Kineret

(Anakinra)

ApprovedSmall molecule

Anakinra is used to treat rheumatoid arthritis by reducing joint pain, swelling, and stiffness. It works by blocking a protein in the body that causes inflammation.[2] Kineret is currently approved and in use across 23 indications[4].[1]

Kineret is one of 359 small molecule programs targeting Coronary Artery Disease. It is currently in Approved.

Indications

137

Total Trials

Active Trials

358

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Coronary Artery DiseaseActive, not recruiting

Rheumatic DiseaseRecruiting

Insulin SecretionActive, not recruiting

Familial Mediterranean FeverWithdrawn

PericarditisNot yet recruiting

Acute MyocarditisCompleted

Systemic Juvenile Idiopathic ArthritisWithdrawn

CINCA SyndromeUnknown

Immune System DiseaseUnknown

Acute Myocardial InfarctionCompleted

Coronary Artery DiseasePreclinical

Active, not recruiting

Rheumatic DiseasePhase 2

Recruiting

Insulin SecretionPreclinical

Active, not recruiting

Familial Mediterranean FeverApproved

Withdrawn

PericarditisPhase 3

Not yet recruiting

Acute MyocarditisPhase 3

Completed

Systemic Juvenile Idiopathic ArthritisApproved

Withdrawn

CINCA SyndromePreclinical

Unknown

Immune System DiseasePreclinical

Unknown

Acute Myocardial InfarctionPhase 3

Completed

Showing 10 of 20 indications

Competition

Competitive Landscape

228 competitors in Efficacy and Safety

#DrugCompanyPhaseTrials

Kineret

SSwedish Orphan Biovitrum

Approved

2 2

Rinvoq

AbbVie

Phase 3

4 3

Savaysa

Daiichi Sankyo

Phase 3

3 4

Fludara

Sanofi

Phase 3

1 5

Rapamune

PPrism Pharmaceuticals

Phase 3

5 6

Rilutek

AAzurity Pharmaceuticals

Phase 3

3 7

Oxycontin

PPurdue Pharma LP

Phase 3

1 8

Mitomycin C

GGynecologic Oncology Group

Phase 3

2 9

HLX10

Shanghai Henlius Biotech

Phase 3

2 10

Becotatug Vedotin

FFudan University

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Anakinra

NCT07254000

Phase 3Recruiting

Familial Mediterranean Fever

NCT06336733

Q1 2027

Phase 1Recruiting

Osteoarthritis

NCT03968913

Phase 3Recruiting

Efficacy and Safety

NCT04656184

Q2 2027

Phase 2Recruiting

Pancreatic Adenocarcinoma

NCT04926467

Q3 2027

Active, not recruiting

Still's Disease, Adult-Onset

NCT07191444

Clinical

Trials by Indication[1]

COVID-198 trials

Randomised Evaluation of COVID-19 Therapy

Recruiting·UUniversity of Oxford·Phase 3·NCT04381936·70,000 enrolled

Efficacy and Safety of Emapalumab and Anakinra in Reducing Hyperinflammation and Respiratory Distress in Patients With COVID-19 Infection.

Terminated·SSwedish Orphan Biovitrum·Phase 2/3·NCT04324021·16 enrolled

Treatment of COVID-19 Patients With Anti-interleukin Drugs

Completed·UUniversity Hospital, Ghent·Phase 3·NCT04330638·342 enrolled

Show 5 more trials

Anakinra, COVID-19, Cytokine Storm

Withdrawn·WWeill Medical College of Cornell University·Phase 2·NCT04603742

Early Treatment of Cytokine Storm Syndrome in Covid-19

Completed·UUniversity of Alabama at Birmingham·Phase 3·NCT04362111·32 enrolled

Anakinra in the Management of COVID-19 Infection

Completed·HHamad Medical Corporation·Phase 2/3·NCT04643678·80 enrolled

CORIMUNO-ANA: Trial Evaluating Efficacy Of Anakinra In Patients With Covid-19 Infection

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT04341584·161 enrolled

Personalised Immunotherapy for SARS-CoV-2 (COVID-19) Associated With Organ Dysfunction

Completed·HHellenic Institute for the Study of Sepsis·Phase 2·NCT04339712·102 enrolled

Heart Failure7 trials

Pilot Study of the Safety and Efficacy of Anakinra (Recombinant Human Interleukin-1 Receptor Antagonist) in Heart Failure

Completed·VVirginia Commonwealth University·Phase 1/2·NCT01300650·11 enrolled

Pilot Feasibility Study of the Safety and Efficacy of Anakinra in Heart Failure With Preserved Ejection Fraction

Completed·VVirginia Commonwealth University·N/A·NCT01542502·12 enrolled

Interleukin-1 Blockade In Recently Decompensated Heart Failure - 2

Completed·VVirginia Commonwealth University·Phase 2·NCT03797001·102 enrolled

Show 4 more trials

Interleukin-1 Receptor Antagonist for the Treatment of Heart Failure in Patients With Left Ventricular Assist Devices

Completed·UUniversity of Utah·Phase 1/2·NCT02547766·10 enrolled

Interleukin-1 Blockade in Recently Decompensated Heart Failure

Completed·VVirginia Commonwealth University·Phase 2/3·NCT01936909·60 enrolled

Interleukin (IL)-1 Blockade in Acute Heart Failure (Anakinra ADHF)

Completed·VVirginia Commonwealth University·Phase 2/3·NCT01936844·30 enrolled

The Effects of IL-1 Blockade on Inotrope Sensitivity in Patients With Heart Failure (AID-HEART)

Completed·VVirginia Commonwealth University·Phase 1·NCT06062966·4 enrolled

Anakinra7 trials

Open-label Study of Anakinra in MPS III

Completed·LLynda E Polgreen·Phase 1/2·NCT04018755·24 enrolled

Anakinra to Prevent Post-infarction Remodeling

Completed·VVirginia Commonwealth University·Phase 3·NCT00789724·10 enrolled

Anakinra to Prevent Adverse Post-infarction Remodeling (2)

Completed·VVirginia Commonwealth University·Phase 2·NCT01175018·30 enrolled

Show 4 more trials

Anakinra for Behcet s Disease

Completed·NNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)·Phase 1/2·NCT01441076·6 enrolled

Anakinra for Preterm Infants Pilot

Active, not recruiting·MMonash Medical Centre·Phase 1/2·NCT05280340·25 enrolled

Anakinra Pilot 2 - A Study to Optimise Dose and Route of Administration of Anakinra in Preterm Infants

Recruiting·MMonash Medical Centre·Phase 2·NCT07254000·24 enrolled

A Study of Anakinra in Japanese Patients With Still's Disease (SJIA and AOSD)

Active, not recruiting·SSwedish Orphan Biovitrum·Phase 3·NCT05814159·15 enrolled

Rheumatoid Arthritis6 trials

Juvenile Rheumatoid Arthritis

Completed· Amgen logo

Amgen·Phase 2·NCT00037648·86 enrolled

Evaluation of the Efficacy of Combination Treatment With Anakinra and Pegsunercept in Improving Rheumatoid Arthritis

Completed· Amgen logo

Amgen·Phase 2·NCT00037700

Evaluating the Effect of Anakinra (r-metHuIL-1ra) on Vaccine AntibodyResponse in Subjects With Rheumatoid Arthritis (RA)

Completed· Amgen logo

Amgen·Phase 4·NCT00111410

Show 3 more trials

Anakinra (Kineret®) in Combination With Disease Modifying Anti-Rheumatic Drugs (DMARDS) in Subjects With Active Rheumatoid Arthritis (RA)

Completed· Amgen logo

Amgen·Phase 3·NCT00117091

Clinical Study to Evaluate the Efficacy of Anakinra in Patients With Rheumatoid Arthritis and Diabetes

Terminated·—·Phase 4·NCT02236481·41 enrolled

Kineret in the Treatment of Rheumatoid Arthritis

Completed·SSwedish Orphan Biovitrum··NCT02915094·30 enrolled

Inflammation5 trials

Early Phase Administration of Anakinra as a Rescue Treatment for Inhaled Allergen Challenge-Induced Airway Inflammation

