CLINICAL TRIALS PROFILE FOR XOLAIR

Biosimilar Clinical Trials for XOLAIR

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05053334 ↗	Biosimilar Study Comparing PK, PD, Safety and Immunogencity of BP11 With US Licensed Xolair and EU Approved Xolair	Not yet recruiting	CuraTeQ Biologics Private Ltd.	Phase 1	2021-11-01	A single dose, double blind comparative trial to assess the pharmacokinetics, pharmacodynamics, safety and immunogenicity of 3 different products (BP11, US-Xolair and EU-Xolair) containing 150mg of Omalizumab as subcutaneous injection in healthy male volunteers.
NCT05053334 ↗	Biosimilar Study Comparing PK, PD, Safety and Immunogencity of BP11 With US Licensed Xolair and EU Approved Xolair	Not yet recruiting	Syneos Health	Phase 1	2021-11-01	A single dose, double blind comparative trial to assess the pharmacokinetics, pharmacodynamics, safety and immunogenicity of 3 different products (BP11, US-Xolair and EU-Xolair) containing 150mg of Omalizumab as subcutaneous injection in healthy male volunteers.

All Clinical Trials for XOLAIR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00084097 ↗	Omalizumab to Treat Eosinophilic Gastroenteritis	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	2004-06-02	This study will evaluate the safety and usefulness of omalizumab (anti-IgE, Xolair) in reducing eosinophil counts and improving symptoms in patients with eosinophilic gastroenteritis (EG). EG is a disorder of unknown cause in which eosinophils, a type of white blood cell, are increased in the blood and gut tissue. Patients with EG have symptoms like stomach pain, bloating, and vomiting. About 50 percent of EG patients have food or environmental allergies, which may play a role in EG. Some patients with EG improve significantly on diets avoiding foods to which they are allergic. Immunoglobulin E (IgE) is an antibody that plays an important role in initiating allergic reactions. Omalizumab is a monoclonal antibody directed against IgE. The Food and Drug Administration approved omalizumab in 2003 for treating patients 12 years of age and older with allergic asthma. Patients between 12 and 76 years of age with eosinophilic gastroenteritis who have a blood eosinophil count of 500 or more and who have a food allergy or allergy to an inhaled allergen may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood and urine tests. Participants undergo the following procedures: - Leukapheresis. This procedure is done to collect quantities of white blood cells to study the effects of omalizumab on eosinophils and other immune substances. Blood flows from a needle placed in an arm vein through a catheter (plastic tube) into a machine that separates the blood into its components by centrifugation (spinning). Some of the white cells are removed and the rest of the blood (red cells, plasma and platelets) is returned to the body through a needle in the other arm. - Skin testing. Participants are tested for allergies to specific substances. A small amount of various allergens (substances that cause allergies) are placed on the subject's arm. The skin is pricked at the sites of the allergens and the skin reaction after several minutes is observed. - Upper and lower endoscopy. One or both of these procedures is done, depending on the part of the gastrointestinal tract that is involved, to examine the tract. If both procedures are done, they are performed at the same time. For the upper endoscopy, the subject's throat is sprayed with a numbing medicine and a long, flexible tube is passed through the esophagus, stomach and small intestine. For the lower endoscopy, the tube is passed through the rectum into t...
NCT00086606 ↗	A Safety and Efficacy Study of Xolair in Peanut Allergy	Terminated	Genentech, Inc.	Phase 2	2004-06-01	This is a 38-week, randomized, double-blind, placebo-controlled, parallel group trial of approximately 150 patients who have a history of immediate hypersensitivity reaction to peanut protein.
NCT00096954 ↗	A Prospective, Randomized, Double-Blind Study of the Efficacy of Omalizumab (Xolair) in Atopic Asthmatics With Good Lung Capacity Who Remain Difficult to Treat (EXACT)	Completed	Genentech, Inc.	Phase 4	2006-02-01	This was a multicenter, parallel-group, double-blind, randomized, placebo-controlled study that enrolled 333 subjects. These subjects were 12-75 years old with atopic asthma, had elevated serum total Immunoglobulin E (IgE), had a baseline forced expiratory volume in 1 second (FEV1) ≥ 80% predicted, and were on inhaled corticosteroids with or without other controller asthma medications (e.g., long-acting β2-agonists [LABAs], leukotriene receptor antagonist [LTRA], or immunotherapy).
NCT00109187 ↗	An Extension Study of Xolair in Moderate to Severe, Persistent Asthma Patients Who Completed Study Q2143g	Completed	Genentech, Inc.	Phase 3	2002-06-01	This is a Phase IIIb, multicenter, open-label, extension study available to subjects who successfully complete Study Q2143g and have not participated in Study Q2195g. Subjects should be registered via the IVRS (Interactive Voice Response System) within 48 hours prior to their baseline visit. All subjects in this study will be treated with Xolair for 24 weeks. Subjects in the New Treatment Group may require additional visits for study drug injections (as frequently as every 2 weeks). Data collection during these additional visits will be limited to the assessment of adverse events. The study will evaluate all serious and nonserious adverse events, laboratory assessments, data on asthma exacerbations, and concomitant medication usage.
NCT00109200 ↗	A Continued Access Protocol to Provide Xolair to Patients With Severe Allergic Asthma	Completed	Genentech, Inc.	Phase 3	2003-05-01	This is a continued access protocol to provide subjects who have completed Genentech, Inc. Study Q2143g, Q2195g, or Q2461g or Novartis Pharmaceuticals Corporation Study CIGE025 0010E1 with continued Xolair treatment. Subject eligibility will be based on disease severity and asthma deterioration upon withdrawal of Xolair treatment. Subjects whose last Xolair dose was
NCT00117611 ↗	Xolair in Patients With Chronic Sinusitis	Completed	Genentech, Inc.	Phase 4	2005-07-01	The purpose of this study is to determine if treatment with the anti-IgE antibody, Xolair (omalizumab), will improve objective and subjective evidence of chronic sinusitis.
NCT00117611 ↗	Xolair in Patients With Chronic Sinusitis	Completed	Novartis Pharmaceuticals	Phase 4	2005-07-01	The purpose of this study is to determine if treatment with the anti-IgE antibody, Xolair (omalizumab), will improve objective and subjective evidence of chronic sinusitis.

Clinical Trial Conditions for XOLAIR

Condition Name

Condition Name for XOLAIR
Intervention	Trials
Asthma	29
Food Allergy	9
Chronic Idiopathic Urticaria	8
Peanut Allergy	6

Condition MeSH

Condition MeSH for XOLAIR
Intervention	Trials
Asthma	34
Urticaria	19
Chronic Urticaria	16
Hypersensitivity	14

Clinical Trial Locations for XOLAIR

Trials by Country

Trials by Country for XOLAIR
Location	Trials
United States	353
China	31
Ukraine	19
Canada	16
Germany	14

Trials by US State

Trials by US State for XOLAIR
Location	Trials
California	25
Maryland	22
New York	16
Colorado	14
Texas	13

Clinical Trial Progress for XOLAIR

Clinical Trial Phase

Clinical Trial Phase for XOLAIR
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
Phase 4	38

Clinical Trial Status

Clinical Trial Status for XOLAIR
Clinical Trial Phase	Trials
Completed	74
Not yet recruiting	8
Recruiting	8

Clinical Trial Sponsors for XOLAIR

Sponsor Name

Sponsor Name for XOLAIR
Sponsor	Trials
Genentech, Inc.	35
Novartis Pharmaceuticals	17
Novartis	14

Sponsor Type

Sponsor Type for XOLAIR
Sponsor	Trials
Other	95
Industry	82
NIH	16

Clinical Trials Update, Market Analysis, and Projection for XOLAIR (Omalizumab)

Last updated: October 28, 2025

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Introduction

XOLAIR (omalizumab) is a biologic therapy developed by Novartis and currently marketed by AstraZeneca and Genentech. It is a monoclonal antibody designed to target immunoglobulin E (IgE), thereby modulating allergic responses. Approved initially for severe asthma and chronic spontaneous urticaria, XOLAIR holds a significant position within the allergy and immunology therapeutic landscape. This report provides a comprehensive update on clinical trials, evaluates market dynamics, and projects future growth prospects for XOLAIR, offering insights for stakeholders in the pharmaceutical and healthcare sectors.

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Clinical Trials Update

Ongoing and Recent Clinical Trials

XOLAIR has been subject to extensive clinical evaluation beyond its initial indications. The latest trials focus on expanding its therapeutic utility and optimizing existing applications:

• Asthma Population Expansion: Several phase III trials are investigating XOLAIR’s efficacy in adolescents and elderly populations with difficult-to-control severe allergic asthma. For instance, the VIRGIN trial (NCT02937150) demonstrated sustained efficacy and safety in adolescents aged 12-17, supporting label expansion.

• Chronic Spontaneous Urticaria (CSU): Ongoing phase IV studies assess long-term safety and real-world effectiveness in CSU. The LIBERTY trial program by AstraZeneca explores its use in diverse patient demographics, with recent interim data indicating sustained symptom control.

• Food Allergy and Comorbidities: Novartis initiated early-phase studies (NCT04581259) for potential applications in peanut allergy, leveraging omalizumab’s role in immune regulation. Similarly, trials are evaluating its utility in atopic dermatitis and chronic rhinosinusitis with nasal polyps.

Key Clinical Findings

• Efficacy: Multiple trials reinforce XOLAIR’s ability to reduce exacerbation rates, improve quality of life, and lower corticosteroid dependence in severe asthma and CSU patients.

• Safety Profile: The drug demonstrates a well-established safety margin with adverse events mostly limited to mild injection site reactions, headache, and upper respiratory symptoms. Recent real-world data (post-marketing surveillance) continue to corroborate its safety.

• Regulatory Advances: The European Medicines Agency (EMA) has extended approvals for pediatric asthma, while U.S. FDA reviews of supplemental indications are pending, with key data supporting expanded use.

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Market Analysis

Current Market Landscape

XOLAIR is a pioneer biologic in the anti-IgE class, commanding a substantial share in allergy and asthma therapies. As of 2023, the global market for anti-IgE therapies is valued at approximately $3.5 billion, with XOLAIR comprising an estimated 50-55% share[1].

• Therapeutic Indications:

  • Severe allergic asthma
  • Chronic spontaneous urticaria
  • Off-label and expanded indications are gradually increasing due to ongoing clinical research

• Key Competitors:

  • Vectibix (benralizumab): An anti-IL-5 receptor
  • Fasenra (benralizumab): Also targeting eosinophilic asthma
  • Dupixent (dupilumab): Targeting IL-4 receptor for atopic dermatitis and asthma

Although biologics targeting different pathways compete in overlapping indications, XOLAIR maintains competitiveness due to its established efficacy, longer market presence, and broad approval profile.

Market Drivers

• Growing Prevalence: The global prevalence of allergic asthma and CSU is increasing, driven by urbanization, environmental factors, and improved diagnostics.

• Unmet Medical Needs: Patients with severe disease refractory to steroids and conventional therapies represent a persistent demand, positioning biologics like XOLAIR as essential options.

• Regulatory Approvals: Dynamic approvals for pediatric and newly emerging indications bolster market penetration.

Market Challenges

• Pricing and Reimbursement: Biologics remain high-cost therapies, facing pricing pressures and variable reimbursement policies across regions[2].

• Biologic Competition: Emerging therapies with differing mechanisms of action threaten to erode XOLAIR’s market share.

• Convenience and Administration: Subcutaneous injections require healthcare setting visits, motivating the development of self-administration or alternative delivery modes.

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Market Projection

Forecast Overview (2023-2033)

The global XOLAIR market is poised to grow at a compound annual growth rate (CAGR) of approximately 6-8% over the next decade, reaching an estimated valuation of $5-6 billion by 2033[3].

Growth Drivers

• Indication Expansion: Regulatory approval for additional indications, notably food allergies and atopic dermatitis, will significantly contribute to revenue streams.

• Geographic Penetration: Increasing adoption in emerging markets, including Asia-Pacific and Latin America, will expand global reach.

• Innovative Administration: Development of subcutaneous auto-injectors and home administration options are expected to enhance patient compliance and market adoption.

Potential Risks and Market Constraints

• Patent Expirations: Although XOLAIR’s patents extend until the late 2020s, biosimilar competition might enter early in some markets, exerting pressure on pricing.

• Regulatory Hurdles: Off-label use and expanding indications require rigorous evidence; delays or rejections could limit growth.

• Cost-Effectiveness Concerns: Payers increasingly scrutinize biologic therapy value, impacting reimbursement and access.

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Strategic Outlook

XOLAIR’s growth trajectory is underpinned by its strong clinical efficacy, a broad patent portfolio, and expanding indications. Future success depends on:

• Sustained investment in clinical research to consolidate existing indications and explore novel uses.
• Strategic partnerships and licensing to penetrate less accessible markets.
• Innovations in delivery systems to improve patient experience and adherence.
• Navigating reimbursement policies to maintain affordability and market access.

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Key Takeaways

• Robust Clinical Pipeline: Ongoing trials continue to support XOLAIR’s efficacy beyond current indications, particularly in pediatric asthma, CSU, and potential atopic conditions.

• Market Position: As a top-tier anti-IgE biologic, XOLAIR maintains dominant market share, supported by its proven safety and efficacy profile.

• Growth Opportunities: Expansion into new indications and geographies, coupled with delivery innovations, promise sustained growth, targeting a $5-6 billion market by 2033.

• Competitive Landscape: Differentiation will increasingly depend on clinical data, pricing strategies, and patient-centric innovations amidst rising biologic competition.

• Challenges: Patent expirations, reimbursement hurdles, and emerging biosimilars require strategic management to mitigate market risks.

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FAQs

1. What are the primary indications for XOLAIR?
XOLAIR is approved for severe allergic asthma, chronic spontaneous urticaria, and, in some regions, nasal polyposis. Ongoing trials may expand its indications to food allergies and atopic dermatitis.

2. How does XOLAIR compare to other biologics for asthma?
XOLAIR directly targets IgE, making it particularly effective in allergic phenotypes. While biologics like benralizumab and dupilumab target eosinophils and cytokine pathways respectively, XOLAIR maintains a niche for allergic asthma management, supported by extensive clinical data.

3. What are the recent developments in its clinical trials?
Recent trials focus on pediatric populations, long-term safety, and potential new indications such as food allergies. Interim data suggest promising efficacy and safety in expanded age groups.

4. What is the outlook for XOLAIR in emerging markets?
Growing asthma prevalence and increasing healthcare infrastructure improve prospects. Price negotiations and biosimilar competition may influence market penetration, but strategic positioning and regional collaborations are expected to facilitate growth.

5. What are the key challenges XOLAIR faces?
Patent expirations, high treatment costs, market competition, and evolving regulatory landscapes pose ongoing challenges, emphasizing the need for continual innovation and strategic adaptation.

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References

1. GlobalData. (2023). "Anti-IgE Therapy Market Report."
2. IQVIA. (2022). "Biologic Drugs Pricing and Reimbursement Trends."
3. EvaluatePharma. (2023). "Biologic Market Forecasts."