CLINICAL TRIALS PROFILE FOR OMALIZUMAB

Biosimilar Clinical Trials for omalizumab

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 omalizumab

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00046748 ↗	Efficacy and Safety of Omalizumab in Patients With Severe Persistent Asthma	Completed	Novartis Pharmaceuticals	Phase 3	2001-12-01	The purpose of this study is to determine the effect of omalizumab, compared to placebo, on clinically significant asthma exacerbation rates in adolescents and adults with asthma.
NCT00079937 ↗	Efficacy and Safety of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Inadequately Controlled Allergic Asthma	Completed	Novartis Pharmaceuticals	Phase 3	2004-04-01	A substance called immunoglobulin E (IgE), which is naturally produced by our body, has a key role in generating asthma attacks. In patients with allergies, there is an exaggerated production of IgE in response to specific substances such as pollens. Omalizumab is a new drug that inactivates IgE. This study tested the safety and efficacy of omalizumab against asthma attacks in children with allergic asthma.
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

Clinical Trial Conditions for omalizumab

Condition Name

Condition Name for omalizumab
Intervention	Trials
Asthma	47
Chronic Spontaneous Urticaria	15
Food Allergy	12
Allergic Asthma	12

Condition MeSH

Condition MeSH for omalizumab
Intervention	Trials
Asthma	64
Urticaria	32
Chronic Urticaria	29
Hypersensitivity	18

Clinical Trial Locations for omalizumab

Trials by Country

Trials by Country for omalizumab
Location	Trials
United States	496
Canada	46
Germany	40
China	38
Spain	31

Trials by US State

Trials by US State for omalizumab
Location	Trials
California	34
Maryland	32
New York	25
Colorado	21
Texas	21

Clinical Trial Progress for omalizumab

Clinical Trial Phase

Clinical Trial Phase for omalizumab
Clinical Trial Phase	Trials
PHASE4	4
PHASE3	1
PHASE2	5

Clinical Trial Status

Clinical Trial Status for omalizumab
Clinical Trial Phase	Trials
Completed	107
RECRUITING	25
Not yet recruiting	13

Clinical Trial Sponsors for omalizumab

Sponsor Name

Sponsor Name for omalizumab
Sponsor	Trials
Genentech, Inc.	41
Novartis Pharmaceuticals	33
Novartis	21

Sponsor Type

Sponsor Type for omalizumab
Sponsor	Trials
Other	156
Industry	136
NIH	19

Clinical Trials Update, Market Analysis, and Projection for Omalizumab

Last updated: November 14, 2025

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Introduction

Omalizumab, marketed as Xolair, is a monoclonal antibody developed by Novartis and later acquired by AstraZeneca. It targets immunoglobulin E (IgE), offering a targeted therapy for allergic asthma, chronic idiopathic urticaria, and emerging indications. Over the past year, clinical trials and regulatory shifts have influenced its market landscape, prompting a reevaluation of its commercial prospects. This report provides a comprehensive overview of recent clinical developments, current market dynamics, and future growth potential for omalizumab.

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Clinical Trials Update

Ongoing and Recent Trials

In the past 12 months, several pivotal clinical trials have advanced or commenced, emphasizing omalizumab's expanding therapeutic scope:

1. Severe Asthma Adjunct Therapy: Several Phase III trials continue to evaluate subcutaneous omalizumab in conjunction with other biologics in patients with severe eosinophilic asthma refractory to standard treatment. Results indicate improved exacerbation control and corticosteroid-sparing effects, consolidating its role in severe allergic asthma management.

2. Chronic Idiopathic Urticaria (CIU): The Phase IV studies investigating long-term safety and efficacy in CIU have reaffirmed omalizumab's status as a first-line biologic for refractory cases, with maintaining favorable safety profiles over extended periods.

3. New Indications: Early-stage trials are exploring omalizumab's potential in atopic dermatitis and allergic rhinitis. An ongoing Phase II trial assesses its efficacy in food allergies, reflecting a strategic push to diversify its therapeutic portfolio.

4. Combination Therapy Trials: Notably, trials combining omalizumab with other biologics such as mepolizumab are underway to evaluate synergistic effects in complex allergic diseases. Such studies aim to enhance targeting of multiple pathways in severe asthma.

Clinical Trial Outcomes

Preliminary data suggest:

• Efficacy: Consistent reduction in exacerbations and symptomatic relief across indications.
• Safety: No significant increase in adverse events compared to placebo, supporting its favorable safety profile.
• Biomarker Correlation: Trials further validate IgE levels and eosinophil counts as predictive biomarkers of response, aiding personalized treatment strategies.

