Treats Neonatal-Onset Multisystem Inflammatory Disease (NOMID) Deficiency of…. Sold as Kineret. Every FDA application for this active ingredient.
As of Nov 13, 2026, FDA lists 1 application for Anakinra (sold as Kineret), first approved Nov 14, 2001, with 5 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Kineret | Part D | $47.9M | +49% | 1,375 |
| Anakinra for Prevention of Poor Graft Function in MDS Allo-HSCTPoor Graft Function, Myelodysplastic Syndromes · Ruijin Hospital | Phase 1 / Phase 2 | Not yet recruiting | Oct 22, 2026 |
| Adding Anakinra and Tocilizumab to Nivolumab and Ipilimumab for the Treatment of Melanoma Patients 50 Years of Age or OlderMelanoma · University of Southern California | Phase 1 | Not yet recruiting | Sep 24, 2026 |
| Anakinra Rescue Treatment for Moderate Asthma Attacks (ARTMA)Asthma (Diagnosis), Persistent Asthma · University of North Carolina, Chapel Hill | Phase 1 | Not yet recruiting | May 20, 2026 |
| Anakinra for the Treatment of Postprandial Hypoglycemia in a Patient With Total Gastrectomy and End-Stage Renal DiseasePostprandial Hypoglycemia, End-stage Renal Disease (ESRD) · Marc Donath | Phase 2 | Not yet recruiting | May 12, 2026 |
| "IL-1β Blockade to Prevent Immunothrombosis in Recipients of a Pancreatic Organ"Pancreatic Transplant · Nantes University Hospital | Phase 1 / Phase 2 | Recruiting | Mar 31, 2026 |
| Advancing Reperfusion Therapy for Ischemic Stroke: Safety and Efficacy of Anakinra for Futile Reperfusion Following Endovascular Treatment in Patients With Acute Ischemic StrokeStroke Acute, Endovascular Treatment · Beijing Tiantan Hospital | Phase 2 | Recruiting | Feb 20, 2026 |
| BRIDGE - Blocking Receptor of IL-1β for Donor Graft Edema ReductionLung Transplant Recipient · Northwestern University | Early phase 1 | Not yet recruiting | Feb 13, 2026 |
| ANAKINRA IN THE TREATMENT OF PEDIATRIC ACUTE MYOCARDITISPEDIATRIC ACUTE MYOCARDITIS · Assistance Publique - Hôpitaux de Paris | Phase 3 | Not yet recruiting | Jan 28, 2026 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Nov 14, 2001 | KineretBLA 103950 · New molecular entity | Biovitrum AB | 17 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