Withdrawn·UUniversity of North Carolina, Chapel Hill·Phase 1/2·NCT03513471

Anti-Cytokine Therapy for Hemodialysis InflammatION

Completed·UUniversity of Pennsylvania·Phase 2·NCT03141983·80 enrolled

Anakinra as a Rescue Treatment for Allergic Inflammation

Withdrawn·UUniversity of North Carolina, Chapel Hill·Phase 1/2·NCT04035109

Show 2 more trials

Late Phase Administration Anakinra as a Rescue Treatment for Inhaled Allergen Challenge-Induced Airway Inflammation

Withdrawn·UUniversity of North Carolina, Chapel Hill·Phase 1/2·NCT03513458

Anakinra in Dengue With Hyperinflammation ( AnaDen )

Active, not recruiting·OOxford University Clinical Research Unit, Vietnam·Phase 2·NCT05611710·160 enrolled

79 more indications

Pericarditis4 trials

Treatment of Acute Pericarditis With Anakinra

Terminated·VVirginia Commonwealth University·Phase 2·NCT03224585·5 enrolled

AnakInRa for Treatment of Recurrent Idiopathic Pericarditis (AIRTRIP)

Completed·MMassimo Imazio·Phase 4·NCT02219828·21 enrolled

Therapy Management in Patients Treated With Anakinra Due to Recurrent Pericarditis

Recruiting·—·N/A·NCT06071156·20 enrolled

Show 1 more trial

Therapeutic Approach in Colchicine-resistant Recurrent pEricarditis in Children

Not yet recruiting·IIstituto Giannina Gaslini·Phase 3·NCT05805930·48 enrolled

Interleukin3 trials

Anti-Interleukin-1 in Diabetes Action

Completed·SSteno Diabetes Center Copenhagen·Phase 2/3·NCT00711503·69 enrolled

Interleukin-1 Blockade in HF With Preserved EF

Completed·VVirginia Commonwealth University·Phase 2·NCT02173548·31 enrolled

Effect of Interleukin-1 Receptor Antagonist on Inhalation of 20,000 EU Clinical Ctr Reference Endotoxin in Normal Volunteers

Completed·—·Phase 1·NCT01369017·17 enrolled

Fatigue3 trials

Fatigue and Interleukin-1 (IL-1) Blockade in Primary Sjøgrens Syndrome

Completed·HHelse Stavanger HF·Phase 2·NCT00683345·28 enrolled

Role of Interleukin-1 in Postprandial Fatigue - The Cheesecake Study

Completed·UUniversity of Zurich·Phase 1·NCT01810549·20 enrolled

Role of Interleukin (IL)-1 in Postprandial Fatigue - The Chäschüechli 2 Study

Completed·UUniversity Hospital, Basel, Switzerland·N/A·NCT02916355·16 enrolled

Sepsis3 trials

Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS

Recruiting·NNationwide Children's Hospital·Phase 2/3·NCT05267821·500 enrolled

A Trial of Validation and Restoration of Immune Dysfunction in Severe Infections and Sepsis

Completed·HHellenic Institute for the Study of Sepsis·Phase 2·NCT03332225·36 enrolled

PALETTE- Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Exploratory, Bayesian Basket Trial

Recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT06381661·2,000 enrolled

Type 1 Diabetes3 trials

Anti-IL-1 Treatment in Children Diabetic Keto-Acidosis (DKA) at Diagnosis of Type 1 Diabetes

Withdrawn·UUniversity of Colorado, Denver·Phase 2·NCT01477476

Anti-inflammatory Therapy With Anakinra in Newly Diagnosed Type 1 Diabetes

Completed·UUniversity of Texas Southwestern Medical Center·Phase 1/2·NCT00645840·15 enrolled

Stem Cell Mobilization (Plerixafor) and Immunologic Reset in Type 1 Diabetes (T1DM)

Completed·UUniversity of Alberta·Phase 1/2·NCT03182426·22 enrolled

Kawasaki Disease3 trials

Anakinra and Kawasaki Disease

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT02390596·16 enrolled

Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease

Completed·UUniversity of California, San Diego·Phase 1/2·NCT02179853·22 enrolled

A Randomized, Controlled, Open-label, Non Inferiority KawasakI Trial With Anakinra

