Ligelizumab

Ligelizumab (INN; development code QGE031) is a humanized IgG1 monoclonal antibody designed for the treatment of severe asthma and chronic spontaneous urticaria.^[1] It is an anti-IgE that binds to IGHE an acts as an immunomodulator.^[2][3] It is delivered as a subcutaneous biologic injection.^[4]

Ligelizumab

Monoclonal antibody
Type	Whole antibody
Source	Humanized (from mouse)
Target	IGHE
Clinical data
Other names	QGE031
ATC code	none
Identifiers
CAS Number	1322627-61-1
ChemSpider	none
UNII	L8LE0L691T
KEGG	D11761
Chemical and physical data
Formula	C6534H10000N1716O2038S44
Molar mass	146612.49 g·mol−1

This drug was developed by Novartis Pharma AG. Research funded by Novartis Pharma concluded that Ligelizumab was more effective in treating chronic spontaneous urticaria than omalizumab or placebo.^[5][6]

In 2021, the US Food and Drug Administration ligelizumab a breakthrough therapy designation for the treatment of patients with chronic spontaneous urticaria who have an inadequate response to H1-antihistamine treatment.^[7]

In December 2021, two phase three clinical trials (PEARL 1 and PEARL 2) of ligelizumab in chronic inducible urticaria failed to show superiority versus omalizumab and were terminated.^[8][9][10]

In January 2023, a phase three study of ligelizumab in chronic inducible urticaria was terminated after primary endpoints versus omalizumab were not achieved.^[11]

In January 2024, a phase three peanut allergy study for ligelizumab was terminated by Novartis.^[12]

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.^[13]