CLINICAL TRIALS PROFILE FOR ANAKINRA

All Clinical Trials for Anakinra

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00037648 ↗	Juvenile Rheumatoid Arthritis	Completed	Amgen	Phase 2	2000-07-01	The purpose of this study is to determine the safety of anakinra in patients with Polyarticular-Course Juvenile Rheumatoid Arthritis, a form of rheumatoid arthritis affecting children.
NCT00037700 ↗	Evaluation of the Efficacy of Combination Treatment With Anakinra and Pegsunercept in Improving Rheumatoid Arthritis	Completed	Amgen	Phase 2	2001-05-01	The purpose of this study is to evaluate the effect of anakinra (IL-1 ra) and pegsunercept (PEG sTNF-RI) when they are used together in improving the signs and symptoms of rheumatoid arthritis. The study will also evaluate the safety of the combination treatment and its effect on slowing down bone and joint destruction due to rheumatoid arthritis. The results will be compared to the effect when only 1 single medication (anakinra or pegsunercept) is used.
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.

Clinical Trial Conditions for Anakinra

Condition Name

Condition Name for Anakinra
Intervention	Trials
Rheumatoid Arthritis	10
Heart Failure	8
Covid-19	7
Inflammation	7

Condition MeSH

Condition MeSH for Anakinra
Intervention	Trials
COVID-19	20
Inflammation	18
Arthritis	17
Syndrome	16

Clinical Trial Locations for Anakinra

Trials by Country

Trials by Country for Anakinra
Location	Trials
United States	186
Greece	25
France	18
Netherlands	13
Japan	13

Trials by US State

Trials by US State for Anakinra
Location	Trials
Virginia	20
Texas	15
California	14
Maryland	12
New York	11

Clinical Trial Progress for Anakinra

Clinical Trial Phase

Clinical Trial Phase for Anakinra
Clinical Trial Phase	Trials
PHASE4	3
PHASE3	4
PHASE2	4

Clinical Trial Status

Clinical Trial Status for Anakinra
Clinical Trial Phase	Trials
Completed	77
Recruiting	46
Not yet recruiting	17

Clinical Trial Sponsors for Anakinra

Sponsor Name

Sponsor Name for Anakinra
Sponsor	Trials
Virginia Commonwealth University	16
Swedish Orphan Biovitrum	11
Radboud University	10

Sponsor Type

Sponsor Type for Anakinra
Sponsor	Trials
Other	250
Industry	42
NIH	39

Last updated: April 29, 2026

Anakinra (Kineret and biosimilars): Clinical Trials Update and Market Outlook

Anakinra is an interleukin-1 (IL-1) blocker used across autoinflammatory and inflammatory indications, with the most durable commercial base tied to rheumatoid arthritis (RA) in combination with methotrexate and selected pediatric autoinflammatory disorders. Clinical development remains active, with incremental study activity in IL-1–driven diseases and life-cycle expansion into additional phenotypes rather than a single transformational new mechanism.

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What is anakinra and how is it positioned clinically?

Drug: Anakinra (recombinant IL-1 receptor antagonist)
MOA: IL-1 blockade through competitive inhibition at the IL-1 receptor, reducing IL-1–mediated inflammatory signaling.

Core approved use-cases by commercial priority (U.S./EU general pattern)

• Rheumatoid arthritis (often described as combination with methotrexate in patients who have inadequate response to DMARDs)
• Autoinflammatory syndromes including:
  • Neonatal-onset multisystem inflammatory disease (NOMID)/chronic infantile neurologic cutaneous disease (CINCA)
  • Familial Mediterranean fever (FMF)
  • Adult-onset Still’s disease (where approved)
  • Other cryopyrin-associated periodic syndromes (CAPS) and related IL-1-driven conditions depending on jurisdiction

Commercial differentiation

• Prescription-driven specialist use in immunology/rheumatology and pediatrics
• Long-term chronic administration in many autoinflammatory indications, which tends to stabilize demand relative to one-off acute therapies.

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What is the latest clinical trial activity for anakinra?

A complete and accurate “latest update” requires current trial-status retrieval across registries (ClinicalTrials.gov / EU CTR) with entry-level specifics (NCT/EudraCT IDs, phases, enrollment status, primary endpoints, and readout dates). The prompt does not provide the specific registry snapshot or a list of trial identifiers, and producing a precise update without that dataset is not possible under an accuracy constraint.

What can be stated reliably from established development patterns

• Development is dominated by indication expansion, pediatric studies, and biomarker-stratified or phenotype-specific cohorts in IL-1–driven inflammation.
• Trials commonly evaluate:
  • Disease activity change (adult RA and other inflammatory endpoints)
  • Fever and inflammatory flare metrics in autoinflammatory disorders
  • Time-to-response and flare reduction across CAPS/NOMID-type cohorts
• Many programs are small-to-mid size relative to oncology, with longitudinal safety as a consistent endpoint due to chronic use in some populations.

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How does anakinra’s competitive landscape shape trial and market prospects?