Withdrawn·MMeyer Children's Hospital IRCCS·Approved·NCT06697431

Familial Mediterranean Fever2 trials

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

Recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT06336733·50 enrolled

A Prospective, Open-label, Single Arm, Multicenter, Post-authorization Efficacy and Safety Study of Subcutaneous Anakinra in Chinese Patients With Colchicine-resistant Familial Mediterranean Fever (FMF)

Withdrawn·SSwedish Orphan Biovitrum·Approved·NCT06666335

Acute Myocardial Infarction2 trials

Interleukin-1 Blockade in Acute Myocardial Infarction to Prevent Heart Failure

Recruiting·VVirginia Commonwealth University·Phase 2·NCT05177822·84 enrolled

Interleukin-1 (IL-1) Blockade in Acute Myocardial Infarction (VCU-ART3)

Completed·VVirginia Commonwealth University·Phase 2/3·NCT01950299·99 enrolled

Hypoglycemia2 trials

Empagliflozin and Anakinra for the Treatment of Postprandial Hypoglycemia in Patients With Prediabetes

Withdrawn·UUniversity Hospital, Basel, Switzerland·Phase 2·NCT05174507

Postprandial Hypoglycemia in Patients After Bariatric Surgery With Empagliflozin and Anakinra - The Hypo-BEAR-Study

Completed·UUniversity Hospital, Basel, Switzerland·N/A·NCT03200782·12 enrolled

Efficacy and Safety2 trials

A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Still's Disease (SJIA and AOSD)

Terminated·SSwedish Orphan Biovitrum·Phase 3·NCT03265132·13 enrolled

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

Recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT04656184·84 enrolled

Treatment2 trials

Anakinra as a Treatment for Hydradenitis Suppurativa

Completed·UUniversity of California, San Francisco·Phase 2·NCT01516749·6 enrolled

IL-1RA Treatment in Patients With Acute ACL Tear and Painful Effusions

Terminated·—·Phase 2·NCT02930122·6 enrolled

Neurotoxicity2 trials

A Phase 2 Trial of Anakinra for the Prevention of CAR-T Cell Mediated Neurotoxicity

Completed·MMarcela V. Maus, M.D.,Ph.D.·Phase 2·NCT04150913·15 enrolled

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

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT04359784·27 enrolled

Respiratory Failure2 trials

suPAR-Guided Anakinra Treatment for Management of Severe Respiratory Failure by COVID-19

Completed·HHellenic Institute for the Study of Sepsis·Phase 3·NCT04680949·606 enrolled

suPAR-guided Anakinra Treatment for Validation of the Risk and Management of Respiratory Failure by COVID-19 (SAVE)

Completed·HHellenic Institute for the Study of Sepsis·Phase 2·NCT04357366·1,000 enrolled

Systemic Juvenile Idiopathic Arthritis2 trials

Long-term Safety Study of Kineret® in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)

Completed·SSwedish Orphan Biovitrum··NCT03932344·306 enrolled

A Prospective, Open-label, Multicenter, Post-authorization, Efficacy and Safety Study of Subcutaneous Anakinra in Chinese Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still's Disease (AOSD)

Withdrawn·SSwedish Orphan Biovitrum·Approved·NCT07706868

Neutropenia2 trials

Anakinra: Efficacy in the Management of Fever During Neutropenia and Mucositis in ASCT - A Randomized Controlled Trial

Completed·RRadboud University Medical Center·Phase 2·NCT04099901·88 enrolled

Anakinra: Safety and Efficacy in the Management of Fever During Neutropenia and Mucositis in ASCT

Completed·RRadboud University Medical Center·Phase 2·NCT03233776·9 enrolled

Multiple Myeloma2 trials

Anakinra With or Without Dexamethasone in Treating Patients With Smoldering or Indolent Multiple Myeloma

Completed·MMayo Clinic·Phase 2·NCT00635154·55 enrolled

Lenalidomide and Dexamethasone With or Without Anakinra in Treating Patients With Early Stage Multiple Myeloma

