Anakinra
Protein / enzyme biologic targets IL1B, IL1R1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 10 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed COVID-19 1 milestone | |||||
| Filed | EU (EMA) | Kineret | COVID-19 | — | “In July, Kineret® was submitted to EMA with a proposed indication for the treatment of coronavirus disease 2019 (COVID-19)” sobi.com ↗ |
| Filed cryopyrin-associated periodic syndrome 1 milestone | |||||
| Filed | EU (EMA) | Kineret | cryopyrin-associated periodic syndrome | 2012-11-19 | “filed an application for an EU Marketing Authorization with the European Medicines Agency (EMA) for Kineret® (anakinra) for the indication of cryopyrin associated periodic...” sobi.com ↗ |
| Filed neonatal-onset severe multisystemic autoinflammatory disease with increased IL18 1 milestone | |||||
| Filed | US (FDA) | Kineret | neonatal-onset severe multisystemic autoinflammatory disease with increased IL18 | 2012-07-06 | “filed an application for Kineret® (anakinra) for the indication of neonatal-onset multisystem inflammatory disease (NOMID) with the Federal Drug Administration” sobi.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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 134 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 05 trials | ||||||
| Phase 0 | NCT07410312 | Jul 2026 → Aug 2027 expected | — | Northwestern University | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT03991520 | Jun 2020 → Jan 2022 | endometriosis | University of California, San Diego | Unknown | No outcome recorded |
| Phase 0 | NCT04747847 | Jun 2019 → Aug 2022 | Kawasaki disease | University of California, San Diego | Completed | No outcome recorded |
| Phase 0 | NCT02550327 | Jan 2016 → Jun 2021 | pancreatic adenocarcinoma | Baylor Research Institute | Completed | No outcome recorded |
| Phase 0 | NCT04136028 | Sep 2015 → Jan 2019 | chronic granulomatous disease | Federal Research Institute of Pediatric Hematology, Oncology and Immunology | Completed | No outcome recorded |
| Phase 115 trials | ||||||
| Phase 1 | NCT07838974 | Nov 2026 → Nov 2029 expected | melanoma | University of Southern California | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06062966 | Feb 2024 → Jun 2026 | heart failure | Virginia Commonwealth University | Completed | No outcome recorded |
| Phase 1 | NCT04942626 | Aug 2021 → Dec 2024 | rectal cancer | Goethe University | Completed | No outcome recorded |
| Phase 1 | NCT05074485 | Jul 2021 → May 2026 | — | Alan Prossin | Unknown | No outcome recorded |
| Phase 1 | NCT04691765 | May → Dec 2021 | B-cell chronic lymphocytic leukemia | Dr. David Spaner | Unknown | No outcome recorded |
| Phase 1 | NCT02780583 | May 2016 → Mar 2023 | macrophage activation syndrome | University of Alabama at Birmingham | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT02492750 | Apr 2016 → Jun 2019 | indolent plasma cell myeloma | Mayo Clinic | Completed | No outcome recorded |
| Phase 1 | NCT03057028 | Apr 2016 → Jun 2018 | pulmonary arterial hypertension | Virginia Commonwealth University | Completed | No outcome recorded |
| Phase 1 | NCT02527460 | Aug 2015 → Mar 2018 | HIV infectious disease, nervous system disorder | National Institute of Neurological Disorders and Stroke (NINDS) | Terminated | No outcome recorded |
| Phase 1 | NCT02021422 | Dec 2013 → Dec 2017 | pancreatic ductal adenocarcinoma | Baylor Research Institute | Completed | No outcome recorded |
| Phase 1 | NCT01802970 | Dec 2012 → Jan 2017 | breast cancer | Baylor Research Institute | Completed | No outcome recorded |
| Phase 1 | NCT01624766 | Jun 2012 → Feb 2021 | metastatic malignant neoplasm | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01122914 | Apr 2010 → Apr 2015 | atopic eczema | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded |
| Phase 1 | NCT00214851 | Sep → Dec 2005 | familial cold autoinflammatory syndrome | Nova Scotia Health Authority | Completed | No outcome recorded |
