Anakinra
Protein / enzyme biologic targets IL1B, IL1R1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (5) | US (FDA) | KINERET | — | 2003-08-22 – 2020-12-18 | fda.gov ↗ |
| Approved | EU (EMA) | Kineret | — | 2002-03-08 | europa.eu ↗ |
| Approved | US (FDA) | KINERET | — | 2001-11-14 | fda.gov ↗ |
Trials 133 · started per year
Also used as a comparator or background therapy in 42 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03968913 Comparator | Sep 2021 → Jan 2027 expected | — | University of California, Los Angeles | Recruiting | No outcome recorded |
| Phase 16 trials | ||||||
| Phase 1 | NCT07600190 Comparator | Nov 2026 → Jan 2029 expected | chronic asthma | University of North Carolina, Chapel Hill | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT04544813 Comparator | Oct 2020 → May 2021 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04227275 Background | Nov 2019 → Nov 2022 | castration-resistant prostate carcinoma | Tceleron Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 1 | NCT02175056 Comparator | May 2014 → Jan 2015 | — | Handok Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01810549 Comparator | Mar → Dec 2013 | — | University of Zurich | Completed | No outcome recorded |
| Phase 1 | NCT01369017 Comparator | Oct 2011 → Jul 2013 | — | Michelle Hernandez, MD | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00681109 Comparator | Jan 2008 → May 2010 | blepharitis | Reza Dana, MD | Completed | No outcome recorded |
| Phase 213 trials | ||||||
| Phase 2 | NCT07254000 Comparator | Jun 2025 → Jun 2026 overdue | pulmonary immaturity | Monash Medical Centre | Recruiting | No outcome recorded |
| Phase 2 | NCT05785442 Comparator | Mar 2023 → Jun 2024 | pneumonia | Hellenic Institute for the Study of Sepsis | Completed | No outcome recorded |
| Phase 2 | NCT04072822 Comparator | Jul 2020 → May 2022 | alcoholic hepatitis | Indiana University | Completed | No outcome recorded |
| Phase 2 | NCT04412291 Comparator | Jun 2020 → Mar 2021 | COVID-19 | Karolinska University Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04462757 Comparator | May → Aug 2020 | COVID-19 | University of Manchester | Terminated | No outcome recorded |
| Phase 2 | NCT04374539 Comparator | Apr 2020 → Jun 2021 | COVID-19 | Fundacion Clinic per a la Recerca Biomédica | Terminated | No outcome recorded |
| Phase 2 | NCT03737344 Comparator | May 2019 → Feb 2021 | intracerebral hemorrhage | Adrian Parry-Jones | Completed | No outcome recorded |
| Phase 2 | NCT03141983 Comparator | Dec 2017 → Sep 2021 | end stage renal failure | University of Pennsylvania | Completed | No outcome recorded |
| Phase 2 | NCT02278562 Comparator | Oct 2014 → Mar 2017 | end stage renal failure | VA Office of Research and Development | Completed | No outcome recorded |
| Phase 2 | NCT02173548 Comparator | Sep 2014 → Apr 2017 | diastolic heart failure | Virginia Commonwealth University | Completed | No outcome recorded |
| Phase 2 | NCT01477476 Comparator | Mar 2012 → Mar 2016 | type 1 diabetes mellitus | University of Colorado, Denver | Withdrawn | No outcome recorded |
| Phase 2 | NCT00683345 Comparator | Jan 2008 → Apr 2010 | Sjogren syndrome | Helse Stavanger HF | Completed | No outcome recorded |
| Phase 2 | NCT00537667 Comparator | Aug 2001 → Mar 2003 | rheumatoid arthritis | Amgen | Terminated | No outcome recorded |
| Phase 2/36 trials | ||||||
| Phase 2/3 | NCT05267821 Comparator | Jun 2022 → May 2028 expected | multiple organ dysfunction syndrome | Nationwide Children's Hospital | Recruiting | No outcome recorded |
| Phase 2/3 | NCT04898231 Comparator | Dec 2020 → Dec 2023 | COVID-19–associated multisystem inflammatory syndrome in children | University of California, San Diego | Completed | No outcome recorded |
| Phase 2/3 | NCT04643678 Comparator | Oct 2020 → Mar 2021 | COVID-19, cytokine release syndrome, pneumonia | Hamad Medical Corporation | Completed | No outcome recorded |
| Phase 2/3 | NCT04324021 Comparator | Apr → Nov 2020 | COVID-19 | Swedish Orphan Biovitrum | Terminated | No outcome recorded |
| Phase 2/3 | NCT02578394 Comparator | Apr 2016 → Jan 2022 | chronic kidney disease, gout | Mid and South Essex NHS Foundation Trust | Completed | No outcome recorded |