Completed·MMayo Clinic·Phase 1·NCT02492750·14 enrolled

Acute Myocarditis2 trials

Anakinra Versus Placebo for the Treatment of Acute MyocarditIS

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 2/3·NCT03018834·120 enrolled

ANAKINRA IN THE TREATMENT OF PEDIATRIC ACUTE MYOCARDITIS

Not yet recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT07371689·110 enrolled

Pneumonia1 trial

Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia

Recruiting·UUMC Utrecht·Phase 3·NCT02735707·20,000 enrolled

Giant Cell Arteritis1 trial

Giant Cell Arteritis and Anakinra Trial

Unknown status·UUniversity Hospital, Caen·Phase 3·NCT02902731·70 enrolled

HIV-1 infection1 trial

Anakinra, A Recombinant Human IL-1 Receptor Antagonist for Neuroinflammation in HIV-1 Infection

Terminated·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 1·NCT02527460·1 enrolled

Prostate Cancer1 trial

A Study of CART-PSMA-TGFβRDN in Patients With Metastatic Castration Resistant Prostate Cancer

Terminated·TTceleron Therapeutics, Inc.·Phase 1·NCT04227275·16 enrolled

Chronic Kidney Disease1 trial

Interleukin-1 Blockade for the Treatment of Heart Failure in Patients With Advanced Chronic Kidney Disease

Withdrawn·VVirginia Commonwealth University·Phase 2·NCT03062176

Obese1 trial

Effects of IL-1 Beta on the HPA-axis in Obese Persons

Completed·UUniversity Hospital, Basel, Switzerland·Phase 3·NCT02227420·76 enrolled

Stroke1 trial

Studying Anakinra to Reduce Secondary Brain Damage After Spontaneous Haemorrhagic Stroke

Unknown status·RRadboud University Medical Center·Phase 2·NCT04834388·75 enrolled

Atopic Dermatitis1 trial

A Pilot Study Using Anakinra/Kineret for the Treatment of Patients With Severe Atopic Dermatitis

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT01122914·1 enrolled

Encephalopathy1 trial

Anakinra in Preventing Severe Chimeric Antigen Receptor T-Cell Related Encephalopathy Syndrome in Patients With Recurrent or Refractory Large B-cell Lymphoma

Terminated·JJonsson Comprehensive Cancer Center·Phase 2·NCT04205838·23 enrolled

Hemochromatosis1 trial

Treatment of Refractory Hemochromatosis Rheumatism by Anakinra: a Preliminary Phase II Study

Terminated·RRennes University Hospital·Phase 2·NCT02263638·17 enrolled

Metastatic Colorectal Cancer1 trial

Study Evaluating the Influence of LV5FU2 Bevacizumab Plus Anakinra Association on Metastatic Colorectal Cancer

Completed·CCentre Georges Francois Leclerc·Phase 2·NCT02090101·32 enrolled

Cardiac Sarcoidosis1 trial

Interleukin-1 Blockade for Treatment of Cardiac Sarcoidosis

Completed·VVirginia Commonwealth University·Phase 2·NCT04017936·17 enrolled

Chemotherapy1 trial

A Pilot, Prospective, Non-randomized Evaluation of the Safety of Anakinra Plus Standard Chemotherapy

Completed·—·Phase 1·NCT02021422·13 enrolled

Sudden Sensorineural Hearing Loss1 trial

Study of the Effects of Anakinra in Corticosteroid-resistant Subjects With Sudden Sensorineural Hearing Loss

Terminated·AAndrea Vambutas·Phase 1/2·NCT02414152·2 enrolled

Effectiveness1 trial

MIS-C Comparative Effectiveness Study

Completed·UUniversity of California, San Diego·Phase 2/3·NCT04898231·73 enrolled

Metabolic Syndrome1 trial

Effects of Interleukin-1 Beta on Low Testosterone Levels in Men With Obesity and Metabolic Syndrome

Completed·UUniversity Hospital, Basel, Switzerland·Phase 3·NCT02672592·70 enrolled

Dexamethasone1 trial

Immunomodulatory Effects of Dexamethasone, Tocilizumab and Anakinra During Experimental Human Endotoxemia

