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An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900, an Oral Plasma Kallikrein Inhibitor, for On-demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema Type I or II

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Trial Profile

An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900, an Oral Plasma Kallikrein Inhibitor, for On-demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema Type I or II

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 28 Jun 2025

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At a glance

  • Drugs Sebetralstat (Primary)
  • Indications Hereditary angioedema
  • Focus Adverse reactions; Registrational
  • Acronyms KONFIDENT-S
  • Sponsors KalVista Pharmaceuticals

Most Recent Events

  • 16 Jun 2025 Results presented in the Media Release a KalVista Pharmaceuticals.
  • 16 Jun 2025 According to a KalVista Pharmaceuticals media release, new data of interim analysis presented at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025 in Glasgow, United Kingdom that underscores the critical role of effective on-demand (OD) treatment for HAE attacks among patients receiving long-term prophylaxis (LTP).
  • 13 Jun 2025 According to a KalVista Pharmaceuticals media release, announced that the U.S. Food and Drug Administration (FDA) has notified the Company that it will not meet the PDUFA goal date (June 17, 2025) for the New Drug Application (NDA) for sebetralstat due to heavy workload and limited resources. The FDA indicated that it expects to deliver a decision within approximately four weeks.

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