| Phase 1 | NCT00072111 | Sep 2003 → ? | cancer of unknown primary site | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1/221 trials · 3 met primary | ||||||
| Phase 1/2 | NCT06703216 | Oct 2026 → Aug 2029 expected | B-cell acute lymphoblastic leukemia, cytokine release syndrome, hemophagocytic syndrome | Kevin McNerney | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07503834 | May 2026 → Nov 2028 expected | pancreas disorder | Nantes University Hospital | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT05280340 | Feb 2022 → Mar 2024 overdue | — | Monash Medical Centre | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05013450 | Sep 2021 → Sep 2025 overdue | non-small cell lung carcinoma | Thomas Marron | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03513458 | Sep 2020 → Dec 2021 | asthma | University of North Carolina, Chapel Hill | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT04018755 | Jan 2020 → Jul 2022 | mucopolysaccharidosis type 3 | Lynda E Polgreen | Completed | No outcome recorded |
| Phase 1/2 | NCT04035109 | Dec 2019 → Oct 2022 | allergic asthma | University of North Carolina, Chapel Hill | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT04025554 | Oct 2019 → Oct 2023 | multiple sclerosis | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | No outcome recorded |
| Phase 1/2 | NCT03513471 | Aug 2019 → Dec 2021 | asthma | University of North Carolina, Chapel Hill | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03430011 | Feb 2018 → Mar 2023 | plasma cell myeloma | Juno Therapeutics, a Subsidiary of Celgene | Completed | No outcome recorded |
| Phase 1/2 | NCT03182426 | Aug 2017 → Jul 2024 | type 1 diabetes mellitus | University of Alberta | Completed | No outcome recorded |
| Phase 1/2 | NCT02547766 | Apr 2015 → Dec 2016 | heart failure | University of Utah | Completed | No outcome recorded |
| Phase 1/2 | NCT02179853 | Nov 2014 → Oct 2022 | Kawasaki disease | University of California, San Diego | Completed | No outcome recorded |
| Phase 1/2 | NCT02414152 | Oct 2013 → Jul 2015 | sudden sensorineural hearing loss | Andrea Vambutas | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT01479010 | Nov 2011 → Nov 2013 | pulmonary hypertension | Virginia Commonwealth University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT01441076 | Sep 2011 → Oct 2014 | connective tissue disorder, immune system disorder | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Completed | No outcome recorded |
| Phase 1/2 | NCT01267994 | Jun 2011 → Sep 2014 | autoimmune inner ear disease, sensorineural hearing loss disorder | Andrea Vambutas | Completed | Met primary |
| Phase 1/2 | NCT01300650 | Feb → Aug 2011 | heart failure | Virginia Commonwealth University | Completed | No outcome recorded |
| Phase 1/2 | NCT00645840 | Mar 2008 → Sep 2009 | type 1 diabetes mellitus | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 1/2 | NCT00332254 | Mar 2006 → Jun 2007 | osteoarthritis, knee | Duke University | Completed | Met primary |
| Phase 1/2 | NCT00069329 | Sep 2003 → Apr 2010 | central nervous system malformation, neurogenic arthropathy, retinal edema, urticaria | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Terminated | Met primary |
| Phase 257 trials · 4 met primary · 6 missed | ||||||
| Phase 2 | NCT07580079 | Jul → Oct 2026 expected | end stage renal failure, hypoglycemia, postgastrectomy syndrome | Marc Donath | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06381661 | May 2026 → Jun 2028 expected | infectious disease with sepsis | Assistance Publique - Hôpitaux de Paris | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07423975 | Mar → Sep 2026 overdue | ischemic stroke | Beijing Tiantan Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07138898 | Dec 2025 → Jan 2028 expected | rheumatic disorder | NYU Langone Health | Recruiting | No outcome recorded |
| Phase 2 | NCT06710197 | Mar 2025 → Feb 2026 | triple-negative breast carcinoma | University Health Network, Toronto | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05854251 | Jun 2023 → May 2024 | hyperinsulinism, prediabetes syndrome | University Hospital, Basel, Switzerland | Completed | No outcome recorded |
