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 prefilled syringe formulation of this drug was approved by the FDA .
- Indication
This drug is an anti-IgE antibody indicated for:
- Associated Conditions
- Chronic Idiopathic Urticaria, Moderate Asthma, Severe Asthma
- Associated Therapies
- -
Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants
- Conditions
- Peanut AllergyMulti-food Allergy
- Interventions
- Drug: OmalizumabOther: Double-Blind Placebo-Controlled Food Challenge Based TreatmentDrug: Placebo for OmalizumabDrug: Multi-Allergen Oral ImmunotherapyDrug: Placebo for Multi-Allergen Oral Immunotherapy
- First Posted Date
- 2019-03-19
- Last Posted Date
- 2024-10-30
- Target Recruit Count
- 471
- Registration Number
- NCT03881696
- Locations
- 🇺🇸
Massachusetts General Hospital, Department of Medicine: Allergy & Clinical Immunology Unit, Boston, Massachusetts, United States
🇺🇸Emory University School of Medicine: Children's Healthcare of Atlanta Pediatrics, Atlanta, Georgia, United States
🇺🇸Johns Hopkins Children's Center: Department of Allergy & Immunology, Baltimore, Maryland, United States
Clinical Study Using Biologics to Improve Multi OIT Outcomes (COMBINE)
- Conditions
- Peanut AllergyFood AllergyHypersensitivity, FoodPeanut HypersensitivityHypersensitivity
- Interventions
- First Posted Date
- 2018-09-20
- Last Posted Date
- 2024-07-08
- Lead Sponsor
- Stanford University
- Target Recruit Count
- 108
- Registration Number
- NCT03679676
- Locations
- 🇺🇸
University of California San Diego (UCSD), San Diego, California, United States
🇺🇸University of California Los Angeles (UCLA), Los Angeles, California, United States
🇺🇸Sean N. Parker Center for Allergy & Asthma Research at Stanford University, Palo Alto, California, United States
A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.
- Conditions
- Chronic Spontaneous Urticaria
- Interventions
- First Posted Date
- 2018-07-09
- Last Posted Date
- 2025-01-07
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 1078
- Registration Number
- NCT03580356
- Locations
- 🇺🇸
Allervie Clinical Research, Birmingham, Alabama, United States
🇺🇸Medical Resch of Arizona-Div of Allergy Asthma and Immunology, Scottsdale, Arizona, United States
🇺🇸Atria Clinical Research Asthma and Allergy Institute, Little Rock, Arkansas, United States
An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps
- Conditions
- Nasal PolypsChronic Rhinosinusitis
- Interventions
- Drug: OmalizumabDrug: Placebo
- First Posted Date
- 2018-03-27
- Last Posted Date
- 2022-04-04
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 249
- Registration Number
- NCT03478930
- Locations
- 🇺🇸
Jonathan Corren MD, Inc., Los Angeles, California, United States
🇺🇸Brigham and Womens Hospital, Boston, Massachusetts, United States
🇺🇸Vitae Research Center, Miami, Florida, United States
Study of Efficacy and Safety of Omalizumab in Severe Japanese Cedar Pollinosis Adult and Adolescent Patients
- First Posted Date
- 2017-12-12
- Last Posted Date
- 2021-01-05
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 337
- Registration Number
- NCT03369704
- Locations
- 🇯🇵
Novartis Investigative Site, Toshima-Ku, Tokyo, Japan
Study of Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria
- First Posted Date
- 2017-11-01
- Last Posted Date
- 2020-11-04
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 418
- Registration Number
- NCT03328897
- Locations
- 🇨🇳
Novartis Investigative Site, Shanghai, China
A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps
- Conditions
- Nasal PolypsChronic Rhinosinusitis
- Interventions
- Drug: PlaceboDrug: Omalizumab
- First Posted Date
- 2017-09-12
- Last Posted Date
- 2020-03-23
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 138
- Registration Number
- NCT03280550
- Locations
- 🇺🇸
Northwell Health, Great Neck, New York, United States
🇨🇦CHAUQ Hospital St Sacrement, Quebec, Canada
🇨🇦Ottawa Allergy Research Corp, Ottawa, Ontario, Canada
A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitus With Nasal Polyps
- Conditions
- Nasal PolypsChronic Rhinosinusitis
- Interventions
- Drug: PlaceboDrug: Omalizumab
- First Posted Date
- 2017-09-12
- Last Posted Date
- 2020-03-23
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 127
- Registration Number
- NCT03280537
- Locations
- 🇪🇸
Hospital Universitari i Politecnic La Fe de Valencia, Valencia, Spain
🇧🇪UZ Gent, Gent, Belgium
🇵🇱Synexus - Warsaw, Warszawa, Poland
Multi OIT to Test Immune Markers After Minimum Maintenance Dose
- First Posted Date
- 2017-06-08
- Last Posted Date
- 2020-04-20
- Lead Sponsor
- Kari Christine Nadeau, MD PhD
- Target Recruit Count
- 60
- Registration Number
- NCT03181009
- Locations
- 🇺🇸
Sean N. Parker Center for Allergy and Asthma Research at Stanford, Mountain View, California, United States
🇺🇸UCLA, Los Angeles, California, United States
Role of Immunoglobulin E (IgE) Bearing Cells in Chronic Idiopathic Urticaria (CIU)
- First Posted Date
- 2017-04-13
- Last Posted Date
- 2021-06-14
- Lead Sponsor
- Johns Hopkins University
- Target Recruit Count
- 18
- Registration Number
- NCT03111628
- Locations
- 🇺🇸
Johns Hopkins Asthma and Allergy Center, Baltimore, Maryland, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.