Omalizumab

Generic Name
Omalizumab
Brand Names
Xolair, Omlyclo
Drug Type
Biotech
Chemical Formula
-
CAS Number
242138-07-4
Unique Ingredient Identifier
2P471X1Z11
Background

Omalizumab, manufactured by Genentech, was first FDA approved in 2003 to treat adults and children 12 years of age and older with moderate to severe persistent allergic asthma which is not controlled by inhaled steroids . Since its U.S. approval, more than 200,000 patients older than 12 with allergic asthma have been treated . In September 2018, a new prefil...

Indication

This drug is an anti-IgE antibody indicated for:

Associated Conditions
Chronic Idiopathic Urticaria, Moderate Asthma, Severe Asthma
Associated Therapies
-

Long-Term Study of IGE025 in Moderate to Severe Bronchial Asthma.

Phase 3
Completed
Conditions
First Posted Date
2005-09-22
Last Posted Date
2011-10-25
Lead Sponsor
Novartis
Target Recruit Count
133
Registration Number
NCT00219323
Locations
🇯🇵

This study is not being conducted in the United States, Tokyo, Japan

Effect of Xolair on Airway Hyperresponsiveness

First Posted Date
2005-09-21
Last Posted Date
2011-09-23
Lead Sponsor
Creighton University
Target Recruit Count
22
Registration Number
NCT00208234
Locations
🇺🇸

Creighton University Division of Allergy & Immunology, Omaha, Nebraska, United States

Efficacy of Omalizumab as Add on Therapy for Minority Patients With Moderate to Severe Asthma

Phase 2
Completed
Conditions
Interventions
First Posted Date
2005-09-16
Last Posted Date
2012-02-28
Lead Sponsor
DiMango, Emily, M.D.
Target Recruit Count
18
Registration Number
NCT00180011
Locations
🇺🇸

Columbia University, New York, New York, United States

Effect of Anti-IgE in Non-Allergic Asthma

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2005-09-13
Last Posted Date
2017-08-28
Lead Sponsor
Johns Hopkins University
Target Recruit Count
29
Registration Number
NCT00162773
Locations
🇺🇸

Johns Hopkins Asthma and Allergy Center, Baltimore, Maryland, United States

The Effect of Omalizumab on Airway Responsiveness to Adenosine in Patients With Poorly Controlled Asthma

Phase 4
Completed
Conditions
First Posted Date
2005-08-22
Last Posted Date
2011-09-20
Lead Sponsor
University of Florida
Target Recruit Count
16
Registration Number
NCT00133042
Locations
🇺🇸

University of Florida Asthma Research Lab, Gainesville, Florida, United States

A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab

Phase 2
Completed
Conditions
Interventions
First Posted Date
2005-07-25
Last Posted Date
2016-05-20
Lead Sponsor
University of Utah
Target Recruit Count
30
Registration Number
NCT00123630
Locations
🇺🇸

University of Utah HSC, Salt Lake City, Utah, United States

Omalizumab to Treat Eosinophilic Gastroenteritis

Phase 2
Completed
Conditions
First Posted Date
2004-06-07
Last Posted Date
2017-07-02
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
30
Registration Number
NCT00084097
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Efficacy and Safety of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Inadequately Controlled Allergic Asthma

Phase 3
Completed
Conditions
Interventions
First Posted Date
2004-03-22
Last Posted Date
2012-04-11
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
628
Registration Number
NCT00079937
Locations
🇺🇸

Clinical Research Institute of Southern Oregon, Medford, Oregon, United States

🇺🇸

Family Allergy and Asthma Center, PC, Atlanta, Georgia, United States

🇺🇸

West Penn Allegheny General Health System, Pittsburgh, Pennsylvania, United States

and more 53 locations

Efficacy and Safety of Omalizumab in Patients With Severe Persistent Asthma

Phase 3
Completed
Conditions
First Posted Date
2002-10-04
Last Posted Date
2017-08-02
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
484
Registration Number
NCT00046748
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