, cartilage degradation, and bone resorption. In patients with Neonatal-Onset Multisystem Inflammatory Disease or Deficiency of Interleukin-1 Receptor Antagonist, the drug addresses systemic inflammation caused by excessive or unopposed IL-1 signaling. By neutralizing these pathways, the medication helps manage the inflammatory and immunological manifestations of these diseases.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2001-11-14
- Patent Cliff
- 2027
- Routes
- SUBCUTANEOUS
- Dosage Forms
- VIAL
KINERET Approval History
What KINERET Treats
4 indicationsKINERET is approved for 4 conditions since its original approval in 2001. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Rheumatoid Arthritis
- Cryopyrin-Associated Periodic Syndromes
- Neonatal-Onset Multisystem Inflammatory Disease
- Deficiency of Interleukin-1 Receptor Antagonist
KINERET Target & Pathway
ProTarget
KINERET Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in KINERET's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications KINERET treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to KINERET
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
95 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07281027 COMBAT-NORSE | 2000041289 RD-2024C2-39648 | Ph 3 | not yet recruiting | COMparison Between Anakinra and Tocilizumab in NORSE - "COMBAT-NORSE" |
| NCT05177822 VA-ART4 | HM20022826 R01AG076360 | Ph 2 | active not recruiting | Interleukin-1 Blockade in Acute Myocardial Infarction to Prevent Heart Failure |
| NCT04381936 RECOVERY | NDPHRECOVERY 2020-001113-21, ISRCTN50189673 | Ph 3 | recruiting | Randomised Evaluation of COVID-19 Therapy |
| NCT02902731 GiAnT | 2015-005804-27 N° CHU : 15-200 | Ph 3 | terminated | Giant Cell Arteritis and Anakinra Trial |
| NCT05267821 TRIPS | TRIPS | Ph 2, Ph 3 | recruiting | Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS |
| NCT04205838 | 19-000604 NCI-2019-02887, 19-000604 | Ph 2 | terminated | Anakinra in Preventing Severe Chimeric Antigen Receptor T-Cell Related Encephalopathy Syndrome in Patients With Recurrent or Refractory Large B-cell Lymphoma |
| NCT05174507 Hypo-PrEA | 2020-01287; me20Donath | Ph 2 | withdrawn | Empagliflozin and Anakinra for the Treatment of Postprandial Hypoglycemia in Patients With Prediabetes |
| NCT02021422 | 013-018 | Ph 1 | completed | A Pilot, Prospective, Non-randomized Evaluation of the Safety of Anakinra Plus Standard Chemotherapy |
| NCT06381661 PALETTE | APHP240385 | Ph 2 | not yet recruiting | Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Exploratory, Bayesian Basket Trial |
| NCT05611710 | 60DX 223004/Z/21/Z | Ph 2 | active not recruiting | Anakinra in Dengue With Hyperinflammation ( AnaDen ) |
| NCT05013450 | STUDY-21-00907 | Ph 1, Ph 2 | active not recruiting | Dupilumab_Metastatic NSCLC |
| NCT04150913 results posted | 19-348 | Ph 2 | completed | A Phase 2 Trial of Anakinra for the Prevention of CAR-T Cell Mediated Neurotoxicity |
| NCT03651518 PIMOC | P160906J 2017-000519-18 | Ph 2 | completed | Personalized Therapies in Inflammatory Complex Disease |
| NCT06062966 AID-HEART | HM20027160 | Ph 1 | recruiting | The Effects of IL-1 Blockade on Inotrope Sensitivity in Patients With Heart Failure (AID-HEART) |
| NCT04926467 | 020-476 | Ph 2 | recruiting | Chemotherapy + Anakinra in Patients With Pancreatic Adenocarcinoma (PDAC) |
| NCT04148430 | 19-168 | Ph 2 | active not recruiting | A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy |
| NCT04898231 MISTIC results posted | 202109 | Ph 2, Ph 3 | completed | MIS-C Comparative Effectiveness Study |
| NCT04359784 results posted | RG1006866 NCI-2020-01861, 10373 | Ph 2 | completed | Anakinra for the Prevention of Cytokine Release Syndrome and Neurotoxicity in Patients With B-Cell Non-Hodgkin Lymphoma Receiving CD19-Targeted CAR-T Cell Therapy |
| NCT02929251 RUBI | P150945 2016-002284-34 | Ph 2 | completed | Randomized Trial Comparing Efficacy of Adalimumab, Anakinra and Tocilizumab in Non-infectious Refractory Uveitis |
| NCT07138898 | 25-00380 | Ph 2 | not yet recruiting | Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty |
| NCT04017936 MAGiC-ART results posted | HM20015843 R21TR003103 | Ph 2 | completed | Interleukin-1 Blockade for Treatment of Cardiac Sarcoidosis |
| NCT03797001 REDHART2 results posted | REDHART2 HM20014686 | Ph 2 | completed | Interleukin-1 Blockade In Recently Decompensated Heart Failure - 2 |
| NCT06336733 KIN-ATTACK-FMF | APHP220828 | Ph 3 | recruiting | Randomized Controlled Trial in Patients on Long-term Colchicine With Colchicine-resistant Familial Mediterranean Fever (FMF) to Evaluate the Efficacy of On-demand Anakinra Treatment for Painful Attacks in Patients Who Refuse Continuous Daily Therapy |
