OMLYCLO
OMLYCLO (omalizumab-igec) is an anti-IgE antibody indicated for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, and chronic spontaneous urticaria. It is also approved for adult and pediatric patients to reduce Type I allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more food allergens. The therapy serves as an add-on maintenance treatment for patients whose symptoms remain inadequately controlled by standard therapies such as inhaled corticosteroids or H1 antihistamines. It is not indicated for the emergency treatment of acute bronchospasm, status asthmaticus, or anaphylaxis.
How OMLYCLO Works
Omalizumab-igec binds to IgE, which inhibits the antibody from binding to the high-affinity IgE receptor (FcεRI) on the surface of mast cells, basophils, and dendritic cells. This process results in the down-regulation of these receptors and, in allergic asthma, inhibits IgE-mediated inflammation by reducing blood and tissue eosinophils and inflammatory mediators. In patients with chronic spontaneous urticaria, the drug lowers free IgE levels and down-regulates IgE receptors, though the exact mechanism for symptom improvement in this specific condition is unknown.
Details
- Status
- Prescription
- First Approved
- 2025-03-07
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
OMLYCLO Approval History
What OMLYCLO Treats
6 indicationsOMLYCLO is approved for 6 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Asthma
- Chronic Rhinosinusitis
- Nasal Polyps
- Food Allergy
- Anaphylaxis
- Chronic Spontaneous Urticaria
OMLYCLO Boxed Warning
ANAPHYLAXIS Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of omalizumab products. Anaphylaxis has occurred as early as after the first dose of omalizumab products, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, initiate Omalizumab-igec therapy in a healthcare setting and closely observe patients for an app...
WARNING: ANAPHYLAXIS Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of omalizumab products. Anaphylaxis has occurred as early as after the first dose of omalizumab products, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, initiate Omalizumab-igec therapy in a healthcare setting and closely observe patients for an appropriate period of time after Omalizumab-igec administration. Health care providers administering Omalizumab-igec should be prepared to manage anaphylaxis which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur. Selection of patients for self-administration of Omalizumab-igec should be based on criteria to mitigate risk from anaphylaxis [see Dosage and Administration (2.6) , Warnings and Precautions (5.1) and Adverse Reactions (6.1 , 6.2) ] . WARNING: ANAPHYLAXIS See full prescribing information for complete boxed warning. Anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of omalizumab products. Anaphylaxis has occurred after the first dose of omalizumab products but also has occurred beyond 1 year after beginning treatment. Initiate Omalizumab-igec therapy in a healthcare setting, closely observe patients for an appropriate period of time after Omalizumab-igec administration and be prepared to manage anaphylaxis which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and have them seek immediate medical care should symptoms occur. Selection of patients for self-administration of Omalizumab-igec should be based on criteria to mitigate risk from anaphylaxis. ( 2.6 , 5.1 , 6.1 , 6.2 )
OMLYCLO Target & Pathway
ProTarget
A cytokine that promotes Th2 immune responses and IgE production. IL-4 drives allergic inflammation in atopic dermatitis and asthma. Blocking IL-4 (often together with IL-13) reduces the type 2 inflammation underlying these conditions.
Pharmacists can substitute OMLYCLO for Xolair without calling the prescriber. This is a lower-cost alternative with no clinically meaningful differences.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
OMLYCLO FDA Label Details
ProIndications & Usage
FDA Label (PDF)Omalizumab-igec is an anti-IgE antibody indicated for: Moderate to severe persistent asthma in adults and pediatric patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment IgE-mediated food allergy in adult and pediatric patients aged 1 year and older for the reduction of allergic reactions (...
WARNING: ANAPHYLAXIS Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of omalizumab products. Anaphylaxis has occurred as early as after the first dose of omalizumab products, but also ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.