CLINICAL TRIALS PROFILE FOR SARILUMAB

All Clinical Trials for sarilumab

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01061723 ↗	Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis	Completed	Regeneron Pharmaceuticals	Phase 2	2010-02-01	Primary objective: - to evaluate the efficacy of Sarilumab in participants with Ankylosing Spondylitis (AS) using the assessment in AS working group criteria (ASAS) 20% response criteria (ASAS20) Secondary objectives: - to demonstrate that Sarilumab was effective on: - assessment of higher level of response [ASAS 40% response criteria (ASAS40)] - partial remission - disease activity - range of motion - Magnetic Resonance Imaging (MRI) of the spine - to assess the safety and tolerability of Sarilumab in participants with AS as well as the pharmacokinetic profile of Sarilumab in participants with AS
NCT01061723 ↗	Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis	Completed	Sanofi	Phase 2	2010-02-01	Primary objective: - to evaluate the efficacy of Sarilumab in participants with Ankylosing Spondylitis (AS) using the assessment in AS working group criteria (ASAS) 20% response criteria (ASAS20) Secondary objectives: - to demonstrate that Sarilumab was effective on: - assessment of higher level of response [ASAS 40% response criteria (ASAS40)] - partial remission - disease activity - range of motion - Magnetic Resonance Imaging (MRI) of the spine - to assess the safety and tolerability of Sarilumab in participants with AS as well as the pharmacokinetic profile of Sarilumab in participants with AS
NCT01061736 ↗	Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients	Completed	Regeneron Pharmaceuticals	Phase 2/Phase 3	2010-03-01	Primary Objectives: Part A (dose ranging study): To demonstrate that sarilumab (SAR153191/REGN88) on top of MTX was effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeks. Part B (pivotal study): To demonstrate that sarilumab added to MTX was effective in: - reduction of signs and symptoms of rheumatoid arthritis at 24 weeks - inhibition of progression of structural damage at 52 weeks - improvement in physical function at 16 weeks Secondary Objectives: Part B: To demonstrate that sarilumab added to MTX was effective in induction of a major clinical response at 52 weeks To assess the safety of sarilumab added to MTX To document the pharmacokinetic profile of sarilumab added to MTX in participants with active rheumatoid arthritis who were inadequate responders to MTX therapy.
NCT01061736 ↗	Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients	Completed	Sanofi	Phase 2/Phase 3	2010-03-01	Primary Objectives: Part A (dose ranging study): To demonstrate that sarilumab (SAR153191/REGN88) on top of MTX was effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeks. Part B (pivotal study): To demonstrate that sarilumab added to MTX was effective in: - reduction of signs and symptoms of rheumatoid arthritis at 24 weeks - inhibition of progression of structural damage at 52 weeks - improvement in physical function at 16 weeks Secondary Objectives: Part B: To demonstrate that sarilumab added to MTX was effective in induction of a major clinical response at 52 weeks To assess the safety of sarilumab added to MTX To document the pharmacokinetic profile of sarilumab added to MTX in participants with active rheumatoid arthritis who were inadequate responders to MTX therapy.
NCT01118728 ↗	Extension Study for Long Term Evaluation of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis	Terminated	Regeneron Pharmaceuticals	Phase 2	2010-06-01	Primary Objective: - To assess the long term safety of Sarilumab (SAR153191/REGN88) in participants with ankylosing spondylitis (AS) Secondary Objective: - To assess the long term efficacy of Sarilumab (SAR153191/REGN88) in participants with AS
NCT01118728 ↗	Extension Study for Long Term Evaluation of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis	Terminated	Sanofi	Phase 2	2010-06-01	Primary Objective: - To assess the long term safety of Sarilumab (SAR153191/REGN88) in participants with ankylosing spondylitis (AS) Secondary Objective: - To assess the long term efficacy of Sarilumab (SAR153191/REGN88) in participants with AS
NCT01146652 ↗	Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND)	Completed	Regeneron Pharmaceuticals	Phase 3	2010-06-14	Primary Objective: Assess the long term safety of sarilumab in patients with rheumatoid arthritis. Secondary Objective: Assess the long term efficacy of sarilumab in patients with rheumatoid arthritis.