| NCT06666335 | Sobi.ANAKIN-701 | Ph 4 | not yet recruiting | A Study to Evaluate Efficacy and Safety of Anakinra in Chinese Patients With Colchicine-resistent FMF |
| NCT04341584 CORIMUNO-ANA results posted | APHP200375-5 | Ph 2 | completed | CORIMUNO-ANA: Trial Evaluating Efficacy Of Anakinra In Patients With Covid-19 Infection |
| NCT05498467 results posted | LEOSIC | Ph 3 | completed | The Role of Interleukin-1 Beta Targeted Therapy for Patients Suffering From Allergic Contact Dermatitis |
| NCT06624436 DEDICATE-LPS | DEDICATE-LPS 2023-506556-24-00 | Ph 4 | recruiting | Immunomodulatory Effects of Dexamethasone, Tocilizumab and Anakinra During Experimental Human Endotoxemia |
| NCT03925194 ANAKIN | EudraCT No.: 2016-004786-80-A | Ph 2 | recruiting | A Study to Evaluate Safety and Efficacy of Subcutaneous Administration of Anakinra in Patients With CF |
| NCT05814159 | Sobi.ANAKIN-303 | Ph 3 | active not recruiting | A Study of Anakinra in Japanese Patients With Still's Disease (SJIA and AOSD) |
| NCT02278562 INSPIRED results posted | NEPH-011-11S | Ph 2 | completed | Nutrition, Inflammation and Insulin Resistance in End Stage Renal Disease-Aim 2 |
| NCT05854251 Hyper-PreDIL | 2023-00497; kt23Donath2 | Ph 2 | completed | Hyperinsulinemia in Prediabetes Mediated by Interleukin-1β |
| NCT04432506 results posted | 2019-1051 NCI-2020-04369, 2019-1051 | Ph 2 | completed | Anakinra for the Reduction of CAR-T Toxicity in Patients With Relapsed or Refractory Large B-cell Lymphoma |
| NCT04025554 results posted | 190124 19-N-0124 | Ph 1, Ph 2 | completed | Anakinra for the Treatment of Chronically Inflamed White Matter Lesions in Multiple Sclerosis |
| NCT06697431 NIKITA | NIKITA | Ph 4 | not yet recruiting | Non Inferiority KawasakI Trial With Anakinra |
| NCT04099901 AFFECT-2 | HEMSC42 | Ph 2 | completed | Anakinra: Efficacy in the Management of Fever During Neutropenia and Mucositis in ASCT - A Randomized Controlled Trial |
| NCT03233776 AFFECT-1 | SC35 | Ph 2 | completed | Anakinra: Safety and Efficacy in the Management of Fever During Neutropenia and Mucositis in ASCT |
| NCT04018755 | 31834-01 | Ph 1, Ph 2 | completed | Open-label Study of Anakinra in MPS III |
| NCT05280340 | RES 21-0000-681A | Ph 1, Ph 2 | active not recruiting | Anakinra for Preterm Infants Pilot |
| NCT02780583 MAS | F151008003 FWA00005960, SOBI_UAB01 | Ph 1 | terminated | Treatment of Macrophage Activation Syndrome (MAS) With Anakinra |
| NCT03182426 | Pro00053082 | Ph 1, Ph 2 | completed | Stem Cell Mobilization (Plerixafor) and Immunologic Reset in Type 1 Diabetes (T1DM) |
| NCT02735707 REMAP-CAP | U1111-1189-1653 2015-002340-14, 602525 | Ph 3 | recruiting | Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia |
| NCT01705756 FMF | SHEBA-11-8557-AL-CTIL | Ph 3 | completed | Kineret (Anakinra), in Adult Patients With Colchicine-Resistant Familial Mediterranean Fever |
| NCT02179853 results posted | KD Anakinra | Ph 1, Ph 2 | completed | Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease |
| NCT04656184 ANACOMP | P200009 | Ph 3 | recruiting | A Trial Comparing the Efficacy and Safety of Anakinra Versus Intravenous Immunoglobulin (IVIG) Retreatment, in Patients With Kawasaki Disease Who Failed to Respond to Initial Standard IVIG Treatment |
| NCT01277315 | ANA-ALS01 | Ph 2 | completed | Safety and Tolerability of Anakinra in Combination With Riluzol in Amyotrophic Lateral Sclerosis |
| NCT02090101 IRAFU | 2013-003367-55 | Ph 2 | completed | Study Evaluating the Influence of LV5FU2 Bevacizumab Plus Anakinra Association on Metastatic Colorectal Cancer |
| NCT04362111 results posted | Chatham-Cytokine Covid-19 | Ph 3 | completed | Early Treatment of Cytokine Storm Syndrome in Covid-19 |
| NCT04227275 | CART-PSMA-TGFβRDN-02 | Ph 1 | terminated | A Study of CART-PSMA-TGFβRDN in Patients With Metastatic Castration Resistant Prostate Cancer |
| NCT04357366 SAVE | SAVE 2020-001466-11 | Ph 2 | completed | suPAR-guided Anakinra Treatment for Validation of the Risk and Management of Respiratory Failure by COVID-19 (SAVE) |
| NCT04544813 | CR108771 77474462ADM1001 | Ph 1 | completed | A Study of JNJ-77474462 in Healthy Participants |
Showing 50 of 95 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
KINERET FDA Label Details
Indications & Usage
FDA Label (PDF)KINERET is indicated for the treatment of Rheumatoid Arthritis; Cryopyrin-Associated Periodic Syndromes; Neonatal-Onset Multisystem Inflammatory Disease; Deficiency of Interleukin-1 Receptor Antagonist.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment