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A Multicentre, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Tezepelumab in Participants With Severe Chronic Rhinosinusitis With Nasal Polyposis (WAYPOINT)

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Trial Profile

A Multicentre, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Tezepelumab in Participants With Severe Chronic Rhinosinusitis With Nasal Polyposis (WAYPOINT)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Nov 2025

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At a glance

  • Drugs Tezepelumab (Primary)
  • Indications Nasal polyps; Rhinosinusitis
  • Focus Registrational; Therapeutic Use
  • Acronyms WAYPOINT
  • Sponsors AstraZeneca; AstraZeneca AB

Most Recent Events

  • 22 Oct 2025 According to AstraZeneca media release, regulatory applications for Tezspire are currently under review in China, Japan and several other countries.
  • 22 Oct 2025 According to AstraZeneca media release, based on the results of this study, AstraZeneca and Amgen's Tezspire (tezepelumab) has been approved in the European Union (EU) as an add-on therapy with intranasal corticosteroids for adult patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) who have not adequately responded to standard therapy (systemic corticosteroids and/or surgery).
  • 17 Oct 2025 According to Amgen media release, company announced that the U.S. Food and Drug Administration (FDA) approved TEZSPIRE (tezepelumab-ekko) for the add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in adult and pediatric patients aged 12 years and older.

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