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

An Exploratory Study to Assess Multiple Doses of Omalizumab in Patients With Cystic Fibrosis Complicated by Acute Bronchopulmonary Aspergillosis (ABPA)

Phase 4

Terminated

Conditions: Cystic Fibrosis
Allergic Bronchopulmonary Aspergillosis

Interventions: Drug: Placebo
Drug: Omalizumab
Drug: Itraconazole

First Posted Date: 2008-11-10

Last Posted Date: 2011-09-26

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 14

Registration Number: NCT00787917

Locations: 🇬🇧
Novartis Investigator Site, London, United Kingdom

The Effect of Xolair (Omalizumab) on Allergy Blood Cells

Phase 4

Completed

Conditions: Asthma

Interventions: Drug: Placebo
Drug: Omalizumab

First Posted Date: 2008-04-14

Last Posted Date: 2013-10-01

Lead Sponsor: Creighton University

Target Recruit Count: 49

Registration Number: NCT00657891

Locations: 🇺🇸
Creighton University Medical Center, Omaha, Nebraska, United States

The Effect of Omalizumab on Responses to Cat Allergen Challenge

Not Applicable

Completed

Conditions: Allergic Rhinitis

Interventions: Drug: placebo
Drug: omalizumab

First Posted Date: 2008-01-30

Last Posted Date: 2017-05-10

Lead Sponsor: Johns Hopkins University

Target Recruit Count: 18

Registration Number: NCT00604786

Locations: 🇺🇸
Johns Hopkins Asthma and Allergy Center, Baltimore, Maryland, United States

Omalizumab Use and Asthma-Related Quality of Life in Patients With Severe Persistent Allergic Asthma

Phase 4

Completed

Conditions: Asthma

Interventions: Drug: Omalizumab
Drug: Inhaled corticosteroids (ICS)
Drug: Long-acting beta 2-adrenergic agonist (LABA)
Drug: Short-acting beta 2-adrenergic agonist (SABA)

First Posted Date: 2007-12-05

Last Posted Date: 2011-06-30

Lead Sponsor: Novartis

Target Recruit Count: 116

Registration Number: NCT00567476

Locations: 🇧🇷
Novartis Investigator Site, São Paulo, Brazil

Therapeutic Utility of Xolair in Patients Undergoing Aspirin Desensitization

Phase 4

Completed

Conditions: Aspirin Sensitivity

Interventions: Drug: placebo
Drug: Omalizumab

First Posted Date: 2007-11-09

Last Posted Date: 2020-11-03

Lead Sponsor: David Lang

Target Recruit Count: 16

Registration Number: NCT00555971

Locations: 🇺🇸
The Cleveland Clinic, Cleveland, Ohio, United States

Safety and Tolerability of Omalizumab in Patients With Mild to Moderate Asthma

Phase 4

Completed

Conditions: Asthma

Interventions: Drug: Omalizumab

First Posted Date: 2007-10-18

Last Posted Date: 2010-09-02

Lead Sponsor: Novartis

Target Recruit Count: 32

Registration Number: NCT00546143

Locations: 🇩🇪
Novartis Investigative Site, Berlin, Germany
🇿🇦
Novartis Investigative site, Bloemfontein, South Africa
🇩🇪
Novartis investigative site, Mainz, Germany

Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation.

Phase 3

Completed

Conditions: Asthma

First Posted Date: 2007-07-12

Last Posted Date: 2011-06-02

Lead Sponsor: Novartis

Target Recruit Count: 155

Registration Number: NCT00500539

Locations: 🇺🇸
Kansas City Allergy & Asthma, Overland Park, Kansas, United States
🇺🇸
Allergy, Asthma and Clinical Immunology, Brick, New Jersey, United States
🇺🇸
Asthma & Allergy Research of NJ, Inc., Mt. Laurel, New Jersey, United States

and more 26 locations

A Study of Omalizumab in Preventing Bronchoconstriction Following Environmental Cat Dander Exposure in Patients With Cat Dander-induced Asthma

Phase 4

Completed

Conditions: Asthma

Interventions: Drug: Placebo
Drug: Omalizumab

First Posted Date: 2007-07-03

Last Posted Date: 2017-06-08

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 69

Registration Number: NCT00495612

Safety and Tolerability of Omalizumab in Adults and Adolescents With Severe Allergic Asthma

Phase 3

Completed

Conditions: Asthma

First Posted Date: 2007-06-05

Last Posted Date: 2016-11-18

Lead Sponsor: Novartis

Target Recruit Count: 132

Registration Number: NCT00482248

Safety and Tolerability of Omalizumab in Poorly Controlled Moderate to Severe Asthma Patients

Phase 3

Completed

Conditions: Asthma

First Posted Date: 2007-06-05

Last Posted Date: 2011-10-25

Lead Sponsor: Novartis

Target Recruit Count: 95

Registration Number: NCT00482508

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