| Phase 2 | NCT05914454 | May 2023 → Jun 2025 | acute respiratory distress syndrome | Azienda Sanitaria-Universitaria Integrata di Udine | Unknown | No outcome recorded |
| Phase 2 | NCT05611710 | Jan 2023 → Oct 2025 overdue | cytokine release syndrome, dengue disease, macrophage activation syndrome | Oxford University Clinical Research Unit, Vietnam | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03925194 | Dec 2022 → Jun 2025 | cystic fibrosis | Heidelberg University | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04834388 | Aug 2022 → Sep 2025 | intracerebral hemorrhage | Radboud University Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT05174507 | Jun 2022 → May 2026 | hypoglycemia | University Hospital, Basel, Switzerland | Withdrawn | No outcome recorded |
| Phase 2 | NCT04844814 | Jun 2022 → Feb 2025 | chronic kidney disease, gout | Assistance Publique - Hôpitaux de Paris | Suspended | No outcome recorded Stop: Business |
| Phase 2 | NCT05177822 | May 2022 → Feb 2027 expected | heart failure | Virginia Commonwealth University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04359784 | Dec 2021 → Oct 2024 | B-cell non-Hodgkin lymphoma | Fred Hutchinson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT04603742 | Dec 2021 → Jun 2022 | COVID-19, cytokine release syndrome | Weill Medical College of Cornell University | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT04990232 | Jul 2021 → Feb 2024 | infectious disease with sepsis | Hellenic Institute for the Study of Sepsis | Completed | Met primary |
| Phase 2 | NCT04926467 | Jul 2021 → Jun 2026 overdue | pancreatic adenocarcinoma | Baylor Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT04017936 | Oct 2020 → Jun 2024 | cardiac sarcoidosis | Virginia Commonwealth University | Completed | No outcome recorded |
| Phase 2 | NCT03651518 | Oct 2020 → Nov 2025 | autoimmune disease, inflammatory disease | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 2 | NCT04150913 | Oct 2020 → Oct 2023 | cytokine release syndrome, non-Hodgkin lymphoma | Massachusetts General Hospital | Completed | Missed primary |
| Phase 2 | NCT04366232 | Aug → Oct 2020 | COVID-19 | Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer | Terminated | No outcome recorded |
| Phase 2 | NCT04432506 | Jul 2020 → May 2024 | high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT04357366 | Apr 2020 → Jan 2022 | COVID-19, viral respiratory tract infection | Hellenic Institute for the Study of Sepsis | Completed | No outcome recorded |
| Phase 2 | NCT04341584 | Apr → May 2020 | COVID-19 | Assistance Publique - Hôpitaux de Paris | Completed | Mixed |
| Phase 2 | NCT04339712 | Apr → Dec 2020 | COVID-19, macrophage activation syndrome | Hellenic Institute for the Study of Sepsis | Completed | No outcome recorded |
| Phase 2 | NCT04205838 | Mar 2020 → Feb 2026 | high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma | Jonsson Comprehensive Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04227769 | Jan 2020 → May 2024 | type 2 diabetes mellitus | University Hospital, Basel, Switzerland | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04099901 | Nov 2019 → Mar 2023 | plasma cell myeloma | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT04148430 | Oct 2019 → Oct 2026 expected | B-cell acute lymphoblastic leukemia | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02930122 | Jun 2019 → Oct 2020 | — | Cale Jacobs, PhD | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03797001 | Jan 2019 → Jul 2024 | systolic heart failure | Virginia Commonwealth University | Completed | Missed primary |
| Phase 2 | NCT03587701 | Jan 2019 → Dec 2026 expected | Meniere disease, autoimmune inner ear disease | Northwell Health | Recruiting | No outcome recorded |
| Phase 2 | NCT03578497 | Aug 2018 → Jul 2020 | polycystic ovary syndrome | University Hospital, Basel, Switzerland | Completed | No outcome recorded |