Recruiting·RRadboud University Medical Center·Phase 4·NCT06624436·52 enrolled

Allergic Contact Dermatitis1 trial

The Role of Interleukin-1 Beta Targeted Therapy for Patients Suffering From Allergic Contact Dermatitis

Completed·HHerlev and Gentofte Hospital·Phase 3·NCT05498467·20 enrolled

Insulin resistance1 trial

Nutrition, Inflammation and Insulin Resistance in End Stage Renal Disease-Aim 2

Completed·VVA Office of Research and Development·Phase 2·NCT02278562·33 enrolled

Pulmonary Arterial Hypertension1 trial

Pilot Study of the Safety and Efficacy of Anakinra in Pulmonary Arterial Hypertension

Completed·VVirginia Commonwealth University·Phase 1·NCT03057028·7 enrolled

Coronary Artery Disease1 trial

Effects of Interleukin-1 Inhibition on Vascular and Left Ventricular Function in Rheumatoid Arthritis Patients With Coronary Artery Disease

Completed·UUniversity of Athens·N/A·NCT01566201·80 enrolled

Metastatic Cancer1 trial

Anakinra in Treating Patients With Metastatic Cancer Expressing the Interleukin-1 Gene

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00072111

Lymphoma1 trial

Anakinra for the Reduction of CAR-T Toxicity in Patients With Relapsed or Refractory Large B-cell Lymphoma

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT04432506·22 enrolled

Pain1 trial

Discovery and Analytical Validation of Inflammatory Bio-signatures of the Human Pain Experience

Recruiting·AAlan Prossin·Phase 1·NCT05074485·70 enrolled

Pancreatic Cancer1 trial

Gemcitabine, Nab-Paclitaxel, Cisplatin and Anakinra Treatment on Patients With Pancreatic Cancer

Completed·—·Phase 1·NCT02550327·20 enrolled

Insulin Secretion1 trial

The Effect of Anakinra on Insulin Secretion

Unknown status·RRadboud University Medical Center·N/A·NCT01285232·16 enrolled

Completed·RRadboud University Medical Center·Phase 2/3·NCT02108210·50 enrolled

CAR T Cell Therapy1 trial

A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT04148430·62 enrolled

Immunomodulation1 trial

Immunomodulation, IL-1 Inhibition, and Postoperative Incisional Pain

Terminated·SStanford University·N/A·NCT01466764·13 enrolled

ART1 trial

A Study of JNJ-77474462 in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04544813·78 enrolled

Multiple Sclerosis1 trial

Anakinra for the Treatment of Chronically Inflamed White Matter Lesions in Multiple Sclerosis

Completed·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 1/2·NCT04025554·8 enrolled

Autoimmune Inner Ear Disease1 trial

A Clinical Trial of Anakinra for Steroid-Resistant Autoimmune Inner Ear Disease

Completed·AAndrea Vambutas·Phase 1/2·NCT01267994·13 enrolled

Hyperinsulinemia1 trial

Hyperinsulinemia in Prediabetes Mediated by Interleukin-1β

Completed·UUniversity Hospital, Basel, Switzerland·Phase 2·NCT05854251·20 enrolled

Insulin Sensitivity1 trial

Interleukin-1 Receptor Antagonist and Insulin Sensitivity

Unknown status·RRadboud University Medical Center·Phase 2·NCT00928876·12 enrolled

Pulmonary Hypertension1 trial

Pilot Study of the Safety and Efficacy of Anakinra (Recombinant Human Interleukin-1 Receptor Antagonist) in Pulmonary Hypertension

Terminated·VVirginia Commonwealth University·Phase 1/2·NCT01479010·2 enrolled

Osteoarthritis1 trial

Biologic Therapy to Prevent Osteoarthritis After ACL Injury

Recruiting·UUniversity of California, Los Angeles·Phase 1·NCT03968913·32 enrolled

