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An Open-Label study to Evaluate the Long-Term Safety of Daily Oral BCX7353 in subjects with Type I and II Hereditary Angioedema

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Trial Profile

An Open-Label study to Evaluate the Long-Term Safety of Daily Oral BCX7353 in subjects with Type I and II Hereditary Angioedema

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 11 Jun 2025

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At a glance

  • Drugs Berotralstat (Primary)
  • Indications Hereditary angioedema
  • Focus Adverse reactions; Registrational
  • Acronyms APeX-S
  • 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.
  • 12 Feb 2025 According to a BioCryst Pharmaceuticals media release, Infarmed in Portugal has recommended ORLADEYO (berotralstat) for the routine prevention of recurrent attacks of hereditary angioedema (HAE) in eligible patients 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.

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