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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: 07 Sep 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

  • 25 Jul 2025 According to a KalVista Pharmaceuticals media release, based on results form this trial the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for sebetralstat, for symptomatic treatment of acute attacks of hereditary angioedema in adults and adolescents aged 12 years and older. The European Commission final decision is expected by early October.
  • 15 Jul 2025 According to a KalVista Pharmaceuticals media release, company announced that the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) has granted marketing authorization for EKTERLY (sebetralstat), based on results from the phase 3 KONFIDENT clinical trial.
  • 07 Jul 2025 According to a KalVista Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has approved EKTERLY (sebetralstat) for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.

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