| Phase 2 | NCT03224585 | May 2018 → Feb 2020 | pericarditis | Virginia Commonwealth University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03332225 | Dec 2017 → Dec 2019 | infectious disease with sepsis, macrophage activation syndrome | Hellenic Institute for the Study of Sepsis | Completed | No outcome recorded |
| Phase 2 | NCT02997371 | Oct 2017 → Oct 2021 | traumatic brain injury | Adel Helmy | Unknown | No outcome recorded |
| Phase 2 | NCT03233776 | Aug 2017 → Apr 2020 | plasma cell myeloma | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT02929251 | Jun 2017 → Oct 2021 | uveitis | Assistance Publique - Hôpitaux de Paris | Completed | Missed primary |
| Phase 2 | NCT03062176 | Apr 2017 → May 2019 | end stage renal failure, systolic heart failure | Virginia Commonwealth University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03002974 | Dec 2016 → Jun 2018 | gout | Swedish Orphan Biovitrum | Completed | Missed primary |
| Phase 2 | NCT02390596 | Feb 2016 → Jan 2019 | Kawasaki disease | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 2 | NCT02263638 | Feb 2015 → Sep 2018 | hereditary hemochromatosis | Rennes University Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02090101 | Oct 2014 | colorectal cancer | Centre Georges Francois Leclerc | Completed | No outcome recorded |
| Phase 2 | NCT01794117 | Jul 2013 → Mar 2019 | Sneddon syndrome, palmoplantar pustulosis, psoriasis 14, pustular | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Completed | No outcome recorded |
| Phase 2 | NCT01516749 | Oct 2012 → May 2013 | hidradenitis suppurativa | University of California, San Francisco | Completed | Met primary |
| Phase 2 | NCT01558375 | Mar 2012 → Feb 2014 | hidradenitis suppurativa | University of Athens | Completed | Met primary |
| Phase 2 | NCT01285245 | Apr → Sep 2011 | diabetes mellitus | Radboud University Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT01277315 | Feb 2011 → Jun 2012 | amyotrophic lateral sclerosis | Charite University, Berlin, Germany | Completed | No outcome recorded |
| Phase 2 | NCT01175018 | Jul 2010 → Sep 2012 | acute myocardial infarction, heart failure | Virginia Commonwealth University | Completed | No outcome recorded |
| Phase 2 | NCT00928876 | Jun 2009 → Mar 2010 | type 2 diabetes mellitus | Radboud University Medical Center | Unknown | Missed primary |
| Phase 2 | NCT01033656 | Dec 2005 → Mar 2010 | adult-onset Still disease | University of Helsinki | Completed | No outcome recorded |
| Phase 2 | NCT00110916 | Jun 2004 → Feb 2005 | osteoarthritis | Amgen | Completed | Missed primary |
| Phase 2 | NCT00303394 | Apr 2004 → Mar 2006 | type 2 diabetes mellitus | University of Zurich | Completed | Met primary |
| Phase 2 | NCT00635154 | Dec 2002 → Dec 2009 | plasma cell myeloma | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT00038298 | Apr 2002 → May 2004 | rheumatoid arthritis | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00037700 | May 2001 → Dec 2002 | rheumatoid arthritis | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00037648 | Jul 2000 → Nov 2003 | polyarticular juvenile rheumatoid arthritis | Amgen | Completed | No outcome recorded |
| Phase 2/310 trials · 5 missed | ||||||
| Phase 2/3 | NCT05926505 | Sep 2023 → Mar 2028 expected | long COVID-19 | Hellenic Institute for the Study of Sepsis | Recruiting | No outcome recorded |
| Phase 2/3 | NCT04443881 | May 2020 → Mar 2021 | COVID-19 | Fundacion Miguel Servet | Completed | Missed primary |
| Phase 2/3 | NCT03018834 | May 2017 → Jun 2021 | acute myocarditis | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 2/3 | NCT01950299 | Jul 2014 → Dec 2018 | acute myocardial infarction | Virginia Commonwealth University | Completed | No outcome recorded |
| Phase 2/3 | NCT02108210 | Jun 2014 → Dec 2015 | myalgic encephalomeyelitis/chronic fatigue syndrome | Radboud University Medical Center | Completed | Missed primary |
