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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

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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: 24 Dec 2025

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At a glance

  • Drugs Berotralstat (Primary)
  • Indications Hereditary angioedema
  • Focus Pharmacokinetics; Registrational
  • Acronyms APeX-P
  • Sponsors BioCryst Pharmaceuticals

Most Recent Events

  • 12 Dec 2025 According to a BioCryst Pharmaceuticals media release, company has filed its application for the use of ORLADEYO oral pellets with the European Medicines Agency and the Japan Pharmaceutical and Medical Devices Agency. Additional regulatory filings are planned in other global territories, including Canada.
  • 12 Dec 2025 According to a BioCryst Pharmaceuticals media release, based on positive interim data from this APeX-P trial, the U.S. FDA has approved its New Drug Application (NDA) for the use of an oral pellet formulation of once-daily ORLADEYO (berotralstat) for prophylactic therapy in pediatric patients with hereditary angioedema (HAE). A capsule formulation of ORLADEYO has received approval in December 2020 and is now approved in more than 45 countries around the world.
  • 06 Nov 2025 According to a BioCryst Pharmaceuticals media release, data from this trial to be presented at the Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI), which is taking place in Orlando, Fla. from November 6-10, 2025.

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