A new study of icatibant in children and teenagers with hereditary angioedema has been launched. The study, which will be in the form of a survey, aims to assess whether 30 mg of subcutaneous icatibant reduces acute hereditary angioedema attacks and their side effects. 

The observational study sponsored by Takeda will recruit 10 participants with the disease aged 2 to 17 years in Japan. The participants will receive the treatment according to their clinic’s standard practice. The side effects of the treatment will be recorded for 3 months.

The primary objective of the study is the number of patients experiencing 1 or more treatment-emergent adverse events. Secondary outcome measures include the time from the onset of an attack to the start of treatment, the time from the first administration of icatibant to the resolution of symptoms, and the duration of the attack.

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The estimated completion date of the study is August 31, 2025.

Read more about icatibant and other treatments for hereditary angioedema

Icatibant, sold under the brand name Firazyr®, is a drug developed for managing acute hereditary angioedema attacks. It is a selective bradykinin B2 receptor antagonist indicated for the treatment of adult patients with hereditary angioedema.

Hereditary angioedema is characterized by the deficiency or dysfunction of component 1 esterase inhibitor (C1-INH), a protease responsible for regulating 3 different cascades. These are the kallikrein-kinin pathway, the complement cascade, and the fibrinolytic system. The primary cause of the clinical manifestations of the disease is the excessive production of bradykinin, which binds to bradykinin B2 receptors on the surface of the vascular endothelium. This promotes vasodilation and the transfer of fluid into tissues, causing swelling.

The disease is caused by a mutation in the SERPING1 gene, which codes for C1-INH and is characterized by recurrent attacks of swelling beginning in childhood.


A survey of icatibant in pediatric participants with hereditary angioedema. ClinicalTrials.gov. August 22, 2022. Accessed August 29, 2022.