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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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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: 03 Mar 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

    • 24 Feb 2025 According to a BioCryst Pharmaceuticals media release, company expects to expand ORLADEYO label to children with HAE aged 2 to 11 using oral granule formulation and NDA submission planned this year.
    • 24 Feb 2025 According to a BioCryst Pharmaceuticals media release, data from this trial will be presented at the 2025 American Academy of Allergy, Asthma & Immunology (AAAAI) / World Allergy Organization (WAO) Joint Congress.
    • 24 Feb 2025 Results presented in the BioCryst Pharmaceuticals media release.

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