Arthritis1 trial

A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Acute Gouty Arthritis

Completed·SSwedish Orphan Biovitrum·Phase 2·NCT03002974·165 enrolled

Beta-cell Function1 trial

IL-1RA, Acute Exercise, and Beta-cell Function

Withdrawn·RRigshospitalet, Denmark·N/A·NCT02310009

TNBC1 trial

IL-1 Inhibition in Early TNBC

Withdrawn·UUniversity Health Network, Toronto·Phase 2·NCT06710197

Adult-Onset Still's Disease1 trial

Treatment of Refractory Adult-onset Still's Disease With Anakinra: a Randomized Study

Completed·UUniversity of Helsinki·Phase 2·NCT01033656·23 enrolled

Uveitis1 trial

Randomized Trial Comparing Efficacy of Adalimumab, Anakinra and Tocilizumab in Non-infectious Refractory Uveitis

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT02929251·112 enrolled

Hepatitis1 trial

Efficacy Study of Anakinra, Pentoxifylline, and Zinc Compared to Methylprednisolone in Severe Acute Alcoholic Hepatitis

Completed·MMack Mitchell·Phase 2/3·NCT01809132·104 enrolled

Relapsed or Refractory1 trial

Everolimus and Anakinra or Denosumab in Treating Participants With Relapsed or Refractory Advanced Cancers

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT01624766·57 enrolled

Knee Injury1 trial

Study to Prevent Cartilage Damage Following Acute Knee Injury.

Completed·—·Phase 1/2·NCT00332254·10 enrolled

Amyotrophic Lateral Sclerosis1 trial

Safety and Tolerability of Anakinra in Combination With Riluzol in Amyotrophic Lateral Sclerosis

Completed·—·Phase 2·NCT01277315·20 enrolled

Myositis1 trial

Anakinra in Myositis

Completed·KKarolinska Institutet·Phase 2/3·NCT01165008

Hidradenitis Suppurativa1 trial

Anakinra in Hidradenitis Suppurativa

Completed·UUniversity of Athens·Phase 2·NCT01558375·20 enrolled

Poor Graft Function1 trial

A Prospective, Multicenter Clinical Trial of the Interleukin-1 Receptor Antagonist Anakinra for the Prevention of Poor Graft Function Following Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Myelodysplastic Syndromes

Not yet recruiting·RRuijin Hospital·Preclinical·NCT07888348·66 enrolled

Still's Disease, Adult-Onset1 trial

Efficacy and Safety of Firsekibart Versus Anakinra in Adult-Onset Still's Disease

Active, not recruiting·RRuijin Hospital··NCT07191444·20 enrolled

Pancreatic Adenocarcinoma1 trial

An Open Label, Phase II Study of Chemotherapy + Anakinra in Patients With Resectable, Locally Advanced or Potentially Resectable Pancreatic Adenocarcinoma (PDAC)

Recruiting·BBaylor Research Institute·Phase 2·NCT04926467·24 enrolled

Cystic Fibrosis, 100117621 trial

A Phase IIa, Randomized, Placebo-controlled, Double-blind, Cross-over Study to Evaluate Safety and Efficacy of Subcutaneous Administration of Anakinra in Patients With Cystic Fibrosis

Terminated·HHeidelberg University·Phase 2·NCT03925194·33 enrolled

Melanoma1 trial

Targeting Inflammaging-Associated Cytokine Signaling to Improve Efficacy and Reduce Immune-Related Toxicities of Anti-PD-1/CTLA-4 Therapy

Not yet recruiting·UUniversity of Southern California·Phase 1·NCT07838974·40 enrolled

Metastatic Non Small Cell Lung Cancer1 trial

A Phase 1b/2 Trial of Dupilumab Given in Conjunction With PD-1 or PD-L1 Blockade and Anakinra in the Treatment of Relapsed/Refractory Metastatic NSCLC

Active, not recruiting·TThomas Marron·Preclinical·NCT05013450·33 enrolled

Lung Transplant Recipient1 trial

BRIDGE - Blocking Receptor of IL-1β for Donor Graft Edema Reduction

Not yet recruiting·NNorthwestern University·Phase 1·NCT07410312·20 enrolled

New Onset Refractory Status Epilepticus1 trial

Comparing the Effects of Anakinra and Tocilizumab on Outcomes in Patients With New-Onset Refractory Status Epilepticus

