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: -

Clinical Trials

Study to Assess the Efficacy and Safety of Omalizumab Treatment on ICS Reduction for Severe IgE-mediated Asthma

Phase 4

Terminated

Conditions: Severe IgE-mediated Asthma

Interventions: Drug: Omalizumab
Drug: Budesonide
Drug: Formoterol

First Posted Date: 2013-07-31

Last Posted Date: 2019-07-02

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 112

Registration Number: NCT01912872

Locations: 🇲🇽
Novartis Investigative Site, Mérida, Yucatán, Mexico

Xolair (Omalizumab) for Treatment of Drug-induced Acute Tubulointerstitial Nephritis (AIN)

Phase 2

Withdrawn

Conditions: Acute Interstitial Nephritis

Interventions: Drug: Omalizumab
Drug: Prednisone

First Posted Date: 2013-07-09

Last Posted Date: 2018-12-06

Lead Sponsor: Mayo Clinic

Registration Number: NCT01893658

Locations: 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States

Peanut Reactivity Reduced by Oral Tolerance in an Anti-IgE Clinical Trial

Phase 1

Completed

Conditions: Peanut Allergy
Food Allergy

Interventions: Drug: placebo
Drug: Omalizumab

First Posted Date: 2013-02-01

Last Posted Date: 2023-02-21

Lead Sponsor: Boston Children's Hospital

Target Recruit Count: 36

Registration Number: NCT01781637

Locations: 🇺🇸
Lurie Children's Hospital, Chicago, Illinois, United States
🇺🇸
Stanford University, Stanford, California, United States
🇺🇸
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

and more 1 locations

Efficacy and Safety of QGE031versus Placebo and Omalizumab in Patients Aged 18-75 Years With Asthma

Phase 2

Completed

Conditions: Asthma

Interventions: Drug: QGE031
Drug: Omalizumab
Drug: Placebo

First Posted Date: 2012-10-30

Last Posted Date: 2017-08-11

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 471

Registration Number: NCT01716754

Locations: 🇬🇧
Novartis Investigative Site, Southampton, United Kingdom

Omalizumab for Lupus

Phase 1

Completed

Conditions: Systemic Lupus Erthematosus
Sjogren's Syndrome

Interventions: Drug: Omalizumab

First Posted Date: 2012-10-29

Last Posted Date: 2022-04-20

Lead Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Target Recruit Count: 17

Registration Number: NCT01716312

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

A Study Evaluating the Efficacy of QGE031 Compared to Omalizumab in Patients With Allergic Asthma

Phase 1

Completed

Conditions: Allergic Asthma

Interventions: Drug: QGE031
Drug: omalizumab
Drug: placebo

First Posted Date: 2012-10-10

Last Posted Date: 2016-04-20

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 37

Registration Number: NCT01703312

Locations: 🇸🇪
Novartis Investigative Site, Stockholm, Sweden

Effect of Omalizumab (Xolair) on Basophils in Patients With Chronic Idiopathic Urticaria

Phase 4

Completed

Conditions: Chronic Urticaria

Interventions: Drug: Omalizumab

First Posted Date: 2012-10-05

Last Posted Date: 2020-12-04

Lead Sponsor: University of Colorado, Denver

Target Recruit Count: 10

Registration Number: NCT01701583

Locations: 🇺🇸
University of Colorado Hospital, Denver, Colorado, United States

Cold Urticaria Treatment With Xolair

Phase 2

Completed

Conditions: Cold Contact Urticaria

Interventions: Drug: Placebo
Drug: Omalizumab

First Posted Date: 2012-04-19

Last Posted Date: 2017-04-07

Lead Sponsor: Charite University, Berlin, Germany

Target Recruit Count: 31

Registration Number: NCT01580592

Locations: 🇩🇪
University Aachen, Aachen, Germany
🇩🇪
Allergie-Centrum-Charité, Charité - Universitätsmedizin Berlin, Berlin, Germany
🇩🇪
Hautklinik Mainz, Mainz, Germany

Omalizumab With Oral Food Immunotherapy With Food Allergies Open Label Safety Study in a Single Center

Phase 1

Completed

Conditions: Immune System Diseases

Interventions: Dietary Supplement: Food proteins
Drug: Omalizumab

First Posted Date: 2012-01-16

Last Posted Date: 2015-12-10

Lead Sponsor: Stanford University

Target Recruit Count: 35

Registration Number: NCT01510626

Locations: 🇺🇸
Stanford University School of Medicine, Stanford, California, United States

Clinical and Biological Effects of Anti-IgE (Omalizumab) in Patients With Bilateral Nasal Polyposis and Asthma

Phase 2

Completed

Conditions: Nasal Polyposis
Asthma

Interventions: Drug: Placebo
Drug: Omalizumab

First Posted Date: 2011-07-13

Last Posted Date: 2011-07-13

Lead Sponsor: University Hospital, Ghent

Target Recruit Count: 23

Registration Number: NCT01393340

Locations: 🇧🇪
University Hospital, Ghent, Ghent, Belgium
🇧🇪
UZ Gasthuisberg, Leuven, Belgium

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

© Copyright 2024. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy