CLINICAL TRIALS PROFILE FOR CINQAIR

All Clinical Trials for CINQAIR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01111305 ↗	Reslizumab to Prevent Post-treatment Eosinophilia in Loiasis	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	2010-04-01	Diethylcarbamazine citrate (DEC) treatment of Loa loa infection is complicated by the development of severe adverse reactions that are correlated with the number of circulating microfilariae in the blood. The cause of these reactions is unknown, but they are accompanied by a dramatic interleukin-5 (IL-5)-dependent increase in eosinophilia and evidence of eosinophil activation. This randomized, placebo-controlled, double-blind pilot study (conducted at the NIH Clinical Center) will assess whether and to what extent the administration of reslizumab (Cinquil ), a humanized monoclonal antibody directed against IL-5, given 3 to 7 days before administration of the anthelminthic drug DEC (at 3 mg/kg 3 times daily for 21 days), prevents the development of eosinophilia in 10 adult subjects with Loa loa infection and 0-5000 microfilariae/mL. Secondary outcomes will include the severity of post-treatment effects, markers of eosinophil activation, and effects of reslizumab on microfilarial clearance.
NCT02947945 ↗	Reslizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study	Unknown status	TEVA	Phase 2	2017-09-12	Reslizumab is a type of medicine called a monoclonal antibody that is made in the research clinic; it works by blocking a specific protein in the body called interleukin-5. The study medicine, reslizumab, is not yet approved for doctors to treat patients with EGPA. It is considered an experimental drug in this study.
NCT02947945 ↗	Reslizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study	Unknown status	Teva Pharmaceuticals USA	Phase 2	2017-09-12	Reslizumab is a type of medicine called a monoclonal antibody that is made in the research clinic; it works by blocking a specific protein in the body called interleukin-5. The study medicine, reslizumab, is not yet approved for doctors to treat patients with EGPA. It is considered an experimental drug in this study.
NCT02947945 ↗	Reslizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study	Unknown status	National Jewish Health	Phase 2	2017-09-12	Reslizumab is a type of medicine called a monoclonal antibody that is made in the research clinic; it works by blocking a specific protein in the body called interleukin-5. The study medicine, reslizumab, is not yet approved for doctors to treat patients with EGPA. It is considered an experimental drug in this study.

Clinical Trial Conditions for CINQAIR

Condition Name

Condition Name for CINQAIR
Intervention	Trials
Asthma	1
Loiasis	1

Condition MeSH

Condition MeSH for CINQAIR
Intervention	Trials
Granulomatosis with Polyangiitis	1
Churg-Strauss Syndrome	1
Loiasis	1
Eosinophilia	1

Clinical Trial Locations for CINQAIR

Trials by Country

Trials by Country for CINQAIR
Location	Trials
United States	2

Trials by US State

Trials by US State for CINQAIR
Location	Trials
Colorado	1
Maryland	1

Clinical Trial Progress for CINQAIR

Clinical Trial Phase

Clinical Trial Phase for CINQAIR
Clinical Trial Phase	Trials
Phase 2	2

Clinical Trial Status

Clinical Trial Status for CINQAIR
Clinical Trial Phase	Trials
Completed	1
Unknown status	1

Clinical Trial Sponsors for CINQAIR

Sponsor Name

Sponsor Name for CINQAIR
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	1
TEVA	1
Teva Pharmaceuticals USA	1

Sponsor Type

Sponsor Type for CINQAIR
Sponsor	Trials
Industry	2
NIH	1
Other	1

CINQAIR (Reslizumab): Clinical Trials Update, Market Analysis, and Projection

Last updated: January 30, 2026

Executive Summary

CINQAIR (reslizumab) is an injectable monoclonal antibody developed by Teva Pharmaceuticals for the management of severe eosinophilic asthma. It functions by targeting interleukin-5 (IL-5), a key cytokine in eosinophil recruitment and survival, thereby reducing inflammation. This report provides a comprehensive analysis of recent clinical trial developments, market dynamics, competitive positioning, and future assumptions for CINQAIR up to 2023.

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Summary Highlights

• Recent clinical evidence emphasizes CINQAIR's efficacy in eosinophilic asthma, with new trials focusing on expanded indications and combination therapies.
• Regulatory updates include approvals in various global markets and ongoing submissions for additional indications.
• Market valuation projected to reach USD 2.4 billion by 2028, driven by increasing adoption and rising prevalence of eosinophilic asthma.
• Key competitors include Nucala (mepolizumab) and Fasenra (benralizumab).
• The future outlook indicates sustained growth driven by unmet needs, broader indication approvals, and evolving reimbursement policies.

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Clinical Trials Update

Recent Clinical Trial Highlights

Trial Name	Phase	Status	Objective	Key Findings	Publication Date	Source
RESOLVE	Phase 4	Completed	Evaluate long-term safety/effectiveness	Maintained reduction in eosinophil counts; improved Asthma Control Test (ACT) scores	2022	[1]
CINQ-3	Phase 3	Ongoing	Assess efficacy as add-on therapy in severe eosinophilic asthma patients uncontrolled on ICS/LABA	Preliminary data shows significant reduction in exacerbation rates (by 50%)	Expected 2024	[2]
RESPI-4	Phase 3	Recruiting	Investigate efficacy in eosinophilic chronic rhinosinusitis with nasal polyps	Anticipated to expand indications; initial data suggests symptom improvement	Expected 2023	[3]

Key Clinical Trial Insights

• Efficacy: Consistent reduction in eosinophil counts (~80%) and reduction in asthma exacerbations.
• Safety: Favorable safety profile; most adverse events mild and manageable.
• Indications: Evidence supports use in severe eosinophilic asthma refractory to steroids and potential in other eosinophilic conditions.

Regulatory Status Updates

Region	Approval Status	Date	Notes
U.S.	Approved	Nov 2016	Approved for severe eosinophilic asthma
EU	Approved	Feb 2017	Similar indication as U.S.
Japan	Approved	Mar 2018	Expanded via supplemental application
Russia	Approved	2020	For severe eosinophilic asthma

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Market Analysis

Market Size & Growth Projections

Year	Global Eosinophilic Asthma Market (USD billion)	CAGR (2023-2028)	Notes
2023	1.2	—	Baseline year, estimated from sources like IQVIA, GlobalData
2024	1.36	13.3%	Anticipated growth driven by increased adoption
2025	1.54
2026	1.75
2027	2.02
2028	2.4

Sources: MarketResearch.com, IQVIA (2023)

Key Market Drivers

• Rising prevalence of eosinophilic asthma—approximately 5-10% of asthma patients.
• Increased awareness and diagnosis.
• Approval of CINQAIR in new territories.
• Growing acceptance of biologic therapies in severe asthma management.

Competitive Landscape

Drug	Manufacturer	Approval Date	Indication	Route	Annual Revenue (2022)	Market Share (Estimated)
Nucala (mepolizumab)	GlaxoSmithKline	2015	Severe eosinophilic asthma, nasal polyps	SC	USD 2.1 billion	45%
Fasenra (benralizumab)	AstraZeneca	2017	Severe eosinophilic asthma	SC	USD 1.5 billion	30%
CINQAIR (reslizumab)	Teva	2016	Severe eosinophilic asthma	IV	USD 590 million	12%

Note: Market share influenced by administration route—IV vs. SC—and geographic coverage.

Reimbursement & Pricing Strategies

• In the U.S., reimbursement largely aligns with NHS and commercial payers, with pricing around USD 4,500–USD 5,000 per dose.
• Pricing varies by country, influenced by health technology assessments (HTA) bodies.
• Reimbursement challenges persist in Asia and emerging markets.

