Ligelizumab (

INN Inns are generally establishments or buildings where travelers can seek lodging, and usually, food and drink. Inns are typically located in the country or along a highway. Before the advent of motorized transportation, they also provided accomm ...

; development code QGE031) is a humanized IgG1 monoclonal antibody designed for the treatment of severe asthma and

chronic spontaneous urticaria Chronic spontaneous urticaria (CSU) also known as Chronic idiopathic urticaria (CIU) is defined by the presence of wheals, angioedema, or both for more than six weeks. The most common symptoms of chronic spontaneous urticaria are angioedema and hi ...

. It is an anti-IgE that binds to

IGHE Ig epsilon chain C region is a protein that in humans is encoded by the ''IGHE'' gene. Function IGHE (Immunoglobulin Heavy constant Epsilon), (located on chromosome 14 for humans) has been predicted to enable antigen binding activity and immu ...

an acts as an

immunomodulator Immunotherapy or biological therapy is the treatment of disease by activating or suppressing the immune system. Immunotherapies designed to elicit or amplify an immune response are classified as ''activation immunotherapies,'' while immunotherap ...

. It is delivered as a subcutaneous biologic injection. This drug was developed by

Novartis Novartis AG is a Swiss multinational corporation, multinational pharmaceutical company, pharmaceutical corporation based in Basel, Switzerland. Novartis is one of the largest pharmaceutical companies in the world and was the eighth largest by re ...

Pharma AG. Research funded by Novartis Pharma concluded that Ligelizumab was more effective in treating chronic spontaneous urticaria than

omalizumab Omalizumab, sold under the brand name Xolair among others, is an injectable medication to treat severe persistent allergic forms of asthma, nasal polyps, urticaria (hives), and immunoglobulin E-mediated food allergy. Omalizumab is a recombi ...

placebo A placebo ( ) can be roughly defined as a sham medical treatment. Common placebos include inert tablets (like sugar pills), inert injections (like saline), sham surgery, and other procedures. Placebos are used in randomized clinical trials ...

. In 2021, the US

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

ligelizumab a

breakthrough therapy Breakthrough therapy is a United States Food and Drug Administration designation that expedites drug development that was created by Congress under Section 902 of the 9 July 2012 Food and Drug Administration Safety and Innovation Act. The FDA's "b ...

designation for the treatment of patients with

who have an inadequate response to H1-

antihistamine Antihistamines are drugs which treat allergic rhinitis, common cold, influenza, and other allergies. Typically, people take antihistamines as an inexpensive, generic (not patented) drug that can be bought without a prescription and provides ...

treatment. In December 2021, two phase three clinical trials (PEARL 1 and PEARL 2) of ligelizumab in chronic inducible urticaria failed to show superiority versus

and were terminated. In January 2023, a phase three study of ligelizumab in chronic inducible urticaria was terminated after primary endpoints versus

were not achieved. In January 2024, a phase three peanut allergy study for ligelizumab was terminated by Novartis. As of November 2024, the long-term safety and efficacy of ligelizumab in study participants who have completed a ligelizumab Phase III study in food allergy is under investigation.

References

Monoclonal antibodies {{monoclonal-antibody-stub