| Phase 2/3 | NCT01936909 | Feb 2014 → Sep 2016 | heart failure | Virginia Commonwealth University | Completed | Missed primary |
| Phase 2/3 | NCT01936844 | Feb 2014 → May 2015 | heart failure | Virginia Commonwealth University | Completed | No outcome recorded |
| Phase 2/3 | NCT01809132 | Sep 2013 → Oct 2018 | alcoholic hepatitis | Mack Mitchell | Completed | Missed primary |
| Phase 2/3 | NCT00711503 | Jan 2009 → Jan 2012 | type 1 diabetes mellitus | Steno Diabetes Center Copenhagen | Completed | Missed primary |
| Phase 2/3 | NCT01165008 | Sep 2003 → Sep 2008 | dermatomyositis, inclusion body myositis | Karolinska Institutet | Completed | No outcome recorded |
| Phase 316 trials · 4 met primary · 1 missed | ||||||
| Phase 3 | NCT07371689 | Feb 2026 → Dec 2029 expected | acute myocarditis | Assistance Publique - Hôpitaux de Paris | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06336733 | Jun 2024 → Dec 2026 expected | familial Mediterranean fever | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 3 | NCT04656184 | Oct 2023 → Mar 2027 expected | Kawasaki disease | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 3 | NCT05805930 | Jun 2023 → Jun 2025 | pericarditis | Gaslini Institute | Unknown | No outcome recorded |
| Phase 3 | NCT05814159 | Aug 2022 → Dec 2025 overdue | adult-onset Still disease, systemic-onset juvenile idiopathic arthritis | Swedish Orphan Biovitrum | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04680949 | Dec 2020 → Mar 2021 | COVID-19 | Hellenic Institute for the Study of Sepsis | Completed | Met primary |
| Phase 3 | NCT04424056 | Sep 2020 → Sep 2022 | COVID-19 | Assistance Publique Hopitaux De Marseille | Unknown | No outcome recorded |
| Phase 3 | NCT04362111 | Aug 2020 → Dec 2021 | COVID-19, cytokine release syndrome | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 3 | NCT04364009 | Apr → Oct 2020 | COVID-19 | University Hospital, Tours | Terminated | No outcome recorded |
| Phase 3 | NCT03265132 | Sep 2017 → Feb 2019 | adult-onset Still disease, systemic-onset juvenile idiopathic arthritis | Swedish Orphan Biovitrum | Terminated | Met primary |
| Phase 3 | NCT02902731 | May 2017 → Nov 2022 | temporal arteritis | University Hospital, Caen | Terminated | Missed primary |
| Phase 3 | NCT02735707 | Apr 2016 → Feb 2026 overdue | pneumonia | UMC Utrecht | Recruiting | Mixed |
| Phase 3 | NCT02227420 | Oct 2014 → Mar 2016 | Cushing syndrome, metabolic syndrome X | University Hospital, Basel, Switzerland | Completed | No outcome recorded |
| Phase 3 | NCT01705756 | Nov 2012 → Dec 2014 | familial Mediterranean fever | Sheba Medical Center | Completed | Met primary |
| Phase 3 | NCT00789724 | Nov 2008 → Aug 2009 | ST-elevation myocardial infarction | Virginia Commonwealth University | Completed | Met primary |
| Phase 3 | NCT00117091 | — | rheumatoid arthritis | Amgen | Completed | No outcome recorded |
| Phase 46 trials | ||||||
| Phase 4 | NCT06666335 | Mar 2026 → Aug 2027 | familial Mediterranean fever | Swedish Orphan Biovitrum | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT07706868 | Sep 2025 → Sep 2028 | adult-onset Still disease, systemic-onset juvenile idiopathic arthritis | Swedish Orphan Biovitrum | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT06697431 | Apr 2025 → Apr 2026 overdue | Kawasaki disease | Meyer Children's Hospital IRCCS | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT01997138 | Mar 2016 → Jan 2018 | — | Oslo University Hospital | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02236481 | Jul 2013 → Dec 2017 | rheumatoid arthritis, type 2 diabetes mellitus | Prof. Roberto Giacomelli | Terminated | No outcome recorded |
| Phase 4 | NCT00111410 | ? → Nov 2003 | rheumatoid arthritis | Amgen | Completed | No outcome recorded |
| Phase not applicable4 trials · 1 met primary | ||||||
| — | NCT02916355 | Aug 2016 → Apr 2017 | obesity disorder | University Hospital, Basel, Switzerland | Completed | No outcome recorded |
| — | NCT02310009 | Dec 2014 → Jun 2015 | type 2 diabetes mellitus | Rigshospitalet, Denmark | Withdrawn | No outcome recorded |
