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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: 19 Feb 2026

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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

  • 12 Feb 2026 According to a KalVista Pharmaceuticals media release, data from this study at the 2026 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting taking place in Philadelphia, Pennsylvania from February 27 to March 2, 2026.
  • 22 Dec 2025 According to a KalVista Pharmaceuticals media release, based on the data from the trial the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing approval for EKTERLY (sebetralstat), for the treatment of acute attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older. The drug also got approval in Australia, Singapore.
  • 06 Oct 2025 According to a KalVista Pharmaceuticals media release, the data from the trial was presented at the 20th German Allergy Congress in Dusseldorf, Germany from October 2-4, 2025.

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