Omalizumab
- Generic Name
- Omalizumab
- Brand Names
- Xolair, Omlyclo
- Drug Type
- Biotech
- 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
Omalizumab for the Treatment of Food Allergy in Patients With Elevated Total IgE Levels
- First Posted Date
- 2025-04-18
- Last Posted Date
- 2025-05-21
- Lead Sponsor
- Johns Hopkins University
- Target Recruit Count
- 32
- Registration Number
- NCT06934200
- Locations
- 🇺🇸
Johns Hopkins, Baltimore, Maryland, United States
The Effect of Omalizumab on Allergic Rhinitis Symptoms: a Comparative Study
- First Posted Date
- 2025-02-04
- Last Posted Date
- 2025-02-04
- Lead Sponsor
- Yuzuncu Yıl University
- Target Recruit Count
- 50
- Registration Number
- NCT06806826
- Locations
- 🇹🇷
Yuzuncu Yıl üniversity dursun odabaş medical center, VAN, Tuşba, Turkey
Combination Therapy of Omalizumab and Allergen Immunotherapy for Moderate to Severe Asthma
- Conditions
- Allergic Asthma
- Interventions
- Biological: Allergen-specific immunotherapy(AIT)
- First Posted Date
- 2025-01-13
- Last Posted Date
- 2025-01-13
- Lead Sponsor
- Qianfoshan Hospital
- Target Recruit Count
- 60
- Registration Number
- NCT06771934
- Locations
- 🇨🇳
Shandong Provincial Qianfoshan Hospital,The First Affliated Hospital of Shandong First Medical University, Jinan, Shandong, China
Real-life Evaluation of the Efficacy of Biologicals in Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)Chronic Rhinosinusitis (CRS)
- First Posted Date
- 2024-11-11
- Last Posted Date
- 2024-11-11
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Target Recruit Count
- 300
- Registration Number
- NCT06683261
- Locations
- 🇧🇪
Onze Lieve Vrouw hospital Aalst, Aalst, Belgium
🇧🇪General hospital Sint-Jan Bruges, Bruges, Belgium
🇧🇪University hospital Saint-Luc, Bruxelles, Belgium
Effect of Omalizumab in the Skin of Food Allergy Patients
- Conditions
- Food AllergyFood Allergy in Children
- Interventions
- First Posted Date
- 2024-10-01
- Last Posted Date
- 2025-05-02
- Lead Sponsor
- National Jewish Health
- Target Recruit Count
- 40
- Registration Number
- NCT06618963
- Locations
- 🇺🇸
National Jewish Health, Denver, Colorado, United States
Trial of JYB1904 in Chronic Spontaneous Urticaria.
- First Posted Date
- 2024-07-19
- Last Posted Date
- 2024-11-28
- Lead Sponsor
- Jemincare
- Target Recruit Count
- 135
- Registration Number
- NCT06509334
- Locations
- 🇨🇳
Peking University People's Hospital, Beijing, Beijing, China
Trial of JYB1904 in Allergic Asthma
- First Posted Date
- 2024-06-03
- Last Posted Date
- 2025-05-07
- Lead Sponsor
- Jemincare
- Target Recruit Count
- 69
- Registration Number
- NCT06438757
- Locations
- 🇨🇳
Shanghai General Hospital, Shanghai, Shanghai, China
To Compare Efficacy and Safety of CMAB007 and Xolair® in Patients With Chronic Spontaneous Urticaria
- First Posted Date
- 2024-04-15
- Last Posted Date
- 2024-08-02
- Lead Sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd
- Target Recruit Count
- 392
- Registration Number
- NCT06365879
- Locations
- 🇨🇳
Huashan Hospital, Shanghai, China
E-B-FAHF-2, Multi OIT and Xolair for Food Allergy
- Conditions
- Food Allergy
- First Posted Date
- 2023-10-27
- Last Posted Date
- 2024-03-25
- Lead Sponsor
- New York Medical College
- Target Recruit Count
- 33
- Registration Number
- NCT06103656
Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension.
- Conditions
- Chronic Spontaneous Urticaria
- Interventions
- First Posted Date
- 2023-09-18
- Last Posted Date
- 2025-05-06
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 468
- Registration Number
- NCT06042478
- Locations
- 🇻🇳
Novartis Investigative Site, Ho Chi Minh, Vietnam
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.