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
- -
A Study of Omalizumab in the Prevention of Allergen Induced Airway Obstruction in Adults With Mild Allergic Asthma
- First Posted Date
- 2007-02-13
- Last Posted Date
- 2022-12-14
- Lead Sponsor
- Genentech, Inc.
- Target Recruit Count
- 61
- Registration Number
- NCT00434434
Efficacy/ Safety of Omalizumab in Patients With Seasonal Allergic Asthma and Seasonal Allergic Rhinoconjunctivitis
- First Posted Date
- 2006-11-07
- Last Posted Date
- 2017-03-30
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 128
- Registration Number
- NCT00396409
- Locations
- 🇩🇪
Novartis Investigator site, Nuremberg, Germany
A Study of Xolair in Peanut-Allergic Subjects Previously Enrolled in Study Q2788g
- First Posted Date
- 2006-09-28
- Last Posted Date
- 2009-12-15
- Lead Sponsor
- Genentech, Inc.
- Target Recruit Count
- 10
- Registration Number
- NCT00382148
Immunologic Basis of Anti-IgE Therapy (Study II: On Patients With Asthma)
- Conditions
- Interventions
- First Posted Date
- 2006-08-22
- Last Posted Date
- 2021-07-13
- Lead Sponsor
- University of California, Davis
- Target Recruit Count
- 6
- Registration Number
- NCT00367016
- Locations
- 🇺🇸
UC Davis Department of Dermatology, Sacramento, California, United States
Effect of Ozone on Airway Inflammation in Allergic Asthmatics Treated With Omalizumab
- First Posted Date
- 2006-02-06
- Last Posted Date
- 2009-06-30
- Lead Sponsor
- University of North Carolina, Chapel Hill
- Target Recruit Count
- 1
- Registration Number
- NCT00287378
- Locations
- 🇺🇸
Center for Environmental Medicine, Asthma and Lung Biology at the University of North Carolina, Chapel Hill, North Carolina, United States
Study to Evaluate the Effect of Omalizumab on Improving the Tolerability of Specific Immunotherapy in Patients With Persistent Allergic Asthma
- Conditions
- Interventions
- First Posted Date
- 2005-12-20
- Last Posted Date
- 2016-09-14
- Lead Sponsor
- Novartis
- Target Recruit Count
- 275
- Registration Number
- NCT00267202
- Locations
- 🇺🇸
Novartis, East Hanover, New Jersey, United States
Omalizumab in Adult and Adolescent Patients With Severe Persistent Allergic Asthma
- First Posted Date
- 2005-12-13
- Last Posted Date
- 2018-06-29
- Lead Sponsor
- Novartis
- Target Recruit Count
- 406
- Registration Number
- NCT00264849
A Pilot Study Investigating the Effect of Omalizumab (Xolair) in Work-Related Animal Induced Asthma
- First Posted Date
- 2005-10-20
- Last Posted Date
- 2019-07-10
- Lead Sponsor
- Bernstein Clinical Research Center
- Registration Number
- NCT00242359
Study of Omalizumab in Moderate to Severe Bronchial Asthma
- Conditions
- First Posted Date
- 2005-10-04
- Last Posted Date
- 2011-10-25
- Lead Sponsor
- Novartis
- Target Recruit Count
- 327
- Registration Number
- NCT00232050
Soluble CD23 Expression in Asthma Patients Treated With OMA
- Conditions
- First Posted Date
- 2005-09-26
- Last Posted Date
- 2008-12-01
- Lead Sponsor
- University of Mississippi Medical Center
- Target Recruit Count
- 80
- Registration Number
- NCT00226200
- Locations
- 🇺🇸
University of Mississippi Medical Center, Jackson, Mississippi, United States
Drug Development Updates
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