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An Open-label Study to Evaluate the Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema

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Trial Profile

An Open-label Study to Evaluate the Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Aug 2026

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At a glance

  • Drugs Garadacimab (Primary)
  • Indications Hereditary angioedema
  • Focus Adverse reactions; Registrational
  • Sponsors CSL Behring

Most Recent Events

  • 27 Jul 2026 According to a CSL Behring media release, CSL plans to begin submitting filings to health authorities in the first half of the company's fiscal year to support an expanded pediatric indication for ANDEMBRY in children aged 2 to 11 years. Full study results will be presented at an upcoming scientific congress and submitted for publication in a peer-reviewed journal.
  • 27 Jul 2026 Results presented in the CSL Media Release
  • 26 Feb 2025 According to a CSL Behring media release, Swiss Agency for Therapeutic Products (Swissmedic) has granted marketing authorization to ANDEMBRY (garadacimab) for long-term prophylaxis of recurring attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. The approval is based on efficacy and safety data from the pivotal international Phase 3 VANGUARD trial and its open-label extension study.

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