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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: 23 Jun 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

  • 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.
  • 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.
  • 20 Feb 2025 According to a CSL Behring media release, the company announced that it has received manufacturing and marketing approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for ANDEMBRY (garadacimab) Subcutaneous (S.C.) Injection 200mg Pens. The approval of ANDEMBRY is based on the efficacy and safety data from the pivotal international Phase 3 VANGUARD trial and its open-label extension study.

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