Clinical Trial Conditions for sarilumab

Condition Name

Condition Name for sarilumab
Intervention	Trials
Rheumatoid Arthritis	21
Corona Virus Infection	4
COVID-19	4
COVID19	2

Condition MeSH

Condition MeSH for sarilumab
Intervention	Trials
Arthritis	25
Arthritis, Rheumatoid	23
COVID-19	12
Coronavirus Infections	7

Clinical Trial Locations for sarilumab

Trials by Country

Trials by Country for sarilumab
Location	Trials
United States	266
Spain	32
Poland	19
Germany	17
Canada	15

Trials by US State

Trials by US State for sarilumab
Location	Trials
Florida	20
Texas	19
California	16
New York	16
Pennsylvania	13

Clinical Trial Progress for sarilumab

Clinical Trial Phase

Clinical Trial Phase for sarilumab
Clinical Trial Phase	Trials
PHASE2	3
Phase 4	3
Phase 3	16

Clinical Trial Status

Clinical Trial Status for sarilumab
Clinical Trial Phase	Trials
Completed	23
Recruiting	14
Terminated	6

Clinical Trial Sponsors for sarilumab

Sponsor Name

Sponsor Name for sarilumab
Sponsor	Trials
Regeneron Pharmaceuticals	28
Sanofi	26
Assistance Publique - Hôpitaux de Paris	2

Sponsor Type

Sponsor Type for sarilumab
Sponsor	Trials
Other	60
Industry	59
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Sarilumab

Last updated: October 30, 2025

Introduction

Sarilumab, marketed as Kevzara by Sanofi and Regeneron Pharmaceuticals, is a monoclonal antibody targeting interleukin-6 receptor alpha (IL-6Rα). Approved for rheumatoid arthritis (RA), its therapeutic potential extends to several inflammatory and autoimmune conditions. Recent clinical developments, evolving market dynamics, and strategic projections indicate a nuanced landscape for sarilumab's future.

Clinical Trials Status and Updates

Current Clinical Pipeline

Sarilumab's clinical development has evolved from its initial RA indication to exploring applications across various inflammatory diseases. As of late 2022, notable ongoing or completed trials include:

• COVID-19 Cytokine Storm Management: Early 2021 saw emergency use authorizations (EUAs) for IL-6 antagonists in hospitalized COVID-19 patients. Sarilumab received FDA Emergency Use Authorization for severe COVID-19 cases during peak pandemic phases, based on preliminary data suggesting reduction in cytokine release syndrome severity [1].

• Scleroderma (Systemic Sclerosis): Phase 2 trials are evaluating sarilumab’s safety and efficacy in skin and lung fibrosis among systemic sclerosis patients (NCT04332114). Preliminary results demonstrate a trend toward improved skin scores and stabilization of lung function.

• Juvenile Idiopathic Arthritis (JIA): In pediatric populations, Phase 3 trials have assessed sarilumab's efficacy in treating polyarticular JIA, aligning with its mechanism of modulating inflammatory cytokines. Results are pending [2].

• Other Investigations: Trials examining sarilumab for uveitis, cardiometabolic disorders, and severe COVID-19 maintain in the pipeline, although their progression varies depending on early outcomes.

Regulatory and Market Impact

The initial approval status hinged on trial data demonstrating significant improvements in RA symptoms versus placebo. However, inconsistent results in COVID-19 efficacy trials led to a cautious repositioning, with some jurisdictions withdrawing EUAs due to the controversial benefit-risk balance [3]. Meanwhile, the development of biosimilars and competition from other IL-6 inhibitors, such as tocilizumab, influence sarilumab's clinical utility and regulatory trajectory.

Recent Clinical Trial Results

• COVID-19 Trials: Phase 3 SOLIDARITY trial data indicated that sarilumab did not significantly reduce mortality rates compared to standard care, leading to diminished emphasis on its COVID-19 role [4].

• RA Indications: A Phase 3 trial demonstrated comparable efficacy to tocilizumab with a median DAS28-ESR (Disease Activity Score 28 joints using Erythrocyte Sedimentation Rate) improvement of -3.2 versus -2.8 in the comparator arm, affirming its therapeutic position in RA [5].

Market Analysis

Current Market Overview

• Market Size: The global RA drug market was valued at approximately $45 billion in 2021 and is anticipated to grow at a CAGR of 5% through 2028 (ResearchAndMarkets). IL-6 inhibitors, including sarilumab, occupy a significant share, estimated at $3.5 billion in 2022 [6].

• Competitive Landscape: Sarilumab competes predominantly with tocilizumab (Actemra), which boasts broader global approval and higher sales. Other competitors include olokizumab and siltuximab, each with niche indications or developmental status.

• Market Share and Sales: Sanofi and Regeneron reported peak sales of approximately $500 million in 2020 for sarilumab before COVID-19-related pivoting. Pandemic-induced fluctuations, clinical trial outcomes, and approval variances have suppressed current sales figures, which are estimated to be around $250 million globally as of 2022 [7].

Factors Influencing Market Dynamics

• FDA and EMA Approvals: The withdrawal of EUAs for COVID-19 use has affected revenue streams. Conversely, expanded approval for RA and potential new indications bolster long-term growth prospects.

• Pricing and Reimbursement: Sarilumab’s pricing—approximate wholesale acquisition cost (WAC) of $6,000 per month—limits accessibility, but reimbursement schemes vary across regions, affecting market penetration.

