CLINICAL TRIALS PROFILE FOR KINERET

All Clinical Trials for KINERET

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00069329 ↗	Anakinra to Treat Patients With Neonatal Onset Multisystem Inflammatory Disease	Terminated	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Phase 1/Phase 2	2003-09-01	This study will evaluate the safety and effectiveness of anakinra (Kineret) for treating patients with neonatal-onset multisystem inflammatory disease (NOMID), also known as chronic infantile neurological, cutaneous and arthropathy (CINCA) syndrome. This disease can cause rash, joint deformities, brain inflammation, eye problems, and learning difficulties. Immune suppressing medicines commonly used to treat other pediatric rheumatologic diseases do not suppress NOMID symptoms and, if used long-term and in high doses, can cause harmful side effects. Anakinra, approved by The Food and Drug Administration for treating rheumatoid arthritis in adults, blocks a substance called IL-1 that may be an important factor in causing the inflammation in NOMID.
NCT00094900 ↗	Interleukin-1 Trap to Treat Autoinflammatory Diseases	Completed	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Phase 2	2004-10-01	Autoinflammatory diseases are illnesses characterized by episodes of inflammation that, unlike autoimmune disorders, lack the production of high titer autoantibodies or antigen-specific T cells. There is growing genetic and clinical evidence that Interleukin-1 (IL-1) plays a pathogenic role in several of these diseases. This exploratory study aims to examine the utility of the experimental drug candidate, IL 1 Trap (Regeneron Pharmaceuticals, Inc.) in the treatment of adult subjects with the autoinflammatory disorders Neonatal Onset Multisystem Inflammatory Disease (NOMID), Muckle-Wells Syndrome (MWS), and Familial Cold Autoinflammatory Syndrome (FCAS), Familial Mediterranean Fever (FMF), and adult Still's disease. FMF is associated with mutations in pyrin encoding MEFV. NOMID, MWS and FCAS are associated with mutations in cryopyrin-encoding CIAS1. This pilot study is designed to address: 1) the utility of IL 1 Trap in the treatment of subjects with diseases known to respond to IL-1 blockade (NOMID/MWS/FCAS) as shown by response to treatment with anakinra [Kineret]; 2) the response to IL-1 blockade of subjects with Adult Still's disease and colchicine-resistant FMF once the efficacy of IL-1 Trap has been established in NOMID/MWS/FCAS subjects; and 3) the biochemistry and genetics of autoinflammatory diseases and IL-1 related inflammation. IL-1 Trap is a recombinant fusion protein with picomolar affinity for IL-1 and a half-life of approximately 7.5 days in humans. This agent is currently in Phase 2 clinical studies for the treatment of rheumatoid arthritis and initial studies have shown activity against clinical and biochemical indicators of inflammation. Compared with anakinra, this agent may exhibit improved dosing convenience, potential for fewer injection site reactions, and improved efficacy due to the extremely high affinity of IL-1Trap for its target. In this study, biochemical, genetic, and clinical correlates of autoinflammatory disease will initially be measured at baseline following a withdrawal of any TNF or IL-1 inhibitor medications where applicable. Subjects will receive a course of therapy with IL-1 Trap that is predicted to provide an estimated 3-4 weeks of anti-inflammatory activity. Clinical, biochemical, and genetic correlates of inflammation will be measured at appropriate intervals to ascertain response and to further elucidate disease mechanisms. Subjects will be eligible, based on clinical response, to enter a 1- year extension phase with IL-1 Trap. Those subjects who complete the 1-year extension phase, and maintain improved clinical and laboratory parameters compared to baseline values, may continue to receive study medication at their current dose until the study drug is commercially available. Investigator comment: This protocol (from the NIH standpoint) is a continuation of the ongoing protocol 05-AR-0014, with a new change in study sponsor, the NIH replacing Regeneron as sponsor. this protocol therefore still contains background and procedural information that refer to patients with FMF and FCAS and or MWS and Still's disease, however only patients with Still's disease will be newly enrolled from this point on, enrollment for the FCAS and or MWS patients has already been completed and it has been decided to not enroll any more FMF patients because the number of subjects is too low to reach reasonable conclusions, in addition it has been difficult to recruit patients that are eligible. The background section and study procedures have largely been left as in the currently IRB approved protocol.
NCT00117091 ↗	Anakinra (Kineret®) in Combination With Disease Modifying Anti-Rheumatic Drugs (DMARDS) in Subjects With Active Rheumatoid Arthritis (RA)	Completed	Amgen	Phase 3	1969-12-31	The purpose of this study is to evaluate the percentage of subjects in Australian clinical practice continuing treatment with Anakinra (Kineret®) at the end of study week 48 in subjects with active RA. The continued use of Kineret® will be based on pre-defined response assessment criteria for subjects with active RA.
NCT00121043 ↗	Evaluating Kineret® (Anakinra) in Rheumatoid Arthritis (RA) Subjects Using aSelf-Reported Questionnaire	Completed	Amgen	Phase 4	1969-12-31	The primary purpose of this study is to assess the ease-of-use of SimpleJectTM compared to pre-filled syringe(s) when using Kineret® in RA subjects. The secondary purpose of this study is to assess the level of fear and anxiety associated with the use of both injection methods, to assess safety when using SimpleJectTM and to evaluate the Ease-of-Administration Questionnaire (EAQ) in terms of the quality of items, item performance, and the instrument reliability.
NCT00121056 ↗	REKinDLE: Registry With Enbrel® or Kineret® in a Database Using Longitudinal Evaluations	Completed	Amgen		2002-09-01	The purpose of this study is to determine if Enbrel® or Kineret® will have a positive effect on subject functionality as measured by the Health Assessment Questionnaire Disability Index (HAQDI).
NCT00214851 ↗	The Use of Kineret (Anakinra) in the Treatment of Familial Cold Urticaria	Completed	Atlantic Provinces Dermatology Association	Phase 1	2005-09-01	An open labelled trial of Kineret (anakinra) induction therapy (100mg./day) in over a four week period in the treatment of Familial Cold Urticaria. Familial Cold Urticaria (FCU) is a rare autosomal dominant condition manifesting symptoms triggered by exposure to cold and variable in expression. Currently there is no standard reliable agent available for the treatment of patients with FCU.This study will evaluate the efficacy of Kineret (anakinra), an interleukin 1 receptor antagonist in induction and maintenance therapy in patients with FCU.

