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
-

XOLAIR (Omalizumab) Outcomes in Pediatric Allergic Asthma Patients in the United States

Completed
Conditions
Interventions
First Posted Date
2021-12-14
Last Posted Date
2021-12-16
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
16246
Registration Number
NCT05157087
Locations
🇺🇸

Novartis Investigational Site, East Hanover, New Jersey, United States

A FIH Study of YH35324 in Atopic Healthy Subjects or Subjects with Mild Allergic Diseases

First Posted Date
2021-09-29
Last Posted Date
2024-12-03
Lead Sponsor
Yuhan Corporation
Target Recruit Count
68
Registration Number
NCT05061524
Locations
🇰🇷

Ajou University Hospital, Suwon-si, Gyeonggi-do, Korea, Republic of

🇰🇷

Severance Hospital, Yonsei University Health System, Sinchon-dong, Seoul, Korea, Republic of

🇰🇷

Seoul National University Bundang Hospital, Gumi, Sungnamsi, Korea, Republic of

and more 1 locations

EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients

First Posted Date
2021-08-10
Last Posted Date
2024-08-29
Lead Sponsor
Sanofi
Target Recruit Count
320
Registration Number
NCT04998604
Locations
🇺🇸

Cedars Sinai Medical Center Site Number : 8400026, Los Angeles, California, United States

🇺🇸

Northwell Health Site Number : 8400044, Great Neck, New York, United States

🇺🇸

Cleveland Clinic Foundation Site Number : 8400029, Cleveland, Ohio, United States

and more 92 locations

Gastrointestinal STRING Test With Oral Immunotherapy

First Posted Date
2021-06-29
Last Posted Date
2024-08-01
Lead Sponsor
Stanford University
Target Recruit Count
13
Registration Number
NCT04943744
Locations
🇺🇸

Sean N Parker Center for Allergy and Asthma Research at Stanford University, Palo Alto, California, United States

The Study of Omalizumab (CMAB007 and Xolair) in Healthy Subjects to Compare the PK, PD and Safety

Phase 1
Completed
Conditions
Interventions
First Posted Date
2021-03-02
Last Posted Date
2021-10-11
Lead Sponsor
Taizhou Mabtech Pharmaceutical Co.,Ltd
Target Recruit Count
114
Registration Number
NCT04778137
Locations
🇨🇳

Shanghai Xuhui Central Hospital, Shanghai, Shanghai, China

Molecular Endotypes of Chronic Idiopathic Urticaria

Phase 4
Active, not recruiting
Conditions
Interventions
First Posted Date
2021-03-01
Last Posted Date
2024-08-15
Lead Sponsor
University of Colorado, Denver
Target Recruit Count
15
Registration Number
NCT04774315
Locations
🇺🇸

University of Colorado Anschutz, Aurora, Colorado, United States

Comparing Treatment Efficacy With Mepolizumab and Omalizumab in Severe Asthma - "Choosebetweenamab".

First Posted Date
2020-10-14
Last Posted Date
2020-10-14
Lead Sponsor
University of Newcastle, Australia
Target Recruit Count
200
Registration Number
NCT04585997
Locations
🇦🇺

John Hunter Hospital, New Lambton, New South Wales, Australia

The Efficacy of Preseasonal Omalizumab Treatment

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2020-07-28
Last Posted Date
2021-01-28
Lead Sponsor
Beijing Tongren Hospital
Target Recruit Count
31
Registration Number
NCT04489121
Locations
🇨🇳

Beijing Tongren Hospital, Beijing, Beijing, China

A Study to Assess the Impact of Omalizumab on Exercise Capacity, Physical Activity, and Sleep Quality in Participants With Moderate to Severe Allergic Asthma

Phase 4
Terminated
Conditions
Interventions
First Posted Date
2019-12-12
Last Posted Date
2022-03-15
Lead Sponsor
Genentech, Inc.
Target Recruit Count
3
Registration Number
NCT04195958
Locations
🇺🇸

Swedish Health Services, Seattle, Washington, United States

🇺🇸

Broward Research Center, Pembroke Pines, Florida, United States

🇺🇸

University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States

and more 9 locations

Behandling af Boern Med Foedevareallergi Med Omalizumab (Xolair)

Phase 4
Completed
Conditions
Interventions
First Posted Date
2019-07-30
Last Posted Date
2023-12-05
Lead Sponsor
Carsten Bindslev-Jensen
Target Recruit Count
20
Registration Number
NCT04037176
Locations
🇩🇰

Odense Research Center for Anaphylaxis, Allergy Center, Odense University Hospital, Odense C, Funen, Denmark

© Copyright 2024. All Rights Reserved by MedPath