Anakinra clinical trials
Anakinra is named as an intervention in 14 current clinical trials in our France, Italy, Spain, Canada, China, India, Germany, Netherlands, Belgium, Switzerland, Portugal, Japan, Australia, Israel, Sweden, Ireland, Czechia, South Korea and Mexico registers. 9 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Assistance Publique - Hôpitaux de Paris (3). The most-studied condition is Respiratory Tract Diseases. The EU clinical trials register (CTIS) separately lists 2 authorised or ongoing trials.
Where Anakinra is approved
All regulators →Of the three regulators tracked here, the first to approve Anakinra was the US, on 14 Nov 2001. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Anakinra
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Anakinra works
All drug targets →- Interleukin-1 receptor antagonist AntagonistTarget: IL1R1 interleukin 1 receptor type 1✓ In ChEMBL and the Guide to Pharmacology
- COVID-19Phase 3
- COVID-19–associated multisystem inflammatory syndrome in childrenPhase 3
- Kawasaki diseasePhase 3
- Orthomyxoviridae infectious diseasePhase 3
- SeizurePhase 3
- Adult-onset Still diseasePhase 3
- Allergic contact dermatitisPhase 3
- Familial Mediterranean feverPhase 3
- HypogonadismPhase 3
- Metabolic syndromePhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1201570, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 6972, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Anakinra
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 2 technology appraisals of Anakinra. 2 are current, and 1 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Anakinra for treating Still’s disease NICE TA685 | Optimised | 31 Mar 2021 | Current |
| The clinical effectiveness and cost effectiveness of anakinra for rheumatoid arthritis NICE TA72 | Only in research | 26 Nov 2003 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Anakinra
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 1 product on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: KineretEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Anakinra
- ATC code
- L04AC03
- ChEMBL
- CHEMBL1201570
- DrugBank
- DB00026
- PubChem CID
- 90470007
- CAS number
- 143090-92-0
- FDA UNII
- 9013DUQ28K
- Wikidata
- Q415411
- Wikipedia
- Anakinra
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Anakinra
14 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Anakinra in the EU trials register (CTIS)
2 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Anakinra. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
Interleukin-1 inhibition to improve the response of myeloproliferative neoplasms resistant to cytoreductive treatment
2025-523921-17-00 · Hemic and Lymphatic Diseases
|
Phase 2 | Authorised | Centre Hospitalier Regional Et Universitaire De Brest | France |
|
THRILL: Treat Hyperinflammation in child oncology study - A single arm, historically controlled, open label phase II study on the efficacy and safety of the recombinant interleukin (IL)-1R antagonist anakinra in pediatric cancer patients admitted to the intensive care with sepsis and signs of hyperinflammation
2025-524541-27-00 · CTIS ↗ · Immune System Diseases
|
Phase 2 | Authorised | Prinses Maxima Centrum voor Kinderoncologie B.V | Netherlands |
Anakinra across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
1 single-substance product containing Anakinra on the HPRA medicines list.
- Kineret 100 mg/0.67 ml solution for injection in pre-filled syringeSwedish Orphan Biovitrum AB · EU/1/02/203/005-007
Supply shortages
No entry for Anakinra in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Anakinra
31 conditionsAll 31 conditions
| Condition (as registered) | Trials |
|---|---|
| Respiratory Tract Diseases | 1 |
| Influenza (Pandemic) | 1 |
| Influenza | 1 |
| Community Acquired Pneumonia | 1 |
| Pneumonia | 1 |
| Poor Graft Function | 1 |
| Myelodysplastic Syndromes | 1 |
| Hematopoietic Stem Cell Transplantation | 1 |
| Still's Disease, Adult-Onset | 1 |
| Stroke Acute | 1 |
| Endovascular Treatment | 1 |
| Post-Acute COVID-19 Syndrome | 1 |
| Post-Acute COVID-19 | 1 |
| Long COVID | 1 |
| Sepsis | 1 |
| New Onset Refractory Status Epilepticus | 1 |
| New-Onset Refractory Status Epilepticus | 1 |
| Febrile Infection-Related Epilepsy Syndrome (FIRES) | 1 |
| FMF | 1 |
| Kawasaki Disease | 1 |
| Postprandial Hypoglycemia | 1 |
| End-stage Renal Disease (ESRD) | 1 |
| Gastrectomy | 1 |
| Glucose Metabolism Disorders | 1 |
| Lactating Women on Select DOI | 1 |
| Breastfed Infants of Mothers on Select DOI | 1 |
| Still's Disease, Juvenile Onset | 1 |
| Still's Disease, Adult-Onset | 1 |
| Premature Infants | 1 |
| Very Premature Infants | 1 |
| Inflammation | 1 |
Sponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Assistance Publique - Hôpitaux de Paris | 3 |
| Ruijin Hospital | 2 |
| UMC Utrecht | 1 |
| University of Oxford | 1 |
| Beijing Tiantan Hospital | 1 |
| Hellenic Institute for the Study of Sepsis | 1 |
| Yale University | 1 |
| Marc Donath | 1 |
| Duke University | 1 |
| Swedish Orphan Biovitrum | 1 |
| Monash Medical Centre | 1 |
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Anakinra trials
How many clinical trials are testing Anakinra?
14 current trials in our France, Italy, Spain, Canada, China, India, Germany, Netherlands, Belgium, Switzerland, Portugal, Japan, Australia, Israel, Sweden, Ireland, Czechia, South Korea and Mexico registers name Anakinra as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Anakinra trials recruiting patients?
Yes. 9 of the 14 trials are recruiting: 5 with sites in France, 3 with sites in Italy, 3 with sites in Spain, 2 with sites in Canada, 1 with sites in China, 2 with sites in India, 2 with sites in Germany, 2 with sites in Netherlands, 2 with sites in Belgium, 1 with sites in Switzerland, 2 with sites in Portugal, 1 with sites in Japan, 2 with sites in Australia, 1 with sites in Israel, 1 with sites in Sweden, 1 with sites in Ireland, 1 with sites in Czechia and 1 with sites in Mexico. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Anakinra clinical trials?
Assistance Publique - Hôpitaux de Paris (3), Ruijin Hospital (2), UMC Utrecht (1) and University of Oxford (1), among 11 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Anakinra clinical trials in Ireland?
Yes. 1 trial in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.
Is Anakinra licensed in Ireland?
Yes. The HPRA medicines list includes 1 single-substance product containing Anakinra, for example Kineret 100 mg/0.67 ml solution for injection in pre-filled syringe (Swedish Orphan Biovitrum AB). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Anakinra shortage?
Not in the lists we track: Anakinra has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Anakinra works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Anakinra works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Anakinra (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.