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A Randomized, Double-Blind, Placebo-Controlled, Phase 3, Three-way Crossover Trial to Evaluate the Efficacy and Safety of Two Dose Levels 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

A Randomized, Double-Blind, Placebo-Controlled, Phase 3, Three-way Crossover Trial to Evaluate the Efficacy and Safety of Two Dose Levels 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: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Jun 2025

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At a glance

  • Drugs Sebetralstat (Primary)
  • Indications Hereditary angioedema
  • Focus Registrational; Therapeutic Use
  • Acronyms KONFIDENT
  • Sponsors KalVista Pharmaceuticals

Most Recent Events

  • 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
  • 21 Jan 2025 According to a KalVista Pharmaceuticals media release, based on data from KONFIDENT and KONFIDENT-S studies the company has submitted a New Drug Application (NDA) for sebetralstat to the Agency.
  • 28 Oct 2024 According to a KalVista Pharmaceuticals media release, data from this study presented at the American College of Allergy Asthma and Immunology (ACAAI) taking place in Boston, MA from October 24 - 28, 2024.

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