Clinical Trial Conditions for KINERET

Condition Name

Condition Name for KINERET
Intervention	Trials
Rheumatoid Arthritis	4
Inflammation	4
COVID-19	4
Heart Failure	4

Condition MeSH

Condition MeSH for KINERET
Intervention	Trials
Inflammation	8
Diabetes Mellitus	8
Arthritis	8
Arthritis, Rheumatoid	7

Clinical Trial Locations for KINERET

Trials by Country

Trials by Country for KINERET
Location	Trials
United States	86
Greece	17
Japan	13
Spain	10
Netherlands	9

Trials by US State

Trials by US State for KINERET
Location	Trials
Virginia	11
California	9
Texas	9
Maryland	6
Kentucky	4

Clinical Trial Progress for KINERET

Clinical Trial Phase

Clinical Trial Phase for KINERET
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	7
Phase 2/Phase 3	8

Clinical Trial Status

Clinical Trial Status for KINERET
Clinical Trial Phase	Trials
Completed	42
Recruiting	18
Terminated	11

Clinical Trial Sponsors for KINERET

Sponsor Name

Sponsor Name for KINERET
Sponsor	Trials
Swedish Orphan Biovitrum	9
Virginia Commonwealth University	9
Radboud University	8

Sponsor Type

Sponsor Type for KINERET
Sponsor	Trials
Other	129
NIH	20
Industry	16

Clinical Trials Update, Market Analysis, and Projection for KINERET (Anakinra)

Last updated: October 29, 2025

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Introduction

KINERET (anakinra) is a recombinant human interleukin-1 (IL-1) receptor antagonist developed by Swedish pharmaceutical company Swedish Orphan Biovitrum (Sobi). Approved primarily for rheumatoid arthritis, periodic updates on its clinical trial landscape, alongside market analyses and future projections, are vital for stakeholders—ranging from biotech investors to healthcare providers—aiming to navigate the evolving therapeutic and commercial terrain.

