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A 52-week, Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Study of the Efficacy and Safety of GSK3511294 Adjunctive Therapy in Adult and Adolescent Participants With Severe Uncontrolled Asthma With an Eosinophilic Phenotype

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Trial Profile

A 52-week, Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Study of the Efficacy and Safety of GSK3511294 Adjunctive Therapy in Adult and Adolescent Participants With Severe Uncontrolled Asthma With an Eosinophilic Phenotype

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 19 Jan 2026

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At a glance

  • Drugs Depemokimab (Primary)
  • Indications Asthma
  • Focus Registrational; Therapeutic Use
  • Acronyms SWIFT-2
  • Sponsors GlaxoSmithKline; GlaxoSmithKline Research & Development; GSK

Most Recent Events

  • 06 Jan 2026 According to GSK media release, based on data from SWIFT-1 and 2 and ANCHOR-1 and 2 trials, Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Exdensur (depemokimab) for severe asthma and chronic rhinosinusitis with nasal polyps. It becomes the first and only ultra-long-acting biologic in Japan.
  • 16 Dec 2025 According to GSK media release, company announced that the US Food and Drug Administration (FDA) has approved Exdensur (depemokimab-ulaa) as an add-on maintenance treatment of severe asthma characterised by an eosinophilic phenotype in adult and paediatric patients aged 12 years and older.
  • 12 Dec 2025 According to GSK media release, company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of depemokimab in severe asthma.The European Commission decision on approval is expected in Q1 2026.

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