omalizumab

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Ligands
omalizumab

GtoPdb Ligand ID: 6890

omalizumab is an approved drug (FDA (2003), EMA (2005))

Comment: Omalizumab is an anti-IgE monoclonal antibody that was desigend to target IgE-mediated allergic inflammatory responses.
Annotated peptide sequences for this antibody are available from its IMGT/mAb-DB record.
Peptide sequence analysis reveals that omalizumab is clone e25 in patent US5994511 [8].

Biosimilars:
The EMA approved Celltrion's biosimilar Omlyclo® in May 2024, to treat allergic asthma, chronic rhinosinusitis with nasal polyps and chronic spontaneous urticaria in patients for whom other therapy options have failed to control symptoms.

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View more information in the IUPHAR Pharmacology Education Project: omalizumab

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Summary of Clinical Use
Used to treat moderate to severe IgE-mediated (i.e. allergy triggered) persistent asthma (US) or severe asthma (EU) [6], in adults and children over 12 years old, inadequately controlled by inhaled corticosteroid treatment. In 2014 the US FDA approved use of this drug for the treatment of chronic idiopathic urticaria (CIU, a.k.a. chronic spontaneous urticaria) which is unresponsive to treatment with anti-histamine H₁ receptor drugs. In July 2016, the FDA expanded asthma approval to include children six to 11 years of age, as indicated previously for those 12 years-adult. Omalizumab has also been evaluated for efficacy to provide protection from food-driven allergic reactions or to augment oral desensitisation protocols [1,4-5,7]. In February 2024, it became the first FDA approved drug to reduce the risk of IgE-mediated allergic reactions (including anaphylaxis) to >1 food allergen.

Summary of Clinical Use

Used to treat moderate to severe IgE-mediated (i.e. allergy triggered) persistent asthma (US) or severe asthma (EU) [6], in adults and children over 12 years old, inadequately controlled by inhaled corticosteroid treatment. In 2014 the US FDA approved use of this drug for the treatment of chronic idiopathic urticaria (CIU, a.k.a. chronic spontaneous urticaria) which is unresponsive to treatment with anti-histamine H₁ receptor drugs.
In July 2016, the FDA expanded asthma approval to include children six to 11 years of age, as indicated previously for those 12 years-adult. Omalizumab has also been evaluated for efficacy to provide protection from food-driven allergic reactions or to augment oral desensitisation protocols [1,4-5,7]. In February 2024, it became the first FDA approved drug to reduce the risk of IgE-mediated allergic reactions (including anaphylaxis) to >1 food allergen.

Mechanism Of Action and Pharmacodynamic Effects
Binds to IgE antibodies thereby preventing their binding to, and activation of mast cells and basophils. This action leads to reduced release of mediators of the allergic response.

Mechanism Of Action and Pharmacodynamic Effects

Binds to IgE antibodies thereby preventing their binding to, and activation of mast cells and basophils. This action leads to reduced release of mediators of the allergic response.

Clinical Trials
Clinical Trial ID	Title	Type	Source	Comment	References
NCT06316414	Omalizumab in Severe Asthmatics With Food Allergy	Observational	Bambino Gesù Hospital and Research Institute
NCT04037176	Behandling af Boern Med Foedevareallergi Med Omalizumab (Xolair)	Phase 4 Interventional	Odense University Hospital
NCT01290913	Xolair Enhances Oral Desensitization in Peanut Allergic Patients	Phase 1/Phase 2 Interventional	Boston Children's Hospital
NCT00968110	Xolair Treatment for Milk Allergic Children	Early Phase 1 Interventional	Boston Children's Hospital
NCT03964051	Protection From Food Induced Anaphylaxis by Reducing the Serum Level of Specific IgE (Protana).	Phase 4 Interventional	Odense University Hospital
NCT03881696	Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants	Phase 3 Interventional	National Institute of Allergy and Infectious Diseases (NIAID)	The OUtMATCH study: omalizumab therapy increased the reaction threshold for peanut and other common food allergens compared to placebo.	9