| — | NCT01542502 | Feb 2012 → Jun 2013 | heart failure | Virginia Commonwealth University | Completed | Met primary |
| — | NCT01285232 | Jan 2011 → Mar 2012 | glucose intolerance, type 2 diabetes mellitus | Radboud University Medical Center | Unknown | No outcome recorded |
| Comparator or background therapy42 trials | ||||||
| Phase 0 | NCT03968913 Comparator | Sep 2021 → Jan 2027 expected | — | University of California, Los Angeles | Recruiting | No outcome recorded |
| 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 1/2 | NCT00681109 Comparator | Jan 2008 → May 2010 | blepharitis | Reza Dana, MD | Completed | No outcome recorded |
| 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 Stop: Enrollment |
| Phase 2 | NCT04374539 Comparator | Apr 2020 → Jun 2021 | COVID-19 | Fundacion Clinic per a la Recerca Biomédica | Terminated | No outcome recorded Stop: Enrollment |
| 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 Stop: Business |
| 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 2/3 | 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 Stop: Enrollment |
| 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 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 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 |
| — | 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 |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 2022-11-10 | Sobi, Inc. | Regulatory Kineret® authorised for emergency use by FDA for the treatment of COVID-19 related pneumonia sobi.com ↗
Sobi® today announced that the US Food and Drug Administration has granted Emergency Use Authorisation (EUA) for the use of Kineret® (anakinra) for the treatment of coronavirus disease 2019 (COVID-19) in hospitalised adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure. |
| 2021-12-16 | Sobi, Inc. | Regulatory Kineret® (anakinra) receives positive opinion from the CHMP for treatment of patients with COVID-19 pneumonia sobi.com ↗
EMA has recommended approval for use of Kineret in COVID-19 to the European Commission which will issue a final decision. |
| 2021-09-03 | Sobi, Inc. | Results Nature Medicine publishes phase 3 anakinra study results in patients with COVID-19 pneumonia sobi.com ↗
Early treatment with anakinra showed considerable efficacy and reduced risk of disease progression and death by 64 percent, according to day 28 results from the SAVE-MORE study. |
| 2021-05-20 | Sobi, Inc. | Results Early use of anakinra reduces risk of mortality for patients with COVID-19 pneumonia, reduces ICU admission and increases likelihood of full recovery sobi.com ↗
SAVE-MORE found that early and targeted use of anakinra, in addition to current SOC, showed a 55% relative reduction in mortality and near threefold benefit in preventing progression to severe respiratory failure (SRF) in hospitalised COVID-19 patients with poor prognosis. |
| 2021-05-03 | Sobi, Inc. | Results Sobi and Hellenic Institute for the Study of Sepsis: anakinra improved overall clinical outcomes by 64% in hospitalised patients with COVID-19 pneumonia sobi.com ↗
Analysis of the primary end point, the comparative 11-point WHO Clinical Progression ordinal Scale (CPS) [i] , at day 28 demonstrated significant improvement in patients receiving standard-of-care treatment plus anakinra vs patients receiving standard-of-care plus placebo (Odds Ratio 0.36, p < 0.001). |
| 2021-02-16 | Sobi, Inc. | Regulatory Kineret® (anakinra) approved in Russia for the treatment of CAPS sobi.com ↗
Swedish Orphan Biovitrum AB (publ) (Sobi™) announces that the Ministry of Health of the Russian Federation has approved Kineret (anakinra) for the treatment of Cryopyrin associated periodic syndromes (CAPS). |
| 2018-10-03 | Sobi, Inc. | Results Results from the anaGO study - a phase 2 study with anakinra in patients with acute gout sobi.com ↗
Swedish Orphan Biovitrum AB (publ) (Sobi™) releases the primary efficacy results from the phase 2 study with anakinra in patients with acute gout – the anaGO study. |