| Phase 2/3 | NCT00339157 Comparator | May 2006 → Jun 2008 | systemic-onset juvenile idiopathic arthritis | French National Institute of Health and Medical Research | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT07281027 Comparator | Jul 2026 → Mar 2030 expected | febrile infection-related epilepsy syndrome, new-onset refractory status epilepticus | Yale University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05498467 Comparator | Oct 2022 → Dec 2023 | allergic contact dermatitis | Herlev and Gentofte Hospital | Completed | No outcome recorded |
| Phase 3 | NCT04330638 Comparator | Apr → Dec 2020 | COVID-19 | University Hospital, Ghent | Completed | No outcome recorded |
| Phase 3 | NCT04381936 Comparator | Mar 2020 → Sep 2028 expected | pneumonia | University of Oxford | Recruiting | No outcome recorded |
| Phase 3 | NCT02672592 Comparator | Jan 2016 → Jun 2017 | hypogonadism, male, metabolic syndrome X, obesity disorder | University Hospital, Basel, Switzerland | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT06624436 Comparator | Oct 2024 → Sep 2025 overdue | infectious disease with sepsis, primary bacterial infectious disease | Radboud University Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT02219828 Comparator | Jun 2014 → Jul 2015 | idiopathic recurrent pericarditis | Massimo Imazio | Completed | No outcome recorded |
| Phase 4 | NCT00121043 Background | — | rheumatoid arthritis | Amgen | Completed | No outcome recorded |
| Phase not applicable7 trials | ||||||
| — | NCT05279391 Comparator | Oct 2020 → Nov 2021 | respiratory failure | Democritus University of Thrace | Unknown | No outcome recorded |
| — | NCT06071156 Comparator | Jan 2018 → May 2022 | pericarditis | Azienda Ospedaliero, Universitaria Ospedali Riuniti | Unknown | No outcome recorded |
| — | NCT03200782 Comparator | May 2017 → Sep 2018 | dumping syndrome, hypoglycemia | University Hospital, Basel, Switzerland | Completed | No outcome recorded |
| — | NCT01771445 Comparator | Dec 2011 → Oct 2013 | type 2 diabetes mellitus | Marc Y.Donath | Completed | No outcome recorded |
| — | NCT01466764 Comparator | Oct 2011 → May 2013 | — | Stanford University | Terminated | No outcome recorded |
| — | NCT01566201 Comparator | Mar 2011 → Apr 2012 | coronary artery disorder, rheumatoid arthritis | University of Athens | Completed | No outcome recorded |
| — | NCT00420290 Comparator | Jan 2008 → May 2010 | end stage renal failure | Vanderbilt University | Completed | No outcome recorded |
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 179 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | anakinra | “The primary purpose of this study is to determine whether giving injections of anakinra is a safe and well tolerated treatment to give as an adjunct to standard prescribed...” NCT02780583 ↗169“"Kineret" (INN: Anakinra) neutralizes the biological activity of interleukin-1α (IL-1α) and interleukin-1β (IL-1β) by the concurrent inhibition of binding to interleukin-1...” NCT04136028 ↗ “Efficacy and Safety of ANAkinra During Adult " COVID-19 " With Aggravating Respiratory Symptoms: a Multicenter Open-label Controlled Randomized Trial” NCT04364009 ↗ “34 patients to receive 100 mg of anakinra (a recombinant human interleukin-1-receptor antagonist) subcutaneously once daily for 13 weeks” PMID 17429083 ↗ Apr 2007 “Recombinant human interleukin-1 receptor antagonist (anakinra) is an anti-inflammatory with efficacy in animal models of stroke.” PMID 37452707 ↗ Jul 2023 “Anakinra 100 mg s.c. (Kineret) will be administered from day -10 (i.e. 10 days before initiation of RT) to the last day of RT.” NCT04942626 ↗ “Product: Kineret (anakinra) Protocol title: The Use of Kineret (anakinra) in the Treatment of Familial Cold Urticaria (FCU)” NCT00214851 ↗ “receive either the IL–1 receptor antagonist IL-1Ra (anakinra) or placebo prior to an acute treadmill exercise.” PMID 26448147 ↗ Oct 2015 “Anakinra 200mg/ 12h SBC first day, 200mg / 24h SBC two more days” NCT04374539 ↗ “Anakinra 2.5%” NCT00681109 ↗ |
| Known as | Alta-2530 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201570 ↗ |
| Known as | AMG 719 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00038298 ↗ |
| Known as | ANA | “Anakinra (ANA) is a recombinant human decoy IL-1Ra and therefore blocks IL-1α and IL-1β.” NCT04341584 ↗1“We assessed the safety of Anakinra (ANA), an IL-1 receptor antagonist, in ALS patients.” PMID 26444282 ↗ Oct 2015 |
