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
- -
Real-life Evaluation of the Efficacy of Biologicals in Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)
- Conditions
- 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
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
- 2024-07-08
- Lead Sponsor
- Jemincare
- Target Recruit Count
- 60
- Registration Number
- NCT06438757
- Locations
- 🇨🇳
Shanghai General Hospital, Shanghai, Shanghai, China
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
- Interventions
- First Posted Date
- 2023-09-18
- Last Posted Date
- 2024-11-15
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 468
- Registration Number
- NCT06042478
- Locations
- 🇻🇳
Novartis Investigative Site, Hanoi, Vietnam
A Single Dose, Phase 1 Study of YH35324 in Patients with Various Allergic Diseases
- Conditions
- Interventions
- First Posted Date
- 2023-07-27
- Last Posted Date
- 2024-11-22
- Lead Sponsor
- Yuhan Corporation
- Target Recruit Count
- 36
- Registration Number
- NCT05960708
- Locations
- 🇰🇷
Hallym University Sacred Heart Hospital, Anyang-si, Gyeonggi-do, Korea, Republic of
🇰🇷Hallym University Dongtan Sacred Heart Hospital, Hwaseong-si, Gyeonggi-do, Korea, Republic of
🇰🇷CHA Bundang Medical Center, Seongnam-si, Gyeonggi-do, Korea, Republic of
A Multiple Ascending Dose, Phase 1b Study of YH35324 in Atopic Healthy Subjects or Subjects with Allergic Diseases
- Conditions
- Interventions
- First Posted Date
- 2022-10-03
- Last Posted Date
- 2024-12-05
- Lead Sponsor
- Yuhan Corporation
- Target Recruit Count
- 46
- Registration Number
- NCT05564221
- Locations
- 🇰🇷
Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea, Republic of
🇰🇷Nowon Eulji Medical Center, Seoul, Korea, Republic of
🇰🇷Korea University Anam Hospital, Seoul, Korea, Republic of
Study of JYB1904 (an Anti-immunoglobulin E Antibody) in Healthy Chinese Subjects
- First Posted Date
- 2022-07-08
- Last Posted Date
- 2023-06-27
- Lead Sponsor
- Jemincare
- Target Recruit Count
- 56
- Registration Number
- NCT05449535
- Locations
- 🇨🇳
Shulan (Hangzhou) Hospital, Hangzhou, Zhejiang, China
Effectiveness and Safety of Omalizumab in Children With Allergic Asthma.
- First Posted Date
- 2022-06-21
- Last Posted Date
- 2022-07-05
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 200
- Registration Number
- NCT05424523
- Locations
- 🇺🇸
Novartis Investigative Site, East Hanover, New Jersey, United States
Omalizumab Efficacy in Patients With Refractory Nasal Polyps
- First Posted Date
- 2022-06-06
- Last Posted Date
- 2022-06-06
- Lead Sponsor
- Shiraz University of Medical Sciences
- Target Recruit Count
- 2
- Registration Number
- NCT05405478
- Locations
- 🇮🇷
Imam Reza Allergy and Immunology clinic, Shiraz University of Medical Sciences, Shiraz, Fars, Iran, Islamic Republic of
Omalizumab Before Onset of Exacerbations
- Conditions
- Interventions
- First Posted Date
- 2022-04-18
- Last Posted Date
- 2023-03-14
- Lead Sponsor
- Stephen J. Teach, MD, MPH
- Target Recruit Count
- 300
- Registration Number
- NCT05332067
- Locations
- 🇺🇸
Children's National Hospital, Washington, District of Columbia, United States
Drug Development Updates
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