| 2018-04-11 | Sobi, Inc. | Regulatory Kineret® (anakinra) approved in the EU for the treatment of Still's disease sobi.com ↗
Swedish Orphan Biovitrum AB (publ) (Sobi™) announces that the European Commission (EC) has approved an extension of the indication for Kineret (anakinra) to include the treatment of Still’s disease, including Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still’s Disease (AOSD), in all 28 European Union (EU) member states. |
| 2018-02-23 | Sobi, Inc. | Regulatory Kineret® (anakinra) receives a positive opinion from CHMP for the treatment of Still's disease sobi.com ↗
Swedish Orphan Biovitrum AB (publ) (Sobi™) today announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for anakinra for the treatment of Still’s disease. |
| 2017-05-30 | Sobi, Inc. | Regulatory Kineret® approved in Canada for the treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID) sobi.com ↗
Swedish Orphan Biovitrum AB (publ) (Sobi™) today announces that Health Canada has approved Kineret® (anakinra) for the treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID) in adults, adolescents, children and infants aged eight months and older with a body weight of 10 kg or above. |
| 2013-11-20 | Sobi, Inc. | Regulatory Sobi receives approval for Kineret® for treatment of rare disease CAPS sobi.com ↗
Swedish Orphan Biovitrum AB (publ) (Sobi) announced today that the European Commission (EC) has approved Kineret (anakinra) for the treatment of Cryopyrin- Associated Periodic Syndromes (CAPS). |
| 2013-09-23 | Sobi, Inc. | Regulatory Sobi receives positive CHMP opinion for Kineret® for treatment of rare disease CAPS sobi.com ↗ |
| 2013-06-11 | Sobi, Inc. | Regulatory Sobi gets FDA approval to manufacture substance for Kineret® with partner Boehringer Ingelheim sobi.com ↗
Swedish Orphan Biovitrum AB (publ) (Sobi) today announced receipt of approval from the Food and Drug Administration (FDA) for the manufacture of drug substance for Kineret® (anakinra) at Boehringer Ingelheim's microbial site in Vienna, Austria. |
| 2012-11-19 | Sobi, Inc. | Regulatory Sobi files to expand Kineret® label to include CAPS sobi.com ↗
Sobi (STO: SOBI) has filed an application for an EU Marketing Authorization with the European Medicines Agency (EMA) for Kineret® (anakinra) for the indication of cryopyrin associated periodic syndromes (CAPS). |
| 2012-07-06 | Sobi, Inc. | Regulatory Sobi files for NOMID indication for Kineret in US sobi.com ↗
Sobi has filed an application for Kineret® (anakinra) for the indication of neonatal-onset multisystem inflammatory disease (NOMID) with the Federal Drug Administration (FDA) in the US. |
| 2010-08-26 | Sobi, Inc. | Regulatory Swedish Orphan Biovitrum's Kineret® has Received Orphan Drug Designation in the USA sobi.com ↗
Swedish Orphan Biovitrum (STO: SOBI) today announced that the US FDA Office of Orphan Products Development (OOPD) has granted orphan drug designation (ODD) to Kineret® for the treatment of cryopyrin-associated periodic syndromes (CAPS). |
All press releases naming this drug 24 releases
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 180 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 ↗170“"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“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 ↗ “Patients on corticosteroids (plus conventional therapy) will be randomized to receive anakinra (Kineret®), or one of the following: methotrexate, azathioprine, leflunomide,...” NCT01033656 ↗ “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 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 ↗ “Anakinra/Kineret\[registered\] is a recombinant, non-glycosylated form of the human interleukin-1 receptor antagonist (IL-1Ra)” NCT01441076 ↗ “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 ↗ |
| 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)” NCT00537667 ↗ “Anakinra (r-metHuIL-1ra)” NCT00111410 ↗ |
| 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 ↗ |