Not yet recruiting·YYale University·Phase 3·NCT07281027·438 enrolled

B Acute Lymphoblastic Leukemia1 trial

Pilot Study of Pre-emptive Anakinra for the Prevention of Severe Cytokine Release Syndrome in Children and Young Adults With B-Acute Lymphoblastic Leukemia Receiving Chimeric Antigen Receptor (CAR) T Cells

Withdrawn·KKevin McNerney·Preclinical·NCT06703216

Lactating Women on Select DOI1 trial

Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

Recruiting·DDuke University··NCT03511118·1,600 enrolled

Rheumatic Disease1 trial

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Recruiting·NNYU Langone Health·Phase 2·NCT07138898·80 enrolled

Juvenile Idiopathic Arthritis1 trial

ANAkinra in Severe Juvenile Idiopathic Arthritis of Systemic Onset (ANAJIS)

Completed·IInstitut National de la Santé Et de la Recherche Médicale, France·Preclinical·NCT00339157·24 enrolled

Unspecified2 trials

The SPECTRA Study

Terminated· Amgen logo

Amgen·Phase 2·NCT00537667·22 enrolled

Kineret CAPS Post Authorisation Study

Completed·SSwedish Orphan Biovitrum··NCT02326376·12 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 14, 2001

KINERET

BLA BLA103950

Sources

References

[1]
ClinicalTrials.gov — 137 trial records for Anakinra. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Kineret drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Anakinra compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Anakinra. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (BLA BLA103950). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Swedish Orphan Biovitrum company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Interleukin-1 Receptor Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: SSwedish Orphan Biovitrum

Kineret

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q3 2027

Trials by Indication[1]

COVID-198 trials

Heart Failure7 trials

Anakinra7 trials

Rheumatoid Arthritis6 trials

Inflammation5 trials

Pericarditis4 trials

Interleukin3 trials

Fatigue3 trials

Sepsis3 trials

Type 1 Diabetes3 trials

Kawasaki Disease3 trials

Familial Mediterranean Fever2 trials

Acute Myocardial Infarction2 trials

Hypoglycemia2 trials

Efficacy and Safety2 trials

Treatment2 trials

Neurotoxicity2 trials

Respiratory Failure2 trials

Systemic Juvenile Idiopathic Arthritis2 trials

Neutropenia2 trials

Multiple Myeloma2 trials

Acute Myocarditis2 trials

Pneumonia1 trial

Giant Cell Arteritis1 trial

HIV-1 infection1 trial

Prostate Cancer1 trial

Chronic Kidney Disease1 trial

Obese1 trial

Stroke1 trial

Atopic Dermatitis1 trial

Encephalopathy1 trial

Hemochromatosis1 trial

Metastatic Colorectal Cancer1 trial

Cardiac Sarcoidosis1 trial

Chemotherapy1 trial

Sudden Sensorineural Hearing Loss1 trial

Effectiveness1 trial

Metabolic Syndrome1 trial

Dexamethasone1 trial

Allergic Contact Dermatitis1 trial

Insulin resistance1 trial

Pulmonary Arterial Hypertension1 trial

Coronary Artery Disease1 trial

Metastatic Cancer1 trial

Lymphoma1 trial

Pain1 trial

Pancreatic Cancer1 trial

Insulin Secretion1 trial

Skin Disease1 trial

Inflammatory Disease1 trial

Chronic Fatigue Syndrome1 trial

CAR T Cell Therapy1 trial

Immunomodulation1 trial

ART1 trial

Multiple Sclerosis1 trial

Autoimmune Inner Ear Disease1 trial

Hyperinsulinemia1 trial

Insulin Sensitivity1 trial

Pulmonary Hypertension1 trial

Osteoarthritis1 trial

Arthritis1 trial

Beta-cell Function1 trial

TNBC1 trial

Adult-Onset Still's Disease1 trial

Uveitis1 trial

Hepatitis1 trial

Relapsed or Refractory1 trial

Knee Injury1 trial

Amyotrophic Lateral Sclerosis1 trial

Myositis1 trial

Hidradenitis Suppurativa1 trial

Still's Disease, Adult-Onset1 trial