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A Phase 3 Study of Danicopan (ALXN2040) as Add-on Therapy to a C5 Inhibitor (Eculizumab or Ravulizumab) in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Have Clinically Evident Extravascular Hemolysis (EVH)

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Trial Profile

A Phase 3 Study of Danicopan (ALXN2040) as Add-on Therapy to a C5 Inhibitor (Eculizumab or Ravulizumab) in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Have Clinically Evident Extravascular Hemolysis (EVH)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 May 2025

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At a glance

  • Drugs Danicopan (Primary) ; Eculizumab; Ravulizumab
  • Indications Paroxysmal nocturnal haemoglobinuria
  • Focus Registrational; Therapeutic Use
  • Acronyms ALPHA
  • Sponsors Alexion AstraZeneca Rare Disease

Most Recent Events

  • 04 May 2025 Planned number of patients changed from 84 to 86.
  • 07 Nov 2024 According to an AstraZeneca media release, data from including new analyses from the ALPHA phase 3 trial will be presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition 7 to 10 December 2024.
  • 23 Jul 2024 According to an AstraZeneca media release, Voydeya (danicopan tablets) has been approved in Canada as an add-on to ravulizumab or eculizumab for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have residual hemolytic anemia due to extravascular hemolysis (EVH), The Notice of Compliance issued by Health Canada is based on the results from the pivotal ALPHA Phase III trial.

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