Competitive intensity depends on the indication:

• RA setting: competition includes TNF inhibitors, IL-6 inhibitors, costimulation modulators, JAK inhibitors, and other biologics with stronger market dominance. Anakinra tends to occupy a smaller niche or use-case segment.
• Autoinflammatory settings (CAPS/NOMID and related): competition includes IL-1β–targeting agents and other IL-1 axis therapies, with treatment choice guided by phenotype, speed of response requirements, and payer coverage.

Implication for development

• In RA and broader inflammatory indications, anakinra’s value proposition relies on patient selection (IL-1–high biology) and tolerability rather than broad-line displacement.
• In autoinflammatory disorders, switching and durability hinge on sustained symptom control and pediatric long-term outcomes, where IL-1 blockade is a core standard.

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What does the market look like for anakinra today?

A full market-sizing analysis requires current category revenue figures, unit sales, geography splits, and biosimilar/competitive pricing dynamics from an external market dataset. The prompt does not include those inputs, and producing exact numbers would be fabricated.

Market reality that is actionable for planning

• Anakinra demand is anchored by chronic indications, which reduces volatility but does not eliminate pricing pressure.
• Biosimilar penetration and payer protocols drive net price and share dynamics where patent protection has expired (timeline varies by geography and product lineage).
• Short-cycle flare therapies (where used off-protocol or in specific inflammatory syndromes) can fluctuate more, but the core autoinflammatory niche tends to be steadier.

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How should investors and R&D leaders project anakinra’s 3–7 year trajectory?

Given limited, non-provided numerical market inputs, the projection can only be expressed as a scenario framework tied to structural drivers rather than a numeric forecast.

1) Base-case drivers (most likely)

• Ongoing label maintenance and incremental clinical evidence supporting existing indications
• Steady underlying demand from chronic autoinflammatory use
• Pricing pressure from biosimilar competition in multiple markets

2) Upside drivers (value expansion)

• Demonstrated efficacy in additional IL-1–mediated phenotypes within immunology and rheumatology
• Better responder identification through biomarkers that supports payer adoption
• New pediatric expansions where long-term disease control improves adherence and reduces switching

3) Downside drivers (value erosion)

• Therapy substitution toward competing IL-1 axis agents in high-value niches
• Payer tightening (prior authorization, step therapy) as competitors gain evidence or rebates
• Safety or adherence issues that affect chronic uptake (commonly managed, but still a practical risk in injectable chronic regimens)

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What is the go-forward R&D strategy that matches the competitive and payer environment?

High-probability development themes

• Responder-enrichment trials: enroll patients with IL-1–driven biomarker patterns or clinical signatures.
• Head-to-head or pragmatic comparative studies against standard-of-care pathways where feasible.
• Pediatric endpoints and long-term safety with endpoints relevant to quality-of-life and growth/development monitoring.

Execution priorities

• Pair clinical endpoints with payer-relevant outcomes (flare reduction, durable response rates, avoidance of corticosteroid rescue where applicable).
• Use study designs that can withstand substitution pressure in RA-like settings.

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What patents and exclusivity dynamics matter for anakinra?

The prompt does not provide a patent list, jurisdictions, or the reference product for the claimed application set. An accurate patent runway analysis requires registry-level inputs (WO/EP/US families, patent numbers, grant/application status, and exclusivity extensions).

Without those inputs, any assertion about specific expiration dates, regulatory exclusivity, or litigation status would be non-actionable for decision-making.

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Key Takeaways

• Anakinra’s clinical and commercial profile is defined by chronic IL-1 blockade in autoinflammatory syndromes and a narrower role in broader inflammatory settings.
• A precise “latest clinical trials update” and a quantified market projection require registry-level and market-dataset inputs that are not provided in the prompt; generating exact updates or numbers would compromise accuracy.
• The most credible medium-term view is: steady demand with net price pressure, offset by incremental label expansions and patient selection strategies.

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FAQs

1. What is anakinra used for most commonly?
   It is used for IL-1–driven autoinflammatory and inflammatory conditions, with major commercial bases in rheumatoid arthritis and pediatric autoinflammatory syndromes depending on jurisdiction.

2. What drives anakinra demand: new patients or continuation?
   Demand is driven primarily by continuation in chronic indications, with smaller contributions from new starts in additional IL-1–mediated phenotypes.

3. Why does biosimilar competition matter for anakinra’s market outlook?
   Injectables face payer pricing pressure; biosimilar availability typically reduces net price and can shift share depending on formulary strategy.

4. What trial types are most likely for anakinra’s next approvals?
   Trials focused on indication expansion, pediatric cohorts, and responder-enrichment in IL-1–mediated populations.

5. How should companies evaluate anakinra’s strategic relevance for R&D?
   Use it as a benchmark for IL-1 biology in clinical development: identify where IL-1 signaling is dominant and where outcome endpoints align with payer decision criteria.

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References

[1] U.S. National Library of Medicine. ClinicalTrials.gov. (Database). https://clinicaltrials.gov/
[2] European Medicines Agency. EudraCT / European clinical trial records. (Database). https://www.ema.europa.eu/
[3] FDA. Kineret (anakinra) product information. https://www.accessdata.fda.gov/
[4] European Medicines Agency. Kineret (anakinra) EPAR. https://www.ema.europa.eu/