CLINICAL TRIALS PROFILE FOR DUPILUMAB

All Clinical Trials for dupilumab

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01312961 ↗	Efficacy, Safety, and Tolerability of Dupilumab in Patients With Persistent Moderate to Severe Eosinophilic Asthma	Completed	Regeneron Pharmaceuticals	Phase 2	2011-03-01	Primary Objective: To investigate the effects of Dupilumab (SAR231893/REGN668) administered subcutaneously (SC) once weekly (qw) for 12 weeks as compared to placebo on reducing the incidence of asthma exacerbation in participants with persistent moderate to severe eosinophilic asthma. Secondary Objectives: - To assess the safety and tolerability of Dupilumab administered SC qw for 12 weeks in participants with persistent moderate to severe eosinophilic asthma. - To assess Dupilumab serum concentrations following qw SC dosing for 12 weeks in participants with persistent moderate to severe eosinophilic asthma.
NCT01312961 ↗	Efficacy, Safety, and Tolerability of Dupilumab in Patients With Persistent Moderate to Severe Eosinophilic Asthma	Completed	Sanofi	Phase 2	2011-03-01	Primary Objective: To investigate the effects of Dupilumab (SAR231893/REGN668) administered subcutaneously (SC) once weekly (qw) for 12 weeks as compared to placebo on reducing the incidence of asthma exacerbation in participants with persistent moderate to severe eosinophilic asthma. Secondary Objectives: - To assess the safety and tolerability of Dupilumab administered SC qw for 12 weeks in participants with persistent moderate to severe eosinophilic asthma. - To assess Dupilumab serum concentrations following qw SC dosing for 12 weeks in participants with persistent moderate to severe eosinophilic asthma.
NCT01385657 ↗	Safety and Tolerability of Dupilumab in Participants With Moderate to Severe Atopic Dermatitis	Completed	Sanofi	Phase 1	2011-07-31	The purpose of this study is to assess the safety and tolerability of repeated subcutaneous (SC) doses of Dupilumab in participants with moderate-to-severe atopic dermatitis (AD).
NCT01385657 ↗	Safety and Tolerability of Dupilumab in Participants With Moderate to Severe Atopic Dermatitis	Completed	Regeneron Pharmaceuticals	Phase 1	2011-07-31	The purpose of this study is to assess the safety and tolerability of repeated subcutaneous (SC) doses of Dupilumab in participants with moderate-to-severe atopic dermatitis (AD).
NCT01548404 ↗	Study of Dupilumab in Adult Patients With Extrinsic Moderate-to-Severe Atopic Dermatitis	Completed	Sanofi	Phase 2	2012-04-01	The primary objective was to assess the clinical efficacy of repeated subcutaneous (SC) doses of Dupilumab in adult participants with moderate-to-severe atopic dermatitis (AD).
NCT01548404 ↗	Study of Dupilumab in Adult Patients With Extrinsic Moderate-to-Severe Atopic Dermatitis	Completed	Regeneron Pharmaceuticals	Phase 2	2012-04-01	The primary objective was to assess the clinical efficacy of repeated subcutaneous (SC) doses of Dupilumab in adult participants with moderate-to-severe atopic dermatitis (AD).
NCT01639040 ↗	Study to Assess the Safety of Dupilumab (REGN668/SAR231893) Administered Concomitantly With Topical Corticosteroids (TCS) in Patients With Moderate-to-severe Atopic Dermatitis (AD)	Completed	Sanofi	Phase 2	2012-07-01	The purpose of this study was to assess the safety of Dupilumab administered concomitantly with topical corticosteroids (TCS) in patients with moderate-to-severe atopic dermatitis (AD).

Clinical Trial Conditions for dupilumab

Condition Name

Condition Name for dupilumab
Intervention	Trials
Atopic Dermatitis	51
Asthma	25
Chronic Rhinosinusitis With Nasal Polyps	9
Dermatitis, Atopic	9

Condition MeSH

Condition MeSH for dupilumab
Intervention	Trials
Dermatitis, Atopic	69
Dermatitis	60
Eczema	55
Asthma	30

Clinical Trial Locations for dupilumab

Trials by Country

Trials by Country for dupilumab
Location	Trials
Canada	147
Japan	126
Poland	100
Germany	100
United Kingdom	82

Trials by US State

Trials by US State for dupilumab
Location	Trials
California	70
Florida	55
New York	52
Texas	52
Pennsylvania	44

Clinical Trial Progress for dupilumab

Clinical Trial Phase

Clinical Trial Phase for dupilumab
Clinical Trial Phase	Trials
PHASE4	15
PHASE3	9
PHASE2	5

Clinical Trial Status

Clinical Trial Status for dupilumab
Clinical Trial Phase	Trials
Recruiting	76
Completed	45
Not yet recruiting	32

Clinical Trial Sponsors for dupilumab

Sponsor Name

Sponsor Name for dupilumab
Sponsor	Trials
Regeneron Pharmaceuticals	109
Sanofi	92
National Institute of Allergy and Infectious Diseases (NIAID)	8

Sponsor Type

Sponsor Type for dupilumab
Sponsor	Trials
Industry	229
Other	106
NIH	11

Dupilumab: Clinical Trial Update, Market Analysis and Forecast

Last updated: February 20, 2026

What is the current status of clinical trials for dupilumab?

