Trial Profile

A PHASE 3 STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETICS OF BEROTRALSTAT PROPHYLAXIS IN CHILDREN WITH HEREDITARY ANGIOEDEMA WHO ARE 2 TO < 12 YEARS OF AGE

Status: Active, no longer recruiting

Phase of Trial: Phase III

Latest Information Update: 02 Sep 2026

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At a glance

25 Aug 2026 According to BioCryst Pharmaceuticals media release, company today announced that Japan's Ministry of Health, Labor and Welfare (MHLW) has granted marketing approval for once-daily ORLADEYO (berotralstat) for prophylactic therapy in pediatric patients with hereditary angioedema (HAE) aged 2 to less than 12 years.
05 Aug 2026 This trial has been completed in Spain, Austria, and Italy.
05 Aug 2026 Planned number of patients changed from 30 to 29.

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