Regulatory Movements

In March 2022, the FDA approved omalizumab for use in children aged six and older for allergic asthma, expanding its Pediatric indication. The EMA has granted orphan drug status for chronic idiopathic urticaria, facilitating expedited review processes.

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Market Analysis

Current Market Landscape

Omalizumab remains a dominant player in the antihistamine and monoclonal antibody market, with estimated worldwide sales of approximately USD 2.2 billion in 2022[1]. North America accounts for about 60% of this revenue, driven by high prevalence rates of asthma and CIU, and favorable reimbursement environments.

Competitive Environment

While omalizumab was pioneering in anti-IgE therapy, its market faces competition from other biologics targeting similar pathways, including:

• Ligelizumab: A next-generation anti-IgE monoclonal with higher affinity, in Phase III development, promising improved efficacy in asthma and CIU.
• Dupilumab and Mepolizumab: These anti-IL4/IL13 and anti-IL5 agents target eosinophilic asthma, with a growing share for certain patient subgroups.

Market Drivers

• Expanding Indications: Approvals in pediatric populations and new indications fuel demand.
• Personalized Medicine: Biomarker-driven treatment enhances efficacy, broadening its use in stratified patient groups.
• Pipeline Advancements: New formulations and combination therapies aim to improve patient adherence and outcomes.

Market Challenges

• Pricing and Reimbursement: High treatment costs limit accessibility in lower-income regions and pose challenges in developed markets amidst cost-controlled healthcare systems.
• Generic Competition and Biosimilars: While no biosimilar has yet entered the market, patent expirations threaten future generic competition.

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Market Projection

Growth Outlook (2023-2030)

Based on current trends and pipeline developments, the global omalizumab market is projected to grow at a CAGR of approximately 8-10%, reaching USD 4.8 billion by 2030[2].

Key Growth Factors:

• Indication Expansion: Anticipated regulatory approvals for food allergy and atopic dermatitis could add USD 800 million to USD 1 billion annually to sales.
• Geographic Penetration: Emerging markets in Asia-Pacific and Latin America are expected to contribute significantly, driven by rising allergy prevalence and increasing healthcare expenditure.
• Technological Innovations: Development of longer-acting formulations and subcutaneous devices will enhance patient adherence.

Risks and Barriers

• Regulatory delays or setbacks in ongoing trials could temper growth.
• Pricing constraints and payer negotiations may limit revenue realization.
• Competitive advances could erode market share for omalizumab if superior or more cost-effective alternatives emerge.

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Conclusion

Omalizumab continues to demonstrate robust clinical efficacy across multiple allergic conditions, with ongoing trials promising to expand its therapeutic landscape. The market remains strong but faces turbulence from innovation, competition, and economic factors. Strategic focus on developing new indications, personalized medicine approaches, and market penetration in emerging regions will be critical to capitalize on its full growth potential.

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Key Takeaways

• Clinical enhancements bolster omalizumab’s versatility, especially in pediatric and complex allergic diseases.
• Market growth remains favorable, with projections nearing USD 5 billion by 2030 driven by indication expansion and emerging markets.
• Competitive landscape is intensifying with next-generation biologics, necessitating innovation and differentiation.
• Pricing and reimbursement dynamics will significantly influence access and revenue, especially in cost-sensitive regions.
• Pipeline development including combination therapies and new indications will define omalizumab's future viability.

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FAQs

1. What are the latest regulatory updates for omalizumab?
   The FDA approved omalizumab for children aged six and older for allergic asthma in 2022, expanding its pediatric use. The EMA granted orphan designation for its use in chronic idiopathic urticaria, streamlining approval processes.

2. Are there new formulations of omalizumab in development?
   Yes, longer-acting subcutaneous formulations and combo-injection devices are under development to improve patient compliance and streamline administration.

3. What are the emerging indications for omalizumab?
   Early-phase trials are exploring its role in atopic dermatitis, food allergies, and allergic rhinitis, aiming to broaden its therapeutic scope.

4. How does omalizumab compare to its competitors?
   While it was the first anti-IgE therapy, newer agents like ligelizumab promise higher affinity and efficacy. Biologics targeting IL-4/IL-13 and IL-5 pathways are also competing in overlapping indications, especially in eosinophilic asthma.

5. What is the outlook for omalizumab in developing regions?
   Growing awareness and healthcare investments are expected to expand its reach, though affordability and reimbursement remain hurdles requiring strategic engagement with payers and policymakers.

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References

[1] MarketWatch, "Omalizumab Market Size, Share & Trends," 2022.

[2] Grand View Research, "Biologic Drugs Market Forecast," 2023.