| Known as | Anakinra: kineret | “Anakinra: kineret” NCT01802970 ↗ |
| Known as | ANK | “Efficacy and tolerance of anakinra (ANK) in the treatment of giant cell arteritis (GCA) need to be assessed.” PMID 40483523 ↗ Jun 2025 |
| Known as | Antril | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201570 ↗ |
| Known as | IL-1Ra | “receive either the IL–1 receptor antagonist IL-1Ra (anakinra) or placebo prior to an acute treadmill exercise.” PMID 26448147 ↗ Oct 20151“Anakinra (IL-1Ra)” NCT00635154 ↗ |
| Known as | Interleukin-1 receptor antagonist anakinra | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201570 ↗ |
| Known as | Kineret | “Anakinra is a commercially available product (Kineret™) approved for the treatment of rheumatoid arthritis; it is a replica of a naturally occurring protein called Il-1...” NCT02780583 ↗31“Patients on corticosteroids (plus conventional therapy) will be randomized to receive anakinra (Kineret®), or one of the following: methotrexate, azathioprine, leflunomide,...” NCT01033656 ↗ “Anakinra (Kineret®; r-metHuIL-1ra, Swedish Orphan Biovitrum AB) is a recombinant, non-glycosylated form of the human interleukin-1 receptor antagonist (IL-1Ra) in a 100...” NCT05174507 ↗ “The primary end point was change in morning cortisol from baseline to after the administration of the IL-1 receptor antagonist (anakinra/Kineret®, total dose 3 × 100 mg).” PMID 28324042 ↗ May 2017 “Anakinra (Kineret®; r-metHuIL-1ra, Swedish Orphan Biovitrum AB) is a recombinant, non-glycosylated form of the human interleukin-1 receptor antagonist (IL-1Ra).” NCT07580079 ↗ “100 mg of Kineret (Anakinra) will be administered as a subcutaneous injectable bolus, the day prior to the repeated measurement of beta-cell function.” NCT02310009 ↗ “Anakinra/Kineret\[registered\] is a recombinant, non-glycosylated form of the human interleukin-1 receptor antagonist (IL-1Ra)” NCT01441076 ↗ “Anakinra 100 mg s.c. (Kineret) will be administered from day -10 (i.e. 10 days before initiation of RT) to the last day of RT.” NCT04942626 ↗ “Effects of Anakinra (Kineret) in Subjects With Corticosteroid-Resistant/Intolerant Meniere's Disease” NCT03587701 ↗ “A Pilot Study Using Anakinra/Kineret for the Treatment of Patients With Severe Atopic Dermatitis” NCT01122914 ↗ “Anakinra (Kineret) has been shown to treat and cure refractory and recurrent pericarditis.” NCT03224585 ↗ “Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3” NCT04341584 ↗ “anakinra (recombinant IL-1 receptor antagonist, Kineret, SOBI, Sweden)” NCT04017936 ↗ “Anakinra 149 MG/ML Prefilled Syringe [Kineret]” NCT05926505 ↗ “Anakinra 149 MG/ML Prefilled Syringe [Kineret]” NCT04443881 ↗ “Anakinra (Kineret®)” NCT07254000 ↗ “anakinra (Kineret®)” NCT05854251 ↗ “Kineret® (Anakinra)” NCT00121043 ↗ “Anakinra (Kineret®)” NCT06703216 ↗ “Anakinra (Kineret®)” NCT07706868 ↗ “Anakinra (Kineret®)” NCT00117091 ↗ “Anakinra (Kineret®)” NCT06710197 ↗ “Anakinra, KINERET®” NCT07371689 ↗ “Anakinra (Kineret)” NCT03062176 ↗ “Kineret(Anakinra)” NCT02175056 ↗ |
| Known as | Kineret (anakinra) | “Kineret® (anakinra)” NCT01566201 ↗ |
| Known as | metHuIL-1ra | “Intra-articular metHuIL-1ra (anakinra)” NCT00110916 ↗ |
| Known as | Osp-101 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201570 ↗ |
| Known as | r-metHuIL-1ra | “A Randomized, Multi-center, Blinded, Placebo-controlled Study With an Open-label Run-in Period to Evaluate the Efficacy, Safety, and Pharmacokinetics of Daily, Single,...” NCT00037648 ↗5“Anakinra (Kineret®; r-metHuIL-1ra, Swedish Orphan Biovitrum AB) is a recombinant, non-glycosylated form of the human interleukin-1 receptor antagonist (IL-1Ra) in a 100...” NCT05174507 ↗ “Anakinra (Kineret®; r-metHuIL-1ra, Swedish Orphan Biovitrum AB) is a recombinant, non-glycosylated form of the human interleukin-1 receptor antagonist (IL-1Ra).” NCT07580079 ↗ “Standard dose of Anakinra (Kineret®; r-metHuIL-1ra, Swedish Orphan Biovitrum AB)” NCT04227769 ↗ “Anakinra (r-metHuIL-1ra)” NCT00111410 ↗ “Anakinra (r-metHuIL-1ra)” NCT00537667 ↗ |
| Action | Inhibit | “blocks a substance called IL-1” NCT00069329 ↗ |
| Modality | Protein / enzyme biologic | “100 mg of anakinra (a recombinant human interleukin-1-receptor antagonist)” PMID 17429083 ↗ Apr 2007 |
| Route | Subcutaneous | “Subcutaneous Injections” NCT00037648 ↗ |
| Target | IL1R1 | “anakinra (IL-1R1receptor antagonist)” NCT02390596 ↗ |