Dupilumab (brand name Dupixent) has completed multiple phases of clinical development, demonstrating efficacy in multiple indications including atopic dermatitis, asthma, and nasal polyposis. As of November 2022, the drug is approved for these indications in over 70 countries.

The drug's clinical program includes over 90 trials registered on ClinicalTrials.gov, with ongoing studies exploring asthma exacerbation, pediatric atopic dermatitis, and chronic rhinosinusitis with nasal polyps. Key late-stage trials include:

• Liberty AD, 52-week Phase 3 trial for atopic dermatitis (NCT03580395): Confirmed long-term safety and efficacy in adolescents and adults.
• Liberty NP, Phase 3 trial for nasal polyps (NCT02912468): Established superiority over placebo in reducing nasal congestion.
• Liberty AT, Phase 3 pediatric trials (NCT03780786): Ongoing to assess efficacy and safety in children aged 6 months to 5 years.

In 2021, the FDA approved dupilumab for children aged 6–11, extending the age range from the original 12 and older.

What are the recent developments in market competition?

Dupilumab is the first biologic to target IL-4 and IL-13 pathways, offering a novel mechanism for inflammatory diseases. Key competitors include:

• Lebrikizumab (Genentech): IL-13 inhibitor in late-stage trials for atopic dermatitis and asthma.
• Tralokinumab (Eli Lilly): Approved for atopic dermatitis in the US since 2021; blocks IL-13.
• KPI-404 (Kiniksa): under investigation for atopic dermatitis and asthma, targeting Th2 pathways more broadly.

Despite competition, dupilumab holds a dominant position in the market with a 45% share of biologics for atopic dermatitis globally, driven by its approval in multiple indications and extensive clinical evidence.

How is the market performing globally?

As of 2022, the dupilumab market was valued at approximately USD 6.6 billion, with projections to reach USD 13.3 billion by 2027, expanding at a compound annual growth rate (CAGR) of over 15%. Growth drivers include:

• Broadening indications, including pediatric populations.
• Increased awareness and diagnosis of atopic conditions.
• Continued expansion into emerging markets like China, Brazil, and India.

Geographically:

• North America dominates, accounting for over 60% of sales.
• Europe remains the second-largest market with steady growth.
• Asia-Pacific displays high growth potential, driven by population size and rising healthcare infrastructure.

Market access varies:

• In the US and EU, insurance coverage and reimbursement policies favor biologic adoption.
• Price points range from USD 37,000 to USD 40,000 annually per patient.

What are the future projection scenarios?

The future market landscape for dupilumab depends on several factors:

• Indication expansion: Positive phase 3 results for pediatric atopic dermatitis and other inflammatory conditions could increase eligible patient populations by 50-70%.
• Pricing and reimbursement: Cost adjustments in emerging markets may influence penetration and adoption rates.
• Competitive pipeline: Entry of new IL-13 or IL-4/13 inhibitors could pressure prices and market share.
• Regulatory approvals: Emergency authorization or accelerated approval pathways could accelerate access in underserved regions.

Based on current trends, the following projections are reasonable:

Year	Global Market Size (USD Billion)	CAGR	Major Growth Drivers
2023	7.0	-	Ongoing expansions, new approvals
2025	9.5	17.6%	Indication expansion, market penetration increase
2027	13.3	14.5%	Pipeline success, cost reductions

Key takeaways

• Dupilumab remains a leader in biologic treatments for inflammatory diseases, with ongoing clinical trials extending its scope.
• The global market is expanding rapidly, reaching over USD 6.6 billion in 2022.
• Competition from IL-13 inhibitors and broader Th2 pathway drugs is intensifying but has yet to diminish dupilumab’s market share significantly.
• Future growth depends on regulatory progress, indication expansion, and market access strategies, especially in emerging economies.

FAQs

1. Will dupilumab's approval expand to new indications?
Yes. Trials for asthma exacerbations, chronic rhinosinusitis, and pediatric atopic dermatitis are ongoing, which may lead to additional approvals.

2. How does dupilumab compare cost-wise to competitors?
Prices range from USD 37,000 to USD 40,000 annually per patient; competitors like lebrikizumab and tralokinumab are similarly priced but lack the extensive indication portfolio.

3. What are the major barriers to market growth?
High costs, reimbursement policies, competition from emerging IL-13 inhibitors, and regional market access limitations.

4. Which regions present the highest growth potential?
Asia-Pacific and Latin America due to population size, increasing healthcare infrastructure, and expanding insurance coverage.

5. How might pipeline failures affect dupilumab's market position?
Failure in key trials could reduce market share, especially if competitors gain approval for similar indications.

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References

[1] ClinicalTrials.gov. (2022). Dupilumab Clinical Trials. Retrieved from https://clinicaltrials.gov/

[2] GlobalData Healthcare. (2022). Dupilumab Market Analysis.

[3] U.S. Food and Drug Administration. (2017). Dupixent Approval Letter.

[4] IQVIA. (2022). Biologic Market Report.

[5] Evaluate Pharma. (2022). 2022 Biologics Market Outlook.