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Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Dose Levels of BCX7353 as an Oral Treatment for the Prevention of Attacks in Subjects With Hereditary Angioedema

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Trial Profile

Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Dose Levels of BCX7353 as an Oral Treatment for the Prevention of Attacks in Subjects With Hereditary Angioedema

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Jun 2025

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At a glance

  • Drugs Berotralstat (Primary)
  • Indications Hereditary angioedema
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms APeX-2
  • Sponsors BioCryst Pharmaceuticals

Most Recent Events

  • 06 Jun 2025 According to a BioCryst Pharmaceuticals media release, company announced following a positive recommendation from the Zorginstituut Nederland, ORLADEYO (berotralstat) has been approved for the routine prevention of hereditary angioedema (HAE) attacks in patients aged 12 years and older.
  • 18 Nov 2024 According to a BioCryst Pharmaceuticals media release, the Health Services Executive (HSE) in Ireland has recommended ORLADEYO (berotralstat) for the routine prevention of recurrent attacks of hereditary angioedema (HAE) in eligible patients 12 years and older. Till date, ORLADEYO is licensed in 44 countries.
  • 19 Dec 2023 According to a BioCryst Pharmaceuticals media release, the company look forward to share additional real-world evidence at upcoming medical congresses.

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