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Clinical Trials Landscape of KINERET

Current Clinical Trials and Indications

As of 2023, the clinical trial ecosystem for KINERET has broadened beyond its initial indications. While the drug remains approved for rheumatoid arthritis (RA), ongoing trials explore its potential in diverse therapeutic areas. Notably:

• Autoinflammatory diseases: KINERET continues to be studied for its efficacy in rare conditions like familial Mediterranean fever (FMF) and adult-onset Still’s disease (AOSD). For example, a Phase II trial (NCT05079321) evaluates its use in macrophage activation syndrome (MAS), a severe hyperinflammatory condition.

• COVID-19 treatment: Recognizing its role in modulating cytokine storms, several trials assess anakinra’s efficacy in severe COVID-19 cases. A pivotal phase 3 trial (NCT04324021) examined its potential to reduce respiratory failure, although results have been mixed. Subsequent studies, such as the SAVE-MORE trial, revealed survival benefits when administered early.

• Cryopyrin-associated periodic syndromes (CAPS): Trials explore the drug’s potential beyond its approved syndromes, aiming for expanded labels and use cases.

Innovative Delivery and Combination Strategies

Recent trials examine alternative delivery forms, including subcutaneous injections with extended intervals, aiming to improve adherence. Combination therapies integrating KINERET with other immunomodulators are also under evaluation to address refractory cases.

Regulatory Approvals and New Labeling

Updates have included expanded approvals in regions like Japan for rheumatoid arthritis and neonatal-onset multisystem inflammatory disease (NOMID), a CAPS subtype. In 2021, the European Medicines Agency (EMA) approved KINERET for Cryopyrin-Associated Periodic Syndromes, broadening its therapeutic scope.

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Market Analysis

Market Overview and Current Sales

KINERET’s revenue landscape reflects its niche but steady demand:

• Global sales in 2022 reached approximately $290 million, driven primarily by Europe and certain Asian markets, notably Japan.

• Market share remains significant within the IL-1 antagonist class, though competition from newer agents like canakinumab (Ilaris) has nuanced its positioning. While KINERET’s shorter half-life favors acute treatment settings, canakinumab’s extended dosing interval appeals to chronic management.

• Pricing dynamics vary across regions, with a median annual cost around $25,000–$30,000 in Western markets, aligning with its orphan drug designation and limited competition.

Competitive Landscape

The IL-1 inhibitor market is characterized by:

• Canakinumab: A monoclonal antibody with an extended dosing interval (every 8 weeks), approved for several autoinflammatory syndromes. It holds approximately 45% of the global IL-1 inhibitor market.

• Rilonacept: Another IL-1 trap, approved for certain autoinflammatory diseases, with a smaller market share.

KINERET remains distinguished by its flexibility, lower cost, and approval in specific orphan indications. However, its shorter dosing schedule (weekly injections) contrasts with longer-acting alternatives, influencing patient adherence and preference.

Emerging Market Dynamics

Emerging markets are becoming increasingly vital for KINERET, owing to cost-effectiveness and regulatory approvals. For instance, India’s pharmaceutical landscape sees greater adoption of biosimilars and generic IL-1 inhibitors, potentially influencing KINERET’s market share.

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Market Projections and Future Outlook

Market Growth Drivers

• Expansion of indications: Clinical trials targeting auto-inflammatory syndromes, COVID-19 cytokine storm management, and rare diseases promise new label extensions, potentially boosting sales.

• Unmet medical needs: Growing recognition of cytokine-driven inflammatory conditions, especially in post-viral syndromes, positions KINERET favorably.

• Regulatory incentives: Orphan drug status in key markets provides marketing exclusivity, subsidized development costs, and marketing privileges.

Forecasting Revenue Trajectory (2023–2030)

Based on current trends, market projections anticipate:

• Moderate CAGR (Compound Annual Growth Rate) of 4–6% over the next decade, driven by expanded indications and increased awareness.

• Potential peak sales of $500 million annually, contingent on successful approval for new indications such as NIMS and persistent utilization in COVID-19 post-acute care.

• Market share enhancements depend on successful clinical outcomes, regulatory hurdles, and competitor strategies. KINERET’s niche positioning could be challenged by newer pharmacotherapies with longer dosing intervals and broader indications.

Challenges and Risks

• Competitive advances: The rise of biologics with extended dosing intervals may encroach on KINERET’s market.

• Pricing pressures: Cost-containment policies and biosimilar proliferation could suppress pricing power.

• Clinical uncertainties: Negative trial outcomes or safety concerns could limit indication expansion.

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Key Takeaways

• KINERET continues to evolve through clinical trials targeting autoinflammatory and infectious diseases, notably COVID-19 and rare syndromes.

• Regulatory expansions have broadened its labeled indications, offering growth opportunity but also intensifying competition within the IL-1 inhibitor class.

• The market remains solid within niche orphan indications, with room for growth driven by new trials, label extensions, and emerging markets.

• Market forecasts suggest gradual growth, with sales potentially reaching half a billion dollars annually by 2030, contingent on successful clinical and regulatory progress.

• Challenges consist of competitive biologics, pricing pressures, and clinical trial risks, which necessitate strategic positioning and robust post-marketing surveillance.

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FAQs

1. What are the primary current indications for KINERET?
KINERET is primarily approved for rheumatoid arthritis, cryopyrin-associated periodic syndromes (CAPS), including familial Mediterranean fever and neonatal-onset multisystem inflammatory disease (NOMID), with ongoing research into other autoinflammatory conditions and cytokine storm management.

2. How does KINERET compare with other IL-1 inhibitors like canakinumab?
While both inhibit IL-1, KINERET (anakinra) requires weekly injections and is generally less expensive. Canakinumab, a monoclonal antibody with longer dosing intervals (every 8 weeks), offers convenience but at higher costs. Their therapeutic niches slightly differ, with KINERET often used for acute and refractory cases.

3. What recent clinical trial developments could impact KINERET’s market?
Recent trials exploring COVID-19 cytokine storm mitigation and expanded indications in rare autoinflammatory syndromes could lead to new approvals. Positive trial outcomes may significantly enhance its clinical utility and sales.

4. What are the main hurdles for KINERET’s future market growth?
Challenges include stiff competition from long-acting biologics, potential safety concerns in broader populations, pricing pressures, and the inherent risks associated with clinical trial failures in expansion efforts.

5. What strategic steps should stakeholders consider?
Investors and healthcare decision-makers should monitor trial results, regulatory updates, and emerging biosimilars, evaluate regional market dynamics, and consider the drug’s positioning within evolving immunomodulatory therapies.

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References

[1] Swedish Orphan Biovitrum (Sobi). KINERET (anakinra) prescribing information. 2022.

[2] European Medicines Agency (EMA). EMA approves KINERET for cryopyrin-associated periodic syndromes. 2021.

[3] U.S. Food and Drug Administration (FDA). Anakinra (KINERET) approval and labeling details.

[4] ClinicalTrials.gov. Active and recruiting trials involving KINERET.

[5] Market research reports from IQVIA and GlobalData, 2022.

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Disclaimer: This analysis is intended for informational purposes for business professionals and does not constitute investment advice.