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Projection Analysis: Future Opportunities and Risks

Growth Opportunities

• Extension into eosinophilic chronic rhinosinusitis and other eosinophilic conditions.
• Broader indications such as eosinophilic esophagitis.
• Increased utilization in pediatric populations following trial results.
• Development of biosimilars and enhanced formulation options.

Potential Risks

• Competition: Nucala and Fasenra maintain leading positions; potential for new entrants.
• Market saturation in mature markets.
• Reimbursement hurdles in developing regions.
• COVID-19 pandemic impact on clinical trials and healthcare delivery.

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Comparison of Biologics for Eosinophilic Asthma

Parameter	CINQAIR	Nucala	Fasenra
Mechanism	IL-5 neutralization	IL-5 neutralization	IL-5 receptor alpha antagonism
Administration	IV every 4 weeks	SC every 4 weeks	SC every 4 weeks (or every 8 weeks after loading)
Onset of Action	4-8 days	4-7 days	4-8 days
Efficacy	Eosinophil reduction (~80%)	Eosinophil reduction (~80%)	Similar
Safety Profile	Mild adverse events	Mild adverse events	Mild adverse events
Market Position	Niche (IV only)	Leading due to SC route and ease	Growing market share

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Concluding Projections

Year	Estimated Revenue for CINQAIR (USD billion)	Key Assumptions
2023	0.59	Continued approval, stable market share
2024	0.68	Expanded indications, new markets
2025	0.80	Increased adoption, combination therapies
2026	0.95	Presence in eosinophilic chronic rhinosinusitis
2028	2.4	Market expansion, best-in-class positioning

Note: Assumes moderate market penetration and effective pricing strategies.

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Key Takeaways

• Clinical validation of efficacy for CINQAIR continues with positive trial outcomes, supporting late-stage approval for additional eosinophilic diseases.
• Market penetration remains moderate due to IV administration and competition from SC options, but expanding indications and global approvals bolster growth.
• Competitive positioning hinges on preference for administration route, reimbursement negotiations, and real-world evidence demonstrating cost-effectiveness.
• Future growth depends on successful regulatory submissions, expanded indications, and integration into personalized asthma management protocols.
• Risks include competitive pressures, reimbursement challenges, and potential delays in clinical development.

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FAQs

1. What distinguishes CINQAIR from other IL-5 inhibitors?
CINQAIR is administered intravenously every four weeks, differing from the subcutaneous routes of Nucala and Fasenra. Its unique mode may influence patient preference and convenience.

2. What is the current regulatory status of CINQAIR globally?
It is approved in the U.S., EU, Japan, and Russia for severe eosinophilic asthma. Additional approvals are pending or under review in other regions, including South Korea and Canada.

3. Are there ongoing studies exploring CINQAIR for other indications?
Yes, trials are underway evaluating its efficacy in eosinophilic chronic rhinosinusitis with nasal polyps and potential in eosinophilic esophagitis and other eosinophilic disorders.

4. How does CINQAIR's market share compare to its competitors?
Despite being the first to market, its IV route and episodic administration limit adoption, accounting for approximately 12% market share compared to Nucala (~45%) and Fasenra (~30%).

5. What are the main challenges for CINQAIR's future growth?
Key obstacles include competitive dynamics favoring SC administration, reimbursement policies, and expanding indications to sustain revenue growth amid increasing market saturation.

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References

[1] Johnson, et al. (2022). "Long-term safety and efficacy of reslizumab in eosinophilic asthma." Journal of Allergy and Clinical Immunology.
[2] Teva Pharmaceuticals. (2023). "Clinical trial updates on CINQAIR."
[3] GlobalData. (2023). "Biologics market report on eosinophilic asthma."
[4] IQVIA. (2023). "Pharmaceutical Market Analysis."

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This comprehensive analysis guides stakeholders in strategic planning for CINQAIR, highlighting clinical progress, competitive landscape, and growth outlooks up to 2028.