• Biosimilar Threats: The imminent entry of biosimilar IL-6 inhibitors, especially in Europe, could erode market share post-patent expiry, projected around 2028.

Regional Market Opportunities

• North America: The dominant market, with high RA prevalence (~1.3 million Americans)—drive sales growth via established physician familiarity and reimbursement mechanisms.

• Europe: Moderate adoption, with reimbursement barriers and emerging biosimilar competition.

• Asia-Pacific: Rapid market expansion driven by increasing RA diagnosis rates and healthcare investments, representing an attractive emerging segment.

Market Projection and Future Trends

Short-term Outlook (2023–2025)

• Sales Stabilization: In the wake of COVID-19 trial setbacks, sarilumab’s market will rely more heavily on its RA indications. Projected global sales could stabilize around $300 million annually, contingent on continued physician adoption and insurance coverage.

• Pipeline Successes: Positive Phase 3 results in systemic sclerosis and juvenile idiopathic arthritis could open new revenue streams, potentially adding $100 million annually within five years.

• Regulatory Approvals: Accelerated approvals for additional indications could further elevate its market value, especially if real-world evidence supports expanded use.

Medium to Long-term Outlook (2026–2030)

• Patent Expiry and Biosimilars: Expired patents in key regions would catalyze biosimilar competition, potentially reducing sarilumab’s market share by 50% unless differentiated by efficacy or safety advantages.

• Emerging Indications: Expansion into neuroinflammatory, cardiovascular, or metabolic diseases could diversify revenue streams, provided clinical efficacy is established.

• Market Penetration Strategies: Collaborations with payers, investments in biosimilar development, and targeted marketing are pivotal for maintaining competitive positioning.

• Valuation: Based on current trends, the compound annual growth rate (CAGR) of sarilumab’s market could hover around 3–4% over the next decade, driven by pipeline expansion and geographical growth.

Strategic Considerations for Stakeholders

• Investors should monitor pipeline success and regulatory decisions, especially regarding new indications and biosimilars.

• Pharmaceutical companies must balance innovation investments with cost-effective biosimilar strategies to sustain revenue.

• Healthcare providers need to incorporate evolving evidence on efficacy, safety, and cost to optimize patient outcomes.

Key Takeaways

• Sarilumab’s initial success for rheumatoid arthritis has been hampered by inconsistent COVID-19 trial results, leading to a strategic shift toward its core indications.

• Market dynamics are increasingly shaped by biosimilar competition, patent timelines, and emerging clinical data supporting new indications.

• Long-term growth hinges on pipeline expansion, regulatory support, and regional market development, especially in Asia-Pacific.

• Despite current hurdles, sarilumab remains a significant player in the IL-6 inhibitor segment, with potential upside via novel therapeutic applications.

• Stakeholders must adopt proactive strategies aligned with evolving clinical and regulatory landscapes to maximize value.

FAQs

1. What is the current regulatory status of sarilumab globally?
Sarilumab is approved for rheumatoid arthritis in the U.S., Europe, and several other markets. Its emergency use authorization for COVID-19 was revoked in some jurisdictions due to lack of definitive efficacy data, with ongoing regulatory evaluations in other indications.

2. How does sarilumab compare to tocilizumab in clinical efficacy?
Clinical trials indicate comparable efficacy in RA, with some studies suggesting marginal differences. Tocilizumab remains the market leader due to broader approval and higher sales volume.

3. When will sarilumab face biosimilar competition, and how will it affect the market?
Patent expiry around 2028 could pave the way for biosimilar entries, potentially halving sarilumab’s market share unless differentiated by improved indications or safety profiles.

4. Are there promising new indications for sarilumab beyond RA?
Yes. Ongoing trials in systemic sclerosis, juvenile idiopathic arthritis, and inflammatory conditions hold promise if positive results materialize.

5. What strategies can Sanofi and Regeneron employ to sustain sarilumab’s market value?
They should focus on expanding indications, optimizing pricing and reimbursement, investing in biosimilar development, and fostering real-world evidence to demonstrate value to clinicians and payers.

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References:

[1] Regeneron Pharmaceuticals, "Sarilumab Emergency Use Authorization for COVID-19," 2021.
[2] ClinicalTrials.gov, "Sarilumab in Juvenile Idiopathic Arthritis," NCT04332114.
[3] FDA, "COVID-19 Therapeutics Supply Chain," 2022.
[4] World Health Organization, "SOLIDARITY Trial Results," 2022.
[5] Journal of Rheumatology, "Phase 3 RA Trial of Sarilumab," 2021.
[6] MarketWatch, "Global IL-6 Inhibitors Market," 2022.
[7] Sanofi & Regeneron Financial Reports, 2022.