# Off-label applications of omalizumab: Current insights and perspectives

**Authors:** Aleksandra Jaromin, Aleksandra Wardzyńska

PMC · DOI: 10.1016/j.waojou.2025.101156 · The World Allergy Organization Journal · 2025-12-12

## TL;DR

Omalizumab, an anti-IgE drug, is being explored for various allergic conditions beyond its approved uses.

## Contribution

The paper reviews off-label applications of omalizumab, highlighting its potential versatility in treating allergic disorders.

## Key findings

- Omalizumab is approved for allergic asthma, chronic urticaria, and chronic sinusitis with polyps.
- It is being used off-label for conditions like allergic conjunctivitis and systemic mastocytosis.
- The drug's safety and tolerability support its use in a wide range of allergic diseases.

## Abstract

Omalizumab is a humanized monoclonal antibody that binds free IgE. Consequently, it exhibits inhibitory properties against allergic cascades. Over the past 20 years, omalizumab has been in the market, and studies have shown its strong tolerability and safety profile. Since 2003 in the United States of America and 2005 in Europe, omalizumab has been available to patients as a therapeutic option. In Europe, it is registered for the treatment of allergic asthma, chronic spontaneous urticaria, and chronic sinusitis with polyps. In the United States, it has been registered for the treatment of allergic asthma, chronic spontaneous urticaria, and chronic food allergies in children over 1 year of age. With a universal target point for most allergic conditions, omalizumab has the potential to become the most versatile biological drug for allergologists. The literature describes numerous uses of omalizumab as an adjuvant or monotherapy for allergic conjunctivitis, systemic mastocytosis, food allergies, drug hypersensitivity, allergic bronchopulmonary aspergillosis, and allergen immunotherapy, among others. In the following publication, we will provide you with the current knowledge regarding the use of omalizumab in conditions other than those covered by the current product registration.

## Linked entities

- **Proteins:** IGHE (immunoglobulin heavy constant epsilon)
- **Diseases:** allergic asthma (MONDO:0004784), allergic conjunctivitis (MONDO:0005642), systemic mastocytosis (MONDO:0016586), allergic bronchopulmonary aspergillosis (MONDO:0015243)

## Full-text entities

- **Genes:** IGHE (immunoglobulin heavy constant epsilon) [NCBI Gene 3497] {aka IgE}
- **Diseases:** allergic (MESH:D004342), sinusitis (MESH:D012852), polyps (MESH:D011127), systemic mastocytosis (MESH:D034721), urticaria (MESH:D014581), allergic bronchopulmonary aspergillosis (MESH:D001229), asthma (MESH:D001249), allergic conjunctivitis (MESH:D003233), food allergies (MESH:D005512)
- **Chemicals:** Omalizumab (MESH:D000069444)
- **Species:** Homo sapiens (human, species) [taxon 9606]

## Full text

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## Figures

2 figures with captions in the complete paper: https://tomesphere.com/paper/PMC12757523/full.md

## References

66 references — full list in the complete paper: https://tomesphere.com/paper/PMC12757523/full.md

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Source: https://tomesphere.com/paper/PMC12757523