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
- -
The Effect of Omalizumab on Responses to Cat Allergen Challenge
- First Posted Date
- 2008-01-30
- Last Posted Date
- 2017-05-10
- Lead Sponsor
- Johns Hopkins University
- Target Recruit Count
- 18
- Registration Number
- NCT00604786
- Locations
- 🇺🇸
Johns Hopkins Asthma and Allergy Center, Baltimore, Maryland, United States
Omalizumab Use and Asthma-Related Quality of Life in Patients With Severe Persistent Allergic Asthma
- First Posted Date
- 2007-12-05
- Last Posted Date
- 2011-06-30
- Lead Sponsor
- Novartis
- Target Recruit Count
- 116
- Registration Number
- NCT00567476
- Locations
- 🇧🇷
Novartis Investigator Site, São Paulo, Brazil
Therapeutic Utility of Xolair in Patients Undergoing Aspirin Desensitization
- First Posted Date
- 2007-11-09
- Last Posted Date
- 2020-11-03
- Lead Sponsor
- David Lang
- Target Recruit Count
- 16
- Registration Number
- NCT00555971
- Locations
- 🇺🇸
The Cleveland Clinic, Cleveland, Ohio, United States
Safety and Tolerability of Omalizumab in Patients With Mild to Moderate Asthma
- First Posted Date
- 2007-10-18
- Last Posted Date
- 2010-09-02
- Lead Sponsor
- Novartis
- Target Recruit Count
- 32
- Registration Number
- NCT00546143
- Locations
- 🇩🇪
Novartis Investigative Site, Berlin, Germany
🇿🇦Novartis Investigative site, Bloemfontein, South Africa
🇩🇪Novartis investigative site, Mainz, Germany
Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation.
- Conditions
- First Posted Date
- 2007-07-12
- Last Posted Date
- 2011-06-02
- Lead Sponsor
- Novartis
- Target Recruit Count
- 155
- Registration Number
- NCT00500539
- Locations
- 🇺🇸
Kansas City Allergy & Asthma, Overland Park, Kansas, United States
🇺🇸Allergy, Asthma and Clinical Immunology, Brick, New Jersey, United States
🇺🇸Asthma & Allergy Research of NJ, Inc., Mt. Laurel, New Jersey, United States
A Study of Omalizumab in Preventing Bronchoconstriction Following Environmental Cat Dander Exposure in Patients With Cat Dander-induced Asthma
- First Posted Date
- 2007-07-03
- Last Posted Date
- 2017-06-08
- Lead Sponsor
- Genentech, Inc.
- Target Recruit Count
- 69
- Registration Number
- NCT00495612
Safety and Tolerability of Omalizumab in Adults and Adolescents With Severe Allergic Asthma
- Conditions
- First Posted Date
- 2007-06-05
- Last Posted Date
- 2016-11-18
- Lead Sponsor
- Novartis
- Target Recruit Count
- 132
- Registration Number
- NCT00482248
Safety and Tolerability of Omalizumab in Poorly Controlled Moderate to Severe Asthma Patients
- Conditions
- First Posted Date
- 2007-06-05
- Last Posted Date
- 2011-10-25
- Lead Sponsor
- Novartis
- Target Recruit Count
- 95
- Registration Number
- NCT00482508
Efficacy and Safety of Omalizumab in Bullous Pemphigoid
- First Posted Date
- 2007-05-10
- Last Posted Date
- 2012-10-16
- Lead Sponsor
- University of Iowa
- Target Recruit Count
- 2
- Registration Number
- NCT00472030
- Locations
- 🇺🇸
University of Iowa, Department of Dermatology, Iowa City, Iowa, United States
Effect of Omalizumab on Expression of IgE Receptors in Adults With Severe, Inadequately Controlled Allergic Asthma
- First Posted Date
- 2007-03-29
- Last Posted Date
- 2011-08-08
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 31
- Registration Number
- NCT00454051
- Locations
- 🇫🇷
Novartis Investigator site, Rueil-Malmaison, France
Drug Development Updates
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