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A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-arm Study to Investigate the Efficacy and Safety of Subcutaneous Administration of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema

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Trial Profile

A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-arm Study to Investigate the Efficacy and Safety of Subcutaneous Administration of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Oct 2025

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At a glance

  • Drugs Garadacimab (Primary)
  • Indications Hereditary angioedema
  • Focus Registrational; Therapeutic Use
  • Acronyms VANGUARD
  • Sponsors CSL; CSL Behring

Most Recent Events

  • 08 Aug 2025 According to a CSL media release, based on data from the pivotal placebo-controlled Phase 3 VANGUARD , ANDEMBRY (Garadacimab) got regulatory approval in Australia, the United Kingdom (UK), the European Union (EU), Japan, Switzerland, and the United States (US).
  • 08 Aug 2025 According to a CSL media release, based on data from the pivotal placebo-controlled Phase 3 VANGUARD trial, company announced that Health Canada has granted a marketing authorization for ANDEMBRY(garadacimab) for routine prevention of attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.
  • 16 Jun 2025 According to a CSL media release, the company announced that theU.S. Food and Drug Administration (FDA) approved ANDEMBRY for prophylactic use